As filed with the U.S. Securities and Exchange Commission on July 3, 2023

Registration No. 333-272872

 
Registration Number 333-163882

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DCD.C. 20549


AMENDMENT NO.1 TO
Form

Amendment No. 1

to

FORM S-1

REGISTRATION STATEMENT

UNDER

THE

SECURITIES ACT OF 1933

INVO BIOSCIENCE, INC.

(Exact name of registrant as specified in its charter)

Nevada

 

3841

 

20-4036208

Nevada384120-4036208
(State or other jurisdiction of
incorporation or organization)
 
(Primary Standard Industrial
Classification Code Number)
 

(IRSI.R.S. Employer

Identification No.)

Number)


100 Cummings Center, Suite 421E
Beverly, Massachusetts 01915

5582 Broadcast Court Sarasota, Florida, 34240

(978) 878-9505

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

Kathleen T. Karloff

Steve Shum

Chief Executive Officer

INVO Bioscience, Inc.

100 Cummings Center, Suite 421E
Beverly, Massachusetts 01915

5582 Broadcast Court

Sarasota, Florida 34240

(978) 878-9505extension 504

(Name, address including zip code, and telephone number, including area code, of agent for service)


With copies to:

Scott Museles,

Greg Carney, Esq.

Shulman, Rogers, Gandal, Pordy

Sheppard Mullin Richter & Ecker, P.A.

Hampton LLP

12505 Park Potomac Avenue 6th333 South Hope Street, 43rd Floor

Potomac, Maryland 20854
(301) 230-5200

Los Angeles, CA 90071

(213) 620-1780

Approximate date of commencement of proposed sale to the public:From time to time after the effective date of this Registration Statement becomes effective.registration statement.

If any of the securities being registered on this Form are beingto be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, as amended, check the following box.  þ

box: ☒

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o

☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”filer,” “smaller reporting company,” and “smaller reporting“emerging growth company” in Rule 12b-2l2b-2 of the Exchange Act. (Check one):

Large accelerated filer o
Accelerated filer o
Non-accelerated filer o
(Do not check if a smaller reporting company)
Smaller reporting company þ
the Securities Act. D

The Registrantregistrant hereby amends this Registration Statementregistration statement on such date or dates as may be necessary to delay its effective date until the Registrantregistrant shall file a further amendment which specifically states that this Registration Statementregistration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the Registration Statementregistration statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.

 


The information in this prospectus is not complete and may be changed. WeThese securities may not sell these securitiesbe sold until the registration statement filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any state where the offer orofferor sale is not permitted.

Subjectpermitted.

PRELIMINARY PROSPECTUSSUBJECT TO COMPLETIONDATED JULY 3, 2023

INVO Bioscience, Inc.

Up to Completion,  December 28, 2009

PRELIMINARY PROSPECTUS
8,790,000 Share
6,241,493 Shares of Restricted Common Stock
and Common Stock Issuable Upon Exercise of Certain Convertible Debentures and Common Stock Purchase Warrants

This prospectus relates to the offer and resale of up to an aggregate of 6,241,493 shares (the “Shares”) of common stock, par value $0.0001 per share (“Common Stock”), of INVO Bioscience, Inc. (the “Company”, “we”, “us” or “our”), consisting of (A) 50,000 shares of Common Stock issued as a commitment fee under the February Purchase Agreement (defined below), (B) 150,000 shares of Common Stock issued as a commitment fee under that certain Equity Purchase Agreement, dated February 3, 2023, between the Company and the February Investor (defined below) and (C) shares of Common Stock issuable upon (i) the exercise of certain common stock purchase warrants (the “March 2023 Warrants”), to purchase up to 5,520,000 shares of Common Stock (the “March 2023 Warrant Shares”), at an exercise price of $0.63 per share, issued by us to certain institutional investors on March 23, 2023 in a private placement transaction pursuant to a securities purchase agreement, dated as of March 23, 2023 (the “March Purchase Agreement”); (ii) the conversion of a convertible debenture (the “Debenture”) in the current outstanding principal amount of $100,000 plus accrued interest of $1,775 through June 23, 2023, which is convertible at a fixed conversion price of $0.52 into 195,721 shares of Common Stock (the “Conversion Shares”) (iii) the exercise of common stock purchase warrants (the “Placement Agent Warrants”) to purchase 147,200 shares of Common Stock (the “Placement Agent Warrant Shares”) issued to Maxim Partners, LLC, as placement agent for the March Purchase Agreement , at an exercise price of $0.8965 per share and (iv) the exercise of certain common stock purchase warrants (the “February 2023 Warrants,” together with the March 2023 Warrants and the Placement Agent Warrants, the “Warrants”), to purchase up to 178,572 shares of Common Stock (the “February 2023 Warrant Shares,” together with the March 2023 Warrant Shares and the Placement Agent Warrant Shares, the “Warrant Shares”), at an exercise price of $0.63 per share, issued by us to a certain institutional investor (the “February Investor”) on February 3, 2023 in a private placement transaction pursuant to a securities purchase agreement, dated as of February 3, 2023 (the “February Purchase Agreement”). The Warrants (other than the Placement Agent Warrants) are immediately exercisable and will expire five and eight years from the date of issuance for the February 2023 Warrants and the March 2023 Warrants, respectively. The Placement Agent Warrants are exercisable beginning on September 27, 2023 and expire five years from the date of issuance on March 27, 2023. The holders of the Warrants and the underlying Warrant Shares and the Debenture and the underlying Conversion Shares are each referred to herein as a “Selling Stockholder” and collectively as the “Selling Stockholders.”

