Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ~~[ ]~~ ☐ NO ~~[X]~~ ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. YES ~~[ ]~~ ☐ NO ~~[X]~~ ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ~~[X]~~ ☒ NO ~~[ ]~~☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES ~~[X]~~ ☒ NO ~~[ ]~~☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ~~[ ]~~☐

Indicate by check mark whether the ~~Registrant~~registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ~~[ ]~~Yes ☐ No ☐

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. Yes ☐ No ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). YES ~~[ ]~~ ☐ NO ~~[X]~~ ☒

~~Prior to November 12, 2020, the Registrant’s common stock was traded on the OTC QB Venture Market.~~ The aggregate market value of the voting stock and non-voting common equity held by non-affiliates of the ~~Registrant,~~registrant as of the last business day of the registrant’s most recently completed second fiscal quarter ended June 30, 2022 was $7,763,391 based onupon the closing price of the ~~shares of~~registrant’s common stock of $0.64 on the ~~OTC QB Venture Market on June 30, 2020, was $19,556,356.~~NASDAQ as of that date.

The number of shares outstanding of the ~~Registrant’s~~registrant’s common stock, $0.0001 par value, as of ~~March 15, 2021~~April 17, 2023 was ~~10,420,380.~~13,971,283.

~~None.~~Portions of the registrant’s Proxy Statement for the 2023Annual Meeting of Stockholders are incorporated herein by reference in Part III of this Annual Report on Form 10-K to the extent stated herein. Such proxy statement will be filed with the Securities and Exchange Commission within 120 days of the registrant’s fiscal year ended December 31, 2022.

Certain statements, other than purely historical information, including estimates, projections, statements relating to our business plans, objectives, and expected operating results, and the assumptions upon which those statements are based, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements generally are identified by the words “believes,” “project,” “expects,” “anticipates,” “estimates,” “intends,” “strategy,” “plan,” “may,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions. We intend such forward-looking statements to be covered by the safe-harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and are including this statement for purposes of complying with those safe-harbor provisions. Forward-looking statements are based on current expectations and assumptions that are subject to risks and uncertainties which may cause actual results to differ materially from the forward-looking statements. Our ability to predict results or the actual effect of future plans or strategies is inherently uncertain. Factors which could have a material adverse effect on our operations and future prospects on a consolidated basis include, but are not limited to: changes in economic conditions, legislative/regulatory changes, availability of capital, interest rates, competition, the impact of the COVID-19 pandemic on our ability to advance our clinical programs and raise additional financing and generally accepted accounting principles. These risks and uncertainties should also be considered in evaluating forward-looking statements and undue reliance should not be placed on such statements. We undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Further information concerning our business, including additional factors that could materially affect our financial results, is included herein and in our other filings with the SEC.

This Amendment No. 2 to Form 10-K (this “Amendment”) amends the Annual Report on Form 10-K for the fiscal year ended December 31, 2020 originally filed on March 30, 2021 (the “Original Filing”) and amended by Amendment No. 1 to 10-K filed on June 21, 2021 (the “Amendment”) by INVO Bioscience, Inc., a Nevada corporation (“INVO Bioscience,” “INVO,” the “Company,” “we,” or “us”). We are filing this Amendment to include management’s definitive conclusion on the effectiveness of our internal control over financial reporting in Item 9A. which was inadvertently omitted from the Report contained in the Original Filing. Except as described above and in the Amendment, no other changes have been made to the Original Filing. The Original Filing continues to speak as of the date of the Original Filing, and we have not updated the disclosures contained therein to reflect any events which occurred at a date subsequent to the filing of the Original Filing. Accordingly, this Amendment should be read in conjunction with our Original Filing and our other filings made the SEC subsequent to the filing of the Form 10-K.

This Annual Report on Form 10-K should be read together and in connection with the other reports that have been filed by us with the SEC for a comprehensive description of our financial condition and operating results. In the interest of disclosure, we have included in this Form 10-K certain material events and developments that have taken place through the date of filing of this Form 10-K with the SEC.

In this Annual Report on Form 10-K, INVO Bioscience, Inc. (INVO Bioscience, Inc., together with its subsidiaries, is referred to in this document as “we”, “us”, “INVO Bioscience”, “INVO,” or the “Company”), incorporates by reference certain information from parts of other documents filed with the Securities and Exchange ~~Commission.~~Commission (“SEC”). The ~~Securities and Exchange Commission~~SEC allows us to disclose important information by referring to it in that manner. Please refer to all such information when reading this Annual Report on Form 10-K. All information is as of December 31, ~~2020~~2022, unless otherwise indicated. For a description of the risk factors affecting or applicable to our business, see “Risk Factors,” below.

We are a ~~medical device~~commercial-stage fertility company ~~focused on~~dedicated to expanding the ~~Assisted Reproductive Technology~~assisted reproductive technology (“ART”) ~~marketplace.~~marketplace by making fertility care accessible and inclusive to people around the world. Our primary mission is to ~~increase access~~implement new medical technologies aimed at increasing the availability of affordable, high-quality, patient-centered fertility care. Our flagship product is INVOcell, a revolutionary medical device that allows fertilization and early embryo development to ~~care and expand fertility treatment and patient care across the globe. Our patented device, the INVOcell, is the first Intravaginal Culture (“IVC”) system in the world used for the~~take place in vivo within the woman’s body. This treatment solution is the world’s first intravaginal culture technique for the incubation of ~~eggs~~oocytes and sperm during fertilization and early embryo development. ~~INVOcell was granted clearance~~This technique, designated as “IVC”, provides patients a more connected and intimate experience at a more affordable cost in comparison to in vitro fertilization (“IVF”), the ~~United States by the U.S. Food & Drug Administration (“FDA”) in November 2015, received the CE mark in October 2019,~~other advanced ART treatment. The IVC procedure can deliver comparable results to IVF and is ~~now positioned to help provide millions of infertile couples across the globe access to~~ a ~~new infertility~~significantly more effective treatment option. We believe this novel device and procedure (the “INVO Procedure”) provides a more natural, safe, effective, efficient and economical fertility treatment compared to current infertility treatments, including in-vitro fertilization (“IVF”) andthan intrauterine insemination (“IUI”). ~~Unlike conventional infertility treatments such as IVF where~~Our commercialization strategy is focused on the eggs and sperm develop into embryos in a laboratory incubator, the INVOcell utilizes the women’s vaginal cavity as the incubator to support a more natural fertilization process. As such, this novel device promotes ~~in vivo~~ ~~conception and early embryo development.~~

~~In both commercial utilization~~opening of INVOcell and in clinical studies, the INVO Procedure has proven to have equivalent pregnancy success and live birth rates as IVF. Additionally, we believe there are emotional benefits with the mother’s participation in fertilization and early embryo development by vaginal incubation compared to that of conventional IVF treatment bydedicated “INVO Centers” offering ~~a more connected and personalized method to achieve pregnancy.~~

For many couples struggling with infertility, access to treatment is often unavailable. Financial challenges (i.e., cost of treatment) and limited availability (or capacity) of fertility medical care are two of the main challenges in the ART marketplace that contribute to a large percentage of untreated patients. Religious, social and cultural roadblocks can also prevent hopeful couples from realizing their dream to have a baby with conventional IVF. We believe INVOcell can address many of the key challenges in the ART market, particularly patient cost and infrastructure capacity constraints. The many benefits to the INVO Solution include:

~~In the second quarter of 2016, the first U.S. baby from~~ the INVOcell and ~~INVO Procedure following FDA clearance was born~~IVC procedure (with three centers in ~~Texas.~~North America now operational) and the acquisition of existing IVF clinics, in addition to continuing to sell our technology solution into existing fertility clinics.

~~We were formed on~~ January ~~5, 2007 under the laws~~and March 2023 Convertible Note and Warrant Financings

In January and March 2023, we sold unsecured convertible notes of the Commonwealth of Massachusetts under the name Bio X Cell, Inc. to acquire the assets of Medelle Corporation (“Medelle”). Dr. Claude Ranoux purchased all of the assets of Medelle, and then he contributed those assets, including four patents relating to the INVOcell technology, to Bio X Cell, Inc. upon its formation in January 2007.

On December 5, 2008, Bio X Cell, Inc., doing business as INVO Bioscience, and each of the shareholders of INVO Bioscience entered into a share exchange agreement and consummated a share exchange with Emy’s Salsa AJI Distribution Company Inc., a Nevada corporation (“Emy’s”). Upon the closing of the share exchange on December 5, 2008, the INVO Bioscience shareholders transferred all of their shares of common stock in INVO Bioscience to Emy’s. In connection with the share exchange, Emy’s changed its name to INVO Bioscience, Inc. and Bio X Cell, Inc. became a wholly owned subsidiary of Emy’s (re-named INVO Bioscience, Inc.).

On November 2, 2015 we were notified by the United States Food & Drug Administration (“FDA”) that the INVOcell and INVO Procedure were granted clearance via the de novo classification (as a Class II device) allowing us to market the INVOcell in the United States. Following this approval, we began marketing and selling INVOcell in many locations across the U.S. We currently have approximately 140 trained clinics or satellite facilities in the U.S. where patients can receive guidance and treatment for the INVO Procedure.

On November 12, 2018, we entered into a U.S. Distribution Agreement (the “Distribution Agreement”) with Ferring International Center S.A. (“Ferring”), which closed on January 14, 2019. At the closing, we received a $5,000,000 license payment upfront from Ferring. Pursuant to the Distribution Agreement, among other things, we granted Ferring an exclusive license in the United States market only, with rights to sublicense under patents related to our proprietary intravaginal culture device (INVOcell™), together with the retention device and any other applicable accessories (collectively, the “Licensed Product”) to market, promote, distribute and sell the Licensed Product with respect to all therapeutic, prophylactic and diagnostic uses of medical devices or pharmaceutical products involving reproductive technology (including infertility treatment) in humans (the “Field”). Ferring is responsible, at its own cost, for all commercialization activities for the Licensed Product in the U.S. market. We retained a limited exception to the exclusive license granted to Ferring allowing us, subject to certain restrictions, to establish up to five clinics that will commercialize INVO cycles in the U.S. This agreement was amended on March 2, 2021 to provide for added flexibility by increasing the number of INVO company-owned clinics initially allowable under the agreement and removing certain geographical requirements. Ferring is obligated to make a second payment to us of $3,000,000 upon procurement of a five (5) day label enhancement from the FDA for the current incubation period for the Licensed Product at least three (3) years prior to the expiration of the term of the license for the Licensed Product and provided further that Ferring has not previously exercised its right to terminate the Distribution Agreement for convenience. In addition, under the terms of a separate Supply Agreement, Ferring is obligated to pay us a specified supply price for each Licensed Product purchased by Ferring for distribution. The Distribution Agreement has an initial term expiring on December 31, 2025 and at the end of the initial term it may be terminated by us if Ferring fails to generate specified minimum revenues to us from the sale of the Licensed Product during the final two years of the initial term. Provided that no such termination occurs at the end of the initial term, thereafter the term of the Distribution Agreement shall automatically be renewed for successive three (3) years terms unless terminated by mutual consent. We retain all commercialization rights for the Licensed Product outside of the United States. See “Amendment to Ferring Distribution Agreement” below regarding Amendment No. 1 to the Distribution Agreement.

In October 2019, we received notice that the INVOcell product received CE Marking. The CE marking (also known as CE mark) is a mandatory conformity mark on many products placed on the single market in the European Economic Area (“EEA”). The CE marking (an acronym for the French “Conformite Europeenne”) certifies that a product has met European Union (“EU”) health, safety and environmental requirements, which ensure consumer safety. It permits us to now commercially distribute INVOcell throughout various countries in the EU provided we comply with local registration requirements that vary by country. We had previously obtained the CE Mark in May 2008, but due to limited resources during that time we let the prior CE Mark lapse. With the re-certification completed, we are now actively marketing INVOcell within the EU.

On March 10, 2021, our wholly owned subsidiary, INVO Centers, LLC (“INVO Centers”), entered into a limited liability company agreement (the “JV LLC Agreement”) with HRCFG, LLC (“HFCRG”) to form a joint venture for the purpose of commercializing our technologies related to our INVOcell and procedure for an in vivo method of vaginal incubation at a dedicated INVO fertility clinic in Birmingham, Alabama. The name of the joint venture LLC is HRCFG INVO, LLC, (the “JV Company”) and the members are INVO Centers and HRCFG. HRCFG’s responsibilities include providing clinical practice expertise perform recruitment functions, provide all necessary training, and provide day-to-day management of the clinic. INVO Centers will provide access to and will be the exclusive provider to the JV Company of the INVOcell and procedure. INVO Centers will also perform all required in vitro fertilization industry specific compliance and accreditation functions and product documentation for product registration. INVOcell will also provide a reasonable amount of funding to the JV Company. In connection with the formation of the JV Company, we provided an initial $30,000 in funding. In connection with such funds, HRCFG issued us a note (the “Note”) under which these funds will be repaid from 30% of JV Company’s operating profit. Interest on such funds accrues at a rate of 1.5%. In addition, promptly upon opening the dedicated INVO Technologies clinic in Birmingham, Alabama, (the “BHAM Clinic”) for business, we will issue to HRCFG 25,000 shares of our common stock. We will issue to HRCFG an additional 25,000 shares of our common stock for each additional INVOcell-based clinic opened for business by the JV Company.

On March 2, 2021, we entered into Amendment No. 1 to Distribution Agreement (the “Amendment”) with Ferring. Pursuant to the Amendment, Ferring agreed to purchase a 2,004 count of product for $501,000 pursuant to the Distribution Agreement in March 2021, at which point the minimum annual target for 2020 set forth in Section 2.4 of the Distribution Agreement will be deemed to be satisfied in full as a result of such purchase. The Amendment provides for added flexibility by increasing the number of INVO company-owned clinics initially allowable under the agreement and removing certain geographical requirements.

On November 23, 2020, we entered into a Distribution Agreement with IDS Medical Systems (“Distributor”) to distribute the INVOcell system to Malaysia under which Distributor was appointed as the exclusive distributor in Malaysia. We can elect to terminate Distributor’s exclusivity upon its failure to meet certain purchase targets, in our sole discretion. The agreement is for a term of three years. We also granted Distributor an exclusive right to the INVO trademarks in Malaysia in connection with the sale of products in Malaysia.

On November 23, 2020, we entered into a separate joint venture agreement with SNS Murni SDN BHD (“SNS Murni”), a company incorporated in Malaysia, to establish an exclusive joint venture in Malaysia to (i) introduce, promote and market our technologies related to the INVOcell and INVO Procedure in dedicated government-owned fertility clinics in Malaysia, and (ii) establish INVO Clinics in Malaysia. The joint venture will be co-managed and owned 50% by each of INVO Bioscience and SNS Murni.

On November 23, 2020, we entered into a joint venture agreement with Ginekaliks Dooel (“Ginekaliks”), a limited liability company incorporated in the Republic of North Macedonia, to establish an exclusive joint venture to (i) commercialize, introduce, promote and market technologies related to the INVOcell and INVO Procedure in North Macedonia, (ii) establish a private healthcare institution to offer the INVO Procedure. The joint venture will be co-managed and owned 50% by each of INVO Bioscience and Ginekaliks.

~~On January 13, 2020, we entered into a joint venture agreement (the “Agreement”) with Medesole Healthcare and Trading Private Limited, India (“Medesole~~”), an Indian corporation that promotes and distributes healthcare technologies, medical equipment and allied services to hospitals, clinics and primary health care centers in India and the Middle East.

Pursuant to the Agreement, Invo Bioscience and Medesole will form a joint venture entity incorporated and registered in India, which will operate under the name Medesole INVO Bioscience India Private Limited (the “JV”). After formation, we will grant to the JV all required licenses for promoting, marketing and selling INVO technology in India. Invo Bioscience and Medesole intend that the JV will open and operate dedicated INVOcell-only clinics in India.

~~The JV will be co-managed and owned 50% by each of INVO Bioscience and Medesole.~~

~~In November 2020, we conducted a public offering of 3,625,000 shares (the “Shares~~”) of our common stock at a price of $3.20 per share. We received approximately $10.1 million after deducting the underwriting discounts and commissions and offering expenses. Concurrent with the initial closing of the offering, our common stock became listed on the Nasdaq Capital Market.

Effective September 24, 2020, INVO Centers, LLC, entered into a Pre-Incorporation and Shareholders Agreement with Francisco Arredondo, MD PLLC (“Arredondo”) and Security Health LLC, a Texas limited liability company (“Ramirez”, and together with INVO and Arredondo, the “Shareholders”) under which the Shareholders will commercialize the INVO Procedure and offer related medical treatments in Mexico. Each party will own one-third of the Mexican incorporated company, Positib Fertility, S.A. de C.V. (the “Mexico Company”). The Mexico Company will acquire the INVOcell product at cost plus any incurred shipping, customs and related fees.

The Mexico Company will operate in Monterrey Nuevo Leon, Mexico and any other cities and places in Mexico as approved by the Mexico Company’s board of directors and Shareholders. In addition, the Shareholders agreed that the Mexico Company will be our exclusive distributor in Mexico. The Shareholders also agreed not to compete directly or indirectly with the Mexico Company in Mexico.

From May 15, 2020 through July 1, 2020, we entered into definitive securities purchase agreements (“Purchase Agreements”) with accredited investors for their purchase of (i) secured convertible notes issued by us in the aggregate original principal amount of ~~$3,494,840~~$410,000 (the ~~“Notes”~~“Convertible Notes”), with a fixed conversion prices of $0.50 (for the $275,000 of January 2023 Notes) and $0.60 (for the $135,000 of March 2023 Notes) and (ii) ~~Unit Purchase Options (“Purchase Options”~~5-year warrants (the “Note Warrants”) to purchase ~~303,623 units (each, a “Unit”), at an exercise price~~387,500 shares of ~~$3.20 per Unit (subject to adjustments), with each Unit exercisable for (A) one share of our common stock and (B) a 5-year warrant (the “Warrants”) to purchase one share of our~~the Company’s common stock at an exercise price of ~~$3.20~~$1.00 (subject to adjustments) (the ~~“Private~~“Note and Warrant Private Placement”). ~~Each purchaser of a Note was issued a 5-year Purchase Option to purchase 0.086875 Units (as adjusted for the Reverse Splits (as defined below) for each dollar of Notes purchased. We received gross~~The proceeds of approximately $3.5 million (of which $3,351,200 was received in cash and $143,640 resulted from cancellation of indebtedness). Tribal Capital Markets, LLC acted as placement agent (the “Placement Agent”) in the Private Placement. We paid the Placement Agent and certain selling agents a cash fee of 8% on a portion of the proceeds for an aggregate amount of $236,000. We also agreed to issue the Placement Agent and the selling agent 5-year warrants to purchase 6,750 shares of our common stock at an exercise price of $3.20. These warrants have the same terms and conditions as the Warrants issued in the Private Placement, except for the different exercise price. We received approximately $2,998,905 in net proceeds from the Private Placement, after deducting Placement Agent fees and selling agent fees payable to the Placement Agent and selling agent, respectively, and investor counsel in connection with the transaction. Wewere used ~~approximately $413,456 in proceeds to repay outstanding 9% promissory notes and we intend to use the remaining proceeds~~ for working capital and general corporate purposes.

~~Pursuant to that certain Form of Secured~~Interest on the Convertible ~~Note entered into in connection with the Purchase Agreement (the “Form of Note”), interest on such~~ Notes accrues at a ~~rates~~rate of ten percent (10%) per annum and is payable at the holder’s option either in cash or in shares of ~~our~~the Company’s common stock at the conversion price ~~of $3.20 (following and subject to adjustment for stock splits, combinations or similar events and anti-dilution provisions, among other adjustments)~~set forth in the Convertible Notes on ~~each of the six and twelve month anniversary of the issuance date and on the maturity dates of November 15, 2021,~~ December ~~22, 2021 and December 30, 2021.~~31, 2023, unless converted earlier.

All amounts ~~of principal and interest~~ due under the Convertible Notes are convertible at any time after the issuance date, in whole or in part (subject to rounding for fractional shares), at the option of the holders into ~~our~~the Company’s common stock at a fixed conversion price ~~of $3.20, which is subject to adjustment~~for the Notes as described above.

Upon any issuance by usthe Company of any of ~~our~~its equity securities in an underwritten offering, including ~~common stock,~~Common Stock, for cash consideration, indebtedness or a combination thereof after the date hereof (a “Subsequent Equity Financing”), each holder ~~of a Note will~~shall have the option to convert the outstanding principal and accrued but unpaid interest of its Convertible Note into the number of fully paid and non-assessable shares of ~~common stock~~securities issued in the Subsequent Equity Financing ~~(“Conversion Securities”)~~ equal to the product of unpaid principal, together with the balance of unpaid and accrued interest and other amounts payable hereunder, ~~multiplied by 1.1,~~ divided by the price per share paid by the investors ~~for~~in the ~~Conversion Securities.~~Subsequent Equity Financing multiplied by 80%, provided however, that any conversion shall only be allowed if the Subsequent Equity Financing conversion price is equal to or greater than the Minimum Price (as defined in the Convertible Notes) including an appropriate allocation any warrants offered.

A Convertible Note may not be converted and shares of common stock may not be issued under the Convertible Notes if, after giving effect to the conversion or issuance, the holder together with its affiliates would beneficially own in excess of 9.99% of ~~our~~the Company’s outstanding ordinary shares.

WeThe Company may prepay the Convertible Notes at any time in whole or in part by paying ~~an amount~~a s sum of money equal to 100% of the principal amount to be redeemed, together with accrued and unpaid interest.

The Company entered into a registration rights agreement with the holders of and of even date with the Convertible Notes (the “Note RRA”). Pursuant to the terms of Note RRA, if the Company determines to register any of its securities, either for its own account or the account of a security holder or holders, other than (i) a registration relating solely to employee benefit plans on Form S-8 (or any successor form) or (ii) a registration relating solely to a Commission Rule 145 transaction on Form S-4 (or any successor form), the Company will include in such registration, and in any underwriting involved therein, the shares underlying the Convertible Notes and Note Warrants delivered pursuant to the Note and Warrant Purchase Agreements, subject to, in the case of an underwritten registration, the discretion of the managing underwriter to reduce any or all piggyback registration shares if in its good faith judgment such inclusion would affect the successful marketing of the underwritten offering.

On February 3, and February 17, 2023, the Company entered into securities purchase agreements (the “February Purchase Agreements”) with accredited investors (the “February Investors”) for the purchase of (i) convertible debentures of the Company in the aggregate original principal amount of $500,000 (the “February Debentures”) for a purchase price of $450,000, (ii) warrants (the “February Warrant”) to purchase 250,000 shares (the “February Warrant Shares”) of the Company’s common stock par value $0.0001 per share (“Common Stock”) at an exercise price of $0.75 per share, and (iii) 83,333 shares of Common Stock (the “February Commitment Shares”) issued as an inducement for issuing the Debentures. The proceeds, net of placement agent and legal fees, are being used for working capital and general corporate purposes.

Pursuant to the February Debentures, interest ~~plus~~on the February Debentures accrues at a ~~prepayment fee~~rate of eight percent (8%) per annum and is payable at maturity, one year from the date of the February Debentures.

All amounts due under the February Debentures are convertible at any time after the issuance date, in whole or in part, at the option of the February Investors into Common Stock at an initial price of $0.52 per share. This conversion price is subject to adjustment for stock splits, combinations or similar events and anti-dilution provisions, among other adjustments and is subject to a floor price.

The Company may prepay the February Debentures at any time in whole or in part by paying a sum of money equal to ~~one percent (1%)~~105% of the principal amount to be ~~repaid.~~redeemed, together with accrued and unpaid interest.

The Notes contain customary events of default including but not limited to: (i) failure to make payments when due; and (ii) bankruptcy or insolvency of the Company. If an event of default occurs, each holder may require us to redeem all orWhile any portion of each February Debenture remains outstanding, if the ~~Notes (including~~Company receives cash proceeds of more than $2,000,000 (the “Minimum Threshold”) in the aggregate from any source or series of related or unrelated sources, the February Investors shall have the right in their sole discretion to require the Company to immediately apply up to 50% of all ~~accrued and unpaid interest thereon), in cash.~~

~~The Notes are secured~~proceeds received by the ~~proceeds from~~Company above the ~~$3,000,000 milestone payment pursuant~~Minimum Threshold to ~~Section 7.2(b) of~~repay the ~~Distribution~~outstanding amounts owed under the February Debentures.

The Company entered into a Registration Rights Agreement ~~dated November 12, 2018 between us and Ferring International Center S.A., after such proceeds are actually received by us from Ferring, all pursuant~~(the “February RRA”) with the February Investor that signed its purchase agreement on February 3, 2023 (the “Feb 3 Investor”). Pursuant to the terms of ~~a Security~~February RRA, the Company has agreed to file with the SEC an initial registration statement on Form S-3 (or Form S-1 if S-3 is not available) covering the resale of all of the securities acquired by the Feb 3 Investor under its February Purchase Agreement. The filing of such initial registration statement is to occur within 90 days of February 3, 2023.

On March 31, 2023, having received notice from the February Investor that signed its purchase agreement on February 17, 2023 (the “Feb 17 Investor”) requesting repayment of its February Debenture, the Company paid the Feb 17 Investor $170,000, including interest and the prepayment premium. After such payment, the principal due the Feb 17 Investor under its debenture was reduced from $200,000 to $39,849.

On April 3, 2023, having received notice from the Feb 3 Investor requesting repayment of its February Debenture, the Company paid the Feb 3 Investor $213,879, including interest and the prepayment premium. After such payment, the principal due the Feb 3 Investor under its debenture was reduced from $300,000 to $100,000.

On February 3, 2023, the Company entered into ~~between~~an equity purchase agreement (the “ELOC”) and registration rights agreement (the “ELOC RRA”) with the Feb 3 Investor pursuant to which the Company has the right, but not the obligation, to direct the Feb 3 Investor to purchase up to $10.0 million (the “Maximum Commitment Amount”) of shares of Common Stock, in multiple tranches. Further, under the ELOC and subject to the Maximum Commitment Amount, the Company has the right, but not the obligation, to submit notices to the Feb 3 Investor to purchase shares of Common Stock (i) in a minimum amount of not less than $25,000 and (ii) in a maximum amount of up to the lesser of (a) $750,000 or (b) 200% of the Company’s average daily trading value of the Common Stock.

Also on February 3, 2023, the Company issued to the Feb 3 Investor 150,000 shares of Common Stock for its commitment to enter into the ELOC.

The obligation of the Feb 3 Investor to purchase shares of Common Stock pursuant to the ELOC ends on the earlier of (i) the date on which the purchases under the ELOC equal the Maximum Commitment Amount, (ii) 24 months after the date of the ELOC (February 3, 2025), (iii) written notice of termination by the Company, (iv) the date that the ELOC RRA is no longer effective after its initial effective date, or (v) the date that the Company commences a voluntary case or any person or entity commences a proceeding against the Company pursuant to or within the meaning of federal or state bankruptcy law, a custodian is appointed for the Company or for all or substantially all of its property, or the Company makes a general assignment for the benefit of its creditors (the “Commitment Period”).

During the Commitment Period, the price that Feb 3 Investor will pay to purchase the shares of Common Stock that it is obligated to purchase under the ELOC shall be 97% of the “market price,” which is defined as the lesser of (i) the lowest closing price of our Common Stock during the 7 trading day-period following the clearance date associated with the applicable put notice from the Company or (ii) the lowest closing bid price of the Common Stock on the principal trading market for the Common Stock (currently, the Nasdaq Capital Market) on the trading day immediately preceding a put date.

Execution of Definitive Agreements to Acquire the Wisconsin Fertility Institute

On March 16, 2023, INVO, through Wood Violet Fertility LLC, a Delaware limited liability company (“Wood Violet”) and wholly owned subsidiary of INVO Centers LLC, a Delaware company (“INVO CTR”) wholly-owned by INVO, entered into binding purchase agreements to acquire Wisconsin Fertility Institute (“Wisconsin Fertility”) for a combined purchase price of $10 million.

The purchase price is payable in four installments of $2.5 million each (which payments may be offset by assumption of certain Wisconsin Fertility liabilities, payable at closing and on each of the subsequent three anniversaries of closing. The sellers have the option to take all or a portion of the final three installments in shares of INVO common stock valued at $6.25, $9.09, and $14.29, for the second, third, and final installments, respectively.

Wisconsin Fertility is comprised of (a) a medical practice, Wisconsin Fertility and Reproductive Surgery Associates, S.C., a Wisconsin professional service corporation d/b/a Wisconsin Fertility Institute (“WFRSA”), and (b) a laboratory services company, Fertility Labs of Wisconsin, LLC, a Wisconsin limited liability company (“FLOW”). WFRSA owns, operates and manages the Clinic’s fertility practice that provides direct treatment to patients focused on fertility, gynecology and obstetrics care and surgical procedures, and employs physicians and other healthcare providers to deliver such services and procedures. FLOW provides WFRSA with related laboratory services.

On March 23, 2023, INVO entered into a securities purchase agreement (the “March Purchase Agreement”) with a certain institutional investor, pursuant to which the Company agreed to issue and sell to such investor (i) in a registered direct offering, 1,380,000 shares (the “March Shares”) of Common Stock, and pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 2,300,000 shares of Common Stock, at an exercise price of $0.01 per share, and (ii) in a concurrent private placement, common stock purchase warrants (the “March Warrants”), exercisable for an aggregate of up to 5,520,000 shares of Common Stock, at an exercise price of $0.63 per share. The securities to be issued in the registered direct offering (priced at the marked under Nasdaq rules) were offered pursuant to the Company’s shelf registration statement on Form S-3 (File 333-255096) (the “Shelf Registration Statement”), initially filed by the Company with the SEC under the Securities Act of 1933, as amended (the “Securities Act”), on April 7, 2021 and declared effective on April 16, 2021. The Pre-Funded Warrants are exercisable upon issuance and will remain exercisable until all of the Pre-Funded Warrants are exercised in full.

On March 27, 2023, the Company closed the offering, raising gross proceeds of approximately $3 million before deducting placement agent fees and other offering expenses payable by the Company. In the event that all March Warrants are exercised for cash, the Company would receive additional gross proceeds of approximately $3.5 million. Under the March Purchase Agreement, the Company may use a portion of the net proceeds of the offering to (a) repay February Debentures, and (b) to pay the down payment for Wisconsin Fertility acquisition. The remainder of the net proceeds will be used for working capital, capital expenditures, and other general corporate purposes.

Under the March Purchase Agreement, the Company is required within 30 days of the closing date of the offering to file a registration statement on Form S-1 (the “Resale Registration Statement”) registering the resale of the shares of Common Stock issuable upon the exercise of the March Warrants. The Company is required to use commercially reasonable efforts to cause such registration to become effective within 75 days of the closing date of the offering (or 120 days if the registration statement is subject to a full-review by the SEC), and to keep such registration statement effective at all times until no March Warrants remain outstanding.

In addition, pursuant to certain “lock-up” agreements, our officers and directors have agreed, for a period of 180 days from the date of the offering, not to engage in any of the following, whether directly or indirectly, without the consent of the March Purchase Agreement investor: offer to sell, sell, contract to sell pledge, grant, lend, or otherwise transfer or dispose of our common stock or any securities convertible into or exercisable or exchangeable for Common Stock (the “Lock-Up Securities”); enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the Lock-Up Securities; make any demand for or exercise any right or cause to be filed a registration statement, including any amendments thereto, with respect to the registration of any Lock-Up Securities; enter into any transaction, swap, hedge, or other arrangement relating to any Lock-Up Securities subject to customary exceptions; or publicly disclose the intention to do any of the foregoing.

On November 23, 2022, we received notice (the “Stockholders’ Equity Notice”) from The Nasdaq Stock Market LLC (“Nasdaq”) advising us that we were not in compliance with the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1) requires companies listed on The Nasdaq Capital Market to maintain stockholders’ equity of at least $2,500,000 (the “Stockholders’ Equity Requirement). In our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, we reported stockholders’ equity of $1,287,224, which is below the Stockholders’ Equity Requirement for continued listing. Additionally, as of the date of the Notice, we did not meet either of the alternative Nasdaq continued listing standards under the Nasdaq Listing Rules, market value of listed securities of at least $35 million, or net income of $500,000 from continuing operations in the most recently completed fiscal year, or in two of the three most recently completed fiscal years.

The Notice has no immediate effect on the listing of our common stock and our common stock continues to trade on The Nasdaq Capital Market under the symbol “INVO” subject to our compliance with the other continued listing requirements.

Pursuant to the Notice, Nasdaq gave us 45 calendar days, or until January 7, 2023, to submit to Nasdaq a plan to regain compliance. If our plan is accepted, Nasdaq may grant an extension of up to 180 calendar days from the date of the Notice to evidence compliance.

On January 18, 2023, we received a letter from Nasdaq under which it stated that based on our submission that Nasdaq has determined to grant us an extension of time to regain compliance with Nasdaq Listing Rule 5550(b) until May 22, 2023. We must furnish to the SEC and Nasdaq a publicly available report (e.g. a Form 8-K) which report, among other things, includes a description of the completed transaction or event that enabled us to satisfy the stockholders’ equity requirement for continued listing After filing the publicly available report described above, if we fail to evidence compliance upon filing its periodic report for the June 30, 2023, with the SEC and Nasdaq, we may be subject to delisting. In the event we do not satisfy these terms, Nasdaq will provide written notification that its securities will be delisted. At that time, we may appeal Nasdaq’s determination to a Hearings Panel.

On January 11, 2023, we received a letter from the staff (the “Staff”) of Nasdaq listing qualifications group indicating that, based upon the closing bid price of our common stock for the last 30 consecutive business days, we were not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing under Nasdaq Listing Rule 5550(a)(2).

The notice has no immediate effect on the listing of our common stock, and our common stock will continue to trade on The Nasdaq Capital Market under the symbol “INVO.”

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been provided an initial period of 180 calendar days, or until July 10, 2023, to regain compliance with the minimum bid price requirement. If at any time before July 10, 2023, the closing bid price of our common stock closes at or above $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification that we have achieved compliance with the minimum bid price requirement, and the ~~noteholders~~matter would be resolved. If we do not regain compliance prior to July 10, 2023, then Nasdaq may grant us a second 180 calendar day period to regain compliance, provided we (i) meets the continued listing requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than the minimum closing bid price requirement, and (ii) notifies Nasdaq of its intent to cure the deficiency within such second 180 calendar day period, by effecting a reverse stock split, if necessary.

We will continue to monitor the closing bid price of our common stock and will consider implementing available options to regain compliance with the minimum bid price requirement under the ~~Purchase Agreements. As of March 30, 2021, $2,994,840 in Note principal has been converted into common shares.~~Nasdaq Listing Rules. If we do not regain compliance with the minimum bid price requirement within the allotted compliance periods, we will receive a written notification from Nasdaq that its securities are subject to delisting. We would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that we will regain compliance during either compliance period, or maintain compliance with the other Nasdaq listing requirements.

On November 12, 2020, we entered into an underwriting agreement (the “Underwriting Agreement”) with Roth Capital Partners, LLC, as representative of the several underwriters (the “Underwriters”), in connection with our public offering (the “Offering”) of 3,625,000 shares of common stock at a public offering price of $3.20 per share. The initial closing of the Offering for 3,625,000 shares of common stock took place on November 17, 2020. On November 18, 2020, the Underwriters exercised their option pursuant to the Underwriting Agreement to purchase an additional 528,750 shares of common stock (the “Option Shares”). The closing for the Option Shares took place on November 20, 2020 for which we received approximately $1.52 million in net proceeds after deducting underwriting discounts and commissions. With the exercise of the option to purchase the Option Shares, the total amount of shares of common stock sold in the Offering was 4,153,750 shares, we received aggregate net proceeds of approximately $11.8 million after deducting underwriting discounts and commissions and offering expenses.Operations

On December 16, 2019, our stockholders approved a reverse stock split at a ratio of between 1-for 5 and 1-for-25, with discretion for the exact ratio to be approved by our board of directors. On February 19, 2020, our board of directors approved a reverse stock split of the our common stock at a ratio of 1-for-20. On May 21, 2020, we filed a certificate of change (with an effective date of May 26, 2020) with the Nevada Secretary of State pursuant to Nevada Revised Statutes 78.209 to effectuate a 1-for-20 reverse stock split of our outstanding common stock. On May 22, 2020, we received notice from FINRA/OTC Corporate Actions that the reverse split would take effect at the open of business on May 26, 2020 and the reverse stock split took effect on that date.

On October 22, 2020, our board of directors approved a reverse stock split of our common stock at a ratio of 5-for-8 and also approved a proportionate decrease in our authorized common stock to 125,000,000 shares from 200,000,000. Pursuant to Nevada Revised Statutes, a company may effect a reverse split without stockholder approval if both the number of authorized shares of common stock and the number of outstanding shares of common stock are proportionally reduced as a result of the reverse split, the reverse split does not adversely affect any other class of stock of the company, and the company does not pay money or issue scrip to stockholders who would otherwise be entitled to receive a fractional share as a result of the reverse split. On November 5, 2020, we filed a certificate of change with the Nevada Secretary of State (with an effective date of November 9, 2020) pursuant to Nevada Revised Statutes 78.209 to (i) decrease the number of authorized shares of common stock from 200,000,000 to 125,000,000 shares and (ii) effectuate a 5-for-8 reverse stock split of the outstanding common stock. On November 6, 2020, we received notice from FINRA/OTC Corporate Actions that the reverse split would take effect at the open of business on November 9, 2020 and the reverse stock split took effect on that date.

~~Our product, the INVOcell®, is the first~~ ~~in vivo~~ Intravaginal Culture (“IVC”) system granted FDA clearance in the United States. This novel device and procedure provide a natural, safe, effective, efficient and economical fertility treatment option for patients. The patented INVOcell device is used for the incubation of eggs and sperm during fertilization and early embryo development. Unlike conventional infertility treatments such as IVF where the eggs and sperm develop into embryos in a laboratory incubator, the INVOcell utilizes the women’s vagina as an incubator to support a more natural fertilization and embryo development environment, and infertility treatment. The device promotes ~~in vivo~~ ~~conception for early embryo development. In clinical studies, the INVO Procedure produced equivalent efficacy, safety and pregnancy rates to conventional IVF treatments.~~

~~The~~ ~~INVOcell Culture Device~~ is used in preparing, holding, and transferring human gametes or embryos during In Vitro Fertilization/Intravaginal Culture and Intra-cytoplasmic Sperm Injection Fertilization/Intravaginal Culture procedures. The INVOcell Culture Device is positioned in the INVOcell Retention Device prior to placement in the patient’s vaginal cavity.

~~The~~ ~~INVOcell Retention Device~~ is used in conjunction with the INVOcell Culture Device to aid in retention of the INVOcell Device in the vaginal cavity during the incubation period. The INVOcell Culture Device is positioned in the INVOcell Retention Device prior to placement in the patient’s vaginal cavity.

During an INVO Procedure, the patient undergoes an ovarian stimulation cycle. Once the eggs are retrieved and sperm is collected, they are placed into the single use INVOcell device. Sperm collection and preparation generally occur before egg retrieval. Culture medium (~1ml) is placed in the inner vessel of the INVOcell. Eggs and a low concentration of motile sperm are placed into the medium and the inner vessel is closed and secured in the protective outer vessel. The INVOcell device is then immediately positioned in the upper vaginal cavity for incubation, where natural fertilization and early development of the embryos take place for a period of 3-5 days. A retention system can be used to maintain the INVOcell system in the vagina during the incubation period. The retention system consists of a diaphragm type device with holes in the membrane to allow natural elimination of vaginal secretions. The INVOcell is designed so that no vaginal fluids penetrate the outer vessel thus ensuring that the inner vessel is not contaminated while allowing the necessary CO2 for fertilization to pass through.

After the three (3) to five (5) day incubation period, the patient returns to the physician’s office where the retention system and the INVOcell are removed. The protective outer vessel is discarded and the contents of the inner vessel are placed into a petri plate an embryologist can evaluate the best embryos for transfer. A trained clinician can readily identify the best embryos for transfer. The embryos to be transferred are aspirated into a standard transfer catheter for transfer into the patient’s uterus. The INVO Procedure can be performed in a physician’s office furnished with the necessary equipment.

We operate with a core internal team and outsource certain operational functions in order to help accelerate our efforts as well as reduce internal fixed overhead needs and in-house capital equipment requirements. Our most critical management and leadership functions are carried out by our core management team. We have contracted out the manufacturing, packaging/labeling and sterilization of the device to a contract medical manufacturing company that completes final product manufacturing as well as manages the gamma sterilization process at ~~an FDA~~a U.S. Food and Drug Administration (“FDA”) registered contract sterilization facility.

As of December 31, 2022, we ~~have completed a series of important steps in the development~~had fifteen full time and ~~manufacturing of the INVOcell:~~one part time employee. We also engage consultants to further support our operations.

The global ~~Assisted Reproductive Technology (“ART”)~~ART marketplace is a large, multi-billion industry growing at a strong pace in many parts of the world as increased infertility rates, increased patient awareness, acceptance of treatment options, and improving financial incentives ~~(insurance etc.) continues~~such as insurance and governmental assistance continue to drive demand. According to the European Society for Human Reproduction 2020 ART Fact Sheet, one in six couples worldwide experience infertility problems. Additionally, the worldwide market remains vastly underserved as a ~~very~~ high percentage of patients ~~(worldwide)~~ in need of care continue to go untreated each ~~year. The industry also remains~~year for many reasons, but key among them are capacity ~~constrained thereby creating challenges in providing access to care to the volume of patients in need. According to the~~ ~~European Society for Human Reproduction~~ ~~(“ESHRE”) 2018 ART Fact Sheet, there were more than 150 million infertile couples in the world.~~constraints and cost barriers. While there have been large increases in the use of ~~in-vitro fertilization (“IVF”),~~IVF, there are still only ~~~2.5~~approximately 2.6 million ART cycles, including IVF, ~~intra uterine insemination (“IUI”)~~IUI and other fertility treatments, ~~are now~~ performed globally each year, producing around ~~~550,000~~500,000 babies. This amounts to less than 3% of the infertile couples worldwide being treated and only 1% having a child though IVF. The industry remains capacity constrained which creates challenges in providing access to care to the volume of patients in need. A survey by “~~Resolve:~~“Resolve: The National Infertility Association,,” indicates the two main reasons couples do not use IVF is cost and geographical availability (and/or capacity).

In the United States, infertility, according to the American Society of Reproductive Medicine ~~(“ASRM”)~~ (2017), affects an estimated 10%-15% of the couples of ~~childbearing age.~~childbearing-age. According to the Centers for Disease Control (“CDC”), there are approximately 6.7 million women with impaired fertility. Based on preliminary ~~2018~~2020 data from the CDC’s National ART Surveillance System, approximately ~~306,000~~326,000 IVF cycles were performed at ~~456~~449 IVF centers, leaving the U.S. with a large, underserved patient ~~market,~~population, similar to most ~~other~~ markets around the world.

We believe that the ~~use~~INVOcell, and the IVC procedure it enables, have the following key advantages:

Lower cost than IVF with equivalent efficacy. The IVC procedure can be offered for less than IVF due to lower cost of supplies, labor, capital equipment and general overhead. The laboratory equipment needed to perform an IVF cycle is ~~still relatively rare,~~expensive and requires ongoing costs as compared to ~~demand,~~what is required for an IVC cycle. As a result, we also believe INVOcell and the IVC procedure enable a clinic and its ~~use has doubled over~~laboratory to be more efficient as compared to conventional IVF.

The IVC procedure is currently being offered at several IVF clinics at a price range of $5,000 - $11,000 per cycle and from $4,500 to $7,000 at the ~~past decade. Today approximately 1.7%~~existing INVO Centers, thereby making it more affordable than conventional IVF (which tends to average $12,000 to $17,000 per cycle or higher).

Improved efficiency providing for greater capacity and improved access to care and geographic availability. In many parts of the ~~infants born in~~world, including the ~~United States every year are conceived through IVF.~~

IVF has long been, and continues to be, a standard (and effective) treatment option for many infertile couples. At the same time, the industry remains capacity constrained as there are a limited number ofU.S., IVF clinics ~~(e.g., a limited number of doctors, embryologists, lab incubators, lab space, etc.), which~~ tend to be concentrated in higher population ~~areas all~~centers and are often capacity constrained in terms of ~~which helps contribute~~how many patients a center can treat, with volume often limited by the number of capital-intensive incubators available in IVF clinic labs. With the significant number of untreated patients along with the growing interest and demand for services, the industry remains challenged to ~~keeping the cost of service and~~provide sufficient access to care ~~out~~and to do so at an economical price. We believe INVOcell, and the IVC procedure it enables, can play a significant role in helping to address these challenges. According to the 2020 CDC Report, there are approximately 449 IVF centers in the U.S. We estimate that by adopting the INVOcell, IVF clinics can increase fertility cycle volume by up to 30% without adding to personnel, space and/or equipment costs. Our own INVO Centers also address capacity constraints by adding to the overall ART cycle capacity and doing so with comparable efficacy to IVF outcomes as well as at a lower per cycle price. Moreover, we believe that we are uniquely positioned to drive more significant growth in fertility treatment capacity in the future by partnering with existing OB/GYN practices. In the U.S., there are an estimated 5,000 OB/GYN offices, many of ~~reach~~which offer fertility services (usually limited to consultation and IUI, but not IVF). Since the IVC procedure requires a much smaller lab facility, less equipment, and fewer lab personnel (in comparison to conventional IVF), it could potentially be offered as an extended service in an OB/GYN office. With proper training and a lighter lab infrastructure, the INVOcell could expand the business for ~~many~~these physicians and allow them to treat patients that are unable to afford IVF and provide patients with a more readily accessible, convenient, and cost-effective solution. With our three-pronged strategy (IVF clinics, INVO Centers and OB/GYN practices), in addition to lowering costs, we believe INVOcell and the IVC procedure can address our industry’s key challenges, capacity and cost, by their ability to expand and decentralize treatment and increase the number of points of care for patients in need. ~~Our patented~~This powerful combination of lower cost and ~~proven INVOcell technology is a unique, effective, efficient and low cost fertility treatment that offers a more natural option compared~~added capacity has the potential to IVF. The procedure can also be provided without a more expensive IVF center and therefore can potentially be available in many more locations. Thus, we believe we are well positioned to capture a significant share of this unmet market and helpdramatically open up access to care for patients around the world.

Greater patient involvement. With the IVC procedure, the patient uses their own body for fertilization, incubation and early embryo development which creates a greater sense of involvement, comfort and participation. In some cases, this may also free people from barriers related to ~~those millions~~ethical or religious concerns, or fears of laboratory mix-ups.

Our approach to market is focused on identifying partners within targeted geographic regions that we believe can best support our efforts to expand access to advanced fertility treatment for the large number of underserved infertile ~~couples that go untreated each year.~~

people hoping to have a baby. We believe that the INVOcell-based IVC procedure is an effective and affordable treatment option that greatly reduces the need for more expensive IVF lab facilities and allows providers to pass on related savings to patients without compromising efficacy. We have been cleared to sell the INVOcell in the United States since November 2015 after receiving de novo class II clearance from the FDA. Our primary focus over the past two years has been on establishing INVO Centers in the U.S. and abroad to promote the INVOcell and the IVC procedure and acquiring existing U.S.-based IVF clinics where we can integrate the INVOcell. While we continue selling the INVOcell directly to IVF clinics and via distributors and other partners around the world, we have transitioned INVO from being a medical device company to one that is mostly focused on providing fertility services.

On November 12, 2018, we entered into a U.S. Distribution Agreement (the “Ferring Agreement”) with Ferring International Center S.A. (“Ferring”), which became effective on January 14, 2019. Pursuant to the Ferring Agreement, among other things, we granted Ferring an exclusive license in the United States to market, promote, distribute, and sell the INVOcell. Ferring was responsible, at its own cost, for all commercialization activities for in the United States. We retained a limited exception to the exclusive license granted to Ferring allowing us, subject to certain restrictions, to establish up to five INVO Centers in the United States, which as of March 2, 2021, was amended to seven centers. We retained all commercialization rights for the INVOcell outside of the United States.

On November 2, 2021, Ferring notified us of its intention to terminate the Ferring Agreement, which required 90-days prior written notice. Accordingly, the Ferring Agreement officially terminated on January 31, 2022. Pursuant to the terms of the Ferring Agreement, upon notice of termination, Ferring was required to use commercially reasonable efforts to transition any customers to us and otherwise facilitate the orderly transition of the distribution from Ferring to us. By its terms, our ~~Distribution~~Supply Agreement with Ferring also terminated on January 31, 2022.

The Ferring license was deemed to be a functional license that provides the counterparty with a ~~significant opportunity~~“right to ~~accelerate~~access” to our ~~goal~~intellectual property during the subscription period and accordingly, revenue is recognized over a period of ~~expanding INVOcell’s usage~~time, which is generally the subscription period. The likelihood of Ferring exercising its rights became remote at the time notice of termination was received, therefore INVO recognized the full remaining amount of the deferred revenue in the fourth quarter of fiscal year 2021. During the years ended December 31, 2022, and ~~help~~2021, we recognized nil and $3.6 million of revenue related to ~~solve~~ the ~~industry’s key challenges by~~Ferring license agreement, respectively, and, as of December 31, 2022, we had no deferred revenue related to the Ferring Agreement.

We have entered into exclusive distribution agreements for a number of international markets. These agreements usually have an initial term with renewal options and require the distributors to meet minimum annual purchases, which vary depending on the market. We are also required to register the product in each market before the distributor can begin importing, a process and timeline that can vary widely depending on the market.

The following table sets forth a list of our current international distribution agreements:

As part of our commercialization strategy, we entered into a number of joint ventures and partnerships designed to establish new INVO Centers.

The following table sets forth a list of our current joint venture arrangements:

On March 10, 2021, INVO CTR entered into a limited liability company agreement with HRCFG, LLC (“HRCFG”) to form a joint venture for the purpose of establishing an INVO Center in Birmingham, Alabama. The name of the joint venture LLC is HRCFG INVO, LLC (the “Alabama JV”). The responsibilities of HRCFG’s principals include providing clinical practice expertise, performing recruitment functions, providing all necessary training, and providing day-to-day management of the clinic. The responsibilities of INVO CTR include providing certain funding to the Alabama JV and providing access to ~~care~~and being the exclusive provider of the INVOcell to the Alabama JV. INVO CTR will also perform all required, industry-specific compliance and accreditation functions, and product documentation for product registration.

On June 28, 2021, INVO CTR entered into a ~~greater number~~limited liability company agreement (the “Bloom Agreement”) with Bloom Fertility, LLC (“Bloom”) to establish a joint venture entity, formed as “Bloom INVO LLC” (the “Georgia JV”), for the purposes of patients by lowering costs and alleviating capacity constraints while also delivering a treatment option with equivalent success rates to existing solutions. Ferring is a visionary, privately held biopharmaceutical company recognized around the world and a leader in women’s healthcare. Its mission is to help patients live better lives by researching, developing, manufacturing and marketing the most effective and innovative products in reproductive health, women’s health, urology, gastroenterology, endocrinology and orthopedics. Ferring makes their products available in over 100 nations with more than 5,000 employees’ worldwide. They have R&D facilities doing groundbreaking work in Denmark, Israel, Switzerland, China, India, Scotlandcommercializing INVOcell, and the ~~U.S.A. To~~related IVC procedure, through the establishment of an INVO Center (the “Atlanta Clinic”) in the Atlanta, Georgia metropolitan area.

In consideration for INVO’s commitment to contribute up to $800,000 within the 24-month period following execution of the Bloom Agreement to support the start-up operations of the Georgia JV, the Georgia JV issued 800 of its units to INVO CTR and in consideration for Bloom’s commitment to contribute physician services having an anticipated value of up to $1,200,000 over the course of a 24-month vesting period, the Georgia JV issued 1,200 of its units to Bloom.

The responsibilities of Bloom include providing all medical services required for the operation of the Atlanta Clinic. The responsibilities of INVO CTR include providing certain funding to the Georgia JV, lab services quality management, and providing access to and being the exclusive provider of the INVOcell ~~initiative Ferring has~~to the Georgia JV. INVO CTR will also perform all required, industry specific compliance and accreditation functions, and product documentation for product registration.

Effective September 24, 2020, INVO CTR entered into a ~~new U.S. Operations~~Pre-Incorporation and Shareholders Agreement with Francisco Arredondo, MD PLLC (“Arredondo”) and Security Health LLC, a Texas limited liability company (“Ramirez”, and together with INVO CTR and Arredondo, the “Shareholders”) under which the Shareholders will commercialize the IVC procedure and offer related medical treatments in Mexico. Each party owns one-third of the Mexican incorporated company, Positib Fertility, S.A. de C.V. (the “Mexico JV”).

The Mexico JV will operate in Monterrey, Nuevo Leon, Mexico and any other cities and places in Mexico as approved by the Mexico JV’s board of directors and Shareholders. In addition, the Shareholders agreed that the Mexico JV will be our exclusive distributor in Mexico. The Shareholders also agreed not to compete directly or indirectly with the Mexico JV in Mexico.

On November 23, 2020, we entered into a joint venture agreement with Ginekaliks Dooel (“Ginekaliks”), a limited liability company incorporated in the Republic of North Macedonia, to establish an exclusive joint venture to (i) commercialize, introduce, promote, and market technologies related to the INVOcell and IVC procedure in the Republic of North Macedonia, and (ii) establish an INVO Center. The joint venture will be co-managed and owned 50% by each of INVO and Ginekaliks. As of December 31, 2022, no joint venture entity had been formed.

On April 9, 2021, we entered into a ~~sprawling 25-acre campus~~partnership agreement (the “Lyfe Agreement”) with Lyfe Medical Center I, LLC (“Lyfe”) in ~~Parsippany, NJ, which includes a state-of-the-art manufacturing suite, next-generation product development laboratories~~connection with Lyfe’s intention to establish an INVO Center in the Bay Area of California (the “Bay Area Clinic”). Pursuant to the Lyfe Agreement, we will provide embryology laboratory services in connection with the IVC procedure and ~~a fully equipped education~~other fertility-related treatments (the “Lab Services”) to be provided by Lyfe to its patients at the Bay Area Clinic. Under the terms of the Lyfe Agreement, we will receive 40% of the net income received by the Bay Area Clinic for the performance of the Lab Services. As of December 31, 2022, the Bay Area Clinic was not yet operational.

IVC procedure compete with when infertile people, in conjunction with their physician, are choosing the treatment method include drug-only stimulation, IUI, and conventional IVF. The ~~infertility~~fertility industry is highly competitive and characterized by long-standing ~~well entrenched~~well-entrenched procedures as well as technological improvements. ~~The first IVF baby, Louise Brown, was born in 1977, making the IVF treatment over 40 years old.~~ Our INVOcell ~~device represents~~enables the first new advanced treatment alternative in ~~40+~~over forty years. The market for fertility treatment and devices is highly competitive in terms of pricing, functionality and service quality, the timing of development and introduction of new products and services and terms of financing. We face competition from all ART practitioners and device manufacturers. To date, most advancements in the ART market have been limited to incremental improvements to the various products designed to simply support conventional IVF. Our competitors may implement new technologies before we do, allowing them to offer more attractively priced or enhanced products, services or solutions. Our competitors may have greater resources in certain business segments or geographic markets than we have. We may also encounter increased competition from new market entrants or alternative ART technologies.

Competition in the area of infertility and ART services is also largely based on pregnancy rates and patient outcomes. Accordingly, the ability of our business to compete is largely dependent on our ability to achieve adequate pregnancy rates and patient satisfaction levels. The INVO Procedure offers an alternative treatment option to couples that may not have access currently due to cost or availability (capacity). We are not aware of any direct competitors to INVO Bioscience or the INVOcell device. However, there are existing infertility treatment regimens that the INVOcell will compete with when an infertile couple, in conjunction with their physician, is choosing the treatment method for their infertility. We believe that the menu of currently available clinical infertility treatment methods generally is limited to IUI and IVF.

~~Intra Uterine Insemination (IUI)~~: In IUI treatments, ovarian stimulation protocols with induction of ovulation are frequently used to recruit several follicles and improve clinical pregnancy rates. When monitoring of ovulation indicates that the female patient is ready to ovulate, the male patient will produce a sperm sample in the fertility doctor’s office. The sperm is then prepared and delivered to the uterus through a catheter. Currently IUI can only treat approximately 40% of the causes of infertility. For example, IUI does not address infertility causes such as tubal disease and other conditions that are treatable by IVF and the INVOcell device and process. In addition, IUI does not produce the diagnostic information such as fertilization that an IVF or INVO cycle produces. Approximately 600,000 IUI cycles are performed annually. In Europe, approximately 220,000 IUI cycles are performed annually (ESHRE, 2016). The cost of a single IUI treatment can range from $500 to $4,000 per cycle in the U.S. and somewhat lower in Europe. The differences in cost primarily depends on the stimulation protocol and the ovulation monitoring used by the physician. Pregnancy success rates with IUI range from 5% to 15% in the U.S.

~~In Vitro Fertilization (IVF)~~: IVF addresses tubal factor, ovulatory dysfunction, diminished ovarian reserve, endometriosis, uterine factor, male factor, unexplained infertility and other causes. IVF bypasses the function of the fallopian tube by achieving fertilization within a laboratory environment. Ovarian hyper-stimulation is common with IVF treatments to recruit numerous follicles to purportedly increase the chances for success. Follicles are retrieved trans-vaginally using a vaginal probe and ultrasound guidance. General anesthesia is frequently used due to the number of follicles retrieved and the resulting discomfort experienced by the patient. The eggs are identified in the follicular fluid and combined with sperm and culture medium in culture dishes, which are placed in an incubator with a temperature and gas environment designed to mimic the condition of the fallopian tubes. Once the embryos develop, typically over a 3-5 day period, they are transferred to the uterine cavity. According to the 2018 U.S. averages as reported by the Society for Assisted Reproductive Technology (“SART”), clinical pregnancy success rates averaged approximately 54% for IVF, with live birth rate success rates at approximately 43%.

The cost to the patient for a single IVF cycle (including drugs) is in the $12,000 - $15,000 range in the U.S. and can go as high as $30,000 depending on the IVF center and which optional add-on services the patient selects. The cost of drugs for an IVF cycle range from $2,500 to $4,000. The average cost per live birth using IVF can exceed $50,000 since a patient may require more than one cycle depending on their age. Many patients suitable for IVF are unable to access treatment because of the high cost and lack of insurance reimbursement. Additional obstacles to IVF often include significant distances to IVF clinics, travel costs and time off from work.

Our principal ART ~~medical-device~~medical device competitor for INVOcell is an intrauterine device called AneVivo™, developed by Anecova, a Swiss life sciences ~~company with an intrauterine device,~~company. The principal difference between the INVOcell and AneVivo™~~, for infertility treatment. This device~~ is ~~a very small silicone tube with 360 micro perforations. Oocytes are fertilized outside the device and then placed in the tube, which is placed~~its placement inside the woman’s uterus for early embryo development. ~~Placing~~We believe that placing the device in the uterus ismay be more invasive and ~~increases~~thus may increase the risk to ~~patient~~patients compared to the INVOcell, which is placed in ~~a natural orifice. After 1-5 days,~~ the device is removed, and the best embryo(s) are transferred back into the woman’s uterus. We believe that the device is much more difficult to use than the INVOcell due to its size and the requirement to place the device in the uterus, a sterile environment. We expect that the precision manufacturing of the Anecova device will drive its cost higher than our price. The Anecova device would also only be available in hospitals and IVF Centers at a significantly higher cost than the INVOcell.vaginal cavity. Currently, ~~the Anecova device~~AneVivo™ has obtained a CE Mark, ~~however it does~~but has not ~~have~~received FDA approval.

~~Lower cost than IVF with equivalent efficacy~~: The INVOcell can be offered for less than IVF due to lower cost of supplies, labor, capital equipment and general overhead. The laboratory equipment needed to perform an IVF cycle is expensive and requires ongoing costs (maintenance and calibration) as compared to what is required for an INVOcell cycle. As a result, we also believe INVOcell enables a clinic (and its laboratory) to be more efficient as compared to conventional IVF.

The INVO Procedure is currently being offered at practicing clinics at a range of $5,000 - $11,000 per cycle inclusive of medications thereby making it more affordable than conventional IVF (which tends to average $12,000 to $16,000 per cycle or higher).

~~Improved efficiency providing for greater capacity and improved access to care and geographic availability: In many parts of the world, including the U.S., IVF clinics tend to be concentrated~~For additional information about competition, see Risk Factors in higher population centers and are often capacity constrained in terms of how many patients a center can treat. With the significant number of untreated patients along with the growing interest and demand for services, the industry remains challenged to provide sufficient access to care and at an economical price. We believe INVOcell can play a significant role in helping to address these challenges. According to the 2018 CDC Report, there are approximately 456 IVF centers in the U.S. However, there are an estimated 5,000 Ob/Gyn offices in the U.S. that currently offer fertility services (which usually involves consultation and IUI, but not IVF). Since the INVOcell Procedure requires a much smaller lab facility, less equipment, and fewer specialized staff (as needed with IVF), INVOcell could potentially be offered in an Ob/Gyn office with proper training and a lighter lab infrastructure, thereby expanding the business for these physicians and allowing them to treat patients that are unable to afford conventional IVF. While INVOcell to date has been primarily offered in existing IVF centers (as an additional option for patients), the lower facility cost hurdles to provide our solution potentially opens the door to utilize the existing Ob/Gyn network of providers as well as establish new start-up clinics dedicated to providing INVOcell. Thus, in addition to lowering costs, we believe INVOcell can address a key industry challenge related to capacity through its ability to expand and decentralize the market and increase the number of points of care for patients. This powerful combination of lower cost and added capacity has the potential to dramatically open up access to care for patients around the world.

~~Greater patient involvement~~: With the INVO Procedure, the patient uses their own body as the incubation environment. This creates a greater sense of involvement, comfort and participation for patients with the fertilization happening within their own body. In some cases, this may also free a couple from ethical or religious concerns, or fears of laboratory mix-ups.

Currently, our direct customers are the distributors and partners we have engaged in various countries, who in turn promote and sell the INVOcell Procedure to doctors and patients. Our focus is on finding the right partners in each region who we believe can best aid us in commercializing the INVOcell device. We actively support our partners to ensure doctors are properly trained on administering the INVOcell procedure. We typically train both a reproductive endocrinologist and an embryologist from a practice. Participating doctors will likely have to make medical and business adjustments as they introduce the INVOcell device and procedure to others within their offices and to prospective patients as they determine where we fit into their practice. Our business is dependent on the continuance of our distribution relationship with Ferring. In 2020, revenues related to our agreement with Ferring accounted for 98.3% of our total revenues.

Every center offering the INVO Procedure today is in their own stage of the integration process. Some centers have completely integrated the INVO Procedure into their product offering, while others are at the beginning stages of patient recruitment. As a result of our partnership with Ferring in early 2019, we continue to experience a growing number of U.S. clinics adopting and offering the INVOcell procedure with an increase of over 100% since the beginning of 2019.

During 2020, we expanded our sales efforts through the creation of several joint ventures designed to establish new, dedicated INVO clinics which will perform the INVO Procedure. As part of our ownership stake in these joint ventures, we expect to invest in the necessary upfront and operating costs to facilitate the clinics in getting the operations up and running and to reach profitability and intend to benefit from procedure revenue as well as device sales. None of the announced joint ventures began operations during 2020, but we anticipate such to occur in 2021.

We currently generate revenue primarily from product sales and the amortization of the upfront licensing fee received in connection with the 2019 Ferring Distribution Agreement. We have entered into additional distribution agreements for several international markets that we expect will begin to generate product sales in 2021. We are also actively pursuing opportunities in which to generate service revenue associated with the INVOcell procedure itself via our joint venture agreements to establish INVO clinics. For the U.S. market, under the terms of our agreement with Ferring (including the recent Amendment No. 1 to the Distribution Agreement), we are allowed to own/operate up to 7 dedicated INVO-only clinics whereby we would generate revenue by offering services. We have yet to open any U.S. clinics, but we are pursuing this initiative and recently entered into our first agreement to establish the first such clinic. Additionally, we recently entered into an agreement to form a joint-venture partnership for several international markets, including India, Mexico, Malaysia, and the Republic of North Macedonia, whereby we will be a partner in the joint ventures that plans to establish dedicated INVO-only clinics.

For the various markets, we price the INVOcell Intravaginal Culture System technology based on discussions with our key partners that reflect the innovative features of the device, the savings in physician’s laboratory fixed costs and the billings the physician will receive from patients to perform the INVO Procedure. Our goal is to have the INVO Procedure offered to infertile couples at a lower cost alternative. While we attempt to keep our pricing consistent across markets, any variation may have an impact on our overall gross margins.

~~INVOcell Culture Device~~: For the U.S. market, our price for the INVOcell and retention devices has been agreed to with Ferring. Ferring has minimum quantities they must purchase from us on an annual basis in order to retain their exclusivity. In the international markets the price will be determined based on current offerings and discussions with key partners. IVF centers or Ob/Gyn groups purchasing a large number of devices and promoting the INVO Procedure may receive discounted prices and certain free advertising of their facility on our website. It is expected that the INVOcell may sell for different prices throughout the world as a reflection of different economies and typical pricing for existing treatment options within different regions.

~~INVOcell Retention Device~~: This is a single-use, modified diaphragm that includes holes to allow for natural drainage of vaginal fluids. The current model is an FDA cleared and CE Marked product purchased from a U.S. company. This retention device is sold in conjunction with the INVOcell device.

~~Fixed Laboratory Equipment~~: The equipment used in the INVO Procedure (microscope with video system, bench centrifuge, incubator without CO2, bench warmer and laminar flow hood) is readily available in the market. Existing IVF labs will generally already have the necessary equipment to perform an INVOcell Procedure. A new facility or non-IVF center can procure the necessary equipment for approximately $75,000-$150,000 (or less) depending on existing equipment they may already possess.

Our product commercialization efforts are focused on identifying distributors and partners within targeted geographic regions that we believe can best promote, market and sell the INVOcell device and INVO Procedure. We are also seeking partners that will contractually commit to meeting agreeable performance objectives that are consistent with our specific goals for the particular region. To date, we have entered into the major agreement with Ferring for the U.S. market, as well as distribution agreements in several other foreign markets, including Turkey, Jordan, Ethiopia, Sudan, Uganda, Nigeria, Malaysia, Mexico, Canada, Pakistan, and Iran as well as joint venture agreements in Mexico, India, Malaysia, and the Republic of North Macedonia. On March 10, 2021, our wholly-owned subsidiary, INVO Centers, LLC, entered into a limited liability company agreement with HRCFG, LLC to form a joint venture for the purpose of commercializing our technologies related to our INVOcell and INVO Procedure for an in vivo method of vaginal incubation at a dedicated INVO fertility clinic in Birmingham, Alabama.

Our sales and marketing activities are being led by our COO and VP of Business Development, Michael Campbell, who joined us in February of 2019. Mr. Campbell was previously the Vice President of IVF Americas Business Unit for Cooper Surgical, Inc., a wholly owned subsidiary of The Cooper Companies (NYSE: COO) and was previously a member of the board of directors for INVO Bioscience from October 2017 through November 2020. Mr. Campbell has substantial medical device sales, marketing and business development leadership experience within Global Fortune 500 and start-up company environments. During his 12-year career at Cooper Surgical, he was responsible for the IVF product portfolio sales globally including the U.S., Canada, Latin America, Europe, Middle East, Africa, and Asia Pacific regions. Throughout 2019 and 2020, we further enhanced our resources with the addition of several experienced international business development personnel, some of whom are located overseas. We may selectively add additional personnel to help support the growing, global interest in our technology during 2021.

Infertility is a global issue with the key industry challenges (cost, capacity, access to care, and a large percentage of patients going untreated each year) being similar across regions. Current treatment options, IUI and IVF, are also common around the world. With INVOcell being FDA cleared and CE Marked, our commercialization strategy is a global effort and approach.

In the United States, there is generally modest insurance coverage for infertility treatments, and what coverage there is varies on a state by state basis. As of August 2020, nineteen (19) states have passed fertility insurance coverage laws, with 13 of those laws including IVF coverage. In addition, under current fertility service insurance standards, many practices require an infertile patient have at least three IUI cycles before pursuing IVF. As a result, many patients are often referred to IVF when multiple IUI attempts have failed. Despite the limited overall insurance coverage, there continues to be improvement in the insurance arena. For example, there has been strong growth in private insurance options and a greater number of large corporations that are now offering added coverage to their employees in the U.S. We generally believe the market will continue to increase insurance coverage, which will further enhance the demand for service.

Most European countries have some level of coverage for infertility treatment, but the level of coverage varies from country to country and even within countries. For example, the National Health Service in the U.K. covers 20% of most costs for infertility treatment. However, that standard is not applied universally throughout the U.K. and some counties provide almost no coverage. In 2010, in Canada, the Province of Quebec mandated the full payment of up to 3 ART cycles for residents; however, in November of 2016 they halted the program.

We have a logo associated with the INVOcell device and have obtained U.S. trademark registrations for trademarked “INVO Bioscience”, “INVOCELL” and “INVO”. We also have pending U.S. applications to register “INVOBABY” and “INVO CENTER.” The “INVOCELL” and “INVO” trademarks are also covered by registrations with the World Intellectual Property Organization, the Canadian Intellectual Property Office, and the trademark office of Israel. Our website now refers patients in the U.S. to Ferring. We will continue to provide updated information to people looking for INVO in the U.S. to support Ferring and our own U.S. and international efforts as well as the comprehensive FAQ section.

The manufacture and sale of our products are subject to extensive regulation by numerous governmental authorities, principally by the FDA in the U.S. and corresponding foreign agencies. The FDA administers the Federal Food, Drug and Cosmetic Act (“FDCA”) and the regulations promulgated thereunder. Unless an exemption applies, each medical device commercially distributed in the U.S. requires either FDA clearance of a 510(k) premarket notification, approval of a premarket approval (“PMA”) or issuance of a de novo classification The FDA classifies medical devices into one of three classes depending on the degree of risk associated with each medical device and the extent of control needed to ensure safety and effectiveness. Class I includes devices with the lowest risk to the patient and are those for which safety and effectiveness generally can be assured by adherence to the FDA’s general controls, which include labeling, compliance with the Quality System Regulation (“QSR”), and registration and listing. Class II devices are subject to the FDA’s general controls, and special controls as deemed necessary by the FDA to ensure the safety and effectiveness of the device. Special controls can include performance standards, post-market surveillance, patient registries and FDA guidance documents. While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA in order to obtain a 510(k) clearance for the device. Under the 510(k) process, the manufacturer must submit to the FDA a premarket notification demonstrating that the device is “substantially equivalent” to either a device that was legally marketed prior to May 28, 1976, the date upon which the Medical Device Amendments of 1976 were enacted, or a device that was reclassified from Class III to Class II or I, or another commercially available device that was cleared through the 510(k) process or that was granted marketing authorization through the de novo classification process under section 513(f)(2) of the FDCA.

If the device is not “substantially equivalent” to a previously cleared device, the device is automatically placed into Class III. The device sponsor must then fulfill more rigorous PMA requirements, or can request a risk-based classification into class I or class II in accordance with the de novo classification process, which is a route to market for medical devices that are low to moderate risk, but are not substantially equivalent to a predicate device. The granting of the de novo request permits the device to be marketed, creates a classification regulation for devicesItem 1A of this generic type, and allows the device to serve as a predicate device for subsequent 510(k) premarket notifications. If FDA does not grant the de novo request, the device remains in Class III. Class III devices require an approved PMA before they can be marketed, although some pre-amendment Class III devices for which the FDA has not yet required a PMA are cleared through the 510(k) process. The PMA process is more demanding than the 510(k) premarket notification process. In a PMA, the manufacturer must demonstrate that the device is safe and effective, and the PMA must be supported by extensive data, including data from preclinical studies and human clinical trials.Annual Report on Form 10-K.

In November 2015, FDA granted our petition for de novo classification of the ~~INVOcell device.~~INVOcell. The INVOcell is intended for use in preparing, holding, and transferring human gametes or embryos during ~~In Vitro Fertilization/Intra Vaginal Culture and Intra-cytoplasmic Sperm Injection Fertilization/Intravaginal Culture procedures.~~IVC procedure with or without intra-cytoplasmic sperm injection fertilization (“ICSI”). The special controls include clinical and non-clinical performance testing, biocompatibility, sterility and shelf-life testing, and labeling. These special controls also apply to competing products that seek 510(k) clearance under the classification regulation for ~~Intravaginal Culture Systems.~~IVC systems, including our own 510(k) effort to expand the labeling on INVOcell from a 3-day incubation period to up to a 5-day incubation period.

~~After a device is cleared or approved or classified through the de novo process, numerous regulatory requirements continue to apply.~~

Our manufacturing processes are required to comply with the applicable portions of the QSR, which cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use. Medical device manufacturers are subject to periodic inspections by the FDA. If the FDA believes that a company may not be operating in compliance with applicable laws and regulations, the FDA and the Department of Justice can take a number of compliance or enforcement actions, including the following:

We have successfully completed two comprehensive inspections by the FDA in January 2012 and November 2014 resulting in no action indicated (“NAI”). We are also a participant in the Medical Device Single Audit Program (“MDSAP”) and successfully completed our second MDSAP audit conducted in December 2020.

All clinical investigations of devices to determine safety and effectiveness must be conducted in accordance with the FDA’s investigational device exemption (“IDE”), regulations that govern investigational device labeling, prohibit promotion of the investigational device, and specify recordkeeping, reporting and monitoring responsibilities of study sponsors and study investigators. If the device presents a “significant risk,” as defined by the FDA, the agency requires the device sponsor to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials. The IDE will automatically become effective 30 days after receipt by the FDA, unless the FDA denies the application or notifies the company that the investigation is on hold and may not begin. If the FDA determines that there are deficiencies or other concerns with an IDE that require modification of the study, the FDA may permit a clinical trial to proceed under a conditional approval. In addition, the study must be approved by, and conducted under the oversight of, an Institutional Review Board (“IRB”), for each clinical site. If the device presents a non-significant risk to the patient, a sponsor may begin the clinical trial after obtaining approval for the trial by one or more IRBs without separate approval from the FDA, but must still comply with abbreviated IDE requirements, such as monitoring the investigation, ensuring that the investigators obtain informed consent, and labeling and record-keeping requirements.

We are subject to regulation in each of the foreign countries where our products are sold. Many of the regulations applicable to our products in such countries are similar to those of the FDA. The national health or regulatory organizations of certain countries require that our products be qualified before they can be marketed in those countries. Many of the countries we are targeting either do not have a formal approval process of their own or will rely on either FDA clearance or the European approval, the CE mark – although many of these countries do require specific registration processes in order to list the INVOcell and make it available for sale.

In particular, marketing of medical devices in the European Union (“EU”) is subject to compliance with Council Directive 93/42/EEC (“MDD”). Similar to the U.S. system, medical devices are classified into one of four classes: I, IIa, IIb and III, with class I representing the lowest risk products and class III the highest risk products. A medical device must be designed and manufactured in such a way that it will not compromise the clinical condition or safety of patients, or the safety and health of users and others. In addition, the device must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in a suitable manner. Except for low-risk medical devices (Class I non-sterile, non-measuring devices), where the manufacturer can self-declare the conformity of its products with the essential requirements (except for any parts that relate to sterility or metrology), a conformity assessment procedure requires the intervention of a notified body. Notified bodies are private entities that are authorized or licensed to perform such assessments by government authorities. The notified body must audit and examine a product’s technical dossiers and the manufacturers’ quality system. If satisfied that the relevant product conforms to the relevant essential requirements, the notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity. The manufacturer may then apply the CE Mark to the device, which allows the device to be placed on the market throughout the. Once the product has been placed on the market in the EU, the manufacturer must comply with requirements for reporting incidents and field safety corrective actions associated with the medical device. The notified body has on-going audit rights and must be notified of all significant changes to the device or the manufacturer’s quality management system.

With our CE marking, we have the necessary regulatory authority to distribute our product, after registration, in the European Economic Area (i.e., Europe, Australia, and New Zealand). In addition, we will have the ability to market in various parts of the Middle East, Asia and South America. Every country has different regulatory and registration requirements, and we have begun or completed registrations in a number of countries. In general, we are registering the product based on the size of the market and our ability to service it given our resources as well as based on interest received from, and the execution of, agreements with distribution and joint venture partners.

~~In 2009, we received clearance from Health Canada~~We may be subject to ~~market, sell~~healthcare fraud, waste, and ~~train on~~abuse regulation and enforcement by the ~~use of~~federal government and the INVOcell and INVO Procedure in Canada. Although the Canadian government approved the INVOcell, in Canada the local physician’s college must authorize the use of new products in each province. These governing colleges also want to see the product approvedgovernments in the ~~country~~states and foreign countries in which we might conduct our business. The federal laws and many state laws generally apply only to entities or individuals that provide items or services for which payment may be made under a government healthcare program. These include laws that prohibit:

These laws are subject to extensive and increasing enforcement by numerous federal, state, and local government agencies including the Office of ~~origin before moving forward in Canada. With~~Inspector General, the ~~2015 FDA approval, Effortless IVF, CA obtained approval~~Department of Justice, the ~~local physician’s college, raised funds in 2016,~~Centers for Medicare & Medicaid Services, and built an INVO center in Calgary Canada. This Calgary center operated on a limited basis initially and was then put on hold by its owner for reasons we believe are unrelated to any issues with INVOcell. We intend to focus our efforts in 2021 to cultivate and buildvarious state authorities. At present, the ~~Canadian market.~~

In 2012 we received Brazil’s National Health Surveillance Agency (“ANVISA”) clearance approving the sale and use of the INVOcell throughout Brazil. The approval opens the door for us to a large and fast growing economy with over 190 million people. In 2016 we completed a new registration with a Brazilian Authorization Holder (“BAM”) that allows flexibility within the distribution channel which was approved by ANVISA in 2017.

In 2020, we completed registrations in Turkey, Jordan and Malaysia, all of which are markets where we have recently established distribution agreements and expect to begin sales shortly with these partners.

~~In February 2021, we completed registration in Mexico, where we recently entered into a joint venture to establish dedicated INVO clinics with a local partner.~~

~~Our success depends in part on our ability to obtain and maintain proprietary protection for our~~Company’s products and ~~technologies. Our goal is to develop a strong intellectual property portfolio~~services are not reimbursable under any government healthcare program. If, however, that ~~enables us to capitalize on the research and development that we have performed to date and will perform~~changes in the future ~~particularly for each~~and it were determined that the Company was not in compliance with these federal fraud, waste, and abuse laws, the Company would be subject to liability.

We are subject to the requirements of the ~~products that~~Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH Act”), and related implementing regulations (together, “HIPAA”). Under HIPAA, the Company must have in place administrative, physical, and technical standards to guard against the misuse of individually identifiable health information. In the ordinary course of our business as a Business Associate, and soon with INVO Centers, as a Covered Entity, we ~~commercialize such as~~may use, collect, and store sensitive data, including protected health information (“PHI”). We face risks relative to protecting this critical information, including loss of access risk, inappropriate disclosure risk, inappropriate modification risk, and the ~~INVOcell.~~ risk of being unable to adequately monitor our controls. Our information technology and infrastructure may be vulnerable to attacks by hackers or viruses or breached due to employee error, malfeasance, or other disruptions. Failure to comply with HIPAA, including through a breach of PHI, could result in penalties and sanctions, and materially harm our business.

For additional information about government regulation applicable to our business, see Risk Factors in Item 1A.

We rely on a combination of patent, copyright, and trademark laws in the United States and other countries to obtain and maintain our intellectual property. We protect our intellectual property by, among other methods, filing patent applications with the U.S. Patent and Trademark Office and its foreign counterparts on inventions that are important to the development of our business.

Our product development process has resulted in the development of one (1) patent currently live and in good standing covering the INVOcell device, which is set to expire on July 14, 2024 (US Pat. No. 7,759,115). We completed a redesign of the INVOcell device as well as process improvements on the ~~INVO Procedure,~~IVC procedure, which supported a new patent application that was filed on November 11, 2020 and is currently pending. We also filed a PCT (Patent Cooperation Treaty) application for the new U.S. application on January 18, 2021 to further expand patent protection in strategic locations across the ~~globe.~~globe, and, in the Spring of 2022, subsequently filed individual applications in the European Union, China, Japan, India and Mexico, which are currently pending.

We also have pending U.S. applications to register the ~~trademarks INVOBABY~~trademark Life Begins Within (App. No. ~~88804749) and INVO CENTER (App. No. 88564596)~~90803801).

~~Employees~~For additional information about our intellectual property, see Risk Factors in Item 1A of this Annual Report on Form 10-K.

~~As of December 31, 2020, we had ten full time employees. We also engage key consultants to further support our operations.~~

We maintain an internet website at ~~www.invobioscience.com.~~www.invobio.com. We make available, free of charge through our website, our annual report on Form 10-K, current reports on Form 8-K, quarterly reports on Form 10-Q and each amendment to these reports. Each such report is posted on our website as soon as reasonably practicable after such report is filed with the SEC via the EDGAR system.

The information on our website is not incorporated by reference into this Annual Report on Form 10-K and should not be considered a part of this Annual Report. Our website address is included in this Annual Report as an inactive textual reference only.

You should carefully consider the following risk factors, in addition to the other information in this report on Form 10-K, including the section of this report titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes. If any of the events described in the following risk factors and the risks described elsewhere in this report on Form 10-K occurs, our business, operating results and financial condition could be seriously harmed. This report on Form 10-K also contains forward-looking statements that involve risks and uncertainties. Our actual results could differ materially from those anticipated in the forward-looking statements as a result of factors that are described below and elsewhere in this report.

The following is a summary of certain important factors that may make an investment in our company speculative or risky. You should carefully consider the full risk factor disclosure set forth in Item 1A of this Annual Report, in addition to the other information herein, including the section of this report titled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and our consolidated financial statements and related notes.

Risks Related to our Financial Condition and our Need For Additional Capital

Our financial situation creates doubt whether we will continue as a going concern.

From the inception of our consolidated subsidiary BioXcell Inc. on January 5, 2007, through December 31, 2022, we had an accumulated net loss of $49.4 million. There can be no assurances that we will be able to achieve a level of revenues adequate to generate sufficient cash flow from operations or additional financing through private placements, public offerings and/or bank financing necessary to support our working capital requirements. To the extent that funds generated from any private placements, public offerings and/or bank financing are insufficient, we will have to raise additional working capital. No assurance can be given that additional financing will be available, or if available, will be on acceptable terms. These conditions raise substantial doubt about our ability to continue as a going concern. If adequate working capital is not available, we may be forced to discontinue operations, which would cause investors to lose their entire investment.

We will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate operations.

We do not expect that our current cash position will be sufficient to fund our current operations for the next 12 months and we do not have sufficient funds to consummate our acquisition of the Wisconsin Fertility Institute. Our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings, government or other third-party funding or a combination of these approaches. Raising funds in the current economic environment may present additional challenges. Even if we believe we have sufficient funds for our current or future operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerations.

Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize our product candidates. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. Moreover, the terms of any financing may adversely affect the holdings or the rights of our stockholders and the issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may cause the market price of our shares to decline. The sale of additional equity or convertible securities may dilute our existing stockholders. The incurrence of indebtedness would result in increased fixed payment obligations, and we may be required to agree to certain restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. We could also be required to seek funds through arrangements with collaborative partners or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of our technologies or product candidates or otherwise agree to terms unfavorable to us, any of which may have a material adverse effect on our business, operating results and prospects.

If we are unable to obtain funding on a timely basis, we may be required to significantly curtail, delay or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our business, financial condition and results of operations.

Even if we can raise additional funding, we may be required to do so on terms that are dilutive to you.

The capital markets have been unpredictable in the past for unprofitable companies such as ours. In addition, it is generally difficult for development stage companies to raise capital under current market conditions. The amount of capital that a company such as ours is able to raise often depends on variables that are beyond our control. As a result, we may not be able to secure financing on terms attractive to us, or at all. If we are able to consummate a financing arrangement, the amount raised may not be sufficient to meet our future needs. If adequate funds are not available on acceptable terms, or at all, our business, including our results of operations, financial condition and our continued viability will be materially adversely affected.

Risks Related to the Proposed Acquisition of the Wisconsin Fertility Institute

Our potential acquisition of the Wisconsin Fertility Institute may not close.

On March 16, 2023, we signed definitive acquisition agreements to acquire Wisconsin Fertility. This transaction is subject to certain customary closing conditions, as well as an initial cash payment of approximately $2.5 million less certain assumed liabilities and a holdback. We have not currently secured sufficient funds to make the initial closing payment which may impact our ability to close the transaction. In the event that we are unable to consummate our acquisition of Wisconsin Fertility, it will have a material adverse effect on our business, financial condition and results of operation.

We may not be able to successfully integrate Wisconsin Fertility into INVO and achieve the benefits expected to result from the acquisition.

The proposed acquisition of Wisconsin Fertility may present challenges to management, including the integration of the operations, and personnel of INVO and Wisconsin Fertility and special risks, including possible unanticipated liabilities, unanticipated integration costs and diversion of management attention.

We cannot assure you that we will successfully integrate or profitably manage Wisconsin Fertility’s businesses. Even if we are able to integrate and profitably manage Wisconsin Fertility’s business, we cannot assure you that, following the transaction, our business will achieve sales levels, profitability, efficiencies or synergies that justify the acquisition or that the acquisition will result in increased earnings for us in any future period.

If we close our acquisition of Wisconsin Fertility and fail to make the required $7.5 million in additional payments, our business would be adversely affected.

Following closing of our pending acquisition of Wisconsin Fertility, if consummated, we would be required to make additional payments of approximately $7.5 million, which payments are secured the sellers having a lien on the assets purchased to acquire Wisconsin Fertility. If we default on our additional payment obligations to the sellers of Wisconsin Fertility, such sellers could exercise their rights and remedies under acquisition agreements, which could include seizing the assets sold to us to acquire Wisconsin Fertility. Any such action would have a material adverse effect on our business and prospects.

We may incur debt financing to provide the cash proceeds necessary to acquire Wisconsin Fertility. If we were unable to service any such debt, our business would be adversely affected.

In order to finance our proposed acquisition of Wisconsin Fertility, we may look to secure debt financing. Any such debt financing would likely require us to pledge all or substantially all of our assets as collateral. If we were unable to satisfy any such debt obligation or fail to pay such debt obligations in a timely fashion, we would be in default under such debt financing agreement and such lender could exercise its rights and remedies under such debt financing agreements, which could include seizing all of our assets. Any such action would have a material adverse effect on our business and prospects.

Our business has posted net operating losses, has a limited operating history, and needs additional capital to grow and finance its operations.

From the inception of our consolidated subsidiary BioXcell Inc. on January 5, 2007, through December 31, ~~2020,~~2022, we had an accumulated net loss of ~~$32,236,082.~~$49.4 million. We have a limited operating history and isare essentially an early-stage operation. We will continue to be dependent on having access to additional new capital or generating positive operating cash flow primarily through increased device sales and the development of our INVO Centers in order to finance the growth of our operations. Continued net operating losses together with limited working capital make investing in our common stock a high-risk proposal. Our limited operating history may make it difficult for management to provide effective insight into future activities, marketing costs, and customer acquisition and retention. This could lead to INVO missing targets for the achievement of profitability, which could negatively affect the value of your investment.

Our existing INVO Centers were established as joint ventures with medical partners. Future INVO Centers may ~~require additional capital to continue~~also be established as ~~a going concern and to continue executing our business plan, which if not obtained could result in a need to curtail operations.~~

As reflected in the accompanying financial statements for the year ended December 31, 2020, we continue to make progress toward commercialization of our INVOcell device, although revenues are not yet sufficient to cover our current operations. Longer term, based on our projected cash needs, wejoint ventures. These joint ventures will be ~~dependent on generating sufficient sales, entering into new distribution agreements, receiving a milestone payment under the Ferring Distribution Agreement or raising additional debt or equity capital~~important to ~~support~~ our operations. No assurance can be given that we will meet the Distribution Agreement milestone or be successful in raising capital in the amounts or at the rates required to continue operations, or that such capital, if available, will be available on terms acceptable to us.business. If we are unable to maintain any of these joint ventures, or if they are not ~~able~~successful, our business could be adversely affected.

We have established, and plan to ~~meet~~establish additional, entered into, and may enter into additional, joint ventures for the ~~Distribution Agreement milestone or otherwise raise additional capital at~~operation of our INVO Centers. Our existing and any future joint ventures may have a number of risks, including that our joint venture partners:

Additionally, if one of our joint venture partners seeks to terminate its agreement with us, we may find it difficult to attract new joint venture partners and the ~~rate and~~perception of our INVO Centers in the ~~amounts needed, our~~ business ~~may~~and financial communities could be ~~significantly impacted, which could materially~~ adversely ~~affect the value of your investment.~~affected.

The ~~infertility~~fertility industry is highly competitive and characterized by well entrenched and long-standing practices as well as technological improvements and advancements. New ~~Assisted Reproductive Technology (“ART”)~~ART services, devices and techniques may be developed that may render the INVOcell obsolete. Competition in the areas of ~~infertility~~fertility and ART services is largely based on pregnancy rates and other patient outcomes. Accordingly, the ability of our business to compete is largely dependent on our ability to achieve adequate pregnancy rates and patient satisfaction levels. Our business operates in highly competitive areas that are subject to change. New health care providers and medical technology companies entering the market may reduce our and our INVO Centers’ market share, patient volume and growth rates, and could force us to alter our planned ~~pricing.~~pricing and INVO Center service offerings. Additionally, increased competitive pressures may require us to commit more resources to our and our INVO Centers’ marketing efforts, thereby increasing our cost structure and affecting our ability to achieve, or the timing of achieving, profitability. There can be no assurance that we will not be able to compete effectively, nor can there be any assurance that additional competitors will not enter the market. Such competition may make it more difficult for us to enter into additional contracts with fertility clinics or open profitable ~~INVOcell clinics.~~INVO Centers.

Under the terms of 2018 Distribution Agreement, Ferring is currently handling all sales and marketing activities for the U.S. market. The Distribution Agreement, as amended on March 2, 2021, provides that we will be allowed to initially open and operate seven (7) dedicated INVO clinics. There can be no assurances that Ferring’s or our commercial activities will be successful. Additionally, pursuant to the Distribution Agreement, Ferring will have the ability to elect to distribute and commercialize competitive products. The development and commercialization of such competitive products could reduce our U.S. market share. Ferring may also terminate the Distribution Agreement at any time without cause, which termination may have a material adverse impact on our domestic commercial activities.