This prospectus describes the general manner in which the Shares may be offered and sold. If necessary, the specific manner in which the Warrant Shares may be offered and sold by AGS Capital Group, LLC (“AGS”), the selling shareholder identifiedwill be described in a supplement to this prospectus. The Warrants and Warrant Shares were each issued to the applicable Selling Stockholders in connection with private placement offerings pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and/or Regulation D promulgated thereunder. For additional information regarding the issuance of the Warrants and Warrant Shares, see “February 2023 Convertible Debenture and Warrant Financing” and “Registered Direct Offering and Concurrent Private Placement” beginning on page 16.

This prospectus also covers any additional shares of commonCommon Stock that may become issuable upon any anti-dilution adjustment pursuant to the terms of the Debenture and the Warrants issued to the Selling Stockholders by reason of stock splits, stock dividends, and other events described therein.

The Shares will be resold from time to time by the Selling Stockholders listed in the section titled “Selling Stockholders” beginning on page 18.

The Selling Stockholders, or their respective transferees, pledgees, donees or other successors-in-interest, will sell the Shares through public or private transactions at prevailing market prices, at prices related to prevailing market prices or at privately negotiated prices. The Selling Stockholders may sell any, all or none of the securities offered underby this prospectus, by AGS are issuable to AGS pursuant toand we do not know when or in what amount the Selling Stockholders may sell their Warrant Shares hereunder following the effective date of this registration statement. We provide more information about how a Reserved Equity Financing Agreement (“REF”) between AGS and us dated October 28, 2009. Selling Stockholder may sell its Warrant Shares in the section titled “Plan of Distribution” on page 23.

We are registering the offer and saleShares on behalf of the sharesSelling Stockholders, to satisfy registration rightsbe offered and sold by them from time to time. While we have granted to AGS. We will not receive any proceeds from the sale of these sharesour Common Stock by AGS.  This registration statement covers only a portion of the shares of common stock that may be issuable pursuant toSelling Stockholders in the REF. We may file subsequent registration statements covering the resale of additional shares of common stock issuable pursuant to the REF with AGS beginning approximately 60 days after we have substantially completed the sale to AGS under the REF of the shares subject to this registration statement. We will bear all costs associated with this registration statement.

AGS may sell the shares of common stockoffering described in this prospectus, in a numberwe may receive up to $0.63 per share upon the cash exercise of different ways and at varying prices. We provide more information about how AGS may sell its shares of common stock in the section entitled “Plan of Distribution.” AGS is an “underwriter” within the meaningeach of the Securities ActWarrants. Upon the exercise of 1933, as amended (the “Securities Act”)the Warrants for all 5,698,572 Warrant Shares by payment of cash, we would receive aggregate gross proceeds of approximately $3.6 million. However, we cannot predict when and in what amounts or if the Warrants will be exercised, and it is possible that the Warrants may expire and never be exercised, in which case we would not receive any cash proceeds. We have agreed to bear all of the expenses incurred in connection with the resaleregistration of our common stock under the REF.  AGSShares. The Selling Stockholders will pay us 92%or assume discounts, commissions, fees of underwriters, selling brokers or dealer managers and similar expenses, if any, incurred for the sale of the volume weighted average price of the common stock during the five consecutive trading days immediately following the date of our notice to AGS of our election to sell shares to AGS pursuant to the REF.
Our shares of common stock are tradedShares.