Our operations, both inside and outside the United States, are subject to risks inherent in conducting business globally and under the laws, regulations and customs of various jurisdictions and geographies. Our operations outside the United States are subject to special risks and restrictions, including, without limitation: fluctuations in currency values and foreign-currency exchange rates; exchange control regulations; changes in local political or economic conditions; governmental pricing directives; import and trade restrictions; import or export licensing requirements and trade policy; restrictions on the ability to repatriate funds; and other potentially detrimental domestic and foreign governmental practices or policies affecting U.S. companies doing business abroad, including the U.S. Foreign Corrupt Practices Act and the trade sanctions laws and regulations administered by the U.S. Department of the Treasury’s Office of Foreign Assets Control. Acts of terror or war may impair our ability to operate in particular countries or regions and may impede the flow of goods and services between countries. Customers in weakened economies may be unable to purchase our products, or it could become more expensive for them to purchase imported products in their local currency, or sell at competitive prices, and we may be unable to collect receivables from such customers. Further, changes in exchange rates may affect our net earnings, the book value of our assets outside the United States and our stockholders’ equity. Failure to comply with the laws and regulations that affect our global operations could have an adverse effect on our business, financial condition or results of operations.

Failure to comply with the United States Foreign Corrupt Practices Act or similar laws could subject us to penalties and other adverse consequences.

We are subject to the United States Foreign Corrupt Practices Act, which generally prohibits United States companies, including their suppliers, distributors and other commercial partners, from engaging in bribery or other prohibited payments to foreign officials for the purpose of obtaining or retaining business. Corruption, extortion, bribery, pay-offs, theft and other fraudulent practices occur from time-to-time in the countries in which we distribute products. We have adopted formal policies and procedures designed to facilitate compliance with these laws. If our employees or other agents, including our distributors or suppliers, are found to have engaged in such practices, we could suffer severe penalties and other consequences that may have a material adverse effect on our business, financial condition and results of operations.

We need to manage growth in operations, and we may not be successful in implementing our growth strategy.

In order to maximize potential growth in our current and potential markets, we ~~believe we must~~may need to expand the scope of our services in the medical device/bioscience industry. We ~~also intend~~continue to seek additional market strategies to increase the adoption of INVOcell, ~~which includes helping to establish~~including the establishment of stand-alone ~~INVO-only clinics~~INVO Centers, IVF clinic acquisitions and ~~attempting~~our efforts to bring the ~~technology~~INVOCell and IVC procedure into the existing OB/~~Gyn~~GYN infrastructure. Such expansion will place a significant strain on our management, operational and sales systems. As a result, we plan to continue to improve our INVOcell technology, operating procedures and management information systems. We will also need to effectively train, motivate and manage our employees. Our failure to manage our growth could disrupt our operations and ultimately prevent us from generating revenues at the levels we expect.

Many factors including, but not limited to, increased competition from similar businesses, unexpected costs, costs associated with marketing efforts and maintaining a strong client base may interfere with our ability to expand successfully. Our inability to implement our internal strategy successfully may have a negative impact on our growth, future financial condition, results of operations and/or cash flows.

Our products incorporate intellectual property rights developed by us that may be difficult to protect or may be found to infringe on the rights of others.

While we currently own U.S. and international patents, these patents may be challenged, invalidated or ~~circumvented.~~circumvented, and will ultimately expire. In addition, the rights granted under these patents may not provide the competitive advantages we currently anticipate. Certain countries, including the United States orand in Europe, could place restrictions on the patentability of various medical devices which may materially affect our business and competitive position. Additionally, the laws of some foreign countries, in particular China and India, do not protect our proprietary rights to the same extent or in the same manner as U.S. laws, and we may encounter significant problems in protecting and defending ~~its~~our proprietary rights in these countries. In addition to relying on patent, copyright and trademark laws, we also utilize a combination of trade secrets, confidentiality policies, non-disclosure and other contractual arrangements to protect our intellectual property rights. However, these measures may not be adequate to prevent or deter infringement or other misappropriation. Further, our intellectual property rights may be found to infringe on intellectual property rights of third parties. Moreover, we may not be able to detect unauthorized use or take appropriate and timely steps to establish and enforce our proprietary rights. Existing laws of some countries in which we conduct business offer only limited protection of our intellectual property rights, if at all. As the number of market entrants as well as the complexity of technology in the ~~technology~~fertility marketplace increases, the possibility of functional overlap and inadvertent infringement of intellectual property rights also increases.

We may be forced to defend our intellectual property rights from infringement through expensive legal action.

Third parties may in the future assert claims against us alleging infringement on their intellectual property rights. Defending such claims may be expensive, time consuming and divert the efforts of our management and/or technical personnel. Because of litigation, we could be required to pay damages and other compensation, develop non-infringing products or enter into royalty and/or licensing agreements. However, we cannot be certain that any such licenses, will be made available to us on commercially reasonable terms.

We regard our trade secrets, patents and similar intellectual property as critical to our successful operations. To protect our ~~propriety~~proprietary rights, we rely on intellectual property and trade secret laws, as well as confidentiality and license agreements with certain employees, customers and ~~third-parties.~~third parties. No assurance can be given that our intellectual property will not be challenged, invalidated, infringed or circumvented. If necessary, we intend to defend our intellectual property rights from infringement through legal action, which could be very costly and could adversely affect our ability to achieve and maintain profitability. Our limited capital resources could put us at a disadvantage if we are required to take legal action to enforce our intellectual property rights.

We face potential liability as a provider of a medical device. These risks may be heightened in the area of artificial reproduction.

The provision of medical devices entails the substantial risk of potential tort injury claims. We do not engage in the practice of medicine or assume responsibility for compliance with regulatory requirements directly applicable to physicians. We currently utilize product liability insurance to provide coverage against potential tort injury ~~claims.~~claims, as well as customary insurance protection for our INVO Centers. However, there can be no assurance such coverage will provide adequate protection against any potential claims. Furthermore, any claim asserted against us could generate costly legal fees, consume management’s time and resources, and adversely affect our reputation and business, regardless of the merit or eventual outcome of such claim.

There are inherent risks specific to the provision of ~~infertility~~fertility and ART services. For example, the long-term effects on women of the administration of fertility medication, integral to most ~~infertility~~fertility and ART services, are of concern to certain physicians and others who fear the medication may prove to be carcinogenic or cause other medical problems. Additionally, any ban or other limitation imposed by the FDA or other foreign regulatory department on fertility medication and services could have a material adverse effect on our business. Any such action would likely adversely affect the value of your investment.

If we fail to maintain adequate quality standards for our products, our reputation and business may be adversely affected and harmed.

Our customers are expecting that our products will perform as marketed and in accordance with industrial standards. We rely on third-party manufacturing companies and their packaging processes in connection with the production of our products. A failure to maintain product quality standards in accordance with our customer’s expectations could result in the loss of demand for our products. Additionally, delays or quality lapses in our production lines could result in substantial economic losses to us. Although we believe that our current quality control procedures adequately address these risks, there can be no assurance that we will not experience occasional or systemic quality lapses in our manufacturing and service operations. Currently, we have limited manufacturing capabilities as we rely on a single manufacturing provider regarding our production process. In the event our manufacturer is unable to produce an adequate supply of products at appropriate quality levels, our growth could be limited, and our business may be harmed. If we experience significant or prolonged disturbance in our quality standards, our business and reputation may be harmed, which may result in the loss of customers, our inability to participate in future customer product opportunities and reduced revenue and earnings.

We heavily rely on third party package delivery services, and a significant disruption in these services or significant increases in prices may disrupt our ability to import or export materials, increase our costs and negatively affect our ability to achieve and maintain profitability.

We ship a significant portion of our products to our customers through independent package delivery companies. If any of our key third party package delivery providers experience a significant disruption such that any of our products, components or raw materials cannot be delivered in a timely fashion or such that we incur additional shipping costs that we are unable to recoup, our costs may increase and our relationships with certain customers may be adversely affected. In particular, if our third-party package delivery providers increase prices and we are not able to find comparable alternatives or adjust our delivery network, our profitability could be adversely affected.

We may not be able to develop or continue our business if we fail to retain key personnel.

We substantially rely upon the efforts and abilities of our executive management and directors. The loss of any of our executive officers and/or directors services could potentially have a material adverse effect on our business, operations, revenues and/or prospects. If one or more of these persons were to become unable or unwilling to continue in their present positions, we may not be able to replace them readily or timely, if at all. We do not maintain key man life insurance on the lives of any of our executive management or directors.

We will need additional, qualified personnel in order to expand our business. Without additional personnel, we will not be able to expand our business.

Expanding our business requires increasing the number of persons engaged in activities for the sale, marketing, administration and delivery of our products as well as clinical training personnel for ~~the~~ proper ~~training of the INVO Procedure.~~IVC procedure training. Our ability to attract and hire personnel to ~~fulfill~~fulfil these efforts is dependent on our ability to attract and retain potential employees with the proper background and training matching the skills required for the positions. In addition, we may not be able to attract personnel who will be able to successfully implement our business operations and growth strategy in the manner that we currently anticipate.

Currency exchange rate fluctuations may affect the results of our operations.

We intend to distribute our INVOcell product internationally with all sales, domestic and international, in U.S. dollars. As a result, our operations could be impacted by fluctuations in currency exchange rates, although we attempt to mitigate such risk by invoicing only in U.S. dollars. In spite of this, our operations may still be negatively impacted by foreign currency exchange rates in the event the U.S. dollar strengthens and the local currency where the product is being sold weakens. In the event such international patients are unable to afford the associated increase costs, international doctors and clinics may not be able to offer the INVOcell ~~product~~ and IVC procedure. As we expand our international footprint with joint ventures, these joint ventures will likely have a functional currency based on their location and as a result, if we are required to consolidate these financial results it may create currency fluctuations. Additionally, as an international business we may be susceptible to adverse foreign currency fluctuations unconnected to the U.S. dollar.

We are subject to risks in connection with changes in international, national and local economic and market conditions.

Our business is subject to risks in connection with changes in international, national and local economic and market conditions, including the effects of global financial crises, effects of terrorist acts, war and global pandemics. Such economic changes could negatively impact infertile ~~couples’~~people’s ability to pay for fertility treatment around the world.

We anticipate that eventually international sales will account for a meaningful part of our revenue. We will experience additional risks associated with international sales, including:

Any of these factors could have a material adverse effect on our business, results of operations and financial condition. From 2011 through ~~2020,~~2022, we sold products in certain international markets mainly through independent distributors, and we anticipate maintaining a similar sales strategy along with our recent joint venture activity for the foreseeable future. In the event a distributor fails to meet annual sales goals, we may be required to obtain a replacement distributor, which may be costly and difficult to ~~locate.~~identify. Additionally, a change in our distributors may increase costs, and create a substantial disruption in our operations resulting loss of revenue.

On November 2, 2021, Ferring International Center S.A. (“Ferring”) notified us of their intent to ~~Ferring in~~terminate the U.S. Distribution Agreement (the “Ferring Agreement”), ~~and if~~pursuant to which we ~~cease selling~~granted Ferring certain rights to ~~Ferring it may be difficult and expensive to find a replacement.~~

We sell our products ~~directly to Ferring~~ in the United States ~~market,~~market. Ferring gave notice of termination for convenience under Section 14.2(b) of the Ferring Agreement which ~~accounted~~required 90-days prior written notice. Accordingly, the Ferring Agreement officially terminated on January 31, 2022. By its terms, our Supply Agreement with Ferring also terminated on such date. Under the terms of these agreements, Ferring was required to make certain minimum annual purchases to maintain U.S. exclusivity for ~~98.3%~~the INVOcell. Such purchases are no longer available now that the Ferring Agreement has been terminated. Ferring’s termination of total 2020 revenues. If Ferring fails to meet its milestones, it may be difficult and costly to locate an acceptable substitute partner. The process of searching for an acceptable substitute may divert significant management attention away from executing our commercial growth strategy, whichthese agreements could have a material adverse ~~impact~~effect on our business, ~~and results of operations.~~

~~The coronavirus pandemic could have a significant negative impact on our business, revenues,~~ financial condition and results of operations.

The persistence of the coronavirus pandemic has severely depressed the level of economic activity around the world. Many businesses and governments have taken preventative or protective actions, including restrictions on travel and business operations, and advising or requiring individuals to limit or forego their time outside of their homes. Temporary closures of many businesses have been ordered and numerous other businesses have temporarily closed voluntarily. Further, individuals’ ability to travel has been curtailed through mandated travel restrictions, voluntary or mandated closures of travel-related businesses, as well as quarantines, shelter-in-place/stay-at-home and social distancing orders.

In particular, our sales and marketing efforts with the INVOcell and INVOcell Procedure could be adversely affected by recently implemented protocols for screening and restricting outside visitors and vendors. The COVID-19 pandemic created substantial disruption within the infertility care marketplace as many clinics ceased performing new procedures for a period of time. We believe that disruption has impacted our key partners, and although it may be temporary in nature and many clinics have already returned to performing new procedures, there can be no assurance that the pandemic will not have long term adverse effects on the industry and our business. Additionally, officially imposed quarantines and self-quarantines could interfere with patients’ ability to see a health care provider and obtain our INVOcell and INVOcell Procedure.

The spread of coronavirus has also caused us to modify our business practices, and we may take further actions as may be required by government authorities or that we determine are necessary or advisable. Work-from-home and other measures introduce additional operational risks, including cybersecurity risks, and have affected the way we conduct our business, which could have an adverse effect on our operations. There is no certainty that such measures will be sufficient to mitigate the risks posed by the virus, and illness and workforce disruptions could lead to unavailability of key personnel and harm our ability to perform critical functions. In addition, work-from-home and related business practice modifications present significant challenges to maintaining our corporate culture, including employee engagement and productivity, both during the immediate pandemic crisis and as we make additional adjustments in the eventual transition from it. Implementing new business practices in order to protect employees, vendors and other parties with whom we interact may result in increased costs. Furthermore, even if we follow what we believe to be best practices, there can be no assurance that our measures will prevent the transmission of COVID-19 between employees. Any incidents of actual or perceived transmission may expose us to liability claims, adversely impact employee productivity and morale, and result in negative publicity and reputational harm.

The degree to which coronavirus impacts our results will continue to depend on future developments that are highly uncertain and cannot be predicted, including, without limitation, the timing, extent, trajectory and duration of the pandemic, the development, rollout and availability of effective treatments and vaccines, the imposition of protective public safety measures, and how quickly and to what extent normal economic and operating conditions can resume, if at all. These uncertainties may result in delays or modifications to our plans, initiatives and results.

We are subject to significant domestic and international governmental regulation.

Our business is heavily regulated domestically in the United States and internationally. In the United States the FDA, and other federal, state and local authorities, implement various regulations that subject us to civil and criminal penalties, including ~~cease~~cessation of operations and recall of products distributed, in the event we fail to comply. Any such actions could severely curtail our sales and business reputation. In addition, additional restrictive laws, regulations or interpretations could be adopted, making compliance with such regulations more difficult or expensive. While we devote substantial resources to ensure our compliance with laws and regulations, we cannot completely eliminate the risk that we may be found non-compliant with applicable legal and regulatory requirements.

We believe that the healthcare industry will continue to be subject to increased regulation as well as political and legal action, as future proposals to reform the health care system are considered by the U.S. Congress and state legislatures. We do not know of, nor do we have any control over, future changes to health care laws and regulations which may have a significant impact on our business.

The FDA regulatory review process for medical devices is expensive, time-consuming and uncertain, and the failure to obtain and maintain required regulatory clearances and approvals could prevent us from commercializing our products.

Unless an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a 510(k) premarket notification, approval of a premarket approval, ~~(“PMA”),~~ or issuance of a de novo classification order. The FDA clearance, de novo classification, and approval processes for medical devices are expensive, uncertain and time-consuming.

Future modifications to the INVOcell that was classified through de novo may require a 510(k) clearance. We may make minor changes to the INVOcell without seeking clearance for the modifications if we determine such clearances are not necessary and document the basis for that conclusion. However, the FDA may disagree with our determination or may require additional information, including clinical data, to be submitted before a determination is made, in which case we may be required to delay the introduction and marketing of our modified products, redesign our products, conduct clinical trials to support any modifications, or we may be subject to enforcement actions. In addition, the FDA may not clear ~~the~~such modified INVOcell for the indications that are necessary or desirable for successful commercialization.

There is no assurance that we will be able to obtain the necessary clearances on a timely basis or at all. Further, the FDA may change its policies, adopt additional regulations or revise existing regulations, or take other actions which may impact our ability to modify the INVOcell on a timely basis, and may prevent or delay clearance of future products. Delays in receipt of, or failure to obtain clearances for any product modifications or future products we may develop would result in delayed or no realization of revenue from such products and the viability of our INVO Centers, and in substantial additional costs, which could decrease our profitability.

In addition, we are required to continue to comply with applicable FDA and other regulatory requirements following de novo classification or clearance. The failure to comply with existing or future regulatory requirements could have a material adverse effect on our business.

Improper marketing and promotion or off-label use of our product could lead to investigations and enforcement by governmental bodies including product recalls or market withdrawal, may harm our reputation and business, and could result in product liability suits.

If the FDA or any foreign regulatory entity determines that our promotional materials or training constitute promotion of an off-label use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions. These enforcement actions could include, for example, a warning letter or untitled letter, injunction, seizure, civil fine or criminal penalties. We cannot, however, prevent a physician from using the INVOcell off-label, when in the physician’s independent professional medical judgement, he or she deems it appropriate. There may be increased risk of injury to patients if physicians attempt to use the INVOcell off-label, or the INVOcell may not be as effective, which could harm our reputation.

If we fail to comply with the FDA’s Quality System Regulation ~~(QSR)~~(“QSR”) or comparable EU requirements, the FDA or EU competent authorities could take various enforcement actions, including suspending our FDA clearance to market, withdrawal of our EU CE Certificate or halting our manufacturing operations, and our business would suffer.

In the United States, as a manufacturer of a medical device, we are required to demonstrate and maintain compliance with the FDA’s QSR. The QSR covers the methods and documentation of the design, testing, control, manufacturing, labeling, quality assurance, packaging, storage and ~~shipping~~distribution of medical devices. The FDA enforces the QSR through periodic inspections and unannounced “for cause” inspections. Outside the United States, our products and operations are also required to comply with national requirements where the product is sold and also standards set by industrial standards bodies, such as the International Organization for Standardization. Foreign regulatory bodies may evaluate our products or the testing that our products undergo against these standards. The specific standards, types of evaluation and scope of review differ among foreign regulatory bodies. Our failure to comply with FDA or foreign ~~quality~~regulatory agency requirements, or failure to take satisfactory and prompt corrective action in response to an adverse inspection, could result in enforcement actions, including a warning letter, adverse publicity, a shutdown of or restrictions on our manufacturing operations, a recall or seizure of our products, fines, injunctions, civil or criminal penalties, or other sanctions, any of which could cause our business and operating results to suffer.

We are subject to continuing regulation by the FDA, and failure to comply may materially harm our business.

We are subject to Medical Device Reporting (“MDR”) regulations, which require us to report to the FDA if we become aware of information that reasonably suggests our product may have caused or contributed to a death or serious injury or has malfunctioned and the device or a similar device we market would likely cause or contribute to a death or serious injury if the malfunction were to recur. We may fail to report adverse events of which we become aware within the prescribed timeframe. We may also fail to recognize that we have become aware of a reportable adverse event. If we fail to comply with our medical device reporting obligations, the FDA could issue warning letters or untitled letters, take administrative actions, commence criminal prosecution, impose civil monetary penalties, request or require a product recall, seize our products, or delay the clearance of our future products. We must report corrections and removals to the FDA where the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the Federal Food, Drug, and Cosmetic Act, or FDCA, caused by the device that may present a risk to health.

Our failure to comply with these or other applicable regulatory requirements could result in enforcement actions by the FDA which may include untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties; customer notifications or repair, replacement or refunds; and criminal prosecution.

Our products are generally subject to regulatory requirements in foreign countries in which we sell those products. We will be required to expend significant resources to obtain regulatory approvals or clearances of our products, and there may be delays and uncertainty in obtaining those approvals or clearances.

In order to sell our products in foreign countries, generally we must obtain regulatory approvals and comply with the regulations of those countries. These regulations, including the requirements for approvals or clearances and the time required for regulatory review, vary from country-to-country.

The EU requires that manufacturers certify compliance of medical devices with Council Directive (93/42/EEC) (“MDD”), as amended, and affix the CE mark before selling such devices in member countries of the EU or European Economic Area (“EEA”). The CE mark is an international symbol of adherence to quality assurance standards and compliance with applicable European medical device directives. In order to obtain the authorization to affix the CE mark to products, a manufacturer must certify that its product complies with the applicable directive, which may include a requirement to obtain certification that its processes and products meet certain European quality standards.

In May 2017, the EU adopted Regulation (EU) 2017/745 (“MDR”), which will repeal and replace the MDD with effect from May 26, 2021. Under transitional provisions, medical devices with notified body certificates issued under the MDD prior to May 26, 2021, may continue to be placed on the market for the remaining validity of the certificate, until May 27, 2024, at the ~~latest.~~latest as long as there have been no significant changes made to the product. After the expiry of any applicable transitional period, only devices that have been CE marked under the MDR may be placed on the market in the EU (or EEA). The MDR includes increasingly stringent requirements in multiple areas, such as pre-market clinical evidence (some of which are now in effect), review of high-risk devices, labeling and post-market surveillance. Under the MDR, pre-market clinical data will now be required to obtain CE Mark approval for high-risk, new and modified medical devices. We believe these new requirements have the potential to be expensive and time-consuming to implement and maintain.

Complying with and obtaining regulatory approval in foreign countries, including compliance with the MDR, have caused and will likely continue to cause us to experience more uncertainty, risk, expense and delay in commercializing products in certain foreign jurisdictions, which could have a material adverse impact on our net sales, market share and operating profits from our international operations.

Our planned additional clinical trial and 510(k) efforts may prove unsuccessful.

We ~~intend to pursue~~are pursuing the expansion of our label, ~~expansion effort~~ and corresponding 510(k) submission utilizing real-market usage (retrospective) ~~data.~~data, to expand the INVOcell incubation period from 3 days to 5 days. We may also conduct an additional prospective clinical trial related to ~~the expansion of INVOcell’s indications to include 5-day incubation.~~such label expansion. While we anticipate a positive ~~outcome~~outcomes of ~~this effort,~~these efforts, an unsuccessful trial or insufficient retrospective data could adversely impact our ability to receive FDA clearance for the particular indication related to 5-day incubation and impact our ability to expand ~~into potential markets, and delay or eliminate~~ our ~~ability to receive the $3 million milestone payment under the Ferring agreement.~~marketing efforts.

~~Our revenues and operating results could fluctuate significantly from quarter to quarter, which may cause our stock price to decline.~~

Since our inception, we have not generated significant revenues. Our results from year-to-year and from quarter-to-quarter have, and are expected to continue to, vary significantly based on ordering cycles of distributors and partners. As a result, we expect period-to-period comparisons of our operating results may not be meaningful as an indication of our future performance for any future period.

Changes in the healthcare industry may require us to decrease the selling price for our products or could result in a reduction in the available market size.

Governmental and private sector initiatives in the U.S. and abroad involving trends toward managed healthcare and cost containment could place an emphasis on our ability to deliver more cost-effective medical therapies. The development of other cost-effective devices could ~~eventuality~~eventually adversely affect the prices and/or sales of our products. Companies in the healthcare industry are subject to various existing and proposed laws and regulations, in both domestic and international markets, regulating healthcare pricing and profitability. Additionally, there have been third-party payer initiatives to challenge the prices associated with medical products, which if successful, could affect our ability to sell products on a competitive basis in the future.

In the United States, there has been a trend of consolidation among healthcare facilities and purchasers of medical devices, allowing such purchasers to limit the number of suppliers from whom they purchase medical products. As result, it is unknown whether such purchasers will decide to stop purchasing our products or demand discounts on our prices. Any pressure to reduce our product prices in response to these industry trends and the decrease in market size could adversely affect our anticipated ~~revenues~~revenue and profitability of our sales, creating a material adverse effect on our business.

If third-party payers do not provide adequate coverage and reimbursement for INVOcell and the ~~INVO Procedure,~~IVC procedure, we may be unable to generate significant ~~revenues.~~revenue.

Our success in marketing and commercializing INVOcell and the ~~INVO Procedure~~IVC procedure may depend in part on whether private health insurers and other payer organizations provide adequate coverage and reimbursement. If physicians or insurers do not find our clinical data compelling or wish to wait for additional studies, they may choose not to use or provide coverage and reimbursement for INVOcell and the ~~INVO Procedure.~~IVC procedure. We cannot provide assurance that data we or others may generate in the future will be consistent with that observed in our existing clinical studies, or that our current or future published clinical evidence will be sufficient to obtain adequate coverage and reimbursement for our products. Moreover, if we cannot obtain adequate coverage for and reimbursement of the cost of our products, we cannot provide assurance that patients will be willing to incur the full cost of INVOcell and the ~~INVO Procedure.~~IVC procedure.

Third-party payers, whether foreign or domestic, or governmental or commercial, are developing increasingly sophisticated methods of controlling healthcare costs. In addition, in the United States, no uniform policy of coverage and reimbursement for INVOcell and the ~~INVO Procedure~~procedure exists among third-party payers. Therefore, coverage and reimbursement for INVOcell and the ~~INVO Procedure~~IVC procedure may differ significantly from payer to payer. In addition, payers continually review new technologies for possible coverage and can, without notice, deny coverage for these new products and procedures. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of INVOcell and the ~~INVO Procedure~~IVC procedure to each payer separately, with no assurance that coverage and adequate reimbursement will be obtained or maintained if obtained.

Reimbursement systems in international markets vary significantly by country and by region within some countries, and reimbursement approvals must be obtained on a country-by-country basis. In many international markets, a product must be approved for reimbursement before it can be approved for sale in that country. Further, many international markets have government-managed healthcare systems that control reimbursement for new devices and procedures. In most markets, there are private insurance systems as well as government-managed systems. If sufficient and timely coverage and reimbursement is not available for our current or future products, in either the United States or internationally, the demand for our products and our revenues may be adversely affected.

We are subject to risks relating to federal and state healthcare fraud, waste, and abuse laws.

We may be subject to healthcare fraud, waste, and abuse regulation and enforcement by the federal government and the governments in the states and foreign countries in which we might conduct our business. Such federal laws generally apply only to entities or individuals that provide items or services for which payment may be made under a federal healthcare program. These laws are subject to extensive and increasing enforcement by numerous federal, state, and local government agencies including the Office of Inspector General, the Department of Justice, the Centers for Medicare & Medicaid Services, and various state authorities. The healthcare laws and regulations that may affect our ability to operate include the following:

At present, our products and services are not reimbursable under any federal healthcare program. If, however, that changes in the future and it were determined that we were not in compliance with these federal fraud, waste, and abuse laws, we would be subject to liability.

Also, as noted above, many states have similar laws and regulations, such as anti-kickback and false claims laws that may be broader in scope and may apply regardless of payor, in addition to items and services reimbursed under Medicaid and other state programs. We may be subject to such laws in Alabama and Georgia due to our joint venture operations in those states. The Georgia State False Medicaid Claims Act (Ga. Code Ann. §§ 49-4-168 – 49-4-168.6), Georgia Medical Assistance Act false statements provision (Ga. Code Ann. §§ 49-4-140 – 49-4-157), and Alabama Medicaid false statements statute (Ala. Code § 22-1-11(a)) contain prohibitions that are analogous to the federal False Claims Act. Alabama law also includes an anti-kickback provision (Ala. Code § 22-1-11(c)) that is analogous to the federal AKS.

The Georgia Patient Self-Referral Act of 1993 (Ga. Code Ann. §§ 43-1B-1 – 43-1B-8) contains prohibitions on self-referral that are similar to those under the Stark Law, however, the Georgia law applies to additional classes of providers, including pharmacists, and is not limited to items or services reimbursable by a federal healthcare program. The Georgia law prohibits health care providers or entities regulated by the law from presenting any claim for payment to any individual, third-party payer, or other entity for a service furnished pursuant to a prohibited referral.

If we are found in violation of applicable laws or regulations, we could suffer severe consequences that would have a material adverse effect on our business, results of operations, financial condition, cash flows, reputation and stock price, including:

Responding to lawsuits and other proceedings as well as defending ourselves in such matters would require management’s attention and cause us to incur significant legal expense. It is also possible that criminal proceedings may be initiated against us or individuals in our business in connection with investigations by the federal government.

Additionally, to the extent that our product is sold or our services are provided in a foreign country, we may be subject to similar foreign laws.

We are subject to the requirements of the Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH Act”), and related implementing regulations (together, “HIPAA”), and failure to comply, including through a breach of protected health information (“PHI”) could materially harm our business.

HIPAA established comprehensive federal protection for the privacy and security of health information. The HIPAA standards apply to three types of organizations, or “Covered Entities”: (1) health plans, (2) health care clearing houses, and (3) health care providers who conduct certain health care transactions electronically. The HIPAA standards also apply to Covered Entities’ “Business Associates.” Covered Entities and their Business Associates must have in place administrative, physical, and technical standards to guard against the misuse of individually identifiable health information. The HITECH Act promotes the adoption and meaningful use of health information technology. The HITECH Act addresses the privacy and security concerns associated with the electronic transmission of health information, in part, through several provisions that strengthen the civil and criminal enforcement of the HIPAA rules. These laws may impact our business in the future. INVO is currently a Business Associate of various Covered Entities. Failure to comply with these confidentiality requirements, including via a breach of PHI, may result in penalties and sanctions.

In the ordinary course of our business, we may use, collect, and store sensitive data, including PHI. We face risks relative to protecting this critical information, including loss of access risk, inappropriate disclosure risk, inappropriate modification risk, and the risk of being unable to adequately monitor our controls. Our information technology and infrastructure may be vulnerable to attacks by hackers or viruses or breached due to employee error, malfeasance or other disruptions. Any such breach or interruption could compromise our networks and the information stored there could be accessed by unauthorized parties, publicly disclosed, lost or stolen. Any such access, disclosure or other loss of information could result in legal claims or proceedings, liability under laws that protect the privacy of personal information, such as HIPAA, and regulatory penalties. There is no guarantee that we can continue to protect our systems from breach. Unauthorized access, loss, or dissemination could also disrupt our operations.

The U.S. Office of Civil Rights in the Department of Health and Human Services enforces the HIPAA privacy and security rules and may impose penalties for failure to comply with requirements of HIPAA. Penalties vary significantly depending on factors such as whether failure to comply was due to willful neglect. These penalties include civil monetary penalties of $100 to $50,000 per violation, up to an annual cap of $1,500,000 for identical violations. A person who knowingly obtains or discloses individually identifiable health information in violation of HIPAA may face a criminal penalty of up to $50,000 per violation and up to one-year imprisonment. The criminal penalties increase to $100,000 per violation and up to five-years imprisonment if the wrongful conduct involves false pretenses, and to $250,000 per violation and up to 10-years imprisonment if the wrongful conduct involves the intent to sell, transfer, or use identifiable health information for commercial advantage, personal gain, or malicious harm. The U.S. Department of Justice is responsible for criminal prosecutions under HIPAA. Furthermore, in the event of a breach as defined by HIPAA, there are reporting requirements to the Office of Civil Rights under the HIPAA regulations as well as to affected individuals, and there may also be additional reporting requirements to other state and federal regulators, including the Federal Trade Commission, and to the media. Issuing such notifications can be costly, time and resource intensive, and can generate significant negative publicity. Breaches of HIPAA may also constitute contractual violations, including violation of the Company’s Business Associate contracts with Covered Entities from which the Company receives PHI, that could lead to contractual damages or terminations.

If we are unable to effectively adapt to changes in the healthcare industry, our business may be harmed.

Federal, state, and local legislative bodies frequently pass legislation and promulgate regulations relating to healthcare reform or that affect the healthcare industry. As has been the trend in recent years, it is reasonable to assume that there will continue to be increased government oversight and regulation of the healthcare industry in the future. We cannot predict the ultimate content, timing, or effect of any new healthcare legislation or regulations, nor is it possible at this time to estimate the impact of potential new legislation or regulations on our business. It is possible that future legislation enacted by Congress or state legislatures, or regulations promulgated by regulatory authorities at the federal or state level, could adversely affect our business. It is also possible that the changes to federal healthcare program reimbursements to providers who purchase our products or use our services may serve as precedent to possible changes in other payors’ reimbursement policies in a manner adverse to us. Similarly, changes in private payor reimbursements could lead to adverse changes in federal healthcare programs, which could have a material adverse effect on our business, financial condition, cash flows, and results of operations.

There can be no assurance that we will be able to successfully address changes in the current regulatory environment. Some of the healthcare laws and regulations applicable to us are subject to limited or evolving interpretations, and a review of our business or operations by a court, law enforcement, or a regulatory authority might result in a determination that could have a material adverse effect on us. Furthermore, the healthcare laws and regulations applicable to us may be amended or interpreted in a manner that could have a material adverse effect on our business, financial condition, cash flows and results of operations.

Economic downturns and declines in consumption in the healthcare market may affect the levels of both our sales and profitability. If a downturn in economic conditions occurs, or if there is deterioration in financial markets and major economies, our financial performance could be adversely affected. The tightening of credit in financial markets may adversely affect the ability of our customers and suppliers to obtain financing, which could result in a decrease in, or deferrals or cancellations of, the sale of our products and services. In addition, weakening economic conditions may result in a decline in spending for ART and fertility assistance that could adversely affect our business operations and liquidity. We are unable to predict the likely duration and severity of any disruption in the domestic and global financial markets.

The unauthorized use of certain social media vehicles could result in the improper collection and/or dissemination of personally identifiable information causing brand damage and various legal implications. In addition, negative or inaccurate social media posts or comments about us on any social networking site could damage our brand, reputation, and goodwill.

We have been notified by Nasdaq of our failure to comply with certain continued listing requirements and, if we are unable to regain compliance with all applicable continued listing requirements and standards of Nasdaq, our common stock could be delisted from Nasdaq. Additionally, if Nasdaq does not grant us an extension or if a favorable decision is not be obtained from a hearings panel, or the Panel, after the hearing, our common stock would be delisted from Nasdaq.

Our common stock is currently listed on Nasdaq. In order to maintain that listing, we must satisfy minimum financial and other continued listing requirements and standards, including those regarding director independence and independent committee requirements, minimum stockholders’ equity, minimum share price, and certain corporate governance requirements.

On November 23, 2022, we received notice (the “Stockholders’ Equity Notice”) from The ~~significant number~~Nasdaq Stock Market LLC (“Nasdaq”) advising us that we were not in compliance with the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1) requires companies listed on The Nasdaq Capital Market to maintain stockholders’ equity of at least $2,500,000 (the “Stockholders’ Equity Requirement). In our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, we reported stockholders’ equity of $1,287,224, which is below the Stockholders’ Equity Requirement for continued listing. Additionally, as of the date of the Notice, we did not meet either of the alternative Nasdaq continued listing standards under the Nasdaq Listing Rules, market value of listed securities of at least $35 million, or net income of $500,000 from continuing operations in the most recently completed fiscal year, or in two of the three most recently completed fiscal years.

The Notice has no immediate effect on the listing of our common ~~shares issuable~~stock and our common stock continues to trade on The Nasdaq Capital Market under the symbol “INVO” subject to our compliance with the other continued listing requirements.

Pursuant to the Stockholders’ Equity Notice, Nasdaq gave us 45 calendar days, or until January 7, 2023, to submit to Nasdaq a plan to regain compliance. If our plan is accepted, Nasdaq may grant an extension of up to 180 calendar days from the date of the Notice to evidence compliance.

On January 18, 2023, we received a letter from Nasdaq under which it stated that based on our submission that Nasdaq has determined to grant us an extension of time to regain compliance with Nasdaq Listing Rule 5550(b) until May 22, 2023. We must furnish to the SEC and Nasdaq a publicly available report (e.g. a Form 8-K) which report, among other things, includes a description of the completed transaction or event that enabled us to satisfy the stockholders’ equity requirement for continued listing After filing the publicly available report described above, if we fail to evidence compliance upon ~~conversion~~filing its periodic report for the June 30, 2023, with the SEC and Nasdaq, the Company may be subject to delisting. In the event we do not satisfy these terms, Nasdaq will provide written notification that its securities will be delisted. At that time, the Company may appeal Nasdaq’s determination to a Hearings Panel.

In addition, on January 11, 2023, we received a letter from the staff (the “Staff”) of ~~outstanding notes could adversely affect~~Nasdaq listing qualifications group indicating that, based upon the ~~trading~~closing bid price of our common ~~shares.~~stock for the last 30 consecutive business days, we were not in compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing under Nasdaq Listing Rule 5550(a)(2).

~~The sale~~In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been provided an initial period of ~~substantial amounts~~180 calendar days, or until July 10, 2023, to regain compliance with the minimum bid price requirement. If at any time before July 10, 2023, the closing bid price of our common stock closes at or above $1.00 per share for a minimum of 10 consecutive business days, Nasdaq will provide written notification that we have achieved compliance with the minimum bid price requirement, and the matter would be resolved. If we do not regain compliance prior to July 10, 2023, then Nasdaq may grant us a second 180 calendar day period to regain compliance, provided we (i) meets the continued listing requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than the minimum closing bid price requirement, and (ii) notifies Nasdaq of its intent to cure the deficiency within such second 180 calendar day period, by effecting a reverse stock split, if necessary.

We will continue to monitor the closing bid price of our common stock and will consider implementing available options to regain compliance with the minimum bid price requirement under the Nasdaq Listing Rules. If we do not regain compliance with the minimum bid price requirement within the allotted compliance periods, we will receive a written notification from Nasdaq that its securities are subject to delisting. We would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that we will regain compliance during either compliance period or maintain compliance with the other Nasdaq listing requirements.

In the event that our common stock is delisted from Nasdaq, as a result of our failure to comply with either the Stockholders’ Equity Requirement or the Minimum Bid Price Requirement, or as a result of Nasdaq not granting us an extension or the Panel not granting us a favorable decision, or due to our failure to continue to comply with any ~~particular time~~other requirement for continued listing on Nasdaq, and is not eligible for listing on another exchange, trading in the shares of our common stock could be conducted in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our common stock, and it would likely be more difficult to obtain coverage by securities analysts and the news media, which could cause the ~~trading~~ price of our common stock to decline ~~significantly. In July 2020,~~further. Also, it may be difficult for us to raise additional capital if we ~~registered 1,220,722 shares of common stock issuable under convertible notes, units and warrants and~~are not listed on September 16, 2019, we registered 1,278,328 shares of common stock for resale. As of December 31, 2020, we had $1,700,000 of Notes outstanding, which are convertible into 536,302 shares of our common stock and at March 19, 2021, we had $500,000 of Notes outstanding, which are convertible into 160,504 shares of our common stock. In the event the Notes are converted into shares of common stock, the issuance of shares of our common stock upon such conversion will result in dilution of ownership to existing stockholders. If our existing stockholders sell substantial amounts of our common stock under either registration statement, including the shares issued upon the conversion of the notes, in the public market, or if the public perceives that such sales could occur, this could have an adverse impact on the market price of our common stock, even if there is no relationship between such sales and the performance of our business.a national exchange.

Our common stock is subject to risks arising from restrictions on reliance on Rule 144 by shell companies or former shell companies.

Under a ~~Securities and Exchange Commission (“SEC”)~~SEC rule known as “Rule 144”, a person who has beneficially owned restricted securities of an issuer and who is not an affiliate of that issuer may sell them without registration under the Securities Act provided that certain conditions have been met. However, Rule 144 is unavailable for the resale of securities issued by an issuer that is a shell company or that has been at any time previously a shell company. The SEC defines a shell company as a company that has no or nominal operations and either (i) no or nominal assets, (ii) assets consisting solely of cash and cash equivalents, or (iii) assets consisting of any amount of cash and cash equivalents and nominal other assets. We are a former shell company.

The SEC has provided an exception to this unavailability if and for as long as the following conditions are met: (a) the issuer of the securities that was formerly a shell company has ceased to be a shell company; (b) the issuer of the securities is subject to the reporting requirements of Section 13 or 15(d) of the Securities Exchange ~~Act;~~Act of 1934, as amended; (c) the issuer of the securities has filed all Exchange Act reports and materials required to be filed, as applicable during the preceding 12 months, other than certain Current Reports on Form 8-K; and (d) at least one (1) year has elapsed form the time the issuer filed current comprehensive disclosure with the SEC reflecting its status as an entity that it is not a shell company.

Because of our prior history as a shell company, stockholders who receive our restricted securities will only be able to sell them pursuant to Rule 144 without registration for only as long as we continue to meet the requirements set forth above. No assurance can be given that we will meet these requirements going forward. Furthermore, any non-registered securities we sell in the future or issue will have limited or no liquidity until and unless such securities are registered with the SEC and/or until we comply with the foregoing requirements.

As a result, it may be harder for us to raise funding through the sale of debt or equity securities unless we agree to register such securities with the SEC, which could require us to deploy additional resources. In addition, if we are unable to attract additional capital, it could have an adverse impact on our ability to implement our business plan and/or sustain our operations. Our status as a former “shell company” could prevent us from raising additional funds to develop additional technological advancements, which could cause the value of our securities to decline in value.

A portion of the ownership of our common stock is concentrated in a small number of investors, some of whom are affiliated with our ~~Board~~board of ~~Directors~~directors and management.

Our management and board of directors own approximately ~~5.2%~~11% of our issued and outstanding shares of common stock. By virtue of such holdings, they have the ability to exercise influence over our business and affairs, including matters requiring approval by our stockholders including but not limited to the following actions:

Our directors have the right to authorize the issuance of shares of our preferred stock and additional shares of our common stock.

Our directors, within the limitations and restrictions contained in our ~~Articles~~articles of ~~Incorporation~~incorporation and without further action by our shareholders, have the authority to issue shares of preferred stock from time to time in one or more series and to fix the number of shares and the relative conversion and voting rights, and terms of redemption, liquidation preferences and any other preferences, special rights and qualifications of any such series. While we have no intention of issuing shares of preferred stock at the present time, we may seek to raise capital through the sale of our securities and may issue shares of preferred stock in connection with a particular investment. Any issuance of shares of preferred stock could adversely affect the rights of holders of our common stock.

Should we issue additional shares of our common stock, each investor’s ownership interest in our stock would be proportionally reduced.

The indemnification rights provided to our directors, officers and employees may result in substantial expenditures by us and may discourage lawsuits against its directors, officers and employees.

Our ~~Articles~~articles of ~~Incorporation~~incorporation and applicable Nevada law provide for the indemnification of our directors, officers, employees. The foregoing indemnification obligations could result in us incurring substantial expenditures to cover the costs of settlement or damage awards against directors, officers and employees, which we may be unable to recoup. These provisions and resultant costs may also discourage us from brining a lawsuit against out directors and officers for breaches of their fiduciary duties and may similarly discourage the filing of derivative litigation by our stockholders against our directs or officer even though such actions, if successful, might otherwise benefit us and our stockholders.

Our shares of common stock are thinly traded, and the price may not reflect our value; there can be no assurance that there will be an active market for our shares now or in the future.

We have a trading symbol for our common stock (“INVO”) and our common stock is currently ~~quoted~~listed on the Nasdaq Capital Market.

Our shares of common stock are thinly traded, and as such the price, if traded, may not reflect our value. There can be no assurance that there will be an active market for our shares of common stock either now or in the future. The market liquidity will be dependent on, among other things, the perception of our operating business and any steps that our management might take to bring us to the awareness of investors. There can be no assurance given that there will be any awareness generated or, if given, that it will be positive.

Consequently, investors may not be able to liquidate their investment or may be able to liquidate it only at a price that does not reflect the value of the business. If a more active market should develop, the price may be highly volatile. Due to the possibility of our common stock being priced lower than its actual value, many brokerage firms may not be willing to effect transactions in the securities. Even if an investor finds a broker willing to effect a transaction in the shares of our common stock, the combination of brokerage commissions, transfer fees, taxes, if any, and any other selling costs may exceed the selling price.

~~Our failure to meet the continued listing requirements of the Nasdaq Stock Market could result in a delisting of our common stock.~~

We are required to satisfy the continued Nasdaq listing requirements. If we fail to satisfy the continued listing requirements of the Nasdaq Stock Market, such as the corporate governance requirements or the minimum closing bid price requirement, Nasdaq may take steps to delist our common stock. Such a delisting would likely have a negative effect on the price of our common stock and would impair your ability to sell or purchase our common stock when you wish to do so. In the event of a delisting, we would take actions to restore our compliance with Nasdaq’s listing requirements, but we can provide no assurance that any such action taken by us would allow our common stock to become listed again, stabilize the market price or improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq minimum bid price requirement or prevent future non-compliance with Nasdaq’s listing requirements.

The Notes contain customary triggering events including but not limited to (i) failure to make payments when due and (ii) our bankruptcy or insolvency. If a triggering event occurs, each holder may require us to redeem all or any portion of the Notes (including all accrued and unpaid interest thereon), in cash. Further, the Notes are secured by the proceeds from the $3 million milestone payment that we are eligible to receive in connection with the Distribution Agreement with Ferring. The occurrence of a triggering event under the Notes could cause a material adverse effect on our business and results of operations, which could materially reduce the value of your investment.