The Common Stock is currently listed on the Over-the-Counter Bulletin Board (the “OTCBB”Nasdaq Capital Market (“Nasdaq”) under the symbol "IVOB.OB."“INVO.” On December 11, 2009,June 22, 2023, the closinglast reported sale price of our common stockCommon Stock was $0.33 per share.

$0.1745.

This investmentoffering will terminate on the earlier of (i) the date when all of the Securities registered hereunder have been sold pursuant to this prospectus or Rule 144 under the Securities Act, and (ii) the date on which all of such securities may be sold pursuant to Rule 144 without volume or manner-of-sale restrictions, unless we terminate it earlier.

Investing in our Common Stock involves a high degree of risk.risks. You should purchase shares only if you can afford a complete loss. See "Risk Factors"carefully review the risks described under the heading “Risk Factors” beginning on page 5.9 and in the documents which are incorporated by reference herein before you invest in our Common Stock.

Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.

The date of this prospectus is December 28, 2009


TABLE OF CONTENTS
, 2023.

 

TABLE OF CONTENTS

 Page
  
ABOUT THIS PROSPECTUS1
 
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS2
INDUSTRY AND MARKET DATA2
  
Prospectus SummaryPROSPECTUS SUMMARY
3
 1
Risk FactorsABOUT THIS OFFERING
58
  
RISK FACTORS9
  
Special Note Regarding Forward Looking StatementFEBRUARY 2023 CONVERTIBLE DEBENTURE AND WARRANT FINANCING
16
 12 
Use of ProceedsREGISTERED DIRECT OFFERING AND CONCURRENT PRIVATE PLACEMENT
16
 12 
Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity SecuritiesSELLING STOCKHOLDERS
18
 13 
CapitalizationUSE OF PROCEEDS
20
 13 
Selected Consolidated Financial DataDIVIDEND POLICY
21
 14 
Management’s Discussion and Analysis of Financial Condition and Results of OperationsSECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
22
 15 
BusinessDESCRIPTION OF SECURITIES THAT THE SELLING STOCKHOLDERS ARE OFFERING
22
 20 
ManagementPLAN OF DISTRIBUTION
23
 27 
Executive CompensationDISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITY
24
 29 
Certain Relationships and Related Party TransactionsLEGAL MATTERS
24
 31 
Principal ShareholdersEXPERTS
24
 31 
Selling ShareholderWHERE YOU CAN FIND MORE INFORMATION
24
 32 
Description of Capital StockINCORPORATION OF DOCUMENTS BY REFERENCE
3224

Plan of Distribution
33
Legal Matters
35
Experts
35
Where You Can Find More Information
35
Index to Financial Statements
F-1
 