~~We are currently involved in a dispute with an existing noteholder over the appropriate value of the notes he holds~~.

On August 7, 2019, we sent James Bowdring, a related party, a check in the amount of $65,197 as full and final payment under those certain promissory notes dated April 8, 2011 and November 9, 2011. On August 8, 2019, Mr. Bowdring’s legal counsel returned the check. A basis for returning the check was a claim that the interest due under the Notes called for compounded interest and not per annum interest. In addition, the letter rejecting the tender of the payment in full check alleged Mr. Bowdring was considering a future intention to convert his Promissory Notes into shares of our common stock. Mr. Bowdring, through his counsel, indicated that such future intention to convert the Notes to common stock were contingent upon Mr. Bowdring addressing certain personal issues which were not disclosed by his counsel in the correspondence returning the checks. We do not believe that Mr. Bowdring has the right to seek conversion of the Notes once payment for the Notes has been tendered. In order to resolve the issue of our tender of payment in full versus Mr. Bowdring’s assertion that he can reject tender and seek conversion, we filed an action in the Suffolk Superior Court in Boston seeking Declaratory Judgment and Judgment for Breach of Contract.

~~Our common stock may be subject to the~~ “~~penny stock~~” ~~rules of the SEC, which will make the shares of our common stock more difficult to sell.~~

Our shares of common stock are subject to the “penny stock” rules of the Exchange Act. The Exchange Act defines “penny stock” as any equity security that has a market price of less than $5.00 per share, subject to certain restrictions. We anticipate our common stock may continue to be considered a penny stock in the future.

The penny stock rules require broker-dealers to deliver to potential investors a standardized risk disclosure document prepared by the SEC, which provides information about penny stocks and the nature and level of risks in the penny stock market. The broker-dealer must also provide the potential investor current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its salesperson, and monthly account statements showing the market value of each penny stock held in the investor’s account. The bid and offer quotations, and the broker-dealer and salesperson compensation information must be given to the potential investor orally or in writing prior to completing the transaction and must be given to the potential investor in writing before or with the investor’s confirmation.

In addition, the penny stock rules require that prior to a transaction the broker-dealer make a special written determination that the penny stock is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. The penny stock rules are burdensome and may reduce purchases of any offerings and reduce the trading activity for shares of our common stock. As long as our shares of common stock are subject to the penny stock rules, the holders of such shares of common stock may find it more difficult to sell their securities.

~~The market for penny stocks has experienced numerous frauds and abuses, which could adversely affect investors in our stock.~~

We believe that the market for penny stocks has suffered from patterns of fraud and abuse. We believe that many of these abuses have occurred with respect to the promotion of low-price stock companies that lacked experienced management, adequate financial resources, an adequate business plan and/or marketable and successful business or product. Because our shares are penny stocks, the share price for our common stock may be adversely affected such frauds and abuses involving other penny stocks.

To date, we have never declared or paid any dividends to our stockholders. Our board of directors does not intend to distribute dividends in the near future. The declaration, payment and amount of any future dividends will be made at the discretion of the board of directors, and will depend upon, among other things, the results of our operations, cash flows and financial conditions, operating and capital requirements, and other factors as the board of directors considers relevant. There is no assurance that future dividends will be paid to stockholders. In the event dividends are paid to stockholders, there is no assurance with respect to the amount of any such dividend.

Our revenue and operating results could fluctuate significantly from quarter to quarter, which may cause our stock price to decline.

Since our inception, we have not generated significant revenue. Our results from year-to-year and from quarter-to-quarter have, and are expected to continue to, vary significantly based on ordering cycles of distributors and partners. As a result, we expect period-to-period comparisons of our operating results may not be meaningful as an indication of our future performance for any future period.

We may have difficulty raising the necessary capital to fund operations and the Wisconsin Fertility acquisition because of the thin market and market price volatility for our shares of common stock.

Throughout ~~2020,~~2022, there has been a thin market for our shares, and the market price for our shares has been volatile. In recent years, the securities markets in the U.S. and around the world have experienced a high level of price and volume volatility, and the market price of securities of many companies have experienced wide fluctuations that have not necessarily been related to the operations, performances, underlying asset values or prospects of such companies. For these reasons, we expect our shares of common stock may also be subject to volatility resulting from market forces over which we will have no control. The success of our products and services may be dependent upon our ability to obtain additional financing through debt and equity or other means. The thin market for our shares, and the volatility in the market price for our shares, may adversely affect our ability to raise needed additional capital.

Shareholders may be diluted significantly through our efforts to obtain financing and from issuance of additional shares of our common stock, including such issuances of shares for services.

To satisfy certain financial obligations, we have issued and may continue to issue shares of our common stock and we have incurred and may continue to incur debt, which may be convertible into shares of our common stock. We may attempt to raise capital by selling shares of our common stock, possibly with warrants, which may be issued or exercised at a discount to the market price for our common stock. These actions would result in dilution of the ownership interests of existing shareholders, and may further dilute the common stock book value, and that dilution may be material. Such issuances may also serve to enhance existing management’s ability to control us as the shares may be issued to our officers, directors, new employees, or other related parties.

We are subject to the reporting requirements of U.S. federal securities laws, which can be expensive.

We are a public reporting company and accordingly subject to the information and reporting requirements of the ~~Securities~~ Exchange Act, ~~of 1934, as amended (the “Exchange Act”),~~ and other federal securities laws, including compliance with the Sarbanes-Oxley Act of 2002. We are required to prepare and file annual and quarterly reports, proxy statements and other information with the SEC and furnishing audited reports. Compliance with such reporting requirements is both time-consuming and costly for us. We may need to hire additional financial reporting, internal control, and other finance personnel in order to develop and implement appropriate internal controls and reporting procedures.

In addition, the Sarbanes-Oxley Act of 2002 and the Dodd-Frank Wall Street Reform and Consumer Protection Act, as well as rules implemented by the SEC and the securities exchanges, require certain corporate governance practices for public companies. Our management and other personnel have devoted and expect to continue to devote a substantial amount of time to public reporting requirements and corporate governance. These rules and regulations have significantly increased our legal and financial compliance costs and made some activities more time-consuming and costly. If these costs are not offset by increased revenues and improved financial performance, our financial condition and results of operations may be materially adversely affected. These rules and regulations also make it more difficult and more expensive for us to obtain director and officer liability insurance in the future. Additionally, we may be required to accept reduced policy limits and coverage or incur substantially higher costs to obtain the same or similar coverage. As a result, it may be more difficult for us to attract and retain qualified personnel to serve on our board of directors or as executive officers.

Failure to comply with internal control attestation requirements could lead to loss of public confidence in our financial statements and negatively impact our stock price.

Pursuant to Section 404 of the Sarbanes-Oxley Act of 2002, we are required to conduct an annual management assessment of the effectiveness of our internal controls over ~~finical~~financial reporting. If we fail to timely develop our internal controls, and management is unable to make this assessment, or, once required, if the independent registered public accounting firm cannot timely attest to this assessment, we could be subject to regulatory sanctions. As a result, a loss of public confidence in our financial controls and the reliability of our consolidated financial statements may develop ultimately negatively impacting our stock price and our ability to raise additional capital when and as needed.

We currently do not own any real property and operate from leased facilities. Our principal executive office is located at 5582 Broadcast Court Sarasota, Florida 34240. The lease is for one 5-year term, with an option to extend for one 3-year term. We lease approximately 1,223 square feet in the Sarasota facility, pursuant to a May 2019 lease with a 3% annual rent increase. We believe that our facilities are adequate to meet our needs.

~~See Note 13~~The Company is not currently subject to any material legal proceedings; however, it could be subject to legal proceedings and claims from time to time in the ~~Consolidated Financial Statements included~~ordinary course of its business, or legal proceedings it considered immaterial may in ~~this Annual Report on Form 10-K.~~the future become material. Regardless of the outcome, litigation can, among other things, be time consuming and expensive to resolve, and can divert management resources.

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Trading of our shares of our common stock is on the Nasdaq Capital Market under the symbol “INVO.” Prior to November 12, 2020, our common stock was traded on the OTC QB Venture Market tier of the over-the-counter (“OTC”) market.

As of ~~December 31, 2020, and 2019,~~April 17, 2023, there were ~~9,639,268 and 4,884,879~~13,971,283 shares of ~~registrant’s~~our common stock ~~outstanding, respectively.~~outstanding.

Information required with respect to Equity Compensation Plans in this Item 5 is included in Item 11 on page 4844 of this report on Form 10-K.

As of ~~December 31, 2020, and 2019,~~April 17, 2023, there were approximately ~~172 and 168~~183 stockholders of record of our common ~~stock, respectively.~~stock. However, we estimate that we have a significantly greater number of beneficial holders of our common stock because a number of shares are held of record by broker-dealers for their customers in street name.

We have never declared or paid a dividend on our common stock. We intend to retain future earnings (if any) to fund the development and growth of our business, rather than to pay them as dividends, for the foreseeable future.

In March 2021, we issued 11,098 shares of our common stock upon conversion of $35,513.60 of accrued interest under certain of our convertible notes. We did not receive any proceeds upon conversion. We relied on the exemption from registration provided by Section 3(a)(9) and/or Section 4(a)(2) of the Securities Act of 1933, as amended.None.

In March 2021, we issued 85,568 shares of our common stock upon exercise of outstanding unit purchase options. The unit purchase options were issued to purchase 131,114 shares and were exercised in full on a cashless basis and accordingly 45,546 shares were withheld by us at the market price of $9.20 per share less the exercise price of $3.20 per share to fund the exercise price. We relied on the exemption from registration provided by Section 3(a)(9) and/or Section 4(a)(2) of the Securities Act of 1933, as amended.

In March 2021, we issued 131,114 warrants upon the exercise in full of 131,114 unit purchase options. We did not receive any proceeds upon exercise. We relied on the exemption from registration provided by Section 3(a)(9) and/or Section 4(a)(2) of the Securities Act of 1933, as amended.

In March 2021, we issued 90,748 shares of our common stock upon exercise of outstanding warrants. The warrants were issued to purchase 139,056 shares and were exercised in full on a cashless basis and accordingly 48,308 shares were withheld by us at the market price of $9.20 per share less the exercise price of $3.20 per share to fund the exercise price. We relied on the exemption from registration provided by Section 3(a)(9) and/or Section 4(a)(2) of the Securities Act of 1933, as amended.

In November 2020, pursuant to Section 4(a)(2) of the Securities Act, we issued 109 shares of common stock in consideration of consulting services rendered. We did not receive any proceeds from the issuance.

In November 2020, pursuant to Section 3(a)(9) of the Securities Act, we issued 453,699 shares of common stock with fair value of $1,366,249 are the result of the conversion of notes payables and accrued interest.

In November 2020, pursuant to Section 4(a)(2) of the Securities Act, we issued 22,250 shares of common stock with a fair value of $70,562 in consideration of consulting services rendered. We did not receive any proceeds from the issuance.

Item 7. ~~Management s~~Management’s Discussion and Analysis of Financial Condition and Results of Operations

This discussion includes certain forward-looking statements about our business and our expectations, including statements relating to revenues, international revenues, revenue growth rates, gross margin, operating expenses, amortization expense, earnings per share, available cash and operating cash flow. Any such statements are subject to risk that could cause the actual results to vary materially from expectations. For a further discussion of the various risks that may affect our business and expectations, see the section titled “Risk Factors” contained in Item 1A of Part I of this Annual Report on Form 10-K. The risks and uncertainties discussed therein do not reflect the potential future impact of any mergers, acquisitions or dispositions. In addition, any forward-looking statements represent our estimates only as of the day this Annual Report was filed with the SEC and should not be relied upon as representing our estimates as of any subsequent date. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if our estimates change.

We were formed on January 5, 2007 under the laws of the Commonwealth of Massachusetts under the name Bio X Cell, Inc. to acquire the assets of Medelle Corporation (“Medelle”). Dr. Claude Ranoux purchased all of the assets of Medelle, and then he contributed those assets, including four patents relating to the INVOcell technology, to Bio X Cell, Inc. upon its formation in January 2007.

On December 5, 2008, Bio X Cell, Inc., doing business as INVO Bioscience, and each of the shareholders of INVO Bioscience entered into a share exchange agreement and consummated a share exchange with Emy’s Salsa AJI Distribution Company, Inc., a Nevada corporation (“Emy’s”). Upon the closing of the share exchange on December 5, 2008, the INVO Bioscience shareholders transferred all of their shares of common stock in INVO Bioscience to Emy’s. In connection with the share exchange, Emy’s changed its name to INVO Bioscience, Inc. and Bio X Cell, Inc. became a wholly owned subsidiary of Emy’s (re-named INVO Bioscience, Inc.).

The share exchange described immediately above was accounted for as a “reverse merger” because the former Bio X Cell shareholders owned a majority of the outstanding shares of common stock of Emy’s immediately following the share exchange. Bio X Cell was deemed the acquirer in the reverse merger. The financial results included in this Annual Report on Form 10-K are based on our audited balance sheet as of December 31, 2020 and 2019 and related audited statements of operations and stockholders’ deficiency and statements of cash flows for the periods ended December 31, 2020 and 2019, respectively.

We are a ~~medical device~~commercial-stage fertility company ~~focused in~~dedicated to expanding the ~~Assisted Reproductive Technology~~assisted reproductive technology (“ART”) ~~marketplace.~~marketplace by making fertility care accessible and inclusive to people around the world. Our primary mission is to ~~increase access~~implement new medical technologies aimed at increasing the availability of affordable, high-quality, patient-centered fertility care. Our flagship product is INVOcell, a revolutionary medical device that allows fertilization and early embryo development to ~~care and expand fertility treatment and patient care across the globe. Our patented device, the INVOcell, is the first Intravaginal Culture (“IVC”) system in the world used for the natural~~take place in vivo within the woman’s body. This treatment solution is the world’s first intravaginal culture technique for the incubation of ~~eggs~~oocytes and sperm during fertilization and early embryo development. ~~INVOcell was granted clearance~~This technique, designated as “IVC”, provides patients a more connected and intimate experience at a more affordable cost in comparison to in vitro fertilization (“IVF”), the ~~United States by the U.S. Food & Drug Administration (“FDA”) in November 2015, received the CE mark in October 2019,~~other advanced ART treatment. The IVC procedure can deliver comparable results to IVF and is ~~now positioned to help provide millions of infertile couples across the globe access to~~ a ~~new infertility~~significantly more effective treatment option. We believe this novel device and procedure provides a more natural, safe, effective, efficient and economical fertility treatment compared to current infertility treatments, including in-vitro fertilization (“IVF”) andthan intrauterine insemination (“IUI”). Our commercialization strategy is focused on the opening of dedicated “INVO Centers” offering the INVOcell and IVC procedure (with three centers in North America now operational) and the acquisition of existing IVF clinics, in addition to continuing to sell our technology solution into existing fertility clinics.

Unlike conventional ~~infertility treatments such as~~ IVF where the ~~eggs~~oocytes and sperm develop into embryos in aan expensive laboratory incubator, the INVOcell ~~utilizes the women’s vaginal cavity as an incubator to support a more natural~~allows fertilization ~~and embryo development environment. As such, this novel device promotes~~ ~~in vivo~~ ~~conception~~ and early embryo ~~development.~~development to take place in the woman’s body. This allows for many benefits in the IVC procedure, including:

In both ~~commercial~~current utilization of the INVOcell, and in clinical studies, the ~~INVO Procedure~~IVC procedure has proven to have equivalent pregnancy success and live birth rates as IVF when comparing similar incubation periods.

We operate with a core internal team and outsource certain operational functions in order to help advance our efforts as well as reduce fixed internal overhead needs and costs and in-house capital equipment requirements. Our most critical management and leadership functions are carried out by our core management team. We have contracted out the manufacturing, assembly, packaging, labeling, and sterilization of the device to a medical manufacturing company and a sterilization specialist to perform the gamma sterilization process.

To date, we have completed a series of important steps in the successful development and manufacturing of the INVOcell:

The global ART marketplace is a large, multi-billion industry growing at a strong pace in many parts of the world as increased infertility rates, increased patient awareness, acceptance of treatment options, and improving financial incentives such as insurance and governmental assistance continue to drive demand. According to the European Society for Human Reproduction 2020 ART Fact Sheet, one in six couples worldwide experience infertility problems. Additionally, the worldwide market remains vastly underserved as a high percentage of patients in need of care continue to go untreated each year for many reasons, but key among them are capacity constraints and cost barriers. While there have been large increases in the use of IVF, there are still only approximately 2.6 million ART cycles, including IVF, IUI and other fertility treatments, performed globally each year, producing around 500,000 babies. This amounts to less than 3% of the infertile couples worldwide being treated and only 1% having a child though IVF. ~~Additionally,~~The industry remains capacity constrained which creates challenges in providing access to care to the volume of patients in need. A survey by “Resolve: The National Infertility Association,” indicates the two main reasons couples do not use IVF is cost and geographical availability (and/or capacity).

In the United States, infertility, according to the American Society of Reproductive Medicine (2017), affects an estimated 10%-15% of the couples of childbearing-age. According to the Centers for Disease Control (“CDC”), there are approximately 6.7 million women with impaired fertility. Based on preliminary 2020 data from CDC’s National ART Surveillance System, approximately 326,000 IVF cycles were performed at 449 IVF centers, leaving the U.S. with a large, underserved patient population, similar to most markets around the world.

We believe that the INVOcell, and the IVC procedure it enables, have the following key advantages:

Lower cost than IVF with equivalent efficacy. The IVC procedure can be offered for less than IVF due to lower cost of supplies, labor, capital equipment and general overhead. The laboratory equipment needed to perform an IVF cycle is expensive and requires ongoing costs as compared to what is required for an IVC cycle. As a result, we also believe INVOcell and the IVC procedure enable a clinic and its laboratory to be more efficient as compared to conventional IVF.

The IVC procedure is currently being offered at several IVF clinics at a price range of $5,000 - $11,000 per cycle and from $4,500 to $7,000 at the existing INVO Centers, thereby making it more affordable than conventional IVF (which tends to average $12,000 to $17,000 per cycle or higher).

Improved efficiency providing for greater capacity and improved access to care and geographic availability. In many parts of the world, including the U.S., IVF clinics tend to be concentrated in higher population centers and are often capacity constrained in terms of how many patients a center can treat, since volume is limited by the number of capital-intensive incubators available in IVF clinic labs. With the significant number of untreated patients along with the growing interest and demand for services, the industry remains challenged to provide sufficient access to care and to do so at an economical price. We believe INVOcell and the IVC procedure it enables can play a significant role in helping to address these challenges. According to the 2020 CDC Report, there are approximately 449 IVF centers in the U.S. We estimate that by adopting the INVOcell, IVF clinics can increase fertility cycle volume by up to 30% without adding to personnel, space and/or equipment costs. Our own INVO Centers also address capacity constraints by adding to the overall ART cycle capacity and doing so with comparable efficacy to IVF outcomes as well as at a lower per cycle price. Moreover, we believe that we are uniquely positioned to drive more significant growth in fertility treatment capacity in the future by partnering with existing OB/GYN practices. In the U.S., there are ~~emotional benefits~~an estimated 5,000 OB/GYN offices, many of which offer fertility services (usually limited to consultation and IUI, but not IVF). Since the IVC procedure requires a much smaller lab facility, less equipment and fewer lab personnel (in comparison to conventional IVF), it could potentially be offered as an extended service in an OB/GYN office. With proper training and a lighter lab infrastructure, the INVOcell could expand the business for these physicians and allow them to treat patients that are unable to afford IVF and provide patients with a more readily accessible, convenient, and cost-effective solution. With our three-pronged strategy (IVF clinics, INVO Centers and OB/GYN practices), in addition to lowering costs, we believe INVOcell and the ~~mother’s participation~~IVC procedure can address our industry’s key challenges, capacity and cost, by their ability to expand and decentralize treatment and increase the number of points of care for patients in need. This powerful combination of lower cost and added capacity has the potential to open up access to care for underserved patients around the world.

Greater patient involvement. With the IVC procedure, the patient uses their own body for fertilization, incubation, and early embryo development ~~by vaginal incubation compared~~which creates a greater sense of involvement, comfort, and participation. In some cases, this may also free people from barriers related to ~~that~~due to ethical or religious concerns, or fears of ~~conventional IVF treatment by offering patients a more connected and personalized method to achieve pregnancy.~~laboratory mix-ups.

For many couples struggling with infertility, access to treatment is often not available. Financial challenges (cost of treatment) and limited availability (or capacity) of fertility medical care are two of the main challenges in the ART marketplace that contribute to the large percentage of untreated patients. Religious, social and cultural roadblocks can also prevent hopeful couples from realizing their dream to have a baby with conventional IVF. We believe INVOcell can address many of the key challenges in the ART market, particularly patient cost and infrastructure capacity constraints. The many benefits to the INVO solution include:

~~In the second quarter of 2016, the first U.S. baby from the INVOcell and INVO Procedure following FDA clearance was born in Texas.~~

Our ~~product commercialization efforts are~~approach to market is focused on identifying ~~distributors and~~ partners within targeted geographic regions that we believe can best promote ~~market and sale~~support our efforts to expand access to advanced fertility treatment for the ~~INVOcell device and process~~large number of underserved infertile people hoping to ~~assist infertile couples in having~~have a baby. We believe that ~~our proven INVOcell~~the INVOcell-based IVC procedure is an effective ~~low-cost~~and affordable treatment option ~~which can also be offered without~~that greatly reduces the need for a more expensive IVF lab ~~facility.~~facilities and allows providers to pass on related savings to patients without compromising efficacy. We have been ~~authorized~~cleared to sell the INVOcell ~~device~~ in the United States since November 2015 after receiving de novo class II clearance from the ~~US Food & Drug Administration (“FDA”). As a result of our January 2019 exclusive sales, marketing and distribution agreement with Ferring for the U.S., our~~FDA. Our primary focus ~~will be~~over the past two years has been on ~~supporting Ferring and~~ establishing ~~INVO-clinics within~~INVO Centers in the U.S. ~~as well as developing key international markets~~and abroad to promote the INVOcell and the IVC procedure and acquiring existing U.S.-based IVF clinics where we can integrated the INVOcell. While we continue selling the INVOcell directly to IVF clinics and via distributors and other partners around the ~~world.~~world, we have transitioned INVO from being a medical device company to one that is mostly focused on providing fertility services.

We anticipate that we will experience quarterly fluctuations in our revenues as a result of our efforts to expand the sales of the INVO technology to new markets. We expect international sales will increase moving forward as we continue to expand our efforts to expand INVOcell globally. We will continue to seek out partners that will contractually commit to meeting agreeable performance objectives that are consistent with our goals and objectives.Ferring

On November 12, 2018, we entered into a U.S. Distribution Agreement (the ~~“Distribution~~“Ferring Agreement”) with Ferring International Center S.A. (“Ferring”), which ~~closed~~became effective on January 14, 2019. Pursuant to the ~~Distribution~~Ferring Agreement, among other things, we granted Ferring an exclusive license in the United States (the “Territory”) with rights to sublicense under patents related to our proprietary INVOcell™ intravaginal culture device together with the retention device and any other applicable accessories (collectively, the “Licensed Product”) to market, promote, distribute, and sell the Licensed Product with respect to all therapeutic, prophylactic and diagnostic uses of medical devices or pharmaceutical products involving reproductive technology (including infertility treatment) in humans (the “Field”).INVOcell. Ferring iswas responsible, at its own cost, for all commercialization activities for ~~the Licensed Product~~ in the United States. We retained a limited exception to the exclusive license granted to Ferring allowing us, subject to certain restrictions, to establish up to ~~establish up to~~ five ~~clinics that will commercialize~~ INVO ~~cycles~~Centers in the ~~U.S. This agreement was amended on~~United States, which as of March 2, 2021, was amended to ~~provide for added flexibility by increasing the number of INVO company-owned clinics initially allowable under the agreement and removing certain geographical requirements.~~seven centers. We retained all commercialization rights for the ~~Licensed Product~~INVOcell outside of the United States. ~~We believe~~

On November 2, 2021, Ferring notified us of its intention to terminate the ~~strategic partnership~~Ferring Agreement, which required 90-days prior written notice. Accordingly, the Ferring Agreement officially terminated on January 31, 2022. Pursuant to the terms of the Ferring Agreement, upon notice of termination, Ferring was required to use commercially reasonable efforts to transition any customers to us and otherwise facilitate the orderly transition of the distribution from Ferring to us. By its terms, our Supply Agreement with ~~a strong reproductive organization such as~~ Ferring ~~has provided us with the necessary sales and marketing resources and overall market credibility to help execute our goal to expand the INVOcell device around the world.~~also terminated on January 31, 2022.

The Ferring license was deemed to be a functional license that provides the counterparty with a “right to access” to our intellectual property during the subscription period and accordingly, revenue is recognized over a period of time, which is generally the subscription period. The likelihood of Ferring exercising its rights became remote at the time notice of termination was received, therefore INVO recognized the full remaining amount of the deferred revenue in the fourth quarter of fiscal year 2021. During the ~~twelve months~~years ended December 31, ~~2020,~~2022, and 2021, we recognized ~~$714,286,~~nil and $3.6 million of revenue related to the Ferring license ~~agreement.~~agreement, respectively, and, as of December 31, 2022, we had no deferred revenue related to the Ferring Agreement.

The following table sets forth a list of our current international distribution agreements:

As part of our commercialization strategy, we entered into a number of joint ventures and partnerships designed to establish new INVO Centers.

The following table sets forth a list of our current joint venture arrangements:

On March 10, 2021, our wholly owned subsidiary, INVO Centers, LLC (“INVO CTR”), entered into a limited liability company agreement with HRCFG, LLC (“HRCFG”) to form a joint venture for the purpose of establishing an INVO Center in Birmingham, Alabama. The name of the joint venture LLC is HRCFG INVO, LLC (the “Alabama JV”). The responsibilities of HRCFG’s principals include providing clinical practice expertise, performing recruitment functions, providing all necessary training, and providing day-to-day management of the clinic. The responsibilities of INVO CTR include providing certain funding to the Alabama JV and providing access to and being the exclusive provider of the INVOcell to the Alabama JV. INVO CTR will also perform all required, industry specific compliance and accreditation functions, and product documentation for product registration.

The Alabama JV is accounted for using the equity method in our consolidated financial statements. As of December 31, 2022 we invested $1.6 million in the Alabama JV in the form of a note. For the years ended December 31, 2022 and 2021, the Alabama JV recorded net losses of $0.3 million and $0.6 million, respectively, of which we recognized losses from equity method investments of $0.2 million and $0.3 million, respectively.

On June 28, 2021, INVO CTR entered into a limited liability company agreement (the “Bloom Agreement”) with Bloom Fertility, LLC (“Bloom”) to establish a joint venture entity, formed as “Bloom INVO LLC” (the “Georgia JV”), for the purposes of commercializing INVOcell, and the related IVC procedure, through the establishment of an INVO Center, (the “Atlanta Clinic”) in the Atlanta, Georgia metropolitan area.

The responsibilities of Bloom include providing all medical services required for the operation of the Atlanta Clinic. The responsibilities of INVO CTR include providing certain funding to the Georgia JV, lab services quality management, and providing access to and being the exclusive provider of the INVOcell to the Georgia JV. INVO CTR will also perform all required, industry specific compliance and accreditation functions, and product documentation for product registration.

The results of the Georgia JV are consolidated in our financial statements. As of December 31, 2022, INVO invested $0.9 million in the Georgia JV in the form of capital contributions as well as $0.5 million in the form of a note. For the years ended December 31, 2022 and 2021, the Georgia JV recorded net losses of $0.6 million and $0.4 million, respectively. Noncontrolling interest in the Georgia JV was $0. See Note 3 of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for additional information on the Georgia JV.

Effective September 24, 2020, INVO CTR entered into a Pre-Incorporation and Shareholders Agreement with Francisco Arredondo, MD PLLC (“Arredondo”) and Security Health LLC, a Texas limited liability company (“Ramirez”, and together with INVO CTR and Arredondo, the “Shareholders”) under which the Shareholders will commercialize the IVC procedure and offer related medical treatments in Mexico. Each party owns one-third of the Mexican incorporated company, Positib Fertility, S.A. de C.V. (the “Mexico JV”).

The Mexico JV is accounted for using the equity method in our consolidated financial statements. As of December 31, 2022, INVO invested $0.1 million in the Mexico JV. For the years ended December 31, 2022 and 2021, the Mexico JV recorded net losses of $0.1 million and $0.04 million, respectively, of which we recognized losses from equity method investments of $0.05 million and $0.01 million, respectively.

On November 23, 2020, we ~~had deferred revenues~~entered into a joint venture agreement with Ginekaliks Dooel (“Ginekaliks”), a limited liability company incorporated in the Republic of ~~$3,571,429 relating~~North Macedonia, to establish an exclusive joint venture to (i) commercialize, introduce, promote and market technologies related to the ~~Distribution~~INVOcell and IVC procedure in the Republic of North Macedonia, and (ii) establish an INVO Center. The joint venture will be co-managed and owned 50% by each of INVO and Ginekaliks. As of December 31, 2022, no joint venture entity had been formed.

On April 9, 2021, we entered into a partnership agreement (the “Lyfe Agreement”) with ~~Ferring.~~Lyfe Medical Center I, LLC (“Lyfe”) in connection with Lyfe’s intention to establish an INVO Center in the Bay Area of California (the “Bay Area Clinic”). Pursuant to the Lyfe Agreement, we will provide embryology laboratory services in connection with the IVC procedure and other fertility-related treatments (the “Lab Services”) to be provided by Lyfe to its patients at the Bay Area Clinic. Under the terms of the Lyfe Agreement, we will receive 40% of the net income received by the Bay Area Clinic for the performance of the Lab Services. As of December 31, 2022, the Bay Area Clinic was not yet operational.

In January and March 2023, we sold unsecured convertible notes of the Company in the aggregate original principal amount of $410,000 (the “Convertible Notes”) with a fixed conversion prices of $0.50 (for the $275,000 of January 2023 Notes) and $0.60 (for the $135,000 of March 2023 Notes) and (ii) 5-year warrants (the “Note Warrants”) to purchase 387,500 shares of the Company’s common stock at an exercise price of $1.00 (subject to adjustments) (the “Note and Warrant Private Placement”). The proceeds were used for working capital and general corporate purposes.

Interest on the Convertible Notes accrues at a rate of ten percent (10%) per annum and is payable at the holder’s option either in cash or in shares of the Company’s common stock at the conversion price set forth in the Convertible Notes on December 31, 2023, unless converted earlier.

All amounts due under the Convertible Notes are convertible at any time after the issuance date, in whole or in part (subject to rounding for fractional shares), at the option of the holders into the Company’s common stock at a fixed conversion price for the Notes as described above.

Upon any issuance by the Company of any of its equity securities in an underwritten offering, including Common Stock, for cash consideration, indebtedness or a combination thereof after the date hereof (a “Subsequent Equity Financing”), each holder shall have the option to convert the outstanding principal and accrued but unpaid interest of its Convertible Note into the number of fully paid and non-assessable shares of securities issued in the Subsequent Equity Financing equal to the product of unpaid principal, together with the balance of unpaid and accrued interest and other amounts payable hereunder, divided by the price per share paid by the investors in the Subsequent Equity Financing multiplied by 80%, provided however, that any conversion shall only be allowed if the Subsequent Equity Financing conversion price is equal to or greater than the Minimum Price (as defined in the Convertible Notes) including an appropriate allocation any warrants offered.

The Company may prepay the Convertible Notes at any time in whole or in part by paying a s sum of money equal to 100% of the principal amount to be redeemed, together with accrued and unpaid interest.

Pursuant to the February Debentures, interest on the February Debentures accrues at a rate of eight percent (8%) per annum and is payable at maturity, one year from the date of the February Debentures.

The Company may prepay the February Debentures at any time in whole or in part by paying a sum of money equal to 105% of the principal amount to be redeemed, together with accrued and unpaid interest.

While any portion of each February Debenture remains outstanding, if the Company receives cash proceeds of more than $2,000,000 (the “Minimum Threshold”) in the aggregate from any source or series of related or unrelated sources, the February Investors shall have the right in their sole discretion to require the Company to immediately apply up to 50% of all proceeds received by the Company above the Minimum Threshold to repay the outstanding amounts owed under the February Debentures.

The Company entered into a Registration Rights Agreement (the “February RRA”) with the February Investor that signed its purchase agreement on February 3, 2023 (the “Feb 3 Investor”). Pursuant to the terms of February RRA, the Company has agreed to file with the SEC an initial registration statement on Form S-3 (or Form S-1 if S-3 is not available) covering the resale of all of the securities acquired by the Feb 3 Investor under its February Purchase Agreement. The filing of such initial registration statement is to occur within 90 days of February 3, 2023.

On April 3, 2023, having received notice from the Feb 3 requesting repayment of its February Debenture, the Company paid the Feb 3 Investor $213,879, including interest and the prepayment premium. After such payment, the principal due the Feb 3 Investor under its debenture was reduced from $300,000 to $100,000.

On February 3, 2023, the Company entered into an equity purchase agreement (the “ELOC”) and registration rights agreement (the “ELOC RRA”) with the Feb 3 Investor pursuant to which the Company has the right, but not the obligation, to direct the Feb 3 Investor to purchase up to $10.0 million (the “Maximum Commitment Amount”) of shares of Common Stock, in multiple tranches. Further, under the ELOC and subject to the Maximum Commitment Amount, the Company has the right, but not the obligation, to submit notices to the Feb 3 Investor to purchase shares of Common Stock (i) in a minimum amount of not less than $25,000 and (ii) in a maximum amount of up to the lesser of (a) $750,000 or (b) 200% of the Company’s average daily trading value of the Common Stock.

Also on February 3, 2023, the Company issued to the Feb 3 Investor 150,000 shares of Common Stock for its commitment to enter into the ELOC.

Execution of Definitive Agreements to Acquire the Wisconsin Fertility Institute

On March 16, 2023, INVO, through Wood Violet Fertility LLC, a Delaware limited liability company (“Wood Violet”) and wholly owned subsidiary of INVO Centers LLC, a Delaware company (“INVO CTR”) wholly-owned by INVO, entered into binding purchase agreements to acquire Wisconsin Fertility Institute ( “Wisconsin Fertility”) for a combined purchase price of $10 million.

OnUnder the March ~~2, 2021, we entered~~Purchase Agreement, the Company is required within 30 days of the closing date of the offering to file a registration statement on Form S-1 (the “Resale Registration Statement”) registering the resale of the shares of Common Stock issuable upon the exercise of the March Warrants. The Company is required to use commercially reasonable efforts to cause such registration to become effective within 75 days of the closing date of the offering (or 120 days if the registration statement is subject to a full review by the SEC), and to keep such registration statement effective at all times until no March Warrants remain outstanding.

In addition, pursuant to certain “lock-up” agreements, our officers and directors have agreed, for a period of 180 days from the date of the offering, not to engage in any of the following, whether directly or indirectly, without the consent of the March Purchase Agreement investor: offer to sell, sell, contract to sell pledge, grant, lend, or otherwise transfer or dispose of our common stock or any securities convertible into ~~Amendment No. 1~~or exercisable or exchangeable for Common Stock (the “Lock-Up Securities”); enter into any swap or other arrangement that transfers to another, in whole or in part, any of the economic consequences of ownership of the Lock-Up Securities; make any demand for or exercise any right or cause to be filed a registration statement, including any amendments thereto, with respect to the ~~Distribution Agreement~~registration of any Lock-Up Securities; enter into any transaction, swap, hedge, or other arrangement relating to any Lock-Up Securities subject to customary exceptions; or publicly disclose the intention to do any of the foregoing.

On November 23, 2022, we received notice (the ~~“Amendment”~~“Stockholders’ Equity Notice”) from The Nasdaq Stock Market LLC (“Nasdaq”) advising us that we were not in compliance with ~~Ferring.~~ the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(1) requires companies listed on The Nasdaq Capital Market to maintain stockholders’ equity of at least $2,500,000 (the “Stockholders’ Equity Requirement). In our Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, we reported stockholders’ equity of $1,287,224, which is below the Stockholders’ Equity Requirement for continued listing. Additionally, as of the date of the Notice, we did not meet either of the alternative Nasdaq continued listing standards under the Nasdaq Listing Rules, market value of listed securities of at least $35 million, or net income of $500,000 from continuing operations in the most recently completed fiscal year, or in two of the three most recently completed fiscal years.

Pursuant to the ~~Amendment, Ferring agreed~~Notice, Nasdaq gave us 45 calendar days, or until January 7, 2023, to ~~purchase~~submit to Nasdaq a ~~2,004 count~~plan to regain compliance. If our plan is accepted, Nasdaq may grant an extension of ~~product for $501,000 pursuant~~up to 180 calendar days from the date of the Notice to evidence compliance.

On January 18, 2023, we received a letter from Nasdaq under which it stated that based on our submission that Nasdaq has determined to grant us an extension of time to regain compliance with Nasdaq Listing Rule 5550(b) until May 22, 2023. We must furnish to the ~~Distribution Agreement~~SEC and Nasdaq a publicly available report (e.g. a Form 8-K) which report, among other things, includes a description of the completed transaction or event that enabled us to satisfy the stockholders’ equity requirement for continued listing After filing the publicly available report described above, if we fail to evidence compliance upon filing its periodic report for the June 30, 2023, with the SEC and Nasdaq, we may be subject to delisting. In the event we do not satisfy these terms, Nasdaq will provide written notification that its securities will be delisted. At that time, we may appeal Nasdaq’s determination to a Hearings Panel.

On January 11, 2023, we received a letter from the staff (the “Staff”) of Nasdaq listing qualifications group indicating that, based upon the closing bid price of our common stock for the last 30 consecutive business days, we were not in ~~March 2021, at which point~~compliance with the requirement to maintain a minimum bid price of $1.00 per share for continued listing under Nasdaq Listing Rule 5550(a)(2).

The notice has no immediate effect on the listing of our common stock, and our common stock will continue to trade on The Nasdaq Capital Market under the symbol “INVO.”

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been provided an initial period of 180 calendar days, or until July 10, 2023, to regain compliance with the minimum ~~annual target~~bid price requirement. If at any time before July 10, 2023, the closing bid price of our common stock closes at or above $1.00 per share for ~~2020 set forth in Section 2.4~~a minimum of 10 consecutive business days, Nasdaq will provide written notification that we have achieved compliance with the ~~Distribution Agreement~~minimum bid price requirement, and the matter would be resolved. If we do not regain compliance prior to July 10, 2023, then Nasdaq may grant us a second 180 calendar day period to regain compliance, provided we (i) meets the continued listing requirement for market value of publicly-held shares and all other initial listing standards for The Nasdaq Capital Market, other than the minimum closing bid price requirement, and (ii) notifies Nasdaq of its intent to cure the deficiency within such second 180 calendar day period, by effecting a reverse stock split, if necessary.

We will ~~be deemed~~continue to ~~be satisfied in full as a result~~monitor the closing bid price of ~~such purchase. The Amendment provides for added flexibility by increasing~~our common stock and will consider implementing available options to regain compliance with the ~~number of INVO company-owned clinics initially allowable~~minimum bid price requirement under the ~~agreement and removing certain geographical~~Nasdaq Listing Rules. If we do not regain compliance with the minimum bid price requirement within the allotted compliance periods, we will receive a written notification from Nasdaq that its securities are subject to delisting. We would then be entitled to appeal that determination to a Nasdaq hearings panel. There can be no assurance that we will regain compliance during either compliance period or maintain compliance with the other Nasdaq listing requirements.

Fiscal year 2022 was an important year of advancement for the Company. Our initial three INVO Centers made steady progress in their first full year of operations, we took significant steps in the development of additional INVO Centers, and we added an acquisition strategy targeting existing, smaller IVF clinics in the U.S. to accelerate INVO’s growth. We ~~operate with~~also continued the fine-tuning of our marketing approach to build awareness for INVOcell and the IVC procedure, and to increase patient flow for our INVO Centers and IVF clinic partners alike.

We are especially excited by the recent signing of definitive documents for our first acquisition of an existing IVF clinic. We expect to close the transaction in the second quarter of 2023 and, in doing so we would be adding a ~~core internal team~~substantial operation in terms of revenue and ~~outsource certain operational functions~~profit to our overall business. Looking ahead, we anticipate opening additional INVO Centers in ~~order to help accelerate our efforts~~key domestic, and select international, markets, as well as ~~reduce fixed internal overhead needs and in-house capital equipment requirements. Our most critical management and leadership functions are carried out by our core management team.~~pursuing additional acquisition candidates. We have ~~contracted out~~selected an initial list or about 20 markets in the ~~manufacturing, assembly, packaging, labeling~~U.S. that we believe are excellent potential locations for an INVO Center, and ~~sterilization~~we believe the universe of suitable acquisition targets for INVO exceeds 80 clinics in the U.S.. We also continue to work on the expansion of INVOcell distribution into existing fertility clinics. In early 2022, we re-assumed control of the ~~device~~U.S. market distribution efforts with the termination of the Ferring Agreement and elected to sell directly ourselves (rather than through a ~~medical manufacturing company~~distributor) to the existing, established fertility clinics. Through these efforts we have experienced both growing interest in our INVOcell solution and in the potential by these clinics of being acquired by INVO.

From a market strategy perspective, our commercialization efforts continue to focus on the substantial, underserved patient population and on expanding access to advanced fertility treatments. We believe our solutions can help address the key challenges of affordability and capacity to provide care to the vast number of patients that go untreated every year. This represents the major opportunity for INVOcell and the IVC procedure it enables. The fertility industry has and continues to expand, even during the global pandemic, and we believe our growing volume of partners (both distributors and JVs) and our acquisition strategy affords us a ~~sterilization specialist~~strong forward-looking outlook. We believe our INVO Center approach adds much needed capacity and affordability, and we expect our acquisition strategy to ~~perform~~allow for ART cycle volume increases at existing clinics. These efforts align with our key mission to open access to care to the ~~gamma sterilization process.~~underserved.

The ART market also continues to benefit from a number of industry tailwinds, including 1) the large under-served potential patient population, 2) increasing infertility rates around the world 3) growing awareness and education of fertility treatment options, 4) a growing acceptance of fertility treatment, 5) improvements in procedure techniques and hence improvements in pregnancy success rates and 6) generally improving insurance (private and public) reimbursement trends.

Revenue for the years ended December 31, 2022 and 2021 was $0.8 million and $4.2 million, respectively, representing a decrease of approximately $3.4 million, or 80% in the year ended December 31, 2022. The decrease was due to the termination of our ~~most significant challenge~~agreement with Ferring, which resulted in ~~growing our business has been our limited resources. Beginning~~the full recognition, in ~~2019, as a result~~2021, of the remaining $3.6 million in deferred revenue related to the Ferring agreement and ~~upfront payment, we expanded our sales~~was partially offset by an increase in 2022 clinic revenue. Excluding Ferring, revenue was $0.6 million last year compared to $0.8 million this year.

Gross profit for the years ended December 31, 2022 and ~~marketing efforts~~2021 was $0.5 million and ~~regulatory~~$4.0 million, respectively. Gross margin was 60% and ~~clinical development activities. Our cash needs are primarily~~97% for the years ended December 31, 2022 and 2021, respectively. The decrease in gross margin was attributable to funding our sales and marketing efforts, strengthening our training capabilities, satisfying existing obligations, funding our planned clinical trial for additional indications for use, building an administrative infrastructure, and costs and professional fees associated with beingthe change in revenue mix as we no longer have license revenue in 2022, as well as increase in clinic revenue which has lower percentage margins, but much higher revenue on a ~~public company. We currently expect our existing distribution and partnership agreements, such as that with Ferring~~per procedure basis and the ~~other more recent agreements with non-U.S. companies to provide increased revenue in the future, which we expect will help offset the~~potential for higher ~~level of spending.~~margins on an absolute dollar basis.

Selling, general and administrative expenses ~~were $6,062,874 and $3,123,875~~ for the years ended December 31, ~~2020~~2022 and ~~2019, respectively.~~2021 were $10.6 million and $9.0 million, respectively, of which $2.2 million and $2.7 million, respectively, was for non-cash, stock-based compensation expense. The ~~$2,938,999~~ increase ~~in selling, general and administrative expenses in 2020~~of approximately $1.6 million or 17% was primarily the result of approximately $1.0 million in increased personnel expense, approximately $0.7 million in increased expenses related to the full-year operations of the consolidated Georgia JV, approximately $0.4 million in increased marketing spend and was partially offset by an approximate $0.3 million decrease in legal and startup costs related to new and potential INVO Centers and an approximate $0.6 million decrease in professional fees.

We began to fund additional research and development (“R&D”) efforts in 2020 as part of our 5-day label expansion efforts. R&D expenses were $0.5 million and $0.2 million, for the years ended December 31, 2022 and 2021, respectively. The increase of approximately $0.3 million was primarily related to our FDA response efforts on the 5-day label expansion.

Loss from equity investments for the years ended December 31, 2022 and 2021, was $0.2 million and $0.3, respectively. The decrease in loss is due to the Alabama JV and Mexico JV being in start-up mode and operational for only a portion of 2021.

Other income for the years ended December 31, 2022 and 2021, was nil and $0.2 million, respectively. The decrease of $0.2 million was the result of our Paycheck Protection Program note and related interest being forgiven in 2021.