ABOUT THIS PROSPECTUS

This prospectus describes the general manner in which the Selling Stockholders may offer from time to time up to an aggregate of 6,241,493 shares (the “Shares”) of common stock, par value $0.0001 per share (“Common Stock”), of INVO Bioscience, Inc. (the “Company”, “we”, “us” or “our”), consisting of (A) 50,000 shares of Common Stock issued as a commitment fee under the February Purchase Agreement (defined below), (B) 150,000 shares of Common Stock issued as a commitment fee under that certain Equity Purchase Agreement, dated February 3, 2023, between the Company and the February Investor (defined below) (the “February 2023 Equity Purchase Agreement”), and (C) shares of Common Stock issuable upon (i) the exercise of certain common stock purchase warrants (the “March 2023 Warrants”), to purchase up to 5,520,000 shares of Common Stock (the “March 2023 Warrant Shares”), at an exercise price of $0.63 per share, issued by us to certain institutional investors on March 23, 2023 in a private placement transaction pursuant to a securities purchase agreement, dated as of March 23, 2023 (the “March Purchase Agreement”); (ii) the conversion of a convertible debenture (the “Debenture”) in the current outstanding principal amount of $100,000 plus accrued interest of $1,775, which is convertible at a fixed conversion price of $0.52 into 195,271 shares of Common Stock (the “Conversion Shares”); (iii) the exercise of common stock purchase warrants (the “Placement Agent Warrants”) to purchase 147,200 shares of Common Stock (the “Placement Agent Warrant Shares”) issued to Maxim Partners, LLC, as placement agent for the March Purchase Agreement, at an exercise price of $0.8965 per share and (iv) the exercise of certain common stock purchase warrants (the “February 2023 Warrants,” together with the March 2023 Warrants and the Placement Agent Warrants, the “Warrants”), to purchase up to 178,572 shares of Common Stock (the “February 2023 Warrant Shares,” together with the March 2023 Warrant Shares and the Placement Agent Warrant Shares, the “Warrant Shares”), at an exercise price of $0.63 per share, issued by us to a certain institutional investor (the “February Investor”) on February 3, 2023 in a private placement transaction pursuant to a securities purchase agreement, dated as of February 3, 2023 (the “February Purchase Agreement”). You should rely only on the information contained in this prospectus and the related exhibits, any prospectus supplement or amendment thereto and the documents incorporated by reference, or to which we have referred you, before making your investment decision. Neither we nor the Selling Stockholders have authorized anyone to provide you with different information. If anyone provides you with different or inconsistent information, you should not rely on it. This prospectus, any prospectus supplement or amendments thereto do not constitute an offer to sell, or a solicitation of an offer to purchase, the shares of Common Stock offered by this prospectus, any prospectus supplement or amendments thereto in any jurisdiction to or from any person to whom or from whom it is unlawful to make such offer or solicitation of an offer in such jurisdiction. You should not assume that the information contained in this prospectus, any prospectus supplement or amendments thereto, as well as information we have previously filed with the U.S. Securities and Exchange Commission (the “SEC”), is accurate as of any date other than the date on the front cover of the applicable document.

If necessary, the specific manner in which the shares of Common Stock may be offered and sold will be described in a supplement to this prospectus, which supplement may also add, update or change any of the information contained in this prospectus. To the extent there is a conflict between the information contained in this prospectus and any prospectus supplement, you should rely on the information in such prospectus supplement, provided that if any statement in one of these documents is inconsistent with a statement in another document having a later date - for example, a document incorporated by reference in this prospectus or any prospectus supplement - the statement in the document having the later date modifies or supersedes the earlier statement.

Neither the delivery of this prospectus nor any distribution of shares of Common Stock pursuant to this prospectus shall, under any circumstances, create any implication that there has been no change in the information set forth or incorporated by reference into this prospectus or in our affairs since the date of this prospectus. Our business, financial condition, results of operations and prospects may have changed since such date.

When used herein, unless the context requires otherwise, references to “INVO”, the “Company”, “we”, “our” or “us” refer to INVO Bioscience, Inc., a Nevada corporation, and its subsidiaries on a consolidated basis.

1

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This prospectus, any amendment and the information incorporated by reference into this prospectus contain various forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), which represent our expectations or beliefs concerning future events. Forward-looking statements include statements that are predictive in nature, which depend upon or refer to future events or conditions, and/or which include words such as “believes,” “plans,” “intends,” “anticipates,” “estimates,” “expects,” “may,” “will” or similar expressions. In addition, any statements concerning future financial performance, ongoing strategies or prospects, and possible future actions including any potential strategic transaction involving us, which may be provided by our management, are also forward-looking statements. Forward-looking statements are based on current expectations and projections about future events and are subject to risks, uncertainties, and assumptions about our company, economic and market factors, and the industry in which we do business, among other things. These statements are not guarantees of future performance, and we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Actual events and results may differ materially from those expressed or forecasted in forward-looking statements due to a number of factors. Factors that could cause our actual performance, future results and actions to differ materially from any forward-looking statements include, but are not limited to, those discussed under the heading “Risk Factors” in this prospectus and in any of our filings with the SEC pursuant to Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act incorporated by reference into this prospectus. The forward-looking statements in this prospectus, and the information incorporated by reference herein represent our views as of the date such statements are made. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date such statements are made.

INDUSTRY AND MARKET DATA

Unless otherwise indicated, information contained in this prospectus concerning our industry and the market in which we operate, including our market position, market opportunity and market size, is based on information from various sources, on assumptions that we have made based on such data and other similar sources and on our knowledge of the markets for our products. These data sources involve a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.