Interest expense and financing fees were for the years ended December 31, 2022 and 2021 were $0.1 million and $1.3 million, respectively. The decrease of approximately $1.2 million, or approximately 96%, was primarily due to a decrease in non-cash amortization of discount, debt issuance cost and interest on convertible notes.

As of December 31, 2022, we had unused federal net operating loss carryforwards (“NOLs”) of $32.8 million. These losses expire in various amounts at varying times beginning in 2027 with a portion carrying on indefinitely. Unless expiration occurs, these NOLs may be used to offset future taxable income and thereby reduce our income taxes.

We recorded a valuation allowance against our deferred tax assets at December 31, 2022 and 2021 totaling $9.3 million and $6.8 million, respectively.

For the years ending December 31, 2022, and 2021, we had net losses of approximately $10.9 million and $6.7 million, respectively. The increase in net loss primarily was due to the increase in operating loss resulting from the absence of license revenue in 2022 and an increase in ~~wages as we expanded our internal team, professional fees, legal fees, and increased our spending on expanded label efforts. However, $1,756,991~~operating expenses. Approximately $3.0 million of ~~this increase is~~the net loss was related to non-cash expenses for the year ended December 31, 2022, compared to $4.2 million for the year ended December 31, 2021. We had negative working capital of approximately $2.8 million as of December 31, 2022, compared to positive working capital of approximately $5.1 million as of December 31, 2021. As of December 31, 2022, we had negative stockholder’s equity of approximately $1.0 million compared to positive stockholder’s equity of approximately $7.3 million as of December 31, 2021. Cash used in operations for the year of 2022 was approximately $6.6 million, compared to approximately $6.0 million for the year of 2021.

We have been dependent on raising capital through debt and equity financings to secure the cash required to fund our operating expenses and investing activities. During 2021, we received proceeds of approximately $3.7 million from the sale of common stock, ~~compensation~~we converted approximately $1.5 million of outstanding debt to equity and ~~stock~~received approximately $0.4 million of proceeds from unit purchase option ~~expense.~~and warrant exercises. During 2022, we received proceeds of $0.8 million from demand notes and net proceeds of approximately $0.3 million for the sale of our common stock. Over the next 12 months, our plan includes opening additional INVO Centers, completing the acquisition of Wisconsin Fertility Institute and pursuing additional IVF clinic acquisitions. Until we can generate a sufficient amount of cash from operations, we will need to raise additional funding to meet our liquidity needs and to execute our business strategy. As in the past, we will seek debt and/or equity financing, which may not be available on reasonable terms, if at all.

Although our audited consolidated financial statements for the ~~period 2019~~year ended December 31, 2022 were prepared under the assumption that we would continue operations as a going concern, the report of our independent registered public accounting firm that accompanies our consolidated financial statements for the year ended December 31, 2022 contains a going concern qualification in which such firm expressed substantial doubt about our ability to ~~2020~~continue as a going concern, based on the consolidated financial statements at that time. Specifically, as noted above, we have incurred ~~annual net~~significant operating losses asand we ~~continued to market our product and proprietary process as we endeavored to increase our revenue base. We~~ expect to continue ~~incurring~~to incur significant expenses and operating losses ~~during 2021~~ as we continue to ~~invest in~~ramp up the development of new INVO ~~clinics in the U.S.~~Centers and the ~~global expansion~~commercialization of our ~~business~~INVOcell solution Prior losses and ~~INVOcell technology.~~

~~We cannot accurately predict the level of success our key partners will enjoy over the next 12-24 months. However, we anticipate that we~~expected future losses have had, and will continue to ~~launch~~have, an adverse effect on our financial condition. If we cannot continue as a going concern, our stockholders would likely lose most or all of their investment in us.

The following table shows a summary of our cash flows for the ~~INVOcell device~~year ended December 31:

As of December 31, 2022, we had approximately $0.09 million in cash compared to approximately $5.7 million as of December 31, 2021. Net cash used in operating activities in 2022, was approximately $6.6 million, compared to approximately $6.0 million for the same period in 2021. The increase in net cash used in operations was primarily due to the increase in operating expenses.

During the year ended December 31, 2022, cash used in investing activities of approximately $0.1 million was primarily related to investments in support of our INVO Center joint ventures. During the year ended December 31, 2021, cash used in investing activities of approximately $2.2 million was primarily related to payments to acquire equipment for and to investments for the start-up and initial operation of our INVO ~~Procedure within~~Center joint ventures.

During the ~~U.S. through our agreement with Ferring,~~year ended December 31, 2022, cash provided by financing activities of approximately $1.1 million was related to proceeds from demand notes and ~~in other parts~~from the sale of common stock. During the ~~world with new distributor partnerships~~year ended December 31, 2021, cash provided by financing activities of approximately $3.8 million was primarily related to proceeds from the sale of common stock and ~~joint venture agreements.~~the exercise of unit purchase options and warrants.

From October through December 2022, we received $0.45 million through the issuance of demand notes from a related party, JAG Multi Investments LLC (“JAG”). Our CFO is a beneficiary of JAG but does not have any control over JAG’s investment decisions with respect to INVO. If paid prior to January 31, 2023, the demand notes are interest free until December 31, 2022. For any amount that remains outstanding past January 31, 2023, 10% annual interest would accrue from the date of issuance. At maturity, we agreed to pay outstanding principal, a 10% financing fee and accrued interest, if any. The demand notes are callable with 10 days prior written notice, beginning on or after March 31, 2023.

In addition, in the fourth quarter of 2022, we received $0.3 million through the issuance of demand promissory notes of which (1) $0.1 million was received from our Chief Executive Officer, Steven Shum, (2) $0.1 million was received from an entity controlled by our Chief Financial Officer, Andrea Goren and (3) $0.1 million was received from nonrelated parties.

The discussion and analysis of ~~INVO Bioscience’s~~our financial condition presented in this section ~~are~~is based upon ~~the~~our audited consolidated financial statements, ~~of INVO Bioscience,~~ which have been prepared in accordance with ~~the~~ generally accepted accounting principles in the United States. During the preparation of the financial statements, ~~INVO Bioscience is~~we are required to make estimates and judgments that affect the reported amounts of assets, liabilities, ~~revenues~~revenue and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, ~~INVO Bioscience evaluates~~we evaluate, based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, ~~the~~our results, of which allows us to form ~~the~~a basis for making judgments ~~about~~on the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates ~~under different~~based on variance with our assumptions orand conditions. A summary of significant accounting policies is included below. Management believes that the application of these policies on a consistent basis enables us to provide useful and reliable financial information about our operating results and financial condition.

See Note 1 of the Notes to Consolidated Financial Statements included in Item 8 of this Annual Report on Form 10-K for a summary of significant accounting policies and the effect on our consolidated financial statements.

~~The Company accounts~~We account for stock-based compensation under the provisions of ASC 718-10 Share-Based ~~Payment~~Payment. ~~(formerly SFAS 123R).~~ This statement requires ~~the Company~~us to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period in which the employee is required to provide service or performance goals in exchange for the award, which is usually immediate but sometimes over a vesting period. Warrants granted to non-employees are recorded as an expense over the requisite service period based on the grant date and the estimated fair value of the grant, which is determined using the Black-Scholes option pricing model.

~~The Company recognizes~~We recognize revenue on arrangements in accordance with ASC 606, Revenue from Contracts with ~~Customers (“ASC 606”).~~Customers. The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services ASC 606 requires companies to assess their contracts to determine the timing and amount of revenue to recognize under the new revenue standard. The model has a five-step approach:

~~In July 2017, FASB issued ASU 2017-11 (Part I) Accounting for Certain Financial Instruments~~Our consolidated financial statements include the accounts of INVO Bioscience, Inc., its wholly owned subsidiaries, and variable interest entities (“VIE”), where we are the primary beneficiary under the provisions of ASC 810, Consolidation (“ASC 810”). A VIE must be consolidated by its primary beneficiary when, along with ~~Down Round Features, (Part II) Replacement~~its affiliates and agents, the primary beneficiary has both: (i) the power to direct the activities that most significantly impact the VIE’s economic performance; and (ii) the obligation to absorb losses or the right to receive the benefits of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (“ASU 2017-11”). The new standard simplifies the accounting for certain financial instruments with down round features. Part I of ASU 2017-11 changes the classification analysis of certain equity-linked financial instruments, such as warrants and embedded conversion features, suchVIE that a down round feature is disregarded when assessing whether the instrument is indexed to an entity’s own stock under Subtopic 815-40, Contracts in Entity’s Own Equity. As a result, a down round feature, by itself, no longer requires an instrument tocould potentially be re-measured at fair value through earnings each period, although all other aspects of the indexation guidance under Subtopic 815-40 continue to apply. Part II of ASU 2017-11 re-characterizes the indefinite deferral of certain provisions of Topic 480, Distinguishing Liabilities from Equity, (currently presented as pending content in the Codification) as a scope exception. No change in practice is expected as a result of these amendments. The new standard is effective for fiscal years beginning after December 15, 2018, early adoption is permitted. The amendments in Part II have no accounting impact and therefore do not have an associated effective date. The Company decided to early adopt this ASU 2017-11 and applied itsignificant to the ~~convertible notes it issued during the year which are reflected in this Form 10K.~~~~Compensation~~ – ~~Stock Compensation (Topic 718): Scope of Modification Accounting.~~ ~~In May 2017, the FASB issued ASU No. 2017-09 which was issued to clarify~~VIE. We reconsider whether an entity is still a VIE only upon certain triggering events and reduce both (i) diversity in practice and (ii) cost and complexity when applying the guidance in Topic 718, “Compensation – Stock Compensation” to changes in the terms and conditions of a share-based payment award. This update is effective for the Company in the fiscal year beginning October 1, 2018. The adoption of this standard is not expected to have a material impact on the Company’scontinually assesses its consolidated ~~financial position, results of operations, or cash flows.~~

~~Leases (Topic 842).~~ In February 2016, FASB issued ASU 2016-02, Leases (“ASU 2016-02”). The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available.

The Company adopted the standard effective January 1, 2019. The standard allows a number of optional practical expedients to use for transition. The Company choose the certain practical expedients allowed under the transition guidance which permitted us to not to reassess any existing or expired contractsVIEs to determine if ~~they contain embedded leases,~~it continues to not to reassess our lease classification on existing leases, to account for lease and non-lease components as a single lease component for equipment leases, and whether initial direct costs previously capitalized would qualify for capitalization under FASB ASC 842. The new standard also provides practical expedients and recognition exemptions for an entity’s ongoing accounting policy elections. The Company has electedbe the ~~short-term lease recognition for all leases that qualify,~~primary beneficiary.

Investments in unconsolidated affiliates in which ~~means that~~ we exert significant influence but do not ~~recognize a ROU asset and lease liability~~control or otherwise consolidate are accounted for ~~any lease with a term of twelve months or less.~~

~~The most significant impact of adopting~~using the ~~standard was~~equity method. Equity method investments are initially recorded at cost. These investments are included in investment in joint ventures in the ~~recognition of ROU assets and lease liabilities for operating leases on the Company’s~~accompanying consolidated balance ~~sheet but it did not have an impact on~~sheets. Our share of the ~~Company’s~~profits and losses from these investments is reported in loss from equity method investment in the accompanying consolidated statements of ~~operations or consolidated statements of cash flows. The Company did not have a cumulative effect on adoption prior to January 1, 2019.~~

~~Intangibles~~ – ~~Goodwill and Other (Topic 350): Simplifying the Test~~operations. Management monitors its investments for ~~Goodwill Impairment~~~~. In January 2017, the FASB issued ASU 2017-04 which simplifies the test for goodwill~~other-than-temporary impairment by ~~eliminating Step 2 from~~considering factors such as current economic and market conditions and the Goodwill impairment test. This new guidance is effective for the Company beginning in fiscal year 2021. The adoption of this standard is not expected to have a material impact on the Company’s financial statements.

Management does not believe that any other recently issued but not yet effective accounting standards, if currently adopted, would have a material effect on the accompanying condensed consolidated financial statements.

Fiscal year 2020 was impacted by the COVID-19 global pandemic, which affected the overall fertility industry as well as impacted some of our key partners and their efforts. However, we also believe important progress was made during the year that will help drive overall awareness and future expansion of INVOcell within key markets. This includes: 1) the availability of additional, real world (retrospective) data demonstrating quality patient outcomes with INVOcell, which further builds confidence and credibility around the technology, 2) the signing of additional distribution and joint venture agreements, 3) the addition of key personnel, and 4) the completion of a major public financing which provides the necessary working capital to execute on our growth and global market expansion efforts. While the ongoing pandemic may continue to impact 2021 and impede certain progress in some markets, the fertility industry has and continues to work toward a return to normal levels and we believe our expanded number of partners and active markets affords us a strong forward looking outlook.

The Assisted Reproductive Technology (“ART”) market also continues to benefit from a number of industry tailwinds, including 1) the large under-served potential patient population, 2) increasing infertility rates around the world 3) growing awareness and education of fertility treatment options, 4) a growing acceptance toward fertility treatment, 5) improvements in procedure techniques and hence improvements in pregnancy success rates and 6) generally improving insurance (private and public) reimbursement trends; all of which should help contribute to strong industry growth and patient demand for treatment. As a result of these dynamics, we feel INVO Bioscience and its novel technology solution are well positioned.

~~Comparison~~operating performance of the ~~years ended December 31, 2020~~investees and ~~2019~~records reductions in carrying values when necessary.

~~Revenue for year ended December 31, 2020 was $1,037,286, compared to $1,480,213 for the ended December 31, 2019. The decrease was the result of a decline in product sales to Ferring.~~None.

However, pursuant to an amendment we entered into subsequent to the year end, Ferring placed a $501,000 order in March 2021, which we agreed would satisfy Ferring’s minimum purchase requirements for 2020.

Gross profit for the year ended December 31, 2020 was $948,526 compared to $1,340,543 for the year ended December 31, 2019. Gross margins were 91% and 91% for the years ended December 31, 2020 and 2019, respectively.

Selling, general and administrative expenses for the year ended December 31, 2020 were $6,065,066, compared to $3,128,635 for the year ended December 31, 2019. The increase of $2,936,431 or 94% was primarily the result of an increase in personnel, stock-based compensation, marketing and other corporate expenses. Approximately $1,756,991 of this increase is related to non-cash stock compensation and stock option expense.

We began to fund additional research and development (“R&D”) efforts in 2020 as part of our 5-day label expansion efforts, and also submitted additional trademark and patent filings. Excluding the investment in inventory in anticipation of clinical trials and patents, R&D expenses were $398,426 for the year ended December 31, 2020. During 2019 we did not fund any R&D.

Interest expense and financing fees were $2,836,504 for the year ended December 31, 2020, compared to $387,646 for the year ended December 31, 2019. The increase of $2,448,858, or approximately 632%, was primarily due to an increase in amortization of discount, debt issuance cost and interest on the 2020 Convertible Notes and was a non-cash related expense.

As of December 31, 2020, we had unused federal net operating loss carryforwards (“NOLs”) of $21,819,421. These losses expire in various amounts at varying times beginning in 2027 with a portion carrying on indefinitely. Unless expiration occurs, these NOLs may be used to offset future taxable income and thereby reduce our income taxes otherwise payable.

We recorded a valuation allowance against our deferred tax assets at December 31, 2020 and 2019 totaling $6,408,401 and $4,401,714, respectively. The valuation allowance has been established for certain deferred tax assets for which we believe it is more likely than not that the tax benefits will not be realized, which are primarily federal and state net operating loss carryforwards. If our expectations for future operating results on a consolidated basis or at the state jurisdiction level vary from actual results due to changes in healthcare regulations, general economic conditions, or other factors, we may need to adjust the valuation allowance, for all or a portion of our deferred tax assets. Our income tax expense in future periods will be reduced or increased to the extent of offsetting decreases or increases, respectively, in our valuation allowance in the period when the change in circumstances occurs. These changes could have a significant impact on our future earnings.

For the years ended December 31, 2020 and 2019, we had net losses of $8,347,316 and $2,167,544, respectively. The increase in net loss was due to increased operating expenses and interest expense. Approximately $2,626,220 of this increase was related to non-cash equity and debt amortization expenses as well as $1,756,991 of equity compensation. As of December 31, 2020, we had working capital of $8,254,540, compared to $42,330 as of December 31, 2019. As of December 31, 2020, our stockholders’ equity was $5,743,106, compared to a stockholders’ deficit of $3,713,595 as of December 31, 2019. Cash used in operations was $4,775,148 for the year ended December 31, 2020, compared to cash provided by operations of $1,370,513 for the year ended December 31, 2019.

During 2020, we raised $13.8 million in debt and equity financings. Based on our current plan, we believe we have sufficient liquidity for at least the next 12 months. To the extent additional funds are necessary to meet our longer-term liquidity needs to execute our business strategy, we may need to raise additional funding by way of debt or equity financings or a combination of these potential sources of funds, although we can provide no assurance that these sources of funding will be available on reasonable terms.

Historically, our primary sources of liquidity have been from equity or debt offerings and up-front distribution licensing fees. Until we can generate a sufficient amount of cash from operations, we may need to finance future cash needs through public or private equity or debt offerings. Additional capital may not be available on reasonable terms, if at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly scale back our operations or delay, scale back or discontinue the continuing development of our products. If we raise additional funds through the issuance of additional debt or equity securities, it could result in dilution to our existing stockholders and increased fixed payment obligations, and these securities may have rights senior to those of our common stock. If we incur indebtedness, we could become subject to covenants that would restrict our operations, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects.

~~The following table shows a summary of our cash flows for the years ended December 31, 2020 and 2019, (in thousands):~~

As of December 31, 2020, we had $10,097,760 in cash compared to $1,238,585 on December 31, 2019. Net cash used in operating activities in 2020 was $4,775,148, as compared to net cash provided by operating activities of $1,370,513 for 2019. The increase in net cash used in operations was primarily due to the increase in net loss and a decrease in deferred revenue as a result of the initial exclusive license and distribution agreement fee we received in January 2019.

In 2020, cash used in investing activities of $187,254 related to new molds, additional trademarks and investment to establish joint ventures. In 2019, cash used in investing activities of $114,706 related to new molds and trademarks.

During 2020, cash provided by financing activities of $13,821,577 primarily related to the public offerings of equity and convertible notes. In 2019, cash used by financing activities of $229,465 primarily related to principal payments on notes payable.

Under SEC regulations, we are required to disclose our off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on our financial condition, such as changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to investors. An off-balance sheet arrangement means a transaction, agreement or contractual arrangement to which any entity that is not consolidated with us is a party, under which we have:

We do not have any off-balance sheet arrangements that we are required to disclose pursuant to these regulations. In the ordinary course of business, we enter into operating lease commitments, purchase commitments and other contractual obligations. These transactions are recognized in our financial statements in accordance with generally accepted accounting principles in the United States.

~~We believe that inflation has not had a material effect on our operations to date.~~

We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not required to provide the information required under this item.

We will be exposed to risk from changes in foreign currency exchange rates related to our foreign joint ventures. Our principal exchange rate exposure relates to the ~~Malaysian Ringgit, the North Macedonian Denar, the~~ Mexican ~~Peso and the Indian Rupee.~~Peso.

We have audited the accompanying consolidated balance sheets of INVO Bioscience, Inc. (the Company) as of December 31, ~~2020~~2022 and ~~2019,~~2021, and the related consolidated statements of operations, stockholders’ equity ~~(deficiency)~~(deficit), and cash flows for each of the years in the two-year period ended December 31, ~~2020,~~2022, and the related notes (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, ~~2020~~2022 and ~~2019,~~2021, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, ~~2020,~~2022, in conformity with accounting principles generally accepted in the United States of America.

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the financial statements, the Company has suffered net losses from operations and has a net capital deficiency, which raises substantial doubt about its ability to continue as a going concern. Management’s plans regarding those matters are discussed in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

The critical audit ~~matter~~matters communicated below ~~is a matter~~are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) ~~relates~~relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the financial statements, taken as a whole, and we are not, by communicating the critical audit ~~matter~~matters below, providing separate opinions on the critical audit ~~matter~~matters or on the accounts or disclosures to which ~~it relates.~~they relate.

As discussed in Note 21 & 3 to the financial statements, ~~due to~~ the ~~net loss~~Company has material investments in consolidated and ~~negative cash flows from operations for the year, the~~unconsolidated entities. The Company evaluated the need ~~for~~to consolidate as a ~~going concern.~~VIE or equity investment under the provisions of ASC 810 and ASC 323, respectively.

Auditing management’s evaluation of ~~a going concern can be a~~the need to consolidate the entities associated with the investments involves significant judgment, given the fact that the agreements require management’s evaluation ownership percentages, influence, control and whether or not the Company ~~uses management estimates on future revenues and expenses which are not able to be easily substantiated.~~is the primary beneficiary.

To evaluate the appropriateness and accuracy of the ~~lack~~assessment by management, we evaluated management’s assessment in relationship to their application of ~~going concern paragraph~~the guidance outlined in ~~our audit opinion, we examined~~ASC 810 and ~~evaluated the financial information that was the initial cause for this consideration along with management’s plans to mitigate the going concern and management’s disclosure on going concern.~~ASC 323.

The accompanying notes are an integral part of these consolidated financial statements.

							2022			2021
	For the Year Ended December 31,						For the Years
	2020			2019			Ended December 31,
							2022			2021
Revenue:
Product revenue	$	323,000		$	765,927		$	207,342			544,942
Clinic revenue								614,854			43,745
License revenue		714,286			714,286			-			3,571,429

Total revenue	$	1,037,286		$	1,480,213			822,196			4,160,116

Cost of goods sold:
Production costs		79,035			133,664
Cost of revenue:
Cost of revenue								286,923			126,326
Depreciation		9,725			6,006			44,600			18,726
Total Cost of goods sold		88,760			139,670

Total cost of revenue								331,523			145,052
Gross profit		948,526			1,340,543			490,673			4,015,064

Operating expenses:
Selling, general and administrative expenses								10,573,111			9,015,158
Research and development expenses		398,426			-			544,043			216,430
Selling, general and administrative expenses		6,065,066			3,128,635
Total operating expenses		6,463,492			3,128,635			11,117,154			9,231,588

Loss from operations		(5,514,966	)		(1,788,092	)		(10,626,481	)		(5,216,524	)

Other income (expense):
Loss from equity method joint ventures								(200,558	)		(327,542	)
Gain on extinguishment of debt								-			159,126
Interest income		4,190			8,627			308			3,657
Interest expense		(2,836,504	)		(387,646	)		(59,445	)		(1,265,359	)
Total other income (expense)		(2,832,314	)		(379,019	)

Loss before income taxes		(8,347,280	)		(2,167,111	)

Provision for income taxes		(36	)		(433	)

Foreign currency exchange loss								(3,463	)		(3,534	)
Total other expenses								(263,158	)		(1,433,652	)
Net loss before income taxes								(10,889,639	)		(6,650,176	)
Income taxes								2,872			4,764
Net loss	$	(8,347,316	)	$	(2,167,544	)	$	(10,892,511	)	$	(6,654,940	)

Net loss per common share:
Basic	$	(1.52	)	$	(0.45	)		(0.90	)		(0.63	)
Diluted	$	(1.52	)	$	(0.45	)		(0.90	)		(0.63	)
Weighted average number of common shares outstanding:
Basic		5,489,738			4,854,878			12,122,606			10,632,413
Diluted		5,489,738			4,854,878			12,122,606			10,632,413

The accompanying notes are an integral part of these consolidated financial statements.

CONSOLIDATED STATEMENTS OF ~~STOCKHOLDERS~~’ STOCKHOLDERS’ EQUITY ~~(DEFICIENCY)~~(DEFICIT)

The accompanying notes are an integral part of these consolidated financial statements.

							2022			2021
	For the Year Ended December 31,						For the Years
	2020			2019			Ended December 31,
							2022			2021
Cash flows from operating activities:
Net loss	$	(8,347,316	)	$	(2,167,544	)	$	(10,892,511	)	$	(6,654,940	)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Adjustments to reconcile net loss to net cash used in operating activities:
Non-cash stock compensation issued for services		150,862			46,000			123,211			804,124
Non-cash stock compensation issued to directors and employees		465,140			17,750			484,807			360,153
Fair value of stock options issued to employees		1,140,989			69,787			1,616,401			1,543,912
Fair value of stock to be issued for legal settlement		-			93,750
Non-cash compensation for services								120,000			-
Amortization of discount on notes payable		2,494,236			337,413			52,644			1,188,310
Debt conversion expense		131,984			-
Amortization of leasehold right of use asset		22,564			14,558			229,018			138,322
Gain on extinguishment of debt								-			(159,126	)
Loss on impairment of intangible assets								132,227			-
Loss from equity method investment								200,558			327,542
Depreciation and amortization		11,917			10,788			77,301			27,760
Changes in assets and liabilities:
Accounts receivable		(14,141	)		218,341			(26,679	)		(28,771	)
Inventories		(163,985	)		(57,874	)
Inventory								24,171			(22,401	)
Prepaid expenses and other current assets		38,210			53,544			92,550			(124,811	)
Accounts payable and accrued expenses								904,060			114,495
Accrued compensation								364,573			54,363
Deferred revenue		(714,286	)		4,266,820			113,976			(3,565,529	)
Accounts payable and accrued expenses		(42,603	)		(200,298	)
Leasehold liability		(21,518	)		(13,582	)		(221,992	)		(53,846	)
Accrued interest		(61,696	)		89,792			1,556			20,921
Accrued compensation		134,309			(1,410,077	)
Income taxes payable		150			912			-			(392	)
Deferred tax liabilities		36			433			810			-
Net cash (used in) provided by operating activities		(4,775,148	)		1,370,513

Cash flows from investing activities:
Payments to acquire property, plant and equipment		(49,261	)		(64,839	)
Payment to acquire trademarks		(39,669	)		(49,867	)
Other assets		(240	)		-
Net cash used in operating activities								(6,603,319	)		(6,029,914	)
Cash from investing activities:
Payments to acquire property, plant, and equipment								(10,785	)		(415,710	)
Payments to acquire intangible assets								(1,943	)		(38,939	)
Investment in joint ventures		(98,084	)		-			(68,489	)		(1,698,863	)
Net cash (used in) investing activities		(187,254	)		(114,706	)

Cash flows from financing activities:
Net cash used in investing activities								(81,217	)		(2,153,512	)
Cash from financing activities:
Proceeds from notes payable								100,000			-
Proceeds from notes payable – related parties								700,000			-
Proceeds from the sale of common stock, net of offering costs		11,475,052			-			289,800			3,650,697
Proceeds from sale of convertible notes payable, net of issuance costs		2,998,905			-
Proceeds from notes payable		157,620			-
Principal payment on notes payable – related parties		(40,000	)		(97,743	)
Principal payments on note payable		(770,000	)		(131,722	)
Net cash provided by (used in) financing activities		13,821,577			(229,465	)

Proceeds from warrant exercise								-			123,562
Proceeds from unit purchase option exercise								-			246,278
Principal payment on notes payable								-			(250,000	)
Net cash provided by financing activities								1,089,800			3,770,537
Increase in cash and cash equivalents		8,859,175			1,026,342			(5,594,736	)		(4,412,889	)

Cash and cash equivalents at beginning of period		1,238,585			212,243			5,684,871			10,097,760

Cash and cash equivalents at end of period	$	10,097,760		$	1,238,585		$	90,135		$	5,684,871

Supplemental disclosure of cash flow information:

Cash paid during the period for:
Interest	$	253,392		$	84,043		$	-		$	52,603

Taxes	$	1,062		$	912		$	800		$	3,307

Non cash activities:

Leasehold right of use asset and liability upon adoption of ASU 2016-02	$	-			116,441

Noncash activities:
Fair value of warrants issued with debt							$	90,000		$	-
Common stock issued upon note payable and accrued interest conversion	$	1,451,824		$	238,723		$	-		$	1,493,788

Beneficial conversion feature on convertible notes	$	2,062,586		$	-

Settlement of accrued compensation	$	-		$	712,162

Fair value of options issued for debt	$	524,452		$	-
��
Fair value of warrants issued with debt	$	524,452		$	-

Fair value of warrants issued to service providers	$	8,660		$	-
Cashless exercise of warrants							$	-		$	9
Cashless exercise of unit purchase options							$	-		$	8
Initial ROU asset and lease liability							$	-		$	2,096,055
Fixed assets transferred to investment in joint venture							$	-		$	20,529

The accompanying notes are an integral part of these consolidated financial statements.

INVO Bioscience, Inc. (“INVO” or the “Company”) is a commercial-stage fertility company dedicated to expanding the assisted reproductive technology (“ART”) marketplace by making fertility care accessible and inclusive to people around the world. The Company’s primary mission is to implement new medical technologies aimed at increasing the availability of affordable, high-quality, patient-centered fertility care. The Company’s flagship product is INVOcell, a revolutionary medical device company focused on the Assisted Reproductive Technology (“ART”) marketplace. The primary focus is the manufacture and sale of the INVOcell device and the INVO technology to provide an alternative infertility treatment for couples. The Company’s patented device, the INVOcell, is the first Intravaginal Culture (“IVC”) system in the world used for the natural ~~in vivo~~ ~~incubation of eggs and sperm during~~that allows fertilization and early embryo development (the “INVO Procedure”). INVOcell was granted clearance in the United States by the U.S. Food & Drug Administration (“FDA”) in November 2015, received the CE mark in October 2019, and is now positioned to help provide millions of infertile couples across the globe access to a new infertility treatment option. The Company believes this novel device and procedure provides a more natural, safe, effective, efficient and economical fertility treatment compared to current infertility treatments, including in-vitro fertilization (“IVF”) and intrauterine insemination (“IUI”). Unlike conventional infertility treatments such as IVF where the eggs and sperm develop into embryos in a laboratory incubator, the INVOcell utilizes the women’s vaginal cavity as an incubator to support a more natural fertilization and embryo development environment. This novel device promotes take place in vivo ~~conception and early embryo development.~~

~~In both current utilization~~within the woman’s body. The Company’s commercialization strategy involves the opening of dedicated “INVO Centers” focused on offering the INVOcell and IVC procedure (with three centers in ~~clinical studies,~~North America now operational) and the ~~INVO Procedure has proven to have equivalent pregnancy success and live birth rates~~acquisition of existing IVF clinics, as the traditional assisted reproductive technique, IVF. Additionally, we believe there are emotional benefits of the mother’s participation in the fertilization and early embryo development by vaginal incubation compared to that of conventional IVF treatment. INVOcell also offers to patients a more personalized way to achieve pregnancy.well as selling its technology solution into existing fertility clinics.

~~(B)~~ Basis of Presentation ~~(Share Exchange and Corporate Structure)~~

The accompanying consolidated financial statements present on a consolidated basis the accounts of the Company and its wholly owned ~~subsidiaries.~~subsidiaries and controlled affiliates. The Company presents noncontrolling interest within the equity section of its consolidated balance sheets and the amount of consolidated net income (loss) that is attributable to the Company and to the noncontrolling interest in its consolidated statement of operations. All significant intercompany accounts and transactions have been eliminated in consolidation.

~~Medesole JV Agreement~~The Company uses the equity method of accounting when it owns an interest in an entity whereby it can exert significant influence over but cannot control the entity’s operations.

~~On January 16, 2020,~~The preparation of the Company’s consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods.

The Company considers events or transactions that have occurred after the consolidated balance sheet date of December 31, 2022, but prior to the filing of the consolidated financial statements with the SEC in this Annual Report on Form 10-K, to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure, as applicable. Subsequent events have been evaluated through the date of the filing of this Annual Report on Form 10-K.

The Company operates in one segment and therefore segment information is not presented.

The Company’s consolidated financial statements include the accounts of the Company, ~~announced a joint venture agreement for~~its wholly owned subsidiaries, and variable interest entities (“VIE”), where the ~~Indian market. Under terms~~Company is the primary beneficiary under the provisions of ASC 810, Consolidation (“ASC 810”). A VIE must be consolidated by its primary beneficiary when, along with its affiliates and agents, the primary beneficiary has both: (i) the power to direct the activities that most significantly impact the VIE’s economic performance; and (ii) the obligation to absorb losses or the right to receive the benefits of the ~~agreement, INVO and our partner, Medesole Healthcare and Trading Pvt Ltd (“Medesole”), will each own 50% of~~VIE that could potentially be significant to the ~~joint venture.~~VIE. The Company ~~will provide the device, training~~reconsiders whether an entity is still a VIE only upon certain triggering events and ~~general technology support~~continually assesses its consolidated VIEs to the joint venture, while Medesole will be responsible for the operations of INVO clinics in India. Both partners will equally invest in start-up and capital expenditures and share in the revenue and profits of the joint venture. The business model allows INVOdetermine if it continues to benefit not only from the sale of the device, but from the delivery of the entire solution. The current joint venture arrangements are in the developmental stage and therefore only the initial startup costs are included in the financial statement for the year ended December 31, 2020.

The Mexico Company will operate in Monterrey Nuevo Leon, Mexico and any other cities and places in Mexico as approved by the Mexico Company’s board of directors and Shareholders. In addition, the Shareholders agreed that the Mexico Company will be the primary beneficiary. See “Note 3 – Variable Interest Entities” for additional information on the Company’s exclusive distributor in Mexico. The Shareholders also agreed not to compete directly or indirectly with the Mexico Company in Mexico. For the year ended December 31, 2020 the Company has invested $51,670 in this joint venture. This joint venture arrangements are in the developmental stage and therefore only the initial startup costs are included in the financial statement for the year ended December 31, 2020.VIEs.

Investments in unconsolidated affiliates, which the Company ~~entered into a joint venture agreement with Ginekaliks Dooel (“Ginekaliks”), a limited liability company incorporated in~~exerts significant influence but does not control or otherwise consolidate are accounted for using the Republic of North Macedonia, to establish an exclusive joint venture to (i) commercialize, introduce, promote and market technologies related to the INVOcell and INVO Procedure in North Macedonia, (ii) establish a private healthcare institution to offer the INVO Procedure. The joint venture will be co-managed and owned 50% by each of INVO and Ginekaliks. For the year ended December 31, 2020 the Company has invested $2,597 in this joint venture. This joint venture arrangementsequity method. Equity method investments are ~~in the developmental stage and therefore only the initial startup costs~~initially recorded at cost. These investments are included in investment in joint ventures in the ~~financial statement for~~accompanying consolidated balance sheets. The Company’s share of the ~~year ended December 31, 2020.~~

~~On November 23, 2020, the Company entered into a separate joint venture agreement with SNS Murni SDN BHD (“SNS Murni”), a company incorporated~~profits and losses from these investments is reported in ~~Malaysia, to establish an exclusive~~loss from equity method joint venture in ~~Malaysia to (i) introduce, promote~~the accompanying consolidated statements of operations. The Company monitors its investments for other-than-temporary impairment by considering factors such as current economic and market ~~our technologies related to~~conditions and the ~~INVOcell~~operating performance of the investees and ~~INVO Procedure~~records reductions in dedicated government-owned fertility clinics in Malaysia, and (ii) establish INVO Clinics in Malaysia. The joint venture will be co-managed and owned 50% by each of INVO Bioscience and SNS Murni. For the year ended December 31, 2020 the Company has invested $7,348 in this joint venture. This joint venture arrangements are in the developmental stage and therefore only the initial startup costs are included in the financial statement for the year ended December 31, 2020.carrying values when necessary.

In preparing financial statements in conformity with generally accepted accounting principles, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and revenues and expenses during the reported period. Actual results could differ from those estimates.

For financial statement presentation purposes, the Company considers time deposits, certificates of deposit and all highly liquid investments with original maturities of three months or less to be cash and cash equivalents. ~~At times, cash and cash equivalents balances exceed amounts insured by the Federal Deposit Insurance Corporation.~~

Inventories consist of raw materials, work in process and finished ~~products~~goods and are stated at the lower of cost or ~~market;~~net realizable value, using the first-in, first-out ~~(FIFO)~~ method as a cost flow ~~convention.~~method.

The Company records property and equipment at cost. Property and equipment is depreciated using the straight-line method over the estimated economic lives of the assets, which are from 3 to 10 years. The Company capitalizes the expenditures for major renewals and improvements that extend the useful lives of property and equipment. Expenditures for maintenance and repairs are charged to expense as incurred. The Company reviews the carrying value of long-lived assets for impairment at least annually or whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of long-lived assets is measured by a comparison of its carrying amount to the undiscounted cash flows that the asset or asset group is expected to generate. If such assets are considered impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the property, if any, exceeds its fair market value.

~~The Company accounts~~Long-lived assets and certain identifiable assets related to those assets are periodically reviewed for ~~stock-based compensation under~~impairment whenever circumstances and situations change such that there is an indication that the ~~provisions~~carrying amounts may not be recoverable. If the non-discounted future cash flows of ~~Accounting Standards Codification subtopic 718-10, Compensation (“ASC 718-10”). This statement requires~~ the ~~Company~~asset are less than their carrying amount, their carrying amounts are reduced to ~~measure~~ the ~~cost of employee services received in exchange for an award of equity instruments based on the grant-date~~ fair value and an impairment loss recognized. There was an impairment of $132,227 recorded during the ~~award. That cost is recognized over~~year ended December 31, 2022, and no impairment in the ~~period in which the employee is required to provide service or based on performance goals in exchange for the award, which is usually the vesting period.~~year ended December 31, 2021.

Basic loss per share calculations are computed by dividing income (loss) available to common shareholders by the weighted-average number of common shares outstanding. Diluted earnings per share are computed similar to basic earnings per share except that the denominator is increased to include securities or other contracts to issue common stock that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. The Company’s diluted loss per share is the same as the basic loss per share for the years ended December 31, 2020 and 2019, as the inclusion of any potential shares would have had an anti-dilutive effect due to the Company generating a loss.

~~The Company has excluded the following dilutive securities from the calculation of fully diluted shares outstanding because the result would have been anti-dilutive:~~

ASC 825-10-50, “Disclosures about Fair Value of Financial Instruments,” requires disclosure of the fair value of certain financial instruments. The carrying value of cash and cash equivalents, accounts payable and borrowings, as reflected in the balance sheets, approximate fair value because of the short-term maturity of these instruments.

Effective January 1, 2008, the Company adopted ASC 820-10, “Fair Value Measurements”, which provides a framework for measuring fair value under GAAP. ASC 820-10 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820-10 requires that valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs.

The Company is subject to income taxes in the United States and its domestic tax liabilities are subject to the allocation of expenses in multiple state jurisdictions. The Company uses the asset and liability method to account for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The recoverability of deferred tax assets is evaluated by assessing the adequacy of future expected taxable income from all sources, including taxable income in prior carryback years, reversal of taxable temporary differences, forecasted operating earnings and available tax planning strategies. To the extent the Company does not consider it more-likely-than-not that a deferred tax asset will be recovered, a valuation allowance is established.

~~The Company operates in one segment and therefore segment information is not presented.~~

Cash includes amounts deposited in financial institutions in excess of insurable Federal Deposit Insurance Corporation (“FDIC”) limits. As of December 31, ~~2020,~~2022, the Company ~~had~~did not have cash balances in excess of FDIC limits.

The Company recognizes revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services ASC 606 requires companies to assess their contracts to determine the timing and amount of revenue to recognize under the new revenue standard. The model has a five-step approach:

~~Revenues for products, including: INVOcell®, INVO TM Retention System, and INVO Microscope Holding Block are~~

Revenue generated from the sale of INVOcell is typically recognized at the time the product is shipped, at which time the title passes to the customer, and there are no further performance obligations.

Revenue generated from clinical and lab services related at the Company’s affiliated INVO Centers is typically recognized at the time the service is performed.

On November 12, 2018, wethe Company entered into a U.S. Distribution Agreement (the ~~“Distribution~~“Ferring Agreement”) with Ferring International Center S.A. (“Ferring”), pursuant to which ~~closed on January 14, 2019. At the closing, we received a $5,000,000 license payment upfront from Ferring. Pursuant to the Distribution Agreement, among other things, we~~it granted Ferring an exclusive license in the United States market only, with rights to sublicense under patents related to our proprietary intravaginal culture device ~~(INVOcell™)~~(INVOcell), together with the retention device and any other applicable accessories (collectively, the “Licensed Product”) to market, promote, distribute and sell the Licensed Product with respect to all therapeutic, prophylactic and diagnostic uses of medical devices or pharmaceutical products involving reproductive technology (including ~~infertility~~fertility treatment) in humans (the “Field”). Ferring is responsible, at its own cost, for all commercialization activities for the Licensed Product in the U.S. market. We retained a limited exception to the exclusive license granted to Ferring allowing us, subject to certain restrictions, to establish up to five clinics that will commercialize INVO cycles in the U.S. This agreement was amended on Marchhumans.

On November 2, 2021, ~~to provide for added flexibility by increasing~~Ferring notified the ~~number~~Company of INVO company-owned clinics initially allowable under the agreement and removing certain geographical requirements. Ferring is obligated to make a second payment to us of $3,000,000 upon procurement of a five (5) day label enhancement from the FDA for the current incubation period for the Licensed Product at least three (3) years prior to the expiration of the term of the license for the Licensed Product and provided further that Ferring has not previously exercised its ~~right~~intention to terminate the ~~Distribution~~Ferring Agreement, ~~for convenience. In addition, under~~which requires 90-days prior written notice. Accordingly, the ~~terms of a separate Supply~~Ferring Agreement ~~Ferring is obligated to pay us a specified supply price for each Licensed Product purchased by Ferring for distribution. The Distribution Agreement has an initial term expiring~~officially terminated on ~~December~~January 31, 2025 and at the end of the initial term it may be terminated by us if Ferring fails to generate specified minimum revenues to us from the sale of the Licensed Product during the final two years of the initial term. Provided that no such termination occurs at the end of the initial term, thereafter the term of the Distribution Agreement shall automatically be renewed for successive three (3) years terms unless terminated by mutual consent. We retain all commercialization rights for the Licensed Product outside of the United States.2022.

The Ferring license was deemed to be a functional license that ~~provide customers~~provides a customer with a “right to access” to ~~our~~the Company’s intellectual property during the subscription period and accordingly, under ASC 606-10-55-60 revenue is recognized over a period of time, which is generally the subscription period. The initial upfront payment of ~~$5,000,000~~$5,000,000 which was received upon the signing of the agreement iswas being recognized toas income over the 7 ~~year~~-year term.

~~Long-lived assets and certain identifiable assets~~As of December 31, 2022, the Company had no deferred revenue related to ~~those assets~~the Ferring Agreement as it was recognized in the fourth quarter of fiscal year 2021 in relation to the contract termination. Per ASC 606-10-55-48 the likelihood of Ferring exercising its rights became remote at the time notice of termination was received so INVO recognized the full remaining amount of the deferred revenue.

The Company accounts for stock-based compensation under the provisions of Accounting Standards Codification (“ASC”) subtopic 718-10, Compensation (“ASC 718-10”). This statement requires the Company to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period in which the employee is required to provide service or based on performance goals in exchange for the award, which is usually the vesting period.

Basic loss per share calculations are ~~periodically reviewed for impairment whenever circumstances and situations change such that there is an indication~~computed by dividing net loss attributable to the Company’s common shareholders by the weighted-average number of common shares outstanding. Diluted earnings per share are computed similar to basic earnings per share except that the ~~carrying amounts may not be recoverable. If~~denominator is increased to include potentially dilutive securities. The Company’s diluted loss per share is the ~~non-discounted future cash flows of~~same as the ~~enterprise are less than their carrying amount, their carrying amounts are reduced to the fair value and an impairment~~basic loss ~~recognized. There was no impairment recorded during~~per share for the years ended December 31, ~~2020~~2022, and ~~2019.~~2021, as the inclusion of any potential shares would have had an anti-dilutive effect due to the Company generating a loss.

The Company has excluded the following dilutive securities from the calculation of fully diluted shares outstanding because the result would have been anti-dilutive:

Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share

In February 2016, FASB issued ASU 2016-02, Leases (“ASU 2016-02”). The new standard establishes a right-of-use (“ROU”) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements, with certain practical expedients available.

The Company adopted the standard effective January 1, 2019. The standard allows a number of optional practical expedients to use for transition. The Company chose the certain practical expedients allowed under the transition guidance which permitted the Company to not to reassess any existing or expired contracts to determine if they contain embedded leases, to not to reassess our lease classification on existing leases, to account for lease and non-lease components as a single lease component for equipment leases, and whether initial direct costs previously capitalized would qualify for capitalization under FASB ASC 842. The new standard also provides practical expedients and recognition exemptions for an entity’s ongoing accounting policy elections. The Company has ~~elected the short-term lease recognition for~~reviewed all ~~leases that qualify, which means that we do not recognize a ROU asset and lease liability for any lease with a term of twelve months or less.~~

The most significant impact of adopting the standard was the recognition of ROU assets and lease liabilities for operating leases on the Company’s consolidated balance sheet but it did not have an impact on the Company’s consolidated statements of operations or consolidated statements of cash flows. The Company did not have a cumulative effect on adoption prior to January 1, 2019.

The Company adopted Accounting Standards Update No. 2016-02: Leases, or ASU 2016-02, effective January 1, 2019. ASC 842 superseded previously existing guidance on accounting for leases and generally requires all leases to be recognized in the statement of financial position.

~~The adoption of ASC 842 had no impact on the Company’s consolidated statement of operations and consolidated statement of cash flows.~~

The Company adopted ASC 842 on a modified retrospective approach at the effective date and, therefore, did not revise comparative period information or disclosure. In addition, the Company elected the package of practical expedients permitted under ASC 842.