We have not independently verified any third-party information. While we believe the market position, market opportunity and market size information included in this prospectus is generally reliable, such information is inherently imprecise. In addition, projections, assumptions and estimates of our future performance and the future performance of the industry in which we operate is necessarily subject to a high degree of uncertainty and risk due to a variety of factors, including those described in the section titled “Risk Factors” and elsewhere in this prospectus and in any documents that we incorporate by reference into this prospectus and the registration statement of which this prospectus forms a part. These and other factors could cause results to differ materially from those expressed in the estimates made by the independent parties and by us.

2

PROSPECTUS SUMMARY

This summary highlights selected information contained elsewhere in this prospectus or incorporated by reference into this prospectus. This summary does not contain all of the information that you should consider before investing in our Common Stock. You should carefully read this entire prospectus, and our other filings with the SEC, including the following sections, which are either included herein and/or incorporated by reference herein, “Risk Factors”, “Special Note Regarding Forward-Looking Statements”, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and the consolidated financial statements incorporated by reference herein, before making a decision about whether to invest in our securities.

Company Overview

We are 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. Our flagship product is INVOcell, a revolutionary medical device that allows fertilization and early embryo development to take place in vivo within the woman’s body. Our primary mission is to implement new medical technologies aimed at increasing the availability of affordable, high-quality, patient-centered fertility care. This treatment solution is the world’s first intravaginal culture technique for the incubation of oocytes and sperm during fertilization and early embryo development. This technique, designated as “IVC”, provides patients a more natural, intimate and more affordable experience in comparison to other ART treatments. The IVC procedure can deliver comparable results at a lower cost than traditional in vitro fertilization (“IVF”) and is a significantly more effective treatment than 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.

Operations

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 a U.S. Food and Drug Administration (“FDA”) registered contract sterilization facility.

Market Opportunity

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. 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 the 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, which is similar to most markets around the world.

Competitive Advantages

We believe that the INVOcell, and the selling shareholder has not, authorized anyoneIVC 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.

3

The IVC procedure is currently being offered at practicing clinics at a 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, 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 provide yousufficient 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 additionalcomparable 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 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 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 dramatically 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 ethical or different information. These securities are not being offeredreligious concerns, or fears of laboratory mix-ups.

Corporate History

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 (which have since expired) relating to the INVOcell technology, to Bio X Cell, Inc. upon its formation in any jurisdiction whereJanuary 2007.

On December 5, 2008, Bio X Cell, Inc., doing business as INVO Bioscience, and each of the offer is not permitted. You should assumeshareholders 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 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.

Recent Developments

Reverse Stock Split

On June 28, 2023, our board of directors approved a reverse stock split of our common stock at a ratio of 1-for-20 and also approved a proportionate decrease in our authorized common stock to 6,250,000 shares from 125,000,000.  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,  None of the information presented in this prospectus is accurate only ashas been updated to reflect the pending 1-for-20 reverse split of our outstanding shares of common stock (and corresponding proportionate reduction of our authorized shares of common stock); provided, however that we intend to promptly update the disclosure in this prospect to reflect such reverse stock split (and corresponding proportionate reduction in our authorized shares of common stock) upon filing of a certificate of change with the Nevada Secretary of State pursuant to Nevada Revised Statutes 78.209 to (i) decrease the number of authorized shares of common stock from 125,000,000 to 6,250,000 shares and (ii) effectuate a 1-for-20 reverse stock split of the dateoutstanding common stock. Despite such board approval, we still have the authority, to determine whether and when to commence or abandon the proposed 1-for-20 reverse stock split.

4

510(k) FDA Clearance

On June 22, 2023, we received U.S. Food and Drug Administration (FDA) 510(k) clearance to expand the labeling on the frontINVOcell device and its indication for use to provide for a 5-day incubation period. The data supporting the expanded 5-day incubation clearance demonstrated improved patient outcomes.

March 2023 Registered Direct Offering

On March 23, 2023, we 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 (the “RD Offering”), 1,380,000 shares of Common Stock, and a pre-funded warrant (the “Pre-Funded Warrant”) 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 (the “March Warrant Placement”), a common stock purchase warrant (the “March Warrant”), 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 RD 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), 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 Warrant is exercisable upon issuance and will remain exercisable until all of the documentshares underlying the Pre-Funded Warrant are exercised in full. All Pre-Funded Warrants were exercised by the investor in June 2023.

The March Warrant (and the shares of Common Stock issuable upon the exercise of the Private Warrants) was not registered under the Securities Act and was 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 Warrant is immediately exercisable upon issuance, will expire eight years from the date of issuance, and in certain circumstances may be exercised on a cashless basis.