In December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. This standard is intended to simplify the accounting and disclosure requirements for income taxes by eliminating various exceptions in accounting for income taxes as well as clarifying and amending existing guidance to improve consistency in application of ASC 740. The provisions of ASU 2019-12 are effective for fiscal years beginning after December 15, 2021, with early adoption permitted. The Company is currently evaluating the impact that ASU 2019-12 will have on its consolidated financial statements.

In July 2017, FASB issued ASU 2017-11 (Part I) Accounting for Certain Financial Instruments with Down Round Features, (Part II) Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception (“ASU 2017-11”). The new standard simplifies the accounting for certain financial instruments with down round features. Part I of ASU 2017-11 changes the classification analysis of certain equity-linked financial instruments, such as warrants and embedded conversion features, such that a down round feature is disregarded when assessing whether the instrument is indexed to an entity’s own stock under Subtopic 815-40, Contracts in Entity’s Own Equity. As a result, a down round feature, by itself, no longer requires an instrument to be re-measured at fair value through earnings each period, although all other aspects of the indexation guidance under Subtopic 815-40 continue to apply. Part II of ASU 2017-11 re-characterizes the indefinite deferral of certain provisions of Topic 480, Distinguishing Liabilities from Equity, (currently presented as pending content in the Codification) as a scope exception. No change in practice is expected as a result of these amendments. The new standard is effective for fiscal years beginning after December 15, 2018, early adoption is permitted. The amendments in Part II have no accounting impact and therefore do not have an associated effective date. The Company decided to early adopt this ASU 2017-11 and applied it to the convertible notes it issued during the quarter which are reflected in this Form 10-K.

~~Management was not aware of any accounting~~recently issued, but not yet effective, accounting ~~standards, if currently adopted would~~pronouncements, and does not believe the future adoption of any such pronouncements will have a material ~~effect~~impact on its financial condition or the ~~consolidated financial statements.~~results of its operations.

~~On May 26, 2020,~~Historically, the Company ~~effected a 1-for-20 reverse stock split of~~has funded its ~~common stock. All shares, options~~cash and ~~warrants throughout these consolidated financial statements have been retroactively restated to reflect the reverse split.~~

~~On November 9, 2020, the Company effected a 5-for-8 reverse stock split of its common stock. All shares, options~~liquidity needs through operating cash flow, equity financings, and ~~warrants throughout these consolidated financial statements have been retroactively restated to reflect the reverse split.~~

On January 14, 2019, INVO Bioscience entered into a distribution agreement (the “Distribution Agreement”) with Ferring International Center S.A. (“Ferring”) which granted Ferring an exclusive licensing rights to sublicense the Company’s INVOcell together with the retention device for the U.S. market. Under the terms of the Distribution Agreement, Ferring was obligated to make an initial payment to the Company of $5,000,000 upon satisfaction of certain closing conditions. The Company received the initial $5 million cash payment upon the execution of the Ferring distribution agreement in January 2019.

On November 12, 2020, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Roth Capital Partners, LLC, as representative of the several underwriters (the “Underwriters”), in connection with the Company’s public offering (the “Offering”) of 3,625,000 shares of the common stock, at a public offering price of $3.20 per share. The initial closing of the Offering for 3,625,000 shares of common stock took place on November 17, 2020. On November 18, 2020, the Underwriters exercised their option pursuant to the Underwriting Agreement to purchase an additional 528,750 shares of common stock (the “Option Shares”). The closing for the Option Shares took place on November 20, 2020 for which the Company received $1,522,800 in net proceeds after deducting underwriting discounts and commissions. With the exercise of the option to purchase the Option Shares, the total amount of shares of common Stock sold in the Offering was 4,153,750 shares with aggregate net proceeds received by the Company of $11,837,800 after deducting underwriting discounts and commissions and offering expenses.

notes payable. For the years ended December 31, ~~2020~~2022 and ~~2019,~~2021, the Company ~~had~~incurred a net ~~losses~~loss of ~~$8,347,316~~approximately $10.9 million and ~~$2,167,544, respectively. The Company had working capital~~$6.7 million, respectively, and has an accumulated deficit of ~~$8,254,540~~approximately $49.8 million as of December 31, ~~2020,~~2022. Approximately $3.0 million of the net loss was related to non-cash expenses for the year ended December 31, 2022, compared to ~~$42,330 as of~~$4.2 million for the year ended December 31, ~~2019. As~~2021

The Company has been dependent on raising capital through debt and equity financings to meet its needs for cash used in operating and investing activities. During 2021, the Company received proceeds of ~~December 31, 2020,~~approximately $3.7 million from the sale of stock, converted approximately $1.5million of outstanding debt to equity and received approximately $0.4million of proceeds from unit purchase option and warrant exercises. During 2022, the Company received proceeds of $0.8 million from demand notes and net proceeds of approximately $0.3million for the sale of its common stock. Over the next 12 months, the Company’s ~~stockholder’s~~plan includes opening additional INVO Centers, completing the acquisition of Wisconsin Fertility Institute and pursuing additional IVF clinic acquisitions. Until the Company can generate a sufficient amount of cash from operations, it will need to raise additional funding to meet its liquidity needs and to execute its business strategy. As in the past, the Company will seek debt and/or equity ~~was $5,743,106 compared to a deficiency of $3,713,595 as of December 31, 2019. Cash used in operation for 2020 was $4,775,148, compared to cash provided by operations of $1,370,513 for 2019.~~financing, which may not be available on reasonable terms, if at all.

~~In connection with~~Although the ~~preparation of its~~Company’s audited consolidated financial statements for the ~~years~~year ended December 31, ~~2020 and 2019,~~2022 were prepared under the assumption that it would continue operations as a going concern, the report of the Company’s ~~management evaluated~~independent registered public accounting firm that accompanies the Company’s consolidated financial statements for the year ended December 31, 2022 contains a going concern qualification in which such firm expressed substantial doubt about the Company’s ability to continue as a going concern, ~~in accordance with the ASU 2014-15,~~ ~~Presentation of Financial Statements~~–~~Going Concern (Subtopic 205-40)~~~~, which requires an assessment of relevant conditions or events, considered in the aggregate, that are known or reasonably knowable by management~~based on the ~~issuance dates of the~~consolidated financial statements ~~which indicated the probable likelihood~~at that time. Specifically, as noted above, the Company ~~will be unable to meet its obligations as they become due within one year after the issuance date of the financial statements.~~

~~As part of its evaluation, management assessed known events, trends, commitments,~~has incurred significant operating losses and ~~uncertainties, which included the profitability of~~ the Company expects to continue to incur significant expenses and operating losses as it continues to ramp up the ~~cash flow generated by its operations,~~commercialization of INVOcell and ~~the amount of capital recently and/or in the process of being raised.~~

~~Working capital at December 31, 2020 improved by $8,212,210 from the previous year.~~

~~As a result of the public offering~~develop new INVO Centers. These prior losses and expected future losses have had, and will continue to have, an adverse effect on November 12, 2020, of 3,625,000 shares of common stock and an over-allotment of 528,750 shares of common stock on November 17, 2020 that resulted in net proceeds received of approximately $11.8 million, combined with the projected cash needs, management believes that it has completely mitigated the circumstance that led to a doubt with respect to the Company’s ~~ability to~~financial condition. If the Company cannot continue as a going concern, ~~which existed~~its stockholders would likely lose most or all of their investment in the Company.

On June 28, 2021, INVO Centers LLC, a Delaware limited liability company (“INVO CTR”) entered into a limited liability company operating agreement (the “Bloom Agreement”) with Bloom Fertility, LLC (“Bloom”) to establish a joint venture entity, formed as “Bloom INVO LLC” (the “Georgia JV”), for the purposes of commercializing INVOcell, and the related IVC procedure, through the establishment of an INVO Center, (the “Atlanta Clinic”) in the Atlanta, Georgia metropolitan area.

The responsibilities of Bloom include providing all medical services required for the operation of the Atlanta Clinic. The responsibilities of INVO CTR include providing certain funding to the Georgia JV, lab services quality management, and providing access to and being the exclusive provider of the INVOcell to the Georgia JV. INVO CTR will also perform all required, industry specific compliance and accreditation functions, and product documentation for product registration.

The Bloom Agreement provides Bloom with a “profits interest” in the Georgia JV and, in connection with such profits interest, states that profits and losses be allocated to its members based on a hypothetical liquidation of the Georgia JV. In such a scenario, liquidation proceeds would be distributed in the following order: (a) to INVO CTR until the difference between its capital contributions and distributions (the “Hurdle Amount”) equals $0; (b) to Bloom until its distributions equal 150% of the liquidation amounts distributed to INVO CTR (a “catch-up” to rebalance the distributions between members); and (c) thereafter on a pro rata basis. The Georgia JV had no assets or liabilities at the time the units were issued, and, as of December 31, 2022, INVO CTR had made capital contributions greater than the net loss of the ~~filing~~Georgia JV. As such, the entire net loss was allocated to INVO CTR, and no loss was allocated to the noncontrolling interest of Bloom.

The Company determined the Georgia JV is a VIE, and that the Company is its primary beneficiary because the Company has an obligation to absorb losses that are potentially significant and the Company controls the majority of the ~~Company’s Annual Report on Form 10-K for~~activities that impact the ~~year~~Georgia JV’s economic performance, specifically control of the INVOcell and lab services quality management. As a result, the Company consolidated the Georgia JV’s results with its own. As of December 31, 2022, the Company invested $0.9 million in the Georgia JV in the form of capital contributions as well as $0.5 million in the form of a note. For the years ended December 31, ~~2019,~~2022 and ~~(ii) it has sufficient liquidity~~2021, the Georgia JV recorded net losses of $0.6 million and $0.4 million, respectively. Noncontrolling interest in the Georgia JV was $0.

On March 10, 2021, INVO CTR entered into a limited liability company agreement with HRCFG, LLC (“HRCFG”) to form a joint venture for ~~at least~~ the ~~next 12 months.~~purpose of establishing an INVO Center in Birmingham, Alabama. The name of the joint venture entity is HRCFG INVO, LLC (the “Alabama JV”). The Company also provides certain funding to the Alabama JV. Each party owns 50% of the Alabama JV.

The Company determined the Alabama JV is a VIE, and that there is no primary beneficiary. As a result, the Company will use the equity method to account for its interest in the Alabama JV. As of ~~inventory are:~~December 31, 2022, the Company invested $1.6 million in the Alabama JV in the form of a note. For the years ended December 31, 2022 and 2021, the Alabama JV recorded net losses of $0.3 million and $0.6 million, respectively, of which the Company recognized losses from equity method investments of $0.2 million and $0.3 million, respectively.

On September 24, 2020, INVO CTR entered into a Pre-Incorporation and Shareholders Agreement with Francisco Arredondo, MD PLLC (“Arredondo”) and Security Health LLC, a Texas limited liability company (“Ramirez”, and together with INVO CTR and Arredondo, the “Shareholders”) under which the Shareholders will commercialize the IVC procedure and offer related medical treatments in Mexico. Each party owns one-third of the Mexican incorporated company, Positib Fertility, S.A. de C.V. (the “Mexico JV”).

The Company determined the Mexico JV is a VIE, and that there is no primary beneficiary. As a result, the Company will use the equity method to account for its interest in the Mexico JV. As of December 31, 2022, the Company invested $0.1 million in the Mexico JV. For the years ended December 31, 2022 and 2021, the Mexico JV recorded net losses of $0.1 million and $0.04 million, respectively, of which the Company recognized a loss from equity method investments of $0.05 million and $0.01 million, respectively.

Schedule of Earnings from Investments in Unconsolidated Variable Interest Entities

The following tables summarize the combined unaudited financial information of our investments in unconsolidated VIEs:

Schedule of Financial Information of Investments in Unconsolidated Variable Interest Entities

The Company sells the INVOcell to its consolidated and unconsolidated VIEs and anticipates continuing to do so in the ordinary course of business. All intercompany transactions with consolidated entities are eliminated in the Company’s consolidated financial statements. Per ASC 323-10-35-8 the Company eliminates any sales to an unconsolidated VIE for INVOcell inventory that the VIE still has remaining on the books at period end.

The estimated useful lives and accumulated depreciation for ~~furniture,~~ equipment ~~and software~~ are as ~~follows:~~follows as of December 31, 2022, and December 31, 2021:

During each of the years ended December 31, 2022, and 2021, the Company recorded depreciation expense of ~~$10,110~~$75,492 and ~~$6,230 in 2020 and 2019,~~$25,952, respectively.

The Company capitalizes the initial expense related to establishing ~~the patent~~patents by country and then amortizes the expense over the life of the patent, typically 20 years. It then expenses annual filing fees to maintain the patents. The Company regularly reviews the value of ~~the patent~~its patents in the marketplace in proportion to the expense it must spend to maintain the patent.

~~The~~years ended December 31, 2022, and 2021, the Company recorded amortization ~~expense~~expenses related to patents of ~~$1,807~~$1,809 and ~~$4,558 in 2020 and 2019,~~$1,809, respectively.

~~As of December 31, 2020, and December 31, 2019, the Company recorded the following trademarks balances:~~

The trademarks have an indefinite life ~~so no amortization expense is calculated.~~and therefore are not amortized. Trademarks are periodically reviewed for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recoverable. ~~The Trademark assets were created in 2019~~

As of December 31, 2022 the Company recorded an impairment loss of $132,227 related to trademarks and ~~no material adverse changes have occurred since their creation.~~patents.

The Company has ~~an operating lease for our office, which have an initial term of 5 years with an option to renew for 3 additional years. There is no early termination clause included. The~~various operating lease agreements ~~does not contain any material restrictive covenants.~~in place for its office and joint ventures. Per FASB’s ASU 2016-02, Leases ~~(Topic 842)~~Topic 842 (“ASU 2016-02”), effective January 1, 2019, the Company is required to report a right-of-use asset and corresponding liability to report the present value of the total ~~least~~lease payments, with appropriate interest calculation. Per the terms of ASU 201-02, the Company can use its implicit interest rate, if known, or applicable federal rate otherwise. Since the Company’s implicit interest rate was not readily determinable, the Company utilized the applicable federal rate, ~~which was 3.0%~~ as of ~~April 2019.~~

~~ROU assets represent~~ the ~~Company’s right to use the underlying assets for the lease term and lease liabilities represent the net present value~~commencement of the ~~Company’s obligation to make payments arising from these leases. The~~lease. Lease renewal options included in any lease ~~liabilities~~ are based on the present value of fixed lease payments over the lease term using the implicit lease interest rate or, when unknown, the Company’s incremental borrowing rate on the lease commencement date. If the lease includes one or more options to extend the term of the lease, the renewal option is considered in the lease term if it is reasonably certain the Company will exercise the option(s). Operating lease expense is recognized on a straight-line basis over the term of the lease. As permitted by ASC 842, leases with an initial term of twelve months or less, or short-term leases, are not recorded on the accompanying consolidated balance sheet.

The Company has lease agreements with lease and non-lease components, which are accounted for as a single lease component under the practical expedient provisions of the standard. The Company has lease agreements with terms less than one year. For the qualifying short-term leases, the Company elected the short-term lease recognition exemption in which the Company will not recognize ROU assets or lease liabilities, including the ROU assets or lease liabilities for existing short-term leases of those assets in upon adoption.

~~Variable lease payments and short-term lease expenses were immaterial~~option to ~~the Company’s financial statements for the years ended December 31, 2020 and 2019.~~renew. The Company’s operating lease agreements do not contain any material restrictive covenants.

~~The~~As of December 31, 2022, the Company’s lease components ofincluded in the ~~lease assets and liabilities are~~consolidated balance sheet were as follows:

Lease Component	Balance Sheet Classification	December 31, 2020

Lease component				Balance sheet classification	December 31, 2022
Assets
ROU assets - operating lease	Other assets	$	79,319	Other assets	$	1,808,034

Total ROU assets		$	79,319		$	1,808,034

Liabilities
Current operating lease liability	Current liabilities	$	22,707	Current liabilities	$	231,604

Long-term operating lease liability	Other liabilities		58,634	Other liabilities		1,669,954

Total lease liabilities		$	81,341		$	1,901,558

~~Rent expense is recognized on a straight-line basis over the life of the lease. Rent expense consists of the following:~~

Future minimum lease payments ~~under non-cancellable leases~~as of December 31, 2022 were as follows:

	December 31, 2020
2021	$	24,839
2022		25,585
2023		26,352		264,108
2024		8,870		251,671
2025 and beyond		-
2025				247,960
2026				253,235
2027 and beyond				1,063,010
Total future minimum lease payments	$	85,646	$	2,079,984
Less: Interest		4,305		(178,426	)
Total operating lease liabilities	$	81,341	$	1,901,558

Current operating lease liability	$	22,707
Long-term operating lease liability		58,634
Total operating lease liabilities	$	81,341

On July 1, 2020, the Company received a loan in the principal amount of $157,620 pursuant to the U.S. Small Business Administration’s Paycheck Protection Program. The loan matured 18 months from the date of funding, was payable over 18 equal monthly installments, and had an interest of 1% per annum.Up to 100% of the principal balance of the loan was forgivable based upon satisfaction of certain criteria under the Paycheck Protection Program. On June 16, 2021, the principal of the loan as well as $1,506 of accrued interest was forgiven and the note was extinguished. The Company recognized a gain of $159,126 on extinguishment of debt during the year ended December 31, 2021.

In the fourth quarter of 2022, the Company received $500,000 through the issuance of five demand notes (the “JAG Notes”) from a related party, JAG Multi Investments LLC (“JAG”). The Company’s CFO is a beneficiary of JAG but does not have any control over JAG’s investment decisions with respect to the Company. If paid prior to December 31, 2022 for the initial 3 notes and January 31, 2023 for the last two months, the JAG Notes ~~Payable~~are interest free. For any amount that remains outstanding past such dates, 10% annual interest accrues from the date of issuance. The notes currently are callable with 10 days prior written notice, which may be delivered to the Company starting on March 31, 2023. At maturity, the Company agreed to pay outstanding principal, a 10% financing fee and accrued interest, if any. The financing fees were recorded as a debt discount and as of December 31, 2022 the Company had amortized $40,333 of the discount.

~~2018 Convertible~~In consideration for subscribing to the JAG Note for $100,000 dated December 29, 2022, and for agreeing to extend the date on which the other JAG Notes ~~Payable~~

~~In April and May 2018,~~are callable to March 31, 2023, the Company issued ~~convertible notes (the “2018 Convertible Notes”) payable~~JAG a warrant to ~~investors in the aggregate principal amount~~purchase 350,000 shares of ~~$895,000. The 2018 Convertible Notes accrued interest at the rate of 9% per annum which was payable in~~Company common stock. The ~~2018 Convertible Notes in an aggregate principal amount~~warrant may be exercised for a period of ~~$550,000, were due on January 30, 2020, and 2018 Convertible Notes with an aggregate principal amount of $345,000 were due on March 31, 2021. The notes were convertible into shares of common stock~~five (5) years from issuance at a price of ~~$6.40~~$0.50 per ~~share, provided, that if~~share. The financing fees and the fair value of the warrants issued were capped at the total proceeds. The relative fair value of the warrants were recorded as a debt discount and as of December 31, 2022 the Company ~~completes a subsequent equity financing, the holders~~had amortized $2,903 of the ~~2018 Convertible~~discount.

In the fourth quarter of 2022, the Company received $200,000 through the issuance of demand promissory notes of which (1) $100,000 was received from our chief executive officer, Steven Shum ($60,000 on November 29, 2022, $15,000 on December 2, 2022, and $25,000 on December 13, 2022) and (2) $100,000 was received from an entity controlled by our chief financial officer, Andrea Goren ($75,000 on November 29, 2022 and $25,000 on December 13, 2022). If paid prior to January 31, 2023, these notes are interest free until January 31, 2023. For any amount that remains outstanding past January 31, 2023, 10% annual interest accrues from the date of issuance. These notes are callable with 10 days prior written notice, which may be delivered to the Company starting 30 days from issuance. At maturity, the Company agreed to pay outstanding principal, a 10% financing fee and accrued interest, if any.

The financing fees were recorded as a debt discount and as of December 31, 2022 the Company had amortized $9,419 of the discount.

In the fourth quarter of 2022, the Company received $100,000 through the issuance of two demand notes. On January 4^th, 2023 these notes were reissued as convertible notes with a fixed conversion prices of $0.50 and (ii) 5-year warrants to ~~convert the notes in~~purchase 100,000 shares of the Company’s common stock at a price equal to 75% of the price paid per share in such subsequent equity financing. During the fourth quarter of 2018, three noteholders converted their notes with a value of $200,000 into 32,982 shares of common stock. During the twelve months ended December 31, 2019, two noteholders converted principal and accrued interest of $235,000 and $3,723, respectively, into a total of 37,301 shares of common stock.

At inception of issuance, the Company calculated a beneficial conversion feature of the 2018 Convertible Notes in the form of a discount of $895,000; In May 2020, the remaining balance of $396,044, which included the principal balance of $420,000, accrued interest of $94,419, and the conversion discount of $118,375. As part of the extinguishment of the 2018 Convertible Notes, the Company issued 2020 Convertible Notes (as described below) to two remaining holders in the amount of $143,640. The remaining balance related to these notes was $116,693, which was comprised of a principal balance of $125,000, accrued interest of $23,318, net of the remaining discount of $31,625. In accordance with ASC 470, the extinguishment for these two holders was accounted for as a modification and no gain or loss was recorded. In May 2020, the remaining balance of $35,483, which included the principal balance of $40,000, accrued interest of $7,355, and a conversion discount of $11,872, was repaid. As of December 31, 2020, the balance of the 2018 Convertible Notes is $0.

From May 15, 2020 through July 1, 2020, the Company entered into definitive securities purchase agreements (“Purchase Agreements”) with accredited investors for their purchase of (i) secured convertible notes issued by us in the aggregate original principal amount of $3,494,840 (the “Notes”), and (ii) Unit Purchase Options (“Purchase Options”) to purchase 303,623 units (each, a “Unit”), at an exercise price of ~~$3.20 per Unit (subject~~$1.00 (subject to adjustments), with each Unit exercisable for (A) one share of the Company’s common stock and (B) a 5-year warrant (the “Warrants”) to purchase one share of our common stock at an exercise price of $3.20 (subject to adjustments) (the “Private Placement”). Each purchaser of a Note was issued a 5-year Purchase Option to purchase 0.086875 Units (as adjusted for the Reverse Splits (as defined below) for each dollar of Notes purchased. The Company received gross proceeds of approximately $3.5 million (of which $3,351,200 was received in cash and $143,640 resulted from cancellation of indebtedness). Tribal Capital Markets, LLC acted as placement agent (the “Placement Agent”) in the Private Placement. The Company paid the Placement Agent and certain selling agents a cash fee of 8% on a portion of the proceeds for an aggregate amount of $236,000. The Company also agreed to issue the Placement Agent and the selling agent 5-year warrants to purchase 6,750 shares of our common stock at an exercise price of $3.20. These warrants have the same terms and conditions as the Warrants issued in the Private Placement, except for the different exercise price. The Company received approximately $2,998,905 in net proceeds from the Private Placement, after deducting Placement Agent fees and selling agent fees payable to the Placement Agent and selling agent, respectively, and investor counsel in connection with the transaction. The Company used approximately $413,456, in proceeds to repay outstanding 9% promissory notes and the Company intends to use the remaining proceeds for working capital and general corporate purposes.

~~Pursuant to that certain Form of Secured Convertible Note entered into in connection with~~Interest on the ~~Purchase Agreement (the “Form of Note”), interest on such Notes~~notes accrues at a ~~rates~~rate of ten percent ~~(10%~~(10%) per annum and is payable at the holder’s option either in cash or in shares of the Company’s common stock at the conversion price ~~of $3.20 (following and subject to adjustment for stock splits, combinations or similar events and anti-dilution provisions, among other adjustments)~~set forth in the notes on ~~each of the six and twelve month anniversary of the issuance date and on the maturity dates of November 15, 2021,~~ December ~~22, 2021 and December 30, 2021.~~31, 2023, unless converted earlier.

All amounts ~~of principal and interest~~ due under the ~~Notes~~notes are convertible at any time after the issuance date, in whole or in part (subject to rounding for fractional shares), at the option of the holders into the Company’s common stock at a fixed conversion price ~~of $3.20, which is subject to adjustment~~for the notes as described above.

Upon any issuance by the Company of any of its equity securities, including common stock, for cash consideration, indebtedness or a combination thereof after the date hereof (a “Subsequent Equity Financing”), each holder of a

Note will have the option to convert the outstanding principal and accrued but unpaid interest of its Note into the number of fully paid and non-assessable shares of common stock issued in the Subsequent Equity Financing (“Conversion Securities”) equal to the product of unpaid principal, together with the balance of unpaid and accrued interest and other amounts payable hereunder multiplied by 1.1, divided by the price per share paid by the investors for the Conversion Securities.10 – Related Party Transactions

A Note may not be converted, and shares of common stock may not be issued under the Notes if, after giving effect to the conversion or issuance, the holder together with its affiliates would beneficially own in excess of 9.99% of our outstanding ordinary shares.

The Company may prepay the Notes at any time in whole or in part by paying an amount equal to 100% of the principal amount to be redeemed, together with accrued and unpaid interest plus a prepayment fee equal to one percent (1%) of the principal amount to be repaid.

The Notes contain customary events of default including but not limited to: (i) failure to make payments when due; and (ii) bankruptcy or insolvency of the Company. If an event of default occurs, each holder may require the Company to redeem all or any portion of the Notes (including all accrued and unpaid interest thereon), in cash.

The Notes are secured by the proceeds from the $3,000,000 milestone payment pursuant to Section 7.2(b) of the Distribution Agreement dated November 12, 2018 between the Obligor and Ferring International Center S.A., after such proceeds are actually received by the Company from Ferring, all pursuant to the terms of a Security Agreement entered into between the Company and the noteholders under the Purchase Agreements.

Of the $3,494,840 in net proceeds received in the offering, $1,048,904 million was allocated to the unit purchase options issued to investors based on their relative fair value and $ 2,062,586 of beneficial conversion feature based on their relative fair value. This amount represented a discount on the debt and additional paid-in-capital at the date of issuance.

In ~~November 2020, $1,319,840 of principal elected to convert as part of the public underwritten offering.~~

~~The remaining principal balances of the 2020 Convertible Notes were as follows:~~

~~Interest expense on the 2020 Convertible Note was $194,631 and $0 for the years ended December 31, 2020 and 2019, respectively.~~

~~Amortization of options discount on the 2020 Convertible note was $300,365 and $0 for the years ended December 31, 2020 and 2019, respectively.~~

~~Amortization of warrant discount on the 2020 Convertible Note was $301,228 and $0 for the years ended December 31, 2020 and 2019, respectively.~~

~~Amortization of beneficial conversion feature on the 2020 Convertible Note was $1,670,135 and $0 for the years ended December 31, 2020 and 2019, respectively.~~

~~Amortization of issuance costs on the 2020 Convertible Note was $222,508 and $0 for the years December 31, 2020 and 2019, respectively.~~

On July 1, 2020, the Company received a loan in the principal amount of $157,620 relating to the U.S. Small Business Administration’s Paycheck Protection Program. The loan will mature 18 months from the date of funding is payable over 18 equal monthly installments, and bears interest at a rate of 1% per annum. The loan is forgivable up to 100% of the principal balance based upon satisfaction of certain criteria under the Paycheck Protection Program. The Company has applied for full forgiveness.

On March 5, 2009, the Company entered into a related party transaction with Kathleen Karloff, the former Chief Executive Officer and a former Director of the Company. During the twelve months ended December 31, 2019, the Company paid the remaining balance due Ms. Karloff in the amount of $62,743 along with $55,000 of accrued interest.

In April 2011, the Company issued a new short-term convertible note (“Q211 Note”) payable to James Bowdring in the amount of $50,000. The Note carries a 10% interest rate. The Company paid $25,000 of the Note in 2011 in cash. The Q211 Note is convertible into common stock of the Company at a conversion price of $0.96 per share, subject to adjustments. During the years ended December 31, 2020 and December 31, 2019, the Company accrued interest in the amount of $0 and $1,493 on the Q211 Note, respectively.

In November 2011, the Company issued a new convertible note (“Q411 Note”) payable to James Bowdring in the amount of $10,000. The Q411 Note carries a 10% interest rate. The Q411 Note was converted into common stock of the Company at a conversion price of $0.32 per share, subject to adjustments. In addition, $0 and $597 of interest was accrued in the years ended December 31, 2020 and 2019, respectively.

On August 7, 2019, the Company sent James Bowdring, a related party, a check in the amount of $65,197 as full payment of the foregoing promissory notes. On August 8, 2019, Mr. Bowdring’s legal counsel returned this check with a letter stating that the check did not properly account for the compound interest identified in such notes. In addition, the letter stated Mr. Bowdring’s desire to convert these promissory notes into shares of the Company’s common stock in lieu of any cash payment. The Company does not believe that Mr. Bowdring has the right to convert such notes upon receiving payment of such notes and intends to vigorously contest any conversion of these notes.

In May 2018, James Bowdring and his children participated in the “2018 Convertible Notes” offerings in the aggregate principal amount of $40,000. The 2018 Convertible Notes accrue interest at the rate of 9% per annum which is paid in stock. These Notes are due on March 31, 2021. The notes are convertible into shares of common stock at a price of $6.40 per share, provided, that if the Company completes a subsequent equity financing, the holders of the 2018 Convertible Notes can elect to convert the notes in shares of our common stock at a price equal to 75% of the price paid per share in such subsequent equity financing. In addition, $1,380 and $3,599 of interest was accrued in the twelve months ended December 31, 2020 and 2019, respectively.

Accounts payable and accrued liabilities balances include accrued directors fees, expenses reports for management and employees for expenses they paid for personally related to travel or normal business expenses.

~~In November 2020,~~October 2021, Paulson Investment Company served as a ~~co-managing underwriter~~placement agent for the Company’s ~~underwritten public~~registered direct offering and received ~~fee~~fees and commissions for such role in the amount of ~~$271,440.~~$323,584. Trent Davis, one of ~~our~~the Company’s directors, is President of Paulson Investment Company. Mr. Davis did not receive any compensation related to the fees and commissions received by Paulson. Steve Shum and Andrea Goren, the CEO and CFO of the Company, respectively, each purchased 30,674 shares in the registered direct offering for gross proceeds of $199,994.

In the fourth quarter of 2022, the Company received $700,000 through the issuance of demand notes from related parties, as follows: (a) $500,000 from JAG; (b) $100,000 from our chief executive officer, Steve Shum; and (c) $100,000 from our chief financial officer, Andrea Goren. The Company’s CFO is a beneficiary of JAG but does not have any control over JAG’s investment decisions with respect to the Company. See Note 9 of the Notes to Consolidated Financial Statements for additional information.

As of December 31, 2022 the Company owed accounts payable to related parties totaling $76,948, primarily related to unpaid employee expense reimbursements and unpaid board fees.

On December 16, 2019, the Company’s stockholders approved a reverse stock split at a ratio of between ~~1-for 5~~1-for-5 and 1-for-25, with discretion for the exact ratio to be approved by the Company’s board of directors. On February 19, 2020, the Company’s board of directors approved a reverse stock split of the Company’s common stock at a ratio of ~~1-for-20.~~1-for-20. On May 21, 2020, the Company filed a certificate of change (with an effective date of May 26, 2020) with the Nevada Secretary of State pursuant to Nevada Revised Statutes 78.209 to effectuate a 1-for-20 reverse stock split of its outstanding common stock. The reverse split took effect at the open of business on May 26, 2020.

On October 22, 2020, the Company’s board of directors approved a reverse stock split of the Company’s common stock at a ratio of 5-for-8 and also approved a proportionate decrease in the Company’s authorized common stock to 125,000,000 shares from ~~200,000,000.~~200,000,000. On November 5, 2020, the Company filed a certificate of change (with an effective date of November 9, 2020) with the Nevada Secretary of State pursuant to Nevada Revised Statutes 78.209 to effectuate a 5-for-8 reverse stock split of its outstanding common stock. As a result of the reverse stock split, 133 shares were issued in lieu of fractional shares. On November 6, 2020, the Company received notice from FINRA/OTC Corporate Actions that the reverse split would take effect at the open of business on November 9, 2020, and the reverse stock split took effect on that date.

The consolidated financial ~~statement~~statements presented reflect the reverse splits.

On ~~November 12, 2020,~~October 1, 2021, the Company and certain institutional and accredited investors and members of the Company’s management team (the “Investors”) entered into ~~an underwriting~~a securities purchase agreement pursuant to which the Company agreed to issue and sell to the Investors 1,240,737 shares of its common stock, in a registered direct offering (the ~~“Underwriting Agreement”~~“Direct Offering”) ~~with Roth Capital Partners, LLC,~~for aggregate gross proceeds of $4,044,803. The purchase price for each share in the Direct Offering was $3.26. The net proceeds to the Company from the Direct Offering, after deducting placement agent fees and the Company’s estimated offering expenses, were approximately $3.65 million. Paulson Investment Company served as ~~representative~~a placement agent for the Direct Offering and received a fee for its role in the amount of $323,584, as well as warrants to purchase 37,222 shares of the ~~several underwriters (the “Underwriters”), in connection with~~Company’s common stock at an exercise price of $3.912 per share.

During 2022, the ~~Company’s public offering (the “Offering”) of 3,625,000~~Company issued 51,528 shares of common stock ~~at a public offering price of $3.20 per share. The initial closing of the Offering for 3,625,000~~to directors and 46,250 shares of common stock ~~took place on November 17, 2020. On November 18, 2020, the Underwriters exercised their option pursuant~~ to the Underwriting Agreement to purchase an additional 528,750 shares of common stock (the “Option Shares”). The closing for the Option Shares took place on November 20, 2020 for which the Company received $1,522,800 in net proceeds after deducting underwriting discounts and commissions. With the exercise of the option to purchase the Option Shares, the total amount of shares of common stock sold in the Offering was 4,153,750 shares with aggregate net proceeds received by the Company of $11,837,800 after deducting underwriting discounts and commissions and offering expenses.

~~During the year ended December 31, 2020 the Company incurred $1,816,948 of offering costs related to issuance of common stock.~~

~~In January 2020, the Company issued 31,250 shares of common stock under its 2019 Stock Incentive Plan~~consultants with a fair value of ~~$221,400~~$218,196 and $95,851, respectively. The shares were issued under the Company’s 2019 Stock Incentive Plan (the “2019 Plan”).

During 2022, the Company granted 106,333 restricted stock units to ~~an officer.~~employees that vest 50% at six months from grant date and 50% at twelve months from grant date. The shares were granted under the 2019 Plan. During 2022, the Company had issued 35,666 vested shares and recognized stock-based compensation expense of $266,611 associated with the equity grants.

~~In February 2020,~~During 2022, the Company issued ~~3,125~~15,000 shares of its common stock ~~under its 2019 Stock Incentive Plan~~to consultants in consideration of services rendered with a fair value of ~~$24,750~~$27,360. These shares were issued pursuant to ~~an employee of which $20,626 was amortized in~~ the ~~twelve months ended December 31, 2020.~~

~~In February 2020, the Company issued 3,098 shares of common stock under its 2019 Stock Incentive Plan with a fair value of $25,000 to a board member.~~

~~In February 2020, the Company issued 1,875 shares of common stock under its 2019 Stock Incentive Plan with a fair value of $15,000 for services.~~

~~In February 2020, pursuant to~~exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as ~~amended (the “Securities Act”), the Company issued 1,563 shares of common stock with a fair value of $11,500 in consideration of consulting services rendered.~~amended. The Company did not receive any cash proceeds from ~~the~~this issuance.

In ~~March 2020, pursuant to Section 4(a)(2) of the Securities Act,~~January 2022, the Company issued ~~1,563~~94,623 shares of ~~common stock with a fair value of $11,500 in consideration of consulting services rendered. The Company did not receive any proceeds from the issuance.~~

In May 2020, pursuant to Section 3(a)(9) of the Securities Act, the Company issued 24 shares of common stock as the result of the rounding on the reverse stock split. The Company did not receive any proceeds from the issuance.

~~In May 2020, the Company issued 3,438 shares of common stock under~~ its ~~2019 Stock Incentive Plan with a fair value of $25,930 to employees of which $19,287 was amortized in the twelve months ended December 31, 2020.~~

In June 2020, pursuant to Section 4(a)(2) of the Securities Act, the Company issued 3,750 shares of common stock with a fair value of $22,800 in consideration of consulting services rendered. The Company did not receive any proceeds from the issuance.

In August 2020, the Company issued 12,500 shares of restricted stock under its 2019 Stock Incentive Plan with a fair value of $72,200 to an employee of which $30,083 was amortized in the twelve months ended December 31, 2020.

In August 2020, pursuant to Section 4(a)(2) of the Securities Act, the Company issued 3,750 shares of common stock with a fair value of $19,500 in consideration of consulting services rendered. The Company did not receive any proceeds from the issuance.

In November 2020, pursuant to Section 4(a)(2) of the Securities Act, the Company issued 109 shares of common stock in consideration of consulting services rendered. The Company did not receive any proceeds from the issuance.

~~In November 2020, the Company issued 4,153,750 shares of~~ common stock for ~~cash~~net proceeds of ~~$13,292,000.~~$289,800.

In November 2020, pursuant to Section 3(a)(9) of the Securities Act, the Company issued 453,699 shares of common stock with fair value of $1,451,824 are the result of the conversion of notes payables and accrued interest. No gain or loss was recorded on conversion, as the issuance of common stock was pursuant to the terms of a prior agreement.Note 12 – Equity-Based Compensation

In November 2020, pursuant to Section 4(a)(2) of the Securities Act, the Company issued 22,250 shares of common stock with a fair value of $70,562 in consideration of consulting services rendered. The Company did not receive any proceeds from the issuance.

In November 2020, the Company issued 5,793 shares of restricted stock under its 2019 Stock Incentive Plan with a fair value of $18,494 to directors of which $18,494 was amortized in the twelve months ended December 31, 2020.

~~In December 2020, the Company issued 49,757 shares of restricted stock to directors under its 2019 Stock Incentive Plan, with a fair value of $152,700.~~

~~In January 2019, pursuant to Section 4(a)(2) of the Securities Act, the Company issued 1,875 shares of common stock with a fair value of $26,600 to service providers.~~

~~In February 2019, pursuant to Section 4(a)(2) of the Securities Act, the Company issued 8,394 shares of common stock for conversion of notes payable and accrued interest in the amount of $53,723.~~

~~In April 2019, pursuant to Section 4(a)(2) of the Securities Act, the Company issued 25,000 shares of common stock for conversion of notes payable in the amount of $160,000.~~

~~In May 2019, pursuant to Section 4(a)(2) of the Securities Act, the Company issued 3,907 shares of common stock for conversion of notes payable in the amount of $25,000.~~

~~In August 2019, pursuant to Section 4(a)(2) of the Securities Act, the Company issued 1,562 shares of common stock with a fair value of $15,000 to service providers.~~

~~In November 2019, pursuant to Section 4(a)(2) of the Securities Act, the Company issued 625 shares of common stock with a fair value of $4,400 to service providers.~~

In November 2019, pursuant to Section 4(a)(2) of the Securities Act, the Company issued 9,375 shares of common stock with a fair value of $93,750 pursuant a legal settlement signed on November 11, 2019.

In October 2019, the Company adopted ~~its~~the 2019 ~~Stock Incentive Plan (the “2019 Plan”).~~Plan. Under the 2019 Plan, the Company’s ~~Board~~board of ~~Directors~~directors is authorized to grant both incentive and ~~non-statutory~~non-qualified stock options to purchase common stock, ~~and~~as well as restricted stock awards to its employees, directors, and consultants. The 2019 Plan initially provided for the issuance of 500,000 shares. ~~In January 2020, the number of available shares was increased to 793,093, pursuant to a~~A provision in the 2019 Plan ~~providing~~provides for an automatic annual increase equal to 6% of the total number of shares of Company common stock outstanding on December 31 of the preceding calendar year. In January 2022, the number of available shares increased by 715,749 shares and on October 12, 2022 shareholders approved an amendment to the plan to add an additional 412,802 shares bringing the total shares available under the 2019 Plan to 2,500,000.

Options granted under the 2019 Plan generally have a life of 3 to 10 years and exercise ~~price~~prices equal to or greater than the fair market value of the common stock as determined by the Company’s ~~Board~~board of ~~Directors.~~

directors. Vesting for employees typically occurs over a ~~three-year period or based on performance objective.~~three-year period.

The following table sets forth the activity of the options to purchase common stock under the 2019 Plan. ~~The prices represent the closing price~~

Schedule of ~~our common stock on the OTC QB Venture Market until November 12, 2020 and the Nasdaq Capital Market on the respective dates.~~Stock Options Activity

The fair value of each option granted is estimated as of the grant date using the Black-Scholes option pricing model with the following assumptions:

	Years ended December 31,						Years ended December 31,
	2020			2019			2022		2021
Risk-free interest rate range		0.48%-1.65	%		1.6	%	1.6 to 3.94	%	0.22% to 0.73	%
Expected life of option-years	$	5.00 -$5.77			2.9		5.00 to 5.77		5.3 to 6.5
Expected stock price volatility		110.8-208.3	%		117	%	110 to 114.6	%	107% to 125	%
Expected dividend yield		—	%		—	%	-	%	-	%

The risk-free interest rate is based on U.S. Treasury interest rates, the terms of which are consistent with the expected life of the stock options. Expected volatility is based upon the average historical volatility of ~~our~~the Company’s common stock over the period commensurate with the expected term of the related instrument. The expected life and estimated post-employment termination behavior is based upon historical experience of homogeneous groups, executives and ~~non-executes,~~non-executives, within the Company. The Company does not currently pay dividends on its common stock, nor does it expect to do so in the foreseeable future.

Schedule of Share Based Payments Arrangements Options Exercised and Options Vested

For the ~~years~~year ended December 31, ~~2020,~~2022, the weighted average grant date fair value of options granted was ~~$6.94~~$2.92 per share. The Company estimates the fair value of options at the grant date using the Black-Scholes model. For all stock options granted through December 31, ~~2020,~~2022, the weighted average remaining service period is ~~3.5~~1.13 years.

The Company recognized $1,141,042 in stock-based compensation expense, which is recorded in selling, general and administrative expenses on the consolidated statement of operations for the years ended December 31, 2019. Unamortized stock option expense at December 31, 2020 that will be amortized over the weighted-average remaining service period of 3.5 years totaled $1,832,069.

On January 6, 2020, the Company granted one former employee a total of 2,500 options to purchase shares of the Company common at a price as of $7.04 per share. The Option Shares will vest when certain economic conditions are met by the Company and are exercisable until January 6, 2030. These economic conditions were met, and the options vested, on November 17, 2020. The total estimated value using the Black-Scholes Model, based on a volatility rate of 110.8%-128.0% and an option fair value of $5.94 was $14,851.

On January 17, 2020, the Company granted one employee a total of 125,000 options to purchase shares of the Company common at a price as of $6.84 per share. The Option Shares will vest ratably over twenty-four (24) months and are exercisable until January 17, 2030. The total estimated value using the Black-Scholes Model, based on a volatility rate of 110.8%-128.0% and an option fair value of $5.94 was $742,542.

On February 1, 2020, the Company granted one employee a total of 9,375 options to purchase shares of the Company common at a price as of $8.32 per share. The Option Shares will vest ratably over twenty-four (24) months and are exercisable until February 1, 2030. The total estimated value using the Black-Scholes Model, based on a volatility rate of 110.8%-128.0% and an option fair value of $6.56 was $61,487.

On February 5, 2020, the Company granted five Board member a total of 15,490 options to purchase shares of the Company common at a price as of $8.07 per share. The Option Shares will vest 16.67% immediately, 83.33% will vest ratably over ten (10) months and are exercisable until December 5, 2030. The total estimated value using the Black-Scholes Model, based on a volatility rate of 110.8%-128.0% and an option fair value of $6.33 was $98,063.

On March 23, 2020, the Company granted one employee a total of 12,500 options to purchase shares of the Company common at a price as of $8.32 per share. The Option Shares will vest ratably over thirty-six (36) months and are exercisable until March 23, 2030. The total estimated value using the Black-Scholes Model, based on a volatility rate of 110.8%-128.0% and an option fair value of $6.98 was $87,258.

On April 6, 2020, the Company granted one employee a total of 938 options to purchase shares of the Company common at a price as of $8.32 per share. The Option Shares will vest ratably over thirty-six (36) months and are exercisable until March 10, 2030. The total estimated value using the Black-Scholes Model, based on a volatility rate of 117.8% and an option fair value of $5.77 was $5,412.

On August 11, 2020, the Company granted one employee a total of 162,500 options to purchase shares of the Company common at a price as of $5.76 per share. The Option Shares will vest ratably over thirty-six (36) months and are exercisable until August 10, 2030. The total estimated value using the Black-Scholes Model, based on a volatility rate of 113.2% and an option fair value of $4.76 was $773,655.

On November 27, 2020, the Company granted three Board members a total of 5,793 options to purchase shares of the Company common at a price as of $3.16 per share. The Option Shares will vest immediately and are exercisable until November 27, 2025. The total estimated value using the Black-Scholes Model, based on a volatility rate of 208.3% and an option fair value of $3.16 was $18,318.

On October 16, 2019, the Company granted one employee a total of 202,599 options to purchase shares of the Company common at a price as of $8.16 per share. The Option Shares will vest ratably over thirty-six (36) months and are exercisable until October 16, 2022. The total estimated value using the Black-Scholes Model, based on a volatility rate of 116.33% and an option fair value of $6.20 was $1,256,163.

On October 29, 2019, the Company granted one former employee a total of 27,345 options to purchase shares of the Company common at a price as of $9.25 per share. The Option Shares will vest when certain economic conditions are met by the Company and are exercisable until October 25, 2029. These economic conditions were met, and the options vested, on November 17, 2020. The total estimated value using the Black-Scholes Model, based on a volatility rate of 119.98% and an option fair value of $7.70 was $210,564.

On October 29, 2019, the Company granted one employee a total of 30,074 options to purchase shares of the Company common at a price as of $9.25 per share. The Option Shares will vest when certain economic conditions are met by the Company and are exercisable until October 25, 2029. These economic conditions were met, and the options vested, on November 17, 2020. The total estimated value using the Black-Scholes Model, based on a volatility rate of 119.98% and an option fair value of $7.70 was $231,579.

In 2020, we issued 70,302 of restricted stock, to certain employees. Shares issued to employees vest monthly over 1 year on the anniversary dates of their grant. In 2020 64,021 shares of restricted stock vested.

~~The following table summarizes our aggregate restricted stock awards and restricted stock unit activity in 2020:~~

The Company recognized $459,890 in stock-based compensation expense, which is recorded in selling, general and administrative expenses on the consolidated statement of operations for the years ended December 31, 2020, and the Company will recognize $77,927 over the remaining requisite service period.

In connection with the issuance of the 2020 Convertible Notes, the Company also issued options to purchase 303,623 units at an exercise price of $3.20 per unit, with each unit consisting of one share of common stock, and a warrant to purchase one share of common stock at an exercise price of $3.20 per share. The units and warrants are exercisable for a period of five years from the date of issuance and are subject to a downward provision if the Company issues securities at a lower price. Warrant holders have a right to require the Company to pay cash in the event of a fundamental transaction. In accordance with ASC 815, the warrants and options issued in this period were determined to require equity treatment and $524,452 related to the options and $533,112 related to warrants was recorded in stockholders’ equity in the year ended December 31, 2020.

In connection with the issuance of the 2020 Convertible Notes, the Company agreed to issue the placement agent and the selling agent five-year warrants to purchase 6,750 shares of the Company’s common stock at an exercise price of $3.20. In the year ended December 31, ~~2020, $47,293 was recorded~~2022, the Company granted 204,111 in ~~stockholders’ equity related~~restricted stock units to ~~these warrants.~~

~~A Monte Carlo model was used because~~certain employees, directors, and consultants under the ~~investor warrants and options contain fundamental transaction payouts and reset events that cannot be modeled with a Black Scholes model.~~

~~The fair value of the options and warrants~~2019 Plan. Restricted stock issued to employees, directors, and consultants generally vest either at grant or vest over a period of one year from the ~~convertible debt holders is estimated as~~date of grant.

The following table summarizes the ~~issue date using a Monte Carlo model with~~Company’s restricted stock awards activity under the ~~following assumptions:~~2019 Plan during the year ended December 31, 2022:

Schedule of Aggregate Restricted Stock Awards and Restricted Stock Unit Activity

The risk-free interest rate is based on U.S. Treasury interest rates, the terms of which are consistent with the expected life of the stock options and warrants. Expected volatility is based upon the historical volatility of the Company’s common stock over the period commensurate with the expected term of the related instrument. The options and warrants are valued assuming projected reset events adjusting the exercise price and a forced exercise upon a projected fundamental transaction by management. The options and warrants early exercise are modeled assuming registration after 180 days. The Company does not currently pay dividends on its common stock nor does it expect to in the foreseeable future.

The provision for income taxes consists of the following for the year ended December 31, ~~2020~~2022, and ~~2019:~~2021:


	December 31					December 31
	2020			2019		2022		2021
Federal income taxes:
Current		-			-	$	-	$	-
Deferred		(84	)		349		315		(280	)
Total federal income taxes		(84	)		349		315		(280	)

State income taxes:
Current		1,212			1824		2,062		4,094
Deferred		120			84		496		390
Total state income taxes		1,332			1908		2,558		4,484
Total income taxes	$	1,248		$	2,257	$	2,872	$	4,764

The effective income tax rate is lower than the U.S. federal and state statutory rates primarily because of the valuation allowance and, to a lesser extent, permanent items. A reconciliation of the ~~2020~~2022 and ~~2019~~2021 federal statutory rate as compared to the effective income tax rate is as follows:

	December 31										December 31
	2020					2019					2022					2021
Pre-Tax Book Income at Statutory Rate	$	(1,688,606	)	21.00	%	$	(461,117	)	21.00	%	$	(2,202,718	)	21.00	%	$	(1,363,829	)	21.00	%
State Tax Expense, net		1,078		-0.01	%		1,524		-0.10	%		1,629		-0.02	%		3,624		-0.06	%
Permanent Items		37,441		-0.47	%		26,430		-1.20	%		348,768		-3.33	%		425,318		-6.55	%
Hanging Credit												811		-0.01	%		-		-
True-Ups		6,790		-0.09	%							(36,554	)	0.35	%		713,398		-10.98	%
Change in Federal Valuation Allowance		1,644,545		-20.45	%		435,420		-19.80	%		1,890,936		-18.03	%		226,255		-3.48	%
Total Expense	$	1,248		-0.02	%	$	2,257		-0.10	%	$	2,872		-0.03	%	$	4,764		-0.07	%

Deferred income taxes reflect the net effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax. Significant components of the deferred tax assets and liabilities as of December 31, ~~2020~~2022 and ~~2019,~~2021, are as follows:


	December 31						December 31
	2020			2019			2022			2021

Deferred tax assets:
Accrued Compensation	$	127,829		$	102,049		$	243,056		$	150,952
Amortization of Discount Notes Payable		93,017			99,635
Lease (ASC 842)		19,718			25,715			342,254			365,602
Charitable Contributions		127			-			2,771			136
Stock Option Expense		28,212			-			117,099			75,590
Restricted Stock Unit		10,665			-			62,090			12,929
Deferred Revenue		865,747			1,112,807
Net Operating Losses		5,361,500			3,111,504			8,395,160			6,406,223
Org Costs								81,255			72,455
-IRC Sec. 174 Expense								275,519			-
Investment in HRCFG INVO, LLC								123,217			81,234
Equity in earnings - Positib								19,950			3,765
Gross deferred tax assets		6,506,815			4,451,710			9,662,371			7,168,886
Less: Valuation Allowance		(6,408,401	)		(4,401,714	)
Net deferred tax asset:		98,414			49,996

Deferred tax liabilities:
Fixed Assets		(32,159	)		(24,281	)		(21,560	)		(26,907	)
ROU Lease (ASC 842)		(19,228	)		(25,715	)		(5,858	)		(353,551	)
Trademark Amortization		(1,529	)		(433	)		(327,946	)		(4,309	)
Convertible Note Interest Expense		(42,111	)		-
Note Issuance Cost		(3,855	)		-

Deferred Revenue								(47	)		-
Tax Amortization of Org Cost								(7,222	)		-
Gain/Loss on sale of assets								(2,561	)		-
Gross deferred tax liability								(365,194	)		(384,767	)
Less: valuation allowance								(9,299,126	)		(6,785,258	)
Net deferred tax liability		(98,882	)		(50,429	)	$	(1,949	)	$	(1,139	)
Net deferred tax liability	$	(468	)	$	(433	)

The Company recorded a full valuation allowance against its net deferred tax asset at December 31, ~~2020~~2022 and ~~2019~~2021 totaling ~~$6,408,401~~$9.3 million and ~~$4,401,714,~~$6.8 million, respectively. A naked credit resulting from indefinite lived intangibles was valued at December 31, ~~2020~~2022, and ~~2019~~2021 totaling ~~($468)~~$(1,949) and ($~~433)~~1,139), respectively.

As of December 31, ~~2020,~~2022, the Company has federal net operating loss carryforwards ~~totaling $21,819,421.~~of approximately $32.8 million. Of that amount, ~~$10,793,313~~$10.8 million will expire, if not utilized, in various years beginning in 2028 and which are also subject to the limitations of IRC §382. The remaining carryforward amount of ~~$11,026,108,~~$15.0 million, has no expiration period and can be applied to 80% of taxable income per year in future periods. State net operating loss carryforwards total ~~$16,774,460.~~$8.9 million. Of that amount, ~~$4,659,523~~$3.5 million will begin to expire in 2033 and are subject to the limitations of IRC §382. The remaining ~~$12,114,937~~$20.0 million of state net operating loss carryforwards are similar to the federal net operating loss in that it has no expiration period and can be applied to 100% of state taxable income per year.

The Company’s insurance coverage is carried with third-party insurers and includes: (i) general liability insurance covering third-party exposures; (ii) statutory workers’ compensation insurance; (iv) excess liability insurance above the established primary limits for general liability and automobile liability insurance; (v) property insurance, which covers the replacement value of real and personal property and includes business interruption; and (vi) insurance covering our directors and officers for acts related to our business activities. All coverage is subject to certain limits and deductibles, the ~~Internal Revenue Code~~terms and conditions of ~~1986, as amended imposes an annual limit on the ability~~which are common for companies with similar types of a corporation that undergoes an “ownership change” to use its NOLs to reduce its tax liability. An “ownership change” is generally defined as any change in ownership of more than 50% of a corporation’s “stock” by its “5-percent shareholders” over a rolling three-year period based upon each of those shareholder’s lowest percentage of stock owned during such period. Such a change in ownership occurred in 2007. At this time, The Company does not believe this limitation, when combined with amounts allowable due to net unrecognized built in gains, will affect its ability to use any NOLs before they expire.operations.

The Company routinely inspect its income tax filings for current and previous positions that could be considered uncertain. If a position is deemed to carry a more-likely-than-not probability of notwithstanding challenge from a tax authority, the Company would record a liability for Uncertain Tax Positions (UTP) for the tax in question. As of December 31, 2020, and for all prior years, the Company does not and have not carried any UTP’s on the balance sheet. If a UTP was recorded, it is the Company’s policy to include interest and penalties on taxes as part of income tax expense.Legal Matters

~~There are currently no income tax examinations being performed at the federal or state level and the~~The Company is not ~~aware~~currently subject to any material legal proceedings; however, it could be subject to legal proceedings and claims from time to time in the ordinary course of ~~any possible~~its business, or legal proceedings it considered immaterial may in the future ~~audits or examinations. The Company’s federal~~become material. Regardless of the outcome, litigation can, among other things, be time consuming and ~~state income tax returns from 2017~~expensive to resolve, and ~~forward remain open to examination by the corresponding taxing authorities under the statute~~can divert management resources.

In January and March 2023, we sold unsecured convertible notes of limitations, generally. However, due to the loss carryforwards established on historical tax filings, it is possible that the taxing authorities could examine tax years as far back as 2007 in order to determine if the net operating loss carryforward is appropriate.

~~On August 7, 2019,~~ the Company ~~sent James Bowdring, the brother of the Company’s then Chief Financial Officer, a check~~ in the aggregate original principal amount of ~~$65,197 as full~~$410,000 (the “Convertible Notes”) with a fixed conversion prices of $0.50 (for the $275,000 of January 2023 Notes) and ~~final payment under those certain promissory notes dated April 8, 2011~~$0.60 (for the $135,000 of March 2023 Notes) and November 9, 2011. On August 8, 2019, Mr. Bowdring’s legal counsel returned the check. The basis for returning the check was a claim that the interest due under the Notes called for compounded interest and not per annum interest, this amount is recorded in Accounts Payable and Accrued Liabilities on the Consolidated Balance Sheet. In addition, the letter rejecting the tender of the payment in full check alleged Mr. Bowdring was considering a future intention(ii) 5-year warrants (the “Note Warrants”) to ~~convert his Promissory Notes into~~purchase 387,500 shares of the Company’s common stock. Mr. Bowdring, through his counsel, indicated that such future intention to convert the Notes to common stock were contingent upon Mr. Bowdring addressing certain personal issues which were not disclosed by his counsel in the correspondence returning the checks. The Company does not believe that Mr. Bowdring has the right to seek conversion of the Notes once payment for the Notes has been tendered. In order to resolve the issue of the Company’s tender of payment in full versus Mr. Bowdring’s assertion that he can reject tender and seek conversion, the Company has filed an action in the Suffolk Superior Court in Boston on September 3, 2019 seeking Declaratory Judgment and Judgment for Breach of Contract. On September 30, 2019, Mr. Bowdring filed an answer and counterclaim under which he alleged breach of contract, fraud, promissory estoppel, unfair and deceptive practices and constructive trust. Mr. Bowdring is seeking receipt of all shares due under the adjusted conversion price.

The 10% Senior Secured Convertible Promissory Notes were issued on April 8, 2011 and November 9, 2011, with maturity dates thirty days subsequent to the dates of issuance. Interest was calculated at 10% per annum, compounded based on a 360-day year. Investors had the option to convert any unpaid principal and accrued interest into shares of Company’s common stock original conversion prices of $0.96 and $0.32, respectively, subject to adjustments upon the Company’s issuances of stock at prices less than the original conversion prices during the 24-months after issuance of each note (i.e., currently $0.2100).

~~The Company does not currently expect the above matter to have a material adverse effect upon either the Company’s results of operations, financial position, or cash flows.~~

On October 10, 2019, the Company entered into an agreement with our newly appointed CEO, Steve Shum. The Company agreed to pay Mr. Shum an annual salary of $260,000. In addition, Mr. Shum earned a bonus compensation of $75,000 bonus upon a successful up-listing to the Nasdaq exchange which was paid as of December 31, 2020. All other bonus amounts will be determined by the Board of Directors, at their sole discretion. In addition to his base salary and performance bonus, the Company granted Mr. Shum: (i) 400,000 shares of our common stock and (ii) a three-year option to purchase 6,483,171 shares of our common stock at an exercise price of ~~$0.255~~$1.00 (subject to adjustments) (the “Note and Warrant Private Placement”). The proceeds were used for working capital and general corporate purposes.

Interest on the Convertible Notes accrues at a rate of ten percent (10%) per ~~share. These options~~annum and is payable at the holder’s option either in cash or in shares of the Company’s common stock at the conversion price set forth in the Convertible Notes on December 31, 2023, unless converted earlier.

The Company entered into a registration rights agreement with the holders of and of even date with the Convertible Notes (the “Note RRA”). Pursuant to the terms of Note RRA, if the Company determines to register any of its securities, either for its own account or the account of a security holder or holders, other than (i) a registration relating solely to employee benefit plans on Form S-8 (or any successor form) or (ii) a registration relating solely to a Commission Rule 145 transaction on Form S-4 (or any successor form), the Company will ~~vest monthly over a 3-year period.~~include in such registration, and in any underwriting involved therein, the shares underlying the Convertible Notes and Note Warrants delivered pursuant to the Note and Warrant Purchase Agreements, subject to, in the case of an underwritten registration, the discretion of the managing underwriter to reduce any or all piggyback registration shares if in its good faith judgment such inclusion would affect the successful marketing of the underwritten offering.

On ~~January 15, 2020,~~February 3, and February 17, 2023, the Company entered into ~~an employment agreement~~securities purchase agreements (the ~~“Campbell Employment Agreement”~~“February Purchase Agreements”) with ~~Michael Campbell~~accredited investors (the “February Investors”) for the purchase of (i) convertible debentures of the Company in the aggregate original principal amount of $500,000 (the “February Debentures”) for a purchase price of $450,000, (ii) warrants (the “February Warrant”) to ~~continue serving as~~purchase 250,000 shares (the “February Warrant Shares”) of the Company’s Chief Operating Officer and Vice President of Business Development. The Campbell Employment Agreement provides for an annual base salary of $220,000, and a target annual incentive bonus of up to 50% of base salary if the Company achieves goals and objectives determined by the board of directors. In connection with the Campbell Employment Agreement, on January 17, 2020, the Company granted Mr. Campbell 31,250 shares of Company common stock ~~and an option to purchase 125,000 shares of Company common stock (the “Option”~~par value $0.0001 per share (“Common Stock”) at an exercise price of ~~$6.84096~~$0.75 per share, and (iii) 83,333 shares of Common Stock (the “February Commitment Shares”) issued as an inducement for issuing the Debentures. The proceeds, net of placement agent and legal fees, are being used for working capital and general corporate purposes.

All amounts due under the February Debentures are convertible at any time after the issuance date, in whole or in part, at the option of the February Investors into Common Stock at an initial price of $0.52 per share. ~~One quarter~~This conversion price is subject to adjustment for stock splits, combinations or similar events and anti-dilution provisions, among other adjustments and is subject to a floor price.

The Company may prepay the February Debentures at any time in whole or in part by paying a sum of money equal to 105% of the ~~Option vested upon grant,~~principal amount to be redeemed, together with accrued and unpaid interest.

On March 31, 2023, having received notice from the February Investor that signed its purchase agreement on February 17, 2023 (the “Feb 17 Investor”) requesting repayment of its February Debenture, the Company paid the Feb 17 Investor $170,000, including interest and the ~~remainder vests~~prepayment premium. After such payment, the principal due the Feb 17 Investor under its debenture was reduced from $200,000 to $39,849.

On February 3, 2023, the Company entered into an equity purchase agreement (the “ELOC”) and registration rights agreement (the “ELOC RRA”) with the Feb 3 Investor pursuant to which the Company has the right, but not the obligation, to direct the Feb 3 Investor to purchase up to $10.0 million (the “Maximum Commitment Amount”) of shares of Common Stock, in ~~monthly increments over~~multiple tranches. Further, under the ELOC and subject to the Maximum Commitment Amount, the Company has the right, but not the obligation, to submit notices to the Feb 3 Investor to purchase shares of Common Stock (i) in a ~~period~~minimum amount of ~~two~~not less than $25,000 and (ii) in a maximum amount of up to the lesser of (a) $750,000 or (b) 200% of the Company’s average daily trading value of the Common Stock.

Also on February 3, 2023, the Company issued to the Feb 3 Investor 150,000 shares of Common Stock for its commitment to enter into the ELOC.

On March 16, 2023, INVO, through Wood Violet Fertility LLC, a Delaware limited liability company (“Wood Violet”) and wholly owned subsidiary of INVO Centers LLC, a Delaware company wholly-owned by INVO, entered into binding purchase agreements to acquire Wisconsin Fertility Institute (“Wisconsin Fertility”) for a combined purchase price of $10 million.

The March Warrants (and the shares of Common Stock issuable upon the exercise of the Private Warrants) were not registered under the Securities Act and were offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder. The March Warrants are immediately exercisable upon issuance, will expire eight years from the date of ~~grant. Mr. Campbell is also entitled to customary benefits, including health insurance~~issuance, and ~~participation~~ in employee benefit plans. The Campbell Employment Agreement provides that if Mr. Campbell terminates the Campbell Employment Agreement for “cause” (as defined in the Campbell Employment Agreement) orcertain circumstances may be exercised on a cashless basis.

On March 27, 2023, the Company ~~terminates~~closed the ~~Campbell Employment~~offering, raising gross proceeds of approximately $3 million before deducting placement agent fees and other offering expenses payable by the Company. In the event that all March Warrants are exercised for cash, the Company would receive additional gross proceeds of approximately $3.5 million. Under the March Purchase Agreement, ~~without “cause,” then he will continue to receive his base salary and certain insurance benefits for three months after termination. The~~the Company may ~~terminate the Campbell Employment Agreement without “cause” on 60 days’ notice.~~

~~The Company has entered into~~use a consulting agreement with Shine Management, Inc. through which it is receiving outsourced accounting and the support of its acting CFO, Debra Hoopes. Debra is the CFO and Chief Administrative Officer of Shine Management, Inc. and Management Services Company in Charlottesville, VA.

The Company has one major customer, Ferring, that accounted for approximately 98.3% and $1,019,286 of sales for the year ended December 31, 2020. The Company expects to maintain this relationship with the customer.

~~The Company adopted ASC 606,~~ ~~Revenue from Contracts with Customers~~ ~~effective January 1, 2018 using the modified retrospective method applied to those contracts which were not substantially completed as of January 1, 2018~~. These standards provide guidance on recognizing revenue, including a five-step model to determine when revenue recognition is appropriate. The standard requires that an entity recognize revenue to depict the transfer of control of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Revenues for 2020 are reported under ASC 606, while prior period amounts are not adjusted and continue to be reported under ASC 605, ~~Revenue Recognition~~.

The Company routinely enters into agreements with customers that include general commercial terms and conditions, notification requirements for price increases, shipping terms and in most cases prices for the products that it offers. However, these agreements do not obligate the Company to provide goods to the customer and there is no consideration promised to us at the onset of these arrangements. For customers without separate agreements, the Company has a standard list price established by geography and by currency for all products and our invoices contain standard terms and conditions that are applicable to those customers where a separate agreement is not controlling. The Company’s performance obligations are established when a customer submits a purchase order or notification (in writing, electronically or verbally) for goods, and it accept the order. The Company identifies performance obligations as the deliveryportion of the requested product(s) in appropriate quantities and to the location specified in the customer’s e-mail/or purchase order. The Company generally recognizes revenue upon the satisfaction of these criteria when controlnet proceeds of the ~~product has been transferred~~offering to (a) repay February Debentures, and (b) to pay the ~~customer at which time it has an unconditional right to receive payment.~~down payment for Wisconsin Fertility acquisition. The Company’s prices are fixed and are not affected by contingent events that could impact the transaction price. The Company does not offer price concessions and does not accept payment that is less than the price stated when it accepted the purchase order, except in rare credit related circumstances. The Company does not have any material performance obligations where it is acting as an agent for another entity.

Revenues for products, including: INVOcell®, INVO TM Retention System, and INVO Microscope Holding Block are typically recognized at the time the product is shipped, at which time the title passes to the customer, and there are no further performance obligations. Revenues from consignment are recognized when the medical device is shipped from the Consignor to the customer.

In January 2019, the Company announced a U.S. license and distribution agreement with Ferring International Center S.A. (“Ferring”). The agreement calls for the issuance of an initial upfront payment of $5,000,000 which we received upon the signingremainder of the ~~agreement, ongoing product revenue,~~net proceeds will be used for working capital, capital expenditures, and ~~then subsequent licensing fee payment of $3,000,000 that will provide us with a source of non-dilutive financing to execute our plan.~~ other general corporate purposes.

Under the terms of the agreement the Company can pursue developing international markets and as well as partnering and opening INVO-only reproductive centers within the U.S. market. The initial upfront payment of $5,000,000 which the Company received upon the signing of the agreement is being recognized to income over the 7-year term.

~~Under the terms of the Distribution~~March Purchase Agreement, Ferring completed its obligation to make an initial payment to the Company of $5,000,000 upon completion of the required closing conditions, including executed agreements from all current manufacturers of the Licensed Product that upon a material supply default by the Company, Ferring can assume a direct purchase relationship with such manufacturers. Ferring is obligated to make a second payment to the Company of $3,000,000 provided that the Company is ~~successful in obtaining a five (5) day label enhancement from the FDA for the current incubation period for the Licensed Product at least three (3) years prior to the expiration~~required within 30 days of the ~~term~~closing date of the ~~license for~~offering to file a registration statement on Form S-1 (the “Resale Registration Statement”) registering the ~~Licensed Product~~resale of the shares of Common Stock issuable upon the exercise of the March Warrants. The Company is required to use commercially reasonable efforts to cause such registration to become effective within 75 days of the closing date of the offering (or 120 days if the registration statement is subject to a full-review by the SEC), and ~~provided further that Ferring has not previously exercised its right~~ to ~~terminate the Distribution Agreement for convenience.~~ keep such registration statement effective at all times until no March Warrants remain outstanding.

In addition, ~~the Company entered into a separate Distribution Agreement. The Distribution Agreement has an initial term expiring on December 31, 2025~~pursuant to certain “lock-up” agreements, our officers and at the end of the initial term it may be terminated by the Company if Ferring fails to generate specified minimum revenues to the Company from the sale of the Licensed Product during the final two years of the initial term.

~~On March 2, 2021, the Company entered into Amendment No. 1 to the Distribution Agreement (the “Amendment”) with Ferring. Pursuant to the Amendment, Ferring~~directors have agreed, ~~to purchase a 2,004 count of product~~ for $501,000 in March 2021, at which point the minimum annual target for 2020 set forth in Section 2.4 of the Distribution Agreement will be deemed to be satisfied in full as a result of such purchase. The Amendment provides for added flexibility by increasing the number of INVO company-owned clinics initially allowable under the agreement and removing certain geographical requirements.

The Ferring license was deemed to be a functional license that provide customers with a “right to access” to our intellectual property during the subscription period and, accordingly, revenue is recognized over a period of ~~time, which is generally~~180 days from the ~~subscription period. During~~date of the ~~twelve months ended December 31, 2020, the Company recognized $714,286 related~~offering, not to ~~the Ferring license agreement.~~

Asengage in any of ~~December 31, 2020, and December 31, 2019, the Company had deferred revenues of $3,571,429 and $4,477,261, respectively.~~

On September 20, 2019, the Company entered into an exclusive distribution agreement with Quality Medicines, Cosmetics & Medical Equipment Import for the territories of Sudan, Uganda and Ethiopia. This distribution agreement has a term of one year and may be extended by mutual agreement and is based on wholesale prices. Quality Medicines is required to register our product in each of these countries.

On September 11, 2019, the Company entered into an exclusive distribution agreement with G-Systems Limited registered in Nigeria. In the territories of Nigeria. This distribution agreement has a term of one year and may be extended by mutual agreement and is based on wholesale prices. G-Systems is required to register our produce in Nigeria.

On November 12, 2019, the Company announced that it had entered into exclusive distribution agreements with Biovate a Jordanian company for the territory of Jordan and Orcan Medical for the territory of Turkey. This agreement has a term of one year with extensions by mutual agreement. Safadi Drugstore is required to register our product in Jordan.

On November 23, 2020, the Company entered into a Distribution Agreement with IDS Medical Systems (“Distributor”) to distribute the INVOcell system to Malaysia under which Distributor was appointed as the exclusive distributor in Malaysia. The Company can elect to terminate Distributor’s exclusivity upon its failure to meet certain purchase targets, in its sole discretion. The agreement is for a term of three years. The Company also granted Distributor an exclusive right to the INVO trademarks in Malaysia in connection with the sale of products in Malaysia.

~~The Company has identified~~ the following, ~~revenues disaggregated by revenue source:~~

~~For the twelve months ended December 31, 2020 and 2019 the source of revenue was derived from:~~

The Company incurs agreement obligations on general customer purchase orders and e-mails that have been accepted but unfulfilled. Due to the short duration of time between order acceptance and delivery of the related product, the Company has determined that the balance related to these obligations is generally immaterial at any point in time. The Company monitors the value of orders accepted but unfulfilled at the close of each reporting period to determine if disclosure is appropriate.

The Company’s general product warranties do not extend beyond an assurance that the product delivered will be consistent with stated specifications and do not include separate performance obligations.

There are no significant judgments associated with the satisfaction of our performance obligations. The Company generally satisfy performance obligations upon delivery of the product to the customer. This is consistent with the time in which the customer obtains control of the products. Therefore, the value of unsatisfied performance obligations at the end of any reporting period is generally immaterial. The Company considers variable consideration in establishing the transaction price. Forms of variable consideration applicable to our arrangements include sales returns, rebates, volume-based bonuses, and prompt pay discounts. The Company uses historical information along with an analysis of the expected value to properly calculate and to consider the need to constrain estimates of variable consideration. Such amounts are included as a reduction to revenue from the sale of products in the periods in which the related revenue is recognized and adjusted in future periods as necessary.

The Company does not use or offer sales commissions of any type. The Company generally does not incur incremental charges associated with securing agreements with customers which would require capitalization and recovery over the life of the agreement.

~~The Company’s payment terms for sales direct to customers and distributors are substantially less than the one year collection period that falls within the practical expedient in determination of~~ whether ~~a significant financing component exists.~~

~~Fees charged to customers for shipping and handling of products are included as an offset to the costs for shipping and handling of products included as a component of cost of products.~~

~~The following table sets forth a list of the Company’s current joint venture arrangements.~~

~~The current joint venture arrangements are in the developmental stage and therefore only the initial startup costs are included in the financial statement for the year ended December 31, 2020.~~

On November 23, 2020, the Company entered into a separate joint venture agreement with SNS Murni SDN BHD (“SNS Murni”), a company incorporated in Malaysia, to establish an exclusive joint venture in Malaysia to (i) introduce, promote and market its technologies related to the INVOcell and INVO Procedure in dedicated government-owned fertility clinics in Malaysia, and (ii) establish INVO Clinics in Malaysia. The joint venture will be co-managed and owned 50% by each of INVO Bioscience and SNS Murni. For the year ended December 31, 2020 the Company has invested $7,348 in this joint venture.

On November 23, 2020, the Company entered into a joint venture agreement with Ginekaliks Dooel (“Ginekaliks”), a limited liability company incorporated in the Republic of North Macedonia, to establish an exclusive joint venture to (i) commercialize, introduce, promote and market technologies related to the INVOcell and INVO Procedure in North Macedonia, (ii) establish a private healthcare institution to offer the INVO Procedure. The joint venture will be co-managed and owned 50% by each of INVO Bioscience and Ginekaliks. For the year ended December 31, 2020 the Company has invested $2,597 in this joint venture.

Effective September 24, INVO Centers, LLC entered into a Pre-Incorporation and Shareholders Agreement with Francisco Arredondo, MD PLLC (“Arredondo”) and Security Health LLC, a Texas limited liability company (“Ramirez”, and together with INVO and Arredondo, the “Shareholders”) under which the Shareholders will commercialize the INVO Procedure and offer related medical treatments in Mexico. Each party will own one-third of the Mexican incorporated company, Positib Fertility, S.A. de C.V. (the “Mexico Company”). The Mexico Company will acquire the INVOcell product at cost plus any incurred shipping, customs and related fees.

The Mexico Company will operate in Monterrey Nuevo Leon, Mexico and any other cities and places in Mexico as approved by the Mexico Company’s board of directors and Shareholders. In addition, the Shareholders agreed that the Mexico Company will be the Company’s exclusive distributor in Mexico. The Shareholders also agreed not to compete directly or indirectly, ~~with~~without the ~~Mexico Company in Mexico. For the year ended December 31, 2020 the Company has invested $51,670 in this joint venture.~~

~~On January 13, 2020, the Company entered into a joint venture agreement (the “Agreement”) with Medesole Healthcare and Trading Private Limited, India (“Medesole~~”), an Indian corporation that promotes and distributes healthcare technologies, medical equipment and allied services to hospitals, clinics and primary health care centers in India and the Middle East.

Pursuant to the Agreement, the Company and Medesole will form a joint venture entity incorporated and registered in India, which will operate under the name Medesole INVO Bioscience India Private Limited (the “JV”). After formation, the Company will grant to the JV all required licenses for promoting, marketing and selling the Company’s INVOcell® technology in India. The Company and Medesole intend that the JV will open and operate dedicated INVOcell® clinics only in India.

~~The JV will be co-managed and owned 50% by each of INVO and Medesole, who will share equally in the expenditures, revenues and profits~~consent of the ~~JV. The~~March Purchase Agreement ~~has a term of three years and may be terminated by either party on 180 days’ prior written notice.~~

As of December 31, 2020, the Company was in negotiations with several potential joint venture partners but had not yet entered into any definitive agreements for additional U.S. INVO Clinics. The Company has invested $30,340 in joint ventures the Company is currently exploring.

On March 10, 2021, the Company’s wholly owned subsidiary, INVO Centers, LLC (“INVO Centers”), entered into a limited liability company agreement (the “JV LLC Agreement”) with HRCFG, LLC (“HRCFG”)investor: offer to form a joint venture for the purpose of commercializing INVOcell and the INVO Procedure at a dedicated fertility clinic in Birmingham, Alabama. The name of the joint venture LLC is HRCFG INVO, LLC (the “JV Company”). The responsibilities of HRCFG’s principals include providing clinical practice expertise, performing recruitment functions, providing all necessary training, and providing day-to-day management of the clinic. The responsibilities of INVO Centers will provide accesssell, sell, contract to and will be the exclusive provider to the JV Company of the INVOcell and the INVO Procedure. INVO Centers will also perform all required in vitro fertilization, industry specific compliance and accreditation functions, and product documentation for product registration. The Company will also provide certain funding to the JV Company. In connection with the formation of the JV Company, the Company provided an initial $30,000 in funding, in exchange for a note issued by HRCFG, which will be repaid from the operating profit of the JV Company. Interest on the note accrues at a rate of 1.5%. In addition, the Company has agreed to issue 25,000 sharessell pledge, grant, lend, or otherwise transfer or dispose of our common stock or any securities convertible into or exercisable or exchangeable for Common Stock (the “Lock-Up Securities”); enter into any swap or other arrangement that transfers to ~~HRCFG (i) upon~~another, in whole or in part, any of the ~~Birmingham clinic opening~~economic consequences of ownership of the Lock-Up Securities; make any demand for ~~business, and (ii) upon each additional INVOcell clinic opened for business by~~or exercise any right or cause to be filed a registration statement, including any amendments thereto, with respect to the ~~JV Company.~~registration of any Lock-Up Securities; enter into any transaction, swap, hedge, or other arrangement relating to any Lock-Up Securities subject to customary exceptions; or publicly disclose the intention to do any of the foregoing.

During the first quarter of 2023, the Company and HRCFG, as lessees, entered into a Lease Agreement with Trustmark National Bank, as lessor, for the lease of a 4,129 square foot facility in Birmingham, Alabama for the clinic associated with the JV LLC Agreement. The lease term will commence upon the earlier of June 1, 20201 or the opening of the clinic, and will be 86 months. The base rent per month will initially be $9,196.44 and will increase 2.25% each year.

On March 2, 2021, the Company entered into Amendment No. 1 to the Distribution Agreement (the “Amendment”) with Ferring. Pursuant to the Amendment, Ferring agreed to purchase a 2,004 count of product for $501,000 in March 2021, at which point the minimum annual target for 2020 set forth in Section 2.4 of the Distribution Agreement will be deemed to be satisfied in full as a result of such purchase. The Amendment provides for added flexibility by increasing the number of INVO company-owned clinics initially allowable under the agreement and removing certain geographical requirements.

~~In March 2021, three noteholders converted $1,237,624 of principal and accrued interest to 386,758~~issued 185,736, shares of common ~~stock.~~

~~In March 2021, the Company issued 77,444 shares of our common~~ stock to employes and ~~77,444 issued warrants upon exercise of outstanding unit purchase options for which it received $247,821 in proceeds.~~

~~In March 2021, the Company issued 39,094 shares of our common stock upon exercise of outstanding warrants for which it received $125,104 in proceeds.~~

In March 2021, the Company issued 85,568 shares of its common stock upon exercise of outstanding unit purchase options. The unit purchase options were exercised to purchase 131,114 shares and were exercised in full on a cashless basis and accordingly 45,546 shares were withheld at the market price of $9.20 per share less the exercise price of $3.20 per share to fund the exercise price.

~~In March 2021, the Company issued 131,114 warrants upon the exercise in full of 131, 114 unit purchase options. The Company did not receive any proceeds upon exercise.~~

In March 2021, the Company issued 90,748 shares of our common stock upon exercise of outstanding warrants. The warrants were exercised to purchase 139,056 shares and were exercised in full on a cashless basis and accordingly 48,308 shares were withheld by the Company at the market price of $9.20 per share less the exercise price of $3.20 per share to fund the exercise price.

~~In January 2021, the Company issued 58,500 shares of our common stock with a fair value of $179,490 in consideration of consulting services rendered.~~

~~In February 2021, the Company issued 5,000 shares of our common stock with a fair value of $15,250 in consideration of consulting services rendered.~~

~~In March 2021, the Company issued 8,000 shares of our common stock with a fair value of $26,640 in consideration of consulting services rendered.~~

~~In January 2021, the Company issued 30,000 shares of our common stock~~consultants under the 2019 Stock Incentive ~~Plan with a fair value of $90,300 to five (5) employees.~~Plan.

Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosures

We maintain disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, that are designed to be effective in providing reasonable assurance that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC, and that such information is accumulated and communicated to our management to allow timely decisions regarding required disclosure.

Our management, ~~under~~including the ~~supervision and with the participation of our~~ Chief Executive Officer and ~~Acting~~the Chief Financial ~~(and principal accounting)~~ Officer, carried out an evaluation of the effectiveness of the ~~design and operation of the~~ Company’s disclosure controls and procedures (as such term is defined in ~~Rule~~Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of ~~the Exchange Act)~~1934, as amended, as of ~~December 31, 2020,~~ the end of the ~~fiscal~~ period covered by this ~~Form 10K. We maintain~~report. These disclosure controls and procedures ~~that~~ are designed to ~~be effective in providing reasonable assurance~~ensure that information required to be disclosed by us in ~~our~~the reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms ~~of the Securities~~ and ~~Exchange Commission (the “SEC”), and that such information is~~(ii) accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure. Based ~~upon that~~on this evaluation, and the identification of the material weakness in the Company’s internal control over financial reporting as of December 31, 2019 (due to limited resources and employees) which has been remediated as of the end of the period December 31, 2020, our Chief Executive Officer and ~~Acting~~ Chief Financial Officer have concluded that our disclosure controls and procedures were effective as of ~~the end of the period covered by this Annual Report. Based on the evaluation of our disclosure controls and procedures as of~~ December 31, ~~2020, our Chief Executive Officer and Acting Chief Financial (and principal accounting) Officer concluded that, as of such date, our disclosure controls and procedures were effective.~~2022.

To mitigate the internal limited resources and limited employees, we continue to rely heavily on direct management oversight of transactions, along with the use of outside legal and accounting professionals. We are taking steps to create effective procedures and controls throughout the organization. We are in the process of establishing procedures and segregating duties where we can. We have implemented a new accounting system, outsourced our accounts payable function, implemented an approval processes, created a number of policies, reporting processes, a standard customer contract and introduced an employee manual. We will continue to monitor our disclosure controls and procedures and will address areas of potential concern. As we grow, we expect to increase our number of employees, which will enable us to implement adequate segregation of duties within the internal control framework.

As a result of the infusion of additional cash in 2020 with proceeds from our offering of convertible notes and our underwritten public offering, we have taken a number of steps to enhance our internal and disclosure controls.

Our management, including our Chief Executive Officer and Acting Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within our company have been detected. These inherent limitations include, but are not limited to, the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

Our management is responsible for establishing and maintaining adequate internal control over financial reporting of the Company. Our management conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in Internal Control—Integrated Framework (1992 Framework) issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on the evaluation of our internal control over financial reporting, management has concluded that, as of December 31, ~~2020,~~2022, our internal control over financial reporting was effective.

To mitigate the current limited resources and limited employees, we rely heavily on direct management oversight of transactions, along with the use of legal and accounting professionals. As we grow, we expect to increase our number of employees, which will enable us to implement adequate segregation of duties within the internal control framework.

This annual report does not include an attestation report of the company’s registered public accounting firm regarding internal control over financial reporting. Management’s report was not subject to attestation by the company’s registered public accounting firm pursuant to rules of the SEC.

Our management, including our Chief Executive Officer and ~~Acting~~ Chief Financial Officer, does not expect that our disclosure controls and procedures or our internal controls will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include, but are not limited to, the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the control.

The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, controls may become inadequate because of changes in conditions, or the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

There were no changes to our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

~~None.~~Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

The ~~following table sets forth~~ information ~~with respect~~required by this Item 10 is incorporated by reference to ~~each of~~ our ~~directors and executive officers including their positions and age as of the date of this Annual Report.~~

~~Steven M. Shum.~~ Mr. Shum is our Chief Executive Officer, a position he has held since October 10, 2019 and is also a director, a position he has held since October 11, 2017. Previously, Mr. Shum was Interim Chief Executive Officer (from May 2019 to October 7, 2019) and Chief Financial Officer of Eastside Distilling (Nasdaq: ESDI) (from October 2015 to August 2019). Prior to joining Eastside, Mr. Shum served as an Officer and Director of XZERES Corp, a publicly-traded global renewable energy company, from October 2008 until April 2015 in various officer roles, including Chief Operating Officer from September 2014 until April 2015, Chief Financial Officer, Principal Accounting Officer and Secretary from April 2010 until September 2014 (under former name, Cascade Wind Corp) and Chief Executive Officer and President from October 2008 to August 2010. Mr. Shum also serves as the managing principal of Core Fund Management, LP and the Fund Manager of Core Fund, LP. He was a founder of Revere Data LLC (now part of Factset Research Systems, Inc.) and served as its Executive Vice President for four years, heading up the product development efforts and contributing to operations, business development, and sales. He spent six years as an investment research analyst and portfolio manager of D.N.B. Capital Management, Inc. His previous employers include Red Chip Review and Laughlin Group of Companies. He earned a B.S. in Finance and a B.S. in General Management from Portland State University in 1992.

~~Debra Hoopes.~~ On August 14, 2019, we appointed Debra Hoopes as our Acting Chief Financial Officer. Ms. Hoopes currently serves as CFO and Chief Administrative Officer of Shine Management, Inc., an outsourced management services organization, a position she has held since August of 2017. Previously, Ms. Hoopes was a co-owner of H2CFO LLC in 2017 and prior to 2017 was the sole owner of Hoopes Management & Advisory Services LLC, through which provides outsourced CFO services. Ms. Hoopes is a Certified Public Accountant (licensed in Virginia and Maryland) with a Bachelor of Science degree in Accounting from Virginia Tech and a Master of Business Administration from George Washington University and is a Chartered Global Management Accountant.

~~Michael J. Campbell.~~ Mr. Campbell is our Chief Operating Officer and Vice-President of Business Development, positions he has held since February 2019 and was a director, from October 2017 to November 2020. Mr. Campbell was previously the Vice President of IVF Americas Business Unit for Cooper Surgical, Inc., a wholly owned subsidiary of The Cooper Companies (NYSE: COO). Mr. Campbell has substantial medical device sales, marketing and business development leadership experience within Global Fortune 500 and startup company environments. During his over 11-year career at Cooper Surgical, Mike has been responsible for IVF product portfolio sales globally including the U.S., Canada, Latin America, Europe, Middle East, Africa, and Asia Pacific regions. In addition to Mr. Campbell’s position as Vice President of IVF Americas Business Unit, he served in various leadership roles including Vice President of International Business Unit from 2013-2014 and as Vice President of IVF Business Unit from 2006 to 2012. Prior to joining Cooper Surgical, Mike was Vice President of Sales, Marketing and Business Development at Retroactive Bioscience from 1997 to 2006 and Vice President of Sales and Marketing for Gabriel Medical from 1994 to 1997. Mr. Campbell also served in various senior management positions across marketing, sales and product management at Boston Scientific Corporation beginning in 1984 through 1994.

~~Matthew Szot.~~ Mr. Szot is a director, a position he has held since September 13, 2020, and Chairman of the Audit Committee and Compensation Committee, positions he has held since September 14, 2020. Mr. Szot is currently the Executive Vice President and Chief Financial Officer of S&W Seed Company (Nasdaq: SANW) where he has served since March 2010. Mr. Szot is also currently a director and serves as Chairman of the Audit Committee and a member of both the Compensation Committee and Nominating and Governance Committees of SenesTech (Nasdaq: SNES), a publicly traded life science company with next generation technologies for managing animal pest populations through fertility control. From June 2018 to August 2019, Mr. Szot served on the board of directors and as Chairman of the Audit Committee of Eastside Distilling, Inc. (Nasdaq; EAST), a publicly traded company in the craft spirits industry. From February 2007 until October 2011, Mr. Szot served as the Chief Financial Officer for Cardiff Partners, LLC, a strategic consulting company that provided executive financial services to various publicly traded and privately held companies. Prior thereto, from 2003 to December 2006, Mr. Szot served as Chief Financial Officer and Secretary of Rip Curl, Inc., a market leader in wetsuit and action sports apparel products. From 1996 to 2003, Mr. Szot was a Certified Public Accountant with KPMG in the San Diego and Chicago offices and served as an Audit Manager for various publicly traded companies. Mr. Szot graduated with High Honors from the University of Illinois, Champaign-Urbana with a Bachelor of Science degree in Agricultural Economics/Accountancy. Mr. Szot is a Certified Public Accountant in the State of California.

~~Kevin Doody, M.D.~~ Dr. Doody serves as Medical Director for INVO Bioscience, a position he has held since April 2017 and is also a member of the Board of Directors, a position he has held since April 7, 2017. Dr. Doody is a renowned fertility specialist who is the founder and Medical Directordefinitive Proxy Statement for the ~~Center for Assisted Reproduction (CARE Fertility) and Effortless IVF located in Bedford Texas. The Center for Assisted Reproduction, established in 1989, has been a pioneer~~2023 Annual Meeting of ~~assisted reproductive technologies in the north Texas region with several firsts including the first ICSI pregnancy and the first~~Stockholders to successfully implement a blastocyst culture system. CARE Fertility had the first pregnancy in the region with a pregnancy following embryo biopsy and pre-implantation genetic testing for cystic fibrosis. CARE Fertility/ Effortless IVF also was the first to adopt the INVOcell™ Intravaginal Culture System since the INVOcell first obtained FDA clearance. Dr. Doody is President of the Society for Assisted Reproductive Technology (SART), on the Board of Directors of the American Society for Reproductive Medicine (ASRM) and a member of the RESOLVE Physician Council. As INVO Bioscience’s Medical Director, Dr. Doody provides medical and clinical guidance, INVO education and training, and oversight of risk management and post-market surveillance activities as well as support current and new product development.

~~Trent Davis.~~ Mr. Davis is one of our directors since his appointment in December 2019. In addition, Mr. Davis is currently CEO of Paulson Investment Company, LLC, a boutique investment firm that specializes in private equity offerings of small and mid-cap companies. From December 2014 to December 2018, Mr. Davis was President and Chief Operating Officer of Whitestone Investment Network, Inc., which provides executive advisory services and also restructures, recapitalizes and makes strategic investments in small to midsize companies. Since March 2018, Mr. Davis served as a director of Senmiao Technology Limited (Nasdaq: AIHS), an online lending platform in China. From August 2016 to August 2019, Mr. Davis served as director of Eastside Distilling, Inc. (Nasdaq: EAST), and from July 2015 to April 2017, he served as director of Dataram Corporation (Nasdaq: DRAM). Mr. Davis helped to successfully complete the reverse merger between Dataram and U.S. Gold Corp (Nasdaq: USAU), a gold exploration and development company. From December 2014 to July 2015, Mr. Davis served as Chairman of the Board of Majesco Entertainment Company (Nasdaq: COOL). Mr. Davis also served as director and President of Paulson Capital Corp. (Nasdaq: PLCC) from November 2013 to July 2014, when Paulson Capital Corp. completed a reverse merger with VBI Vaccine (Nasdaq: VBIV). Mr. Davis continued to serve on the board and the audit committee of VBI until May 2016. Prior to serving on the board of Paulson Capital Corp., Mr. Davis served as the Chief Executive Officer of its subsidiary, Paulson Investment Company, LLC, where he oversaw he syndication of approximately $600 million of investment in over 50 client companies in both public and private transactions. In 2003, Mr. Davis served as Chairman of the Board of the National Investment Banking Association. Mr. Davis holds a B.S. in Business and Economics from Linfield College and an M.B.A. from the University of Portland. Mr. Davis is qualified to serve on the Board because of his deep knowledge of finance and public company issues, capital market, advisory and entrepreneurial experiences, and extensive expertise in operational and executive management.

~~Barbara Ryan~~. Ms. Ryan is a director, a position she has held since September 2020. Ms. Ryan founded Barbara Ryan Advisors, a capital markets and communications firm, in 2012 following a more than 30-year career on Wall Street as a sell-side research analyst covering the US Large Cap Pharmaceutical Industry. Ms. Ryan has deep experience in equity and debt financings, M&A, valuation, SEC reporting, financial analysis and corporate strategy across a broad range of life sciences companies. Barbara worked on several of the industry’s largest M&A transactions; Shire’s defense versus a hostile takeover attempt by Abbvie, Shire’s takeover of Baxalta, Allergan’s defense against Valeant and Perrigo’s defense versus Mylan. Barbara served as an executive team member and on the disclosure committee for Radius Health from January 2014 to December 2017 and played a critical role in the Company’s IPO and subsequent follow on offerings which raised over $1 billion. Ms. Ryan has also served as an executive team member at Eloxx Pharmaceuticals, a development stage rare disease company, where she played a critical role in its uplisting to Nasdaq and subsequent follow on offering. Previously, Ms. Ryan was a Managing Director at Deutsche Bank/Alex Brown and Head of the company’s Pharmaceutical Research Team for 19 years and began her research career covering the Pharmaceutical industry at Bear Stearns in 1982. Ms. Ryan also covered the drug wholesalers and PBMs and was the lead analyst on many high-profile IPO’s including Express Scripts, PSSI, Henry Schein, and Flamel Technologies. Ms. Ryan currently serves as a director for Gilda’s Club NYC, a non-profit organization and is the Founder of Fabulous Pharma Females, a non-profit whose mission is to advance women in the biopharma industry. Ms. Ryan has led the development of women leadership programs at Radius Health and Eloxx Pharmaceuticals.

~~Jeffrey J. Segal, M.D.~~ Dr. Segal founded Medical Justice Services Inc., an organization focused on protecting physicians from frivolous lawsuits in 2004, and currently serves as CEO. In 2010, Dr. Segal also launched the eMerit platform for Medical Justice Services, Inc. to enable hospitals and doctors to maximize their online presence and provide patients an ability to locate doctors online. In December 2019, Dr. Segal joined the Byrd Adatto Law Firm as a partner. From 2000-2004, Dr. Segal co-founded and served as CEO of DarPharma, Inc., a clinic focused on therapies for schizophrenia, Parkinson’s disease and other targeted CNS disorders. From 1999 through 2002, Dr. Segal co-founded and served as CEO of On-Call Solutions, Inc., a company focused on web-based design of physician call schedules. Dr. Segal is also a board certified neurosurgeon and operated a private neurosurgery practice from 1991-2000. Dr. Segal received his B.A. from the University of Texas, his medical degree from Baylor College of Medicine and his juris doctor from Concord Law School.

The listing rules of Nasdaq require us to maintain a Board comprised of a majority of independent directors, as determined affirmatively by our Board. In addition, the Nasdaq listing rules require that, subject to specified exceptions, each member of our Audit, Compensation and Nominating and Corporate Governance Committees must be independent. Audit Committee members and Compensation Committee members must also satisfy the independence criteria set forth in Rule 10A-3 and Rule 10C-1, respectively, under the Exchange Act. Under Nasdaq listing rules, a director will only qualify as an “independent director” if, in the opinion of our Board, the director does not have a relationship that would interferefiled with the ~~exercise~~SEC within 120 days of ~~independent judgment in carrying out his or her responsibilities.~~December 31, 2022.

Our Board has undertaken a review of the independence of our directors and considered whether any director has a material relationship with us that could compromise his or her ability to exercise independent judgment in carrying out his or her responsibilities, and determined that Trent Davis, Mathew Szot, Barbara Ryan and Jeffrey Segal, M.D., representing four of our six directors, are independent under Nasdaq listing rules. Mr. Shum is not considered independent due to his position as our Chief Executive Officer. Mr. Doody is not considered independent due to the level of compensation received by him from the Company in 2018.

In making these determinations, our Board considered the relationships that each nonemployee director has with us and all other facts and circumstances our Board deemed relevant in determining their independence, including consulting relationships, family relationships and the beneficial ownership of our capital stock by each non-employee director.

We have adopted a Code of Conduct that applies to all employees including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions. The text of our Code of Conduct is posted in the “Investor Information—Corporate Governance” section of our website, www.INVOBioscience.com.

We intend to disclose on our website any amendments to, or waivers from, our Code of Business Conduct and Ethics that are required to be disclosed pursuant to the disclosure requirements of Item 5.05 of Form 8-K

~~Our Compensation Committee currently consists of Mr. Szot (Chair), Mr. Davis and Ms. Ryan.~~

The Compensation Committee oversees our compensation policies, plans and programs, and to review and determine the compensation to be paid to our executive officers and directors. In addition, the Compensation Committee has the authority to act on behalf of the Board in fulfilling the Board’s responsibilities with respect to compensation-based and related disclosures in filings as required by the Securities and Exchange Commission.

~~Our Nominating and Corporate Governance Committee consists of Mr. Szot, Mr. Davis and Ms. Ryan.~~

The Nominating and Corporate Governance Committee (i) oversees our corporate governance functions on behalf of the Board; (ii) makes recommendations to the Board regarding corporate governance issues; (iii) identify and evaluate candidates to serve as our directors consistent with the criteria approved by the Board and reviews and evaluates the performance of the Board; (iv) serves as a focal point for communication between director candidates, non-committee directors and management; (v) selects or recommends to the Board for selection candidates to the Board, or, to the extent required below, to serve as nominees for director for the annual meeting of shareholders; and (vi) makes other recommendations to the Board regarding affairs relating to our directors.

Our Audit Committee members currently consist of Mr. Szot (Chair), Dr. Segal and Ms. Ryan. Each of the members of our Audit Committee is an independent director under the Nasdaq listing rules, satisfies the additional independence criteria for Audit Committee members and satisfies the requirements for financial literacy under the Nasdaq listing rules and Rule 10A-3 of the Exchange Act, as applicable.

Our board has also determined that Mr. Szot qualifies as an Audit Committee financial expert within the meaning of the applicable rules and regulations of the SEC and satisfies the financial sophistication requirements of the Nasdaq listing rules.

Our Audit Committee oversees our corporate accounting and financial reporting process and assists our Board in monitoring our financial systems and our legal and regulatory compliance. Our Audit Committee also:

Our Audit Committee operates under a written charter approved by our Board and that satisfies the applicable rules and regulations of the SEC and the listing requirements of Nasdaq. The charter is available on the corporate governance section of our website, which is located at www.invobioscience.com.

The ~~following Summary Compensation Table sets forth,~~information required by this Item 11 is incorporated by reference to our definitive Proxy Statement for the ~~years indicated, all cash compensation paid, distributed or accrued for services, including salary and bonus amounts, rendered in all capacities by~~2023 Annual Meeting of Stockholders to be filed with the ~~Company’s “named executive officers” for~~ SEC ~~reporting purposes.~~

~~The following table provides information about outstanding stock options issued by the Company held by each of our NEOs as~~within 120 days of December 31, ~~2020. None of our NEOs held any other equity awards from the Company as of December 31, 2020.~~2022.

On October 16, 2019, the Company entered into an employment agreement with Steven Shum (the “Shum Employment Agreement”), pursuant to which Mr. Shum serves as Chief Executive Officer on an at-will basis at an annual base salary of $260,000. The Shum Employment Agreement provides for a performance bonus of $75,000 upon a successful up-listing to the Nasdaq Stock Market, with all other bonuses to be determined by the board in its sole discretion. In addition to his base salary and performance bonus, we granted Mr. Shum: (i) 12,500 shares of our common stock and (ii) a three-year option to purchase 202,599 shares of our common stock at an exercise price of $8.1600 per share. These options will vest monthly over a 3-year period. Pursuant to the Shum Employment Agreement, Mr. Shum is also entitled to customary benefits, including health insurance and participation in employee benefit plans.

On January 15, 2020, the Company entered into an employment agreement (the “Campbell Employment Agreement”) with Michael Campbell to continue serving as the Company’s Chief Operating Officer and Vice President of Business Development. The Campbell Employment Agreement provides for an annual base salary of $220,000, and a target annual incentive bonus of up to 50% of base salary if the Company achieves goals and objectives determined by the board of directors. In connection with the Campbell Employment Agreement, on January 17, 2020, the Company granted Mr. Campbell 31,250 shares of Company common stock, and an option to purchase 125,000 shares of Company common stock (the “Option”) at an exercise price of $6.84096 per share. One quarter of the Option vested upon grant, and the remainder vests in monthly increments over a period of two years from the date of grant. Mr. Campbell is also entitled to customary benefits, including health insurance and participation in employee benefit plans. The Campbell Employment Agreement provides that if Mr. Campbell terminates the Campbell Employment Agreement for “cause” (as defined in the Campbell Employment Agreement) or the Company terminates the Campbell Employment Agreement without “cause,” then he will continue to receive his base salary and certain insurance benefits for three months after termination. The Company may terminate the Campbell Employment Agreement without “cause” on 60 days’ notice.

~~If Mr. Shum is involuntarily terminated without cause or constructively terminated (in each case, as defined in the Shum Employment Agreement), then he is entitled to 12 months’ severance.~~

If (i) Mr. Campbell terminates his employment agreement for cause, (ii) the Company provides notice not to renew his employment agreement on any anniversary date, or (iii) the Company terminates his employment agreement without cause, then he is entitled to three months’ severance and insurance benefits.

The following table provides information about outstanding stock options issued by the Company held by each of our NEOs as of December 31, 2019. None of our NEOs held any other equity awards from the Company as of December 31, 2019.

The following table sets forth quantitative information with respect to potential payments to be made to either Mr. Shum or Mr. Campbell upon termination in various circumstances. The potential payments are based on the terms of each of the Employment Agreement discussed above. For a more detailed description of the Employment Agreement, see the “Employment Agreements” section above.

~~The following table shows information regarding our equity compensation plans as of December 31, 2020.~~

~~(1)~~ ~~2019 Stock Incentive Plan.~~ ~~On October 3, 2019, our Board adopted the 2019 Stock Incentive Plan (the “Plan”)~~. The purpose of our Plan is to advance the best interests of the company by providing those persons who have a substantial responsibility for our management and growth with additional incentive and by increasing their proprietary interest in the success of the company, thereby encouraging them to maintain their relationships with us. Further, the availability and offering of stock options and common stock under the plan supports and increases our ability to attract and retain individuals of exceptional talent upon whom, in large measure, the sustained progress, growth and profitability which we depend. The total number of shares available for the grant of either stock options or compensation stock under the plan is 793,093 shares, subject to adjustment.

~~(2) We granted 70,302 shares subject to restricted stock grants under the Plan in the year ended December 31, 2020.~~

Our Board administers our plan and has full power to grant stock options and common stock, construe and interpret the plan, establish rules and regulations and perform all other acts, including the delegation of administrative responsibilities, it believes reasonable and proper. Any decision made, or action taken, by our Board arising out of or in connection with the interpretation and administration of the plan is final and conclusive.

The Board, in its absolute discretion, may award common stock to employees of, consultants to, and directors of the company, and such other persons as the Board or compensation committee may select, and permit holders of common stock options to exercise such options prior to full vesting therein and hold the common stock issued upon exercise of the option as common stock. Stock options may also be granted by our Board or compensation committee to non-employee directors of the company or other persons who are performing or who have been engaged to perform services of special importance to the management, operation or development of the company.

In the event that our outstanding common stock is changed into or exchanged for a different number or kind of shares or other securities of the company by reason of merger, consolidation, other reorganization, recapitalization, combination of shares, stock split-up or stock dividend, prompt, proportionate, equitable, lawful and adequate adjustment shall be made of the aggregate number and kind of shares subject to stock options which may be granted under the plan.

Our Board may at any time, and from time to time, suspend or terminate the plan in whole or in part or amend it from time to time in such respects as our Board may deem appropriate and in our best interest.

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

The ~~following table and notes set forth the beneficial ownership of the common stock of the Company as of March~~information required by this Item 12 ~~2021,~~is incorporated by each person who was known by the Company to beneficially own more than 5% of the common stock, by each director and named executive officer, and by all directors and executive officers as a group. Beneficial ownership is determined in accordance with the rules of the SEC and includes voting or dispositive power with respect to the securities. Unless otherwise indicated below,reference to our ~~knowledge, all persons listed below have sole voting and dispositive power with respect~~definitive Proxy Statement for the 2023 Annual Meeting of Stockholders to their shares of our common stock, except to the extent authority is shared by spouses under applicable law. Unless otherwise noted, the address of all of the individuals and entities named below is care of INVO Bioscience, Inc., 5582 Broadcast Court Sarasota, Florida, 34240.

~~The following table sets forth the beneficial ownership of our common shares as of March 12, 2021 for:~~

The percentage ownership information is based upon 10,420,380 common shares outstanding as of March 12, 2021. We have determined beneficial ownership in accordance with the rules of the SEC. These rules generally attribute beneficial ownership of securities to persons who possess sole or shared voting power or investment power with respect to those securities. Unless otherwise indicated, the persons or entities identified in this table have sole voting and investment power with respect to all shares shown as beneficially owned by them, subject to applicable community property laws. The address for persons listed in the table is c/o INVO Bioscience, Inc., 5582 Broadcast Court, Sarasota, FL 34240.

~~Section 16(a) of the Exchange Act requires our officers and directors to file~~be filed with the SEC ~~reports~~within 120 days of ownership on Form 3 and changes in ownership on Form 4 and Form 5. Officers and directors are required by Commission regulations to furnish to us copies of all Section 16(a) forms they file. Based solely on our review of the copies of such forms received by us, or written representations from certain reporting persons, to our knowledge all Section 16(a) filing requirements applicable to our officers and directors were timely filed during the fiscal year ended December 31, ~~2020 except as follows: Matthew Szot and Barbara Ryan failed to timely file their Form 3s, although such forms have now been filed.~~2022.

~~There are no present arrangements, including pledges of the Company’s securities, known to the Company, the operation of which may result at a subsequent date in a change in control of the Company.~~

~~We have adopted a written policy with respect~~The information required by this Item 13 is incorporated by reference to ~~the review, approval, and ratification of related party transactions. Under the policy, any transactions where the amount involved exceeds the lesser of $120,000 or one percent (1%) of the average of~~ our ~~total assets at year-end~~definitive Proxy Statement for the last two completed fiscal years and in which any related person has or will have a direct or indirect material interest, other than equity and other compensation, termination and other arrangements which are described under2023 Annual Meeting of Stockholders to be filed with the ~~headings “Compensation~~SEC within 120 days of ~~Directors” and “Executive Compensation,” is defined as a related party transaction. Any such related party transactions are reviewed and must be approved by the Company’s board of directors.~~

From November 2012 to May 2019, the Company rented its corporate office from Forty Four Realty Trust, an entity owned by James Bowdring, pursuant to a month-to-month rental arrangement at less than the fair market rate. The Company paid $3,000 to this entity during the twelve months ended December 31, ~~2019.~~2022.

The Company purchased stationary supplies and marketing items at discounted rates from Superior Printing & Promotions, an entity owned by James Bowdring. The Company paid $8,168 to Superior during the twelve months ended December 31, 2019.

In November 2020, Paulson Investment Company served as a co-managing underwriter for the Company’s underwritten public offering and received fee and commissions for such role in the amount of $271,440. Trent Davis, one of our directors is President of Paulson Investment Company. Mr. Davis did not receive any compensation related to the fees and commissions received by Paulson.

The ~~following table summarizes~~information required by this Item 14 is incorporated by reference to our definitive Proxy Statement for the ~~approximate aggregate fees billed to us or expected~~2023 Annual Meeting of Stockholders to be ~~billed to us by our independent registered accounting firm for our 2020 and 2019 fiscal years:~~filed with the SEC within 120 days of December 31, 2022.

~~Audit Fees~~ includes fees billed for the fiscal year shown for professional services for the audit of the Company’s annual financial statements, quarterly reviews, and review of the Company’s registration statements and other SEC filings. Audit fees of $45,450 were billed M&K CPAs, PLLC during 2020.

~~Audit-Related Fees~~ are fees for the audit of the Company’s annual financial statements, quarterly reviews, and review of the Company’s registration statements and other SEC filings. Audit related fees of $15,596 were paid to M&K CPAs, PLLC during 2020.

Our Board of Directors has adopted a procedure for pre-approval of all fees charged by our independent auditors. Under the procedure, the Board approves the engagement letter with respect to audit and review services. Other fees are subject to pre-approval by the Board, or, in the period between meetings, by a designated member of the Board. Any such approval by the designated member is disclosed to the entire Board at the next meeting. The audit fees paid to the auditors with respect to fiscal year 2020 and 2019 were pre-approved by the entire Board of Directors.

Information required by Schedule II is shown in the Notes to Consolidated Financial Statements. All other schedules for which provision is made in the applicable accounting regulation of the Securities and Exchange Commission are not required under the related instructions or are inapplicable, and therefore have been omitted.

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this ~~report~~Annual Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized on ~~July 8, 2021.~~April 17, 2023.

Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities indicated on ~~July 8, 2021.~~April 17, 2023.

Title of each class		Trading symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		INVO		The Nasdaq Stock Market LLC

Large accelerated filer ~~[ ]~~☐	Accelerated filer ~~[ ]~~☐
Non-accelerated filer ~~[ ]~~ ☐	Smaller reporting company ~~[X]~~☒
	Emerging Growth Company ~~[ ]~~☐

●	Cost: Many current clinics offering INVOcell are doing so at approximately half the cost of IVF treatment, due to less drugs often being prescribed for INVOcell, fewer office visits needed, and less laboratory time needed as incubation is occurring inside the body rather than the lab incubator.
●	Enhanced patient capacity: The INVOcell device eliminates the need for a lab incubator as well as helps reduce the overall need for lab-support resources during the incubation period. We believe this generally supports the ability to lower costs as well as enable a clinic to handle a higher volume of patients on average.
●	~~Promotes greater involvement by couples in the treatment and conception.~~
●	~~Reduces the risk of errors of wrong embryo transfers since the embryos are never separated from the woman.~~
●	~~Creates a more natural and environmentally stable incubation than conventional IVF incubation in a laboratory.~~

●	Manufacturing: We are ISO 13485:2016 Certified and manage all aspects of production and manufacturing with qualified suppliers. Our key suppliers have been steadfast partners since our company first began and can provide us with virtually an unlimited capability to support our growth objectives, with all manufacturing done in New England.
●	All raw materials utilized for the INVOcell are medical grade and commonly used in medical devices (e.g., medical grade silicone, medical grade plastic). Our principal mold supplier is a well-established company in the molding industry and is ISO 9001 Certified. Our contract manufacturer for the INVOcell is ISO 13485 Certified and FDA registered.
●	CE Mark: INVO Bioscience received the CE Mark in October 2019. The CE Mark permits the sale of devices in Europe, Australia and other countries that recognize the CE Mark, subject to local registration requirements.
●	~~US Marketing Clearance: The safety and efficacy of the INVOcell device has been demonstrated and cleared for marketing and use by the U.S. FDA in November 2015.~~
●	Clinical Trials: The Institutional Review Board (“IRB”) approved our planned clinical trial to evaluate the modified INVOcell system for effectiveness of achieving fertilization, implantation, embryo development, clinical pregnancy, and live birth after 5-days of continuous vaginal incubation. The objective of this study is to assess the efficacy, safety, comfort and retention of the INVOcell with the retention device, and demonstrate superiority following 5-day vaginal incubation as compared to the current 3-day vaginal incubation indication. The pivotal trial (clinicaltrials.gov identifier: NCT04246268) is a single arm, multicenter, open label trial at three clinical centers in the United States with each center enrolling 60 patients between the ages of 18 and 37 years old. The providers at each center will conduct the processes of ovarian stimulation, egg retrieval and embryo transfer per the standard protocols for their centers. As a result of the COVID-19 pandemic, patient recruitment at each site was placed on hold. However, as a result of additional retrospective, real-market usage (5-day) data that became available during 2020, we initiated a 510(k) filing utilizing that retrospective data. We intend to continue pursuing the use of the retrospective data to achieve the label expansion and as such we are evaluating the need to separately complete the clinical trial.

				INVOcell Registration
Market	Distribution Partner	Date	Initial Term	Status in Country

Mexico (a)	Positib Fertility, S.A. de C.V.	Sept 2020	TBD**	Completed
Malaysia	iDS Medical Systems	Nov 2020	3-year	Completed
Pakistan	Galaxy Pharma	Dec 2020	1-year	In process
Thailand	IVF Envimed Co., Ltd.	April 2021	1-year	Completed
Sudan	Quality Medicines, Cosmetics & Medical Equipment Import	Sept 2020	1-year	In process
Ethiopia	Quality Medicines, Cosmetics & Medical Equipment Import	Sept 2020	1-year	In process
Uganda	Quality Medicines, Cosmetics & Medical Equipment Import	Sept 2020	1-year	Not required
Nigeria	G-Systems Limited	Sept 2020	5-year	Completed
Iran	Tasnim Behboud	Dec 2020	1-year	Completed
Sri Lanka	Alsonic Limited	July 2021	1-year	In process
China	Onesky Holdings Limited	May 2022	5-year	In process

~~[X]~~☒	Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

	For the fiscal year ended December 31 ~~2020~~, 2022

~~[ ]~~☐	Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

	For the transition period from to

			Page
Part I

~~Item 1.~~	~~Business~~	5
Item 1.	Business		4
Item 1A.	Risk Factors	19	13
Item 1B.	Unresolved Staff Comments	32	27
Item 2.	Properties	32	27
Item 3.	Legal Proceedings	32	27
Item 4.	Mine Safety Disclosures	32
		27
~~Part II~~

Part II

Item 5.	Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	33	28
Item 6.	~~Selected Financial Data~~[Reserved]	34	29
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	34	29
Item 7A.	Quantitative and Qualitative Disclosure About Market Risk	40	41
Item 8.	Financial Statements and Supplementary Data	41	42
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	42	43
Item 9A.	Controls and Procedures	42	43
Item 9B.	Other Information	43
		44

Part III


Item 10.	Directors, Executive Officers and Corporate Governance		44
Item 11.	Executive and Director Compensation	48	44
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	51	44
Item 13.	Certain Relationships and Related Transactions, and Director Independence	53	44
Item 14.	Principal Accountant Fees and Services	53
		44

Part IV


Item 15.	Exhibits, Financial Statement Schedules	54
		45

SIGNATURES		57	48

Affiliate Name	Country	Percent (%) Ownership

HRCFG INVO, LLC	United States		50	%
Bloom Invo, LLC	United States		40	%
Positib Fertility, S.A. de C.V.	Mexico		33	%
Ginekalix INVO Bioscience LLC Skopje	Republic of North Macedonia		50	%

	●	~~establishment registration and device listing;~~

	●	~~QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent quality assurance procedures during all aspects of the design and manufacturing process;~~

	●	~~labeling regulations that require truthful, not misleading, and fairly balanced labeling and prohibit the promotion of products for “off-label” uses and impose other restrictions on labeling;~~

	●	clearance of a new 510(k) premarket notification for modifications to 510(k) cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of the device;

	●	medical device reporting regulations, which require that a manufacturer report to the FDA information that reasonably suggests a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur;

	●	correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;

	●	~~complying with the Unique Device Identification (“UDI”) requirements, including the submission of certain information about each device to the FDA’s Global Unique Device Identification Database;~~

	●	the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations if the FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death; and

	●	~~post-market surveillance activities deemed by FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.~~

	●	~~issue a form 483 to initiate corrective actions by the company;~~

	●	~~issue a warning letter or untitled letter apprising of violative conduct;~~

	●	~~detain or seize products;~~

	●	~~mandate a recall;~~

	●	~~seek to enjoin future violations; and~~

	●	~~seek civil and criminal penalties against the company, its officers or its employees~~

●	the payment or receipt of anything of value in exchange for referrals of business (e.g. Anti-Kickback Statute (42 U.S.C. § 1320a-7b) (the “AKS”); Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a) (the “CMPL”); Ala. Code § 22-1-11(c));
●	the presenting of a false or fraudulent claim for payment by a government healthcare program, such as Medicare or Medicaid (e.g. False Claims Act (31 U.S.C. §§ 3729 – 3733); Georgia State False Medicaid Claims Act (Ga. Code Ann. §§ 49-4-168 – 49-4-168.6)); and
●	the referral by certain ordering licensed healthcare providers of certain healthcare items and services that are payable by a government healthcare program to an entity in which the healthcare provider or his or her immediate family member has an investment or other financial relationship (e.g. Section 1877 of the Social Security Act (42 U.S.C. § 1395nn), commonly referred to as the “Stark Law”; Georgia Patient Self-Referral Act of 1993 (Ga. Code Ann. §§ 43-1B-1 – 43-1B-8)).

	●	Our financial situation creates doubt whether we will continue as a going concern.
	●	We will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate operations.
	●	Even if we can raise additional funding, we may be required to do so on terms that are dilutive to you.
	●	Our potential acquisition of the Wisconsin Fertility Institute may not close.
	●	We may not be able to successfully integrate the Wisconsin Fertility Institute into INVO Bioscience and achieve the benefits expected to result from the acquisition.
	●	If we close our acquisition of the Wisconsin Fertility Institute and fail to make the required $7.5 million in additional payments, our business would be adversely affected.
	●	We may incur debt financing to provide the cash proceeds necessary to acquire the Wisconsin Fertility Institute. If we were unable to service any such debt, our business would be adversely affected.
	●	Our business has posted net operating losses, has a limited operating history, and needs additional capital to grow and finance its operations.
	●	Our existing INVO Centers were established as joint ventures with medical partners. Future INVO Centers may also be established as joint ventures. These joint ventures will be important to our business. If we are unable to maintain any of these joint ventures, or if they are not successful, our business could be adversely affected.
	●	~~We may require additional capital to continue as a going concern and to continue executing our business plan, which if not obtained could result in a need to curtail operations.~~

	●	Our business is subject to significant competition.
	●
	●	We are subject to risks associated with doing business globally.
	●
	●	We need to manage growth in operations, and we may not be successful in implementing our growth strategy.
	●
	●	Our products incorporate intellectual property rights developed by us that may be difficult to protect or may be found to infringe on the rights of others.
	●
	●	We may be forced to defend our intellectual property rights from infringement through expensive legal action.
	●
	●	We face potential liability as a provider of a medical device. These risks may be heightened in the area of artificial reproduction.
	●
	●	We may not be able to develop or continue our business if we fail to retain key personnel.
	●
	●	~~We sell directly to Ferring in the U.S., and if we cease selling to Ferring it may be difficult and expensive to find a replacement.~~

	●	~~The coronavirus pandemic could have a significant negative impact on our business, revenues, financial condition and results of operations.~~

	●	We are subject to significant domestic and international governmental ~~regulation.~~regulations.
	●
	●	The FDA regulatory review process is expensive, time-consuming and uncertain, and the failure to obtain and maintain required regulatory clearances and approvals could prevent us from commercializing our products.
	●
	●	We are subject to continuing regulation by the FDA, and failure to comply may materially harm our business.
	●
	●	Our products are generally subject to regulatory requirements in foreign countries in which we sell those products. We will be required to expend significant resources to obtain regulatory approvals or clearances of our products, and there may be delays and uncertainty in obtaining those approvals or clearances.
	●
	●	~~Our revenues and operating results could fluctuate significantly from quarter to quarter, which may cause our stock price to decline.~~

	●	If third-party payers do not provide adequate coverage and reimbursement for INVOcell and the ~~INVO Procedure,~~IVC procedure, we may be unable to generate significant ~~revenues.~~revenue.
	●	We are subject to risks relating to federal and state healthcare fraud, waste, and abuse laws.
	●	We are subject to requirements of the Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH Act”), and related implementing regulations (together, “HIPAA”), and failure to comply, including through a breach of protected health information (“PHI”) could materially harm our business.
	●	We have been notified by Nasdaq of our failure to comply with certain continued listing requirements and, if we are unable to regain compliance with all applicable continued listing requirements and standards of Nasdaq, our common stock could be delisted from Nasdaq. Additionally, if Nasdaq does not grant us an extension or if a favorable decision is not be obtained from a hearings panel, or the Panel, after the hearing, our common stock would be delisted from Nasdaq.
	●	The significant number of common shares registered for resale pursuant to the registration ~~statement and common shares issuable upon conversion of outstanding notes~~statements described under Recent Developments in Item 1, could adversely affect the trading price of our common shares.
	●
	●	Our shares of common stock are thinly traded, and the price may not reflect our value; there can be no assurance that there will be an active market for our shares now or in the future.
	●
	●	~~Our failure to meet the continued listing requirements of the Nasdaq Capital Market could result in a delisting of our common stock.~~

	●	We have convertible notes outstanding, which could give rise to additional issuances of our common stock, potential dilution of ownership to existing stockholders and volatility in the price of our securities.

	●	We do not expect to pay any dividends to shareholders.
	●	Our revenue and operating results could fluctuate significantly from quarter to quarter, which may cause our stock price to decline.
	●	We may have difficulty raising the necessary capital to fund operations and the Wisconsin Fertility acquisition because of the thin market and market price volatility for our shares of common stock.
	●
	●	Shareholders may be diluted significantly through our efforts to obtain financing and from issuance of additional shares of our common stock, including such issuances of shares for services.
	●
	●	Failure to comply with internal control attestation requirements could lead to loss of public confidence in our consolidated financial statements and negatively impact our stock price.

	●	have significant discretion in determining the efforts and resources that they will apply;
	●	may not perform their obligations as expected;
	●	may dispute the amounts of payments owed;
	●	may fail to comply with applicable legal and regulatory requirements regarding the distribution or marketing of our INVOcell product;
	●	may not properly maintain or defend their or our relevant intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation and liability;
	●	may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;
	●	could become involved in a business combination or cessation that could cause them to deemphasize or terminate the development or commercialization of our INVOcell product; and
	●	may seek to terminate our joint venture, which could require us to raise additional capital and to develop new joint venture relationships.

●	political and economic instability;
●	export controls;
●	~~export controls;~~

●	changes in international legal and regulatory requirements;
●
●	United States and foreign government policy changes affecting the product marketability; and
●
●	changes in tax laws, duties and tariffs.

	●	The federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b) (the “AKS”), a criminal statute, makes it illegal for any person or entity to knowingly and willfully, directly or indirectly, solicit, receive, offer, or pay any remuneration that is in exchange for or to induce the referral of business, including the purchase, order, lease of any good, facility, item, or service for which payment may be made under a federal healthcare program, such as Medicare or Medicaid. The term “remuneration” has been broadly interpreted to include anything of value. The Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a) (the “CMPL”) also contains a provision that prohibits the payment of anything of value in return for referrals and provides for the imposition of civil penalties.

	●	Federal false claims and false statement laws, including the federal civil False Claims Act (31 U.S.C. §§ 3729 – 3733), prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, for payment to, or approval by, federal programs, including Medicare and Medicaid, claims for items or services that are false or fraudulent.

	●	Section 1877 of the Social Security Act (42 U.S.C. § 1395nn), commonly referred to as the “Stark Law, prohibits referrals by ordering by a physician of “designated health services,” which include durable medical equipment and supplies as well as inpatient and outpatient hospital services, that are payable, in whole or in part, by Medicare or Medicaid, to an entity in which the physician or the physician’s immediate family member has an investment interest or other financial relationship, subject to several exceptions. Financial relationships that are implicated by the Stark Law can include arrangements ranging from marketing arrangements and consulting agreements to medical director agreements with physicians who order our products. The Stark Law also prohibits billing for services rendered pursuant to a prohibited referral. Several states have enacted laws similar to the Stark Law. These state laws may cover all (not just Medicare and Medicaid) patients. Many federal healthcare reform proposals in the past few years have attempted to expand the Stark Law to cover all patients as well. If we violate the Stark Law, our financial results and operations could be adversely affected. Penalties for violations include denial of payment for the services, significant civil monetary penalties, and exclusion from the Medicare and Medicaid programs;

	●	The federal Physician Payments Sunshine Act (42 U.S.C. § 1320a–7h) requires certain manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services information related to payments or other transfers of value made to physicians and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members.

	●	suspension or termination of our participation in federal healthcare programs;

	●	criminal or civil liability, fines, damages or monetary penalties for violations of healthcare fraud and abuse laws, including the federal False Claims Act, CMPL, and AKS;

	●	repayment of amounts received in violation of law or applicable payment program requirements, and related monetary penalties;

	●	mandated changes to our practices or procedures that materially increase operating expenses;

	●	imposition of corporate integrity agreements that could subject us to ongoing audits and reporting requirements as well as increased scrutiny of our business practices;

	●	termination of various relationships or contracts related to our business; and

	●	harm to our reputation which could negatively affect our business relationships, decrease our ability to attract or retain patients and physicians, decrease access to new business opportunities and impact our ability to obtain financing, among other things.

●	the election of members of the ~~Board~~board of ~~Directors;~~directors;
●
●	amending our ~~Articles~~articles of ~~Incorporation~~incorporation or bylaws; and
●
●	approving a merger, sale of assets, or other corporate transaction.

	●	Eliminates expensive and time-consuming lab procedures, allowing clinics and doctors to increase patient capacity and reduce costs;
	●	Provides a natural, stable incubation environment;
	●	Offers a more personal, intimate experience in creating a baby; and
	●	Reduces the risk of errors and wrong embryo transfers.

●	Manufacturing: we are ISO 13485:2016 certified and manage all aspects of production and manufacturing with qualified suppliers. Our key suppliers have been steadfast partners since our company first began and can provide us with virtually an unlimited capability to support our growth objectives, with all manufacturing performed in the New England region of the U.S..
●	Raw Materials: all raw materials utilized for the INVOcell are medical grade and commonly used in medical devices (e.g., medical grade silicone, medical grade plastic). Our principal molded component suppliers are well-established companies in the molding industry and are either ISO 13485 or ISO 9001 certified. The molded components are supplied to our contract manufacturer for assembly and packaging of the INVOcell system. The contract manufacturer is ISO 13485 certified, and U.S. Food & Drug Administration (“FDA”) registered.
●	CE Mark: INVO Bioscience received the CE Mark in October 2019. The CE Mark permits the sale of devices in Europe, Australia and other countries that recognize the CE Mark, subject to local registration requirements.

●	Cost: Many current clinics offering INVOcell are doing so at approximately half the cost of IVF treatment, due to: less drugs often being prescribed for INVOcell, fewer office visits needed, and less laboratory time needed as incubation is occurring inside the body rather than in the lab incubator.

●	Enhances patient capacity: The INVOcell device eliminates the need for a lab incubator as well as helps reduce the overall need for lab-support resources during the incubation period. We believe this generally supports the ability to lower costs and enables a clinic to handle a higher volume of patients on average.

●	~~Reduces the risk of errors of wrong embryo transfers since the embryos are never separated from the woman.~~

●	~~Promotes greater involvement by couples in the treatment and conception.~~

●	~~Creates a more natural and environmentally stable incubation than conventional IVF incubation in a laboratory.~~

	2022			2021
Cash (used in) provided by:
Operating activities		(6,603,319	)		(6,029,914	)
Investing activities		(81,217	)		(2,153,512	)
Financing activities		1,089,800			3,770,537

1.	Identify the contract with the customer.

2.	Identify the performance obligations in the contract.

3.	Determine the total transaction price.

4.	Allocate the total transaction price to each performance obligation in the contract.

5.	Recognize as revenue when (or as) each performance obligation is satisfied.

	-	~~Any obligation under certain guarantee contracts;~~

	-	~~Any retained or contingent interest in assets transferred to an unconsolidated entity or similar arrangement that serves as credit, liquidity or market risk support to that entity for such assets;~~

	-	Any obligation under a contract that would be accounted for as a derivative instrument, except that it is both indexed to our stock and classified in stockholder’s equity in our statement of financial position; and

	-	Any obligation arising out of a material variable interest held by us in an unconsolidated entity that provides financing, liquidity, market risk or credit risk support to us, or engages in leasing, hedging or research and development services with us.

		Page

Report of Independent Registered Public Accounting Firm (PCAOB ID No. 2738)		F-1

Consolidated Balance Sheets as of December 31, ~~2020~~2022 and ~~2019~~2021		F-2

Consolidated Statements of Operations for the Years Ended December 31, ~~2020~~2022 and ~~2019~~2021		F-3

Consolidated Statements of Stockholders’ Equity ~~(Deficiency)~~(Deficit) for the Period from January 1, ~~2019~~2021 to December 31, ~~2020~~2022		F-4

Consolidated Statements of Cash Flows for the Years Ended December 31, ~~2020~~2022 and ~~2019~~2021		F-5

Notes to Consolidated Financial Statements		F-6

	December 31, 2020			December 31, 2019

ASSETS
Current assets
Cash	$	10,097,760		$	1,238,585
Accounts receivable net		21,699			7,558
Inventory, net		265,372			101,387
Prepaid expenses and other current assets		157,700			195,910
Total current assets		10,542,531			1,543,440

Property and equipment, net		132,206			93,055
Capitalized patents, net		5,427			7,234
Lease right of use		79,319			101,883
Trademarks		89,536			49,867
Other assets		240			-
Investment in joint ventures		98,084			-
Total other assets		272,606			158,984

Total assets	$	10,947,343		$	1,795,479

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIENCY)
Current liabilities
Accounts payable and accrued liabilities, including related parties	$	328,927		$	371,530
Accrued compensation		527,326			393,017
Deferred revenue		714,286			714,286
Current portion of lease liability		22,707			21,365
Note payable – Payroll Protection Program		157,620			-
Convertible notes, net		536,063			-
Income taxes payable		1,062			912
Total current liabilities		2,287,991			1,501,110

Lease liability, net of current portion		58,634			81,494
Deferred revenue, net of current portion		2,857,143			3,571,429
Convertible notes, net		-			325,784
Convertible notes – related party, net		-			28,824
Deferred tax liability		469			433

Total liabilities		5,204,237			5,509,074

Stockholders’ equity (deficiency)
Common Stock, $.0001 par value; 125,000,000 shares authorized; 9,639,268 and 4,884,879 issued and outstanding as of December 31, 2020 and December 31, 2019, respectively		964			489
Additional paid-in capital		37,978,224			20,174,682
Accumulated deficit		(32,236,082	)		(23,888,766	)
Total stockholders’ equity (deficiency)		5,743,106			(3,713,595	)

Total liabilities and stockholders’ equity (deficiency)	$	10,947,343		$	1,795,479

	2022			2021
	December 31,			December 31,
	2022			2021
ASSETS
Current assets
Cash	$	90,135		$	5,684,871
Accounts receivable		77,149			50,470
Inventory		263,602			287,773
Prepaid expenses and other current assets		190,201			282,751
Total current assets		621,087			6,305,865
Property and equipment, net		436,729			501,436
Intangible assets, net		-			132,093
Lease right of use		1,808,034			2,037,052
Investment in joint ventures		1,237,865			1,489,934
Total assets	$	4,103,715		$	10,466,380

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities
Accounts payable and accrued liabilities	$	1,349,038		$	443,422
Accrued compensation		946,262			581,689
Notes payable, net		100,000			-
Notes payable - related party, net		662,644			-
Deferred revenue		119,876			5,900
Lease liability, current portion		231,604			221,993
Total current liabilities		3,409,424			1,253,004
Lease liability, net of current portion		1,669,954			1,901,557
Deferred tax liability		1,949			1,139
Total liabilities		5,081,327			3,155,700

Stockholders’ equity (deficit)
Common Stock, $.0001 par value; 125,000,000 shares authorized; 12,172,214 and 11,929,147 issued and outstanding as of December 31, 2022, and 2021, respectively		1,217			1,193
Additional paid-in capital		48,804,704			46,200,509
Accumulated deficit		(49,783,533	)		(38,891,022	)
Total stockholders’ equity (deficit)		(977,612	)		7,310,680
Total liabilities and stockholders’ equity (deficit)	$	4,103,715		$	10,466,380

	Common Stock				Additional Paid-in		Accumulated
	Shares		Amount		Capital		Deficit			Total
Balance, January 1, 2019		4,821,641	$	482	$	18,996,517	$	(21,721,222	)	$	(2,724,223	)

Common stock issued to directors and employees		12,500		1		17,749		-			17,750
Common stock issued to service providers		4,062		1		45,999		-			46,600
Conversion of notes payable and accrued interest		37,301		4		238,719		-			238,723
Common stock issues for settlement		9,375		1		93,749		-			93,750
Stock options issued to employees		-		-		69,787		-			69,787
Settlement of accrued compensation		-		-		712,162		-			712,162
Net loss for the twelve months ended December 31, 2019		-		-		-		(2,167,544	)		(2,167,544	)
Balance, December 31, 2019		4,884,879	$	489	$	20,174,682	$	(23,888,766	)	$	(3,713,595	)

Proceeds from the sale of common stock, net of offering costs		4,153,750		416		11,474,636		-			11,475,052
Common stock issued to directors and employees		112,056		11		465,129		-			465,140
Common stock issued to service providers		34,751		3		150,859		-			150,862
Conversion of notes payable and accrued interest		453,699		45		1,451,779		-			1,451,824
Discount on convertible notes payable		-		-		3,120,150		-			3,120,150
Stock options issued to directors and employees		-		-		1,140,989		-			1,140,989
Rounding shares as a result of reverse stock split		133		-		-		-			-
Net loss for the twelve months ended December 31, 2020		-		-		-		(8,347,316	)		(8,347,316	)
Balance, December 31, 2020		9,639,268	$	964	$	37,978,224	$	(32,236,082	)	$	5,743,106


	Year Ended December 31,
	2022			2021
Net loss (numerator)	$	(10,892,511	)	$	(6,654,940	)
Basic and diluted weighted-average number of common shares outstanding (denominator)		12,122,606			10,632,413
Basic and diluted net loss per common share		(0.90	)		(0.63	)

	2022		2021
	As of December 31,
	2022		2021
Options		1,297,006		1,055,894
Unit purchase options and warrants		610,165		260,165
Total		1,907,171		1,316,059

	December 31, 2020		December 31, 2019
Raw materials	$	72,022	$	44,333
Work in process		29,645		55,502
Finished goods		163,705		1,552
Total inventory	$	265,372	$	101,387

					Carrying Value as of
	Location	Percentage Ownership			December 31, 2022		December 31, 2021
HRCFG INVO, LLC	Alabama, United States		50	%	$	1,106,905		1,387,495
Positib Fertility, S.A. de C.V.	Mexico		33	%		130,960		102,439
Total investment in unconsolidated VIEs					$	1,237,865		1,489,934

	2022			2021
	Year Ended December 31,
	2022			2021
HRCFG INVO, LLC	$	(154,954	)		(313,033	)
Positib Fertility, S.A. de C.V.		(45,604	)		(14,509	)
Total earnings from unconsolidated VIEs	$	(200,558	)		(327,542	)


	December 31, 2022			December 31, 2021
Balance sheets:
Current assets	$	261,477			456,967
Long-term assets		1,094,490			1,302,067
Current liabilities		(396,619	)		(404,155	)
Long-term liabilities		(107,374	)		(142,321	)
Net assets	$	851,974			1,212,558