On March 27, 2023, the Company closed the RD Offering and March Warrant Placement, raising gross proceeds of approximately $3 million before deducting placement agent fees and other offering expenses payable by the Company. In the event the March Warrant is fully exercised for cash, the Company would receive additional gross proceeds of approximately $3.5 million. The Company used $383,879 in proceeds to repay a portion of the convertible debenture issued in February 2023 and the remainder of the proceeds are being used for working capital and general corporate purposes.

Under the March Purchase Agreement, the Company is required within 30 days of the closing date of the March Warrant Placement 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 Warrant. 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 the Resale Registration Statement effective at all times until no shares of Common Stock remain exercisable under the March Warrant.

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 RD Offering and March Warrant Placement, 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 information weof 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.

Execution of Definitive Agreements to Acquire the Wisconsin Fertility Institute

On March 16, 2023, INVO Bioscience Inc., a Nevada corporation (“INVO”), through Wood Violet Fertility LLC, a Delaware limited liability company (“Buyer”) 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 (the “Clinic”) for a combined purchase price of $10 million, including an asset purchase agreement with Wisconsin Fertility and Reproductive Surgery Associates, S.C., a Wisconsin professional service corporation d/b/a Wisconsin Fertility Institute (“WFRSA”) and The Elizabeth Pritts Revocable Living Trust and a Membership Interest Purchase Agreement with Fertility Labs of Wisconsin, LLC, a Wisconsin limited liability company (“FLOW”)., IVF Science, LLC owned by Wael Megid Ph.D. and Dr. Elizabeth Pritts as trustee for the Elizabeth Pritts Revocable Living Trust.

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The purchase price is payable in four installments of $2.5 million each (which payments may be offset by assumption of certain Clinic 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. The additional $7.5 million in payments are secured by the Clinic having a lien on the assets purchased to acquire the Clinic.

The Clinic is comprised of (a) a medical practice, WFRSA, and (b) a laboratory services 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. The combined financial statements of WFRSA and FLOW are incorporated by reference into this prospectus as further described under “Experts” on page 24.

Notices from Nasdaq of Failure to Satisfy Continued Listing Rules.

Notice Regarding Non-Compliance with Minimum Stockholders’ Equity

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 accurate onlybelow the Stockholders’ Equity Requirement for continued listing. Additionally, as of the date of the document incorporated by reference, regardlessNotice, we did not meet either of the time of delivery of this prospectus or of any sale of our common stock. Unless the context otherwise requires, references to “we,” “our,” “us,” or the “Company” in this prospectus mean INVO Bioscience, Inc. a Nevada corporation.

PROSPECTUS SUMMARY
This summary highlights information described more fully elsewhere in this prospectus.  You should read the entire prospectus carefully, including the risk factors, the financial statements and the notes to the financial statements included herein. Investing our securities involves risks. Therefore, please carefully consider the information providedalternative Nasdaq continued listing standards under the heading “Risk Factors” included herein.
The Company
We are a development stage company that hasNasdaq 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 begun to commercialize our proven and patented technology that we believe will revolutionize the treatment of infertility.  Our device, the INVOcell, and the INVO procedure are designed to provide an alternative infertility treatment for the patient and the clinician; it is less expensive and simpler to perform than current infertility treatments.  The simplicitycompleted fiscal year, or in two of the INVO procedure relates to the ability to potentially perform the infertility procedure in a physician’s practice rather than in a specialized facility at a much lower cost overall than current infertility treatments, including in vitro fertilization (“IVF”).  Therefore, we believe that the INVO procedure will be available in many more locations than conventional IVF especially outside the United States.  INVO also allows conception and embryo development to take place inside the woman's body; an attractive feature forthree most couples.
Through September 30, 2009, we have generated minimal revenues, have incurred significant expenses and have sustained losses.  Consequently, our operations are subject to all the risks inherent in the establishment of a new business enterprise.
In May 2008, we received notice that the INVOcell product meets all the essential requirements of the relevant European Directive(s), and received CE Marking.  recently completed fiscal years.

The CE marking (also known as CE mark) is a mandatory conformity mark on many products placedNotice has no immediate effect on the single market in the European Economic Area (EEA).  The CE marking (an acronym for the French “Conformité Européenne”) certifies that a product has met EU health, safety and environmental requirements, which ensure consumer safety.

With CE Marking, we now have the ability and necessary regulatory authority to distribute our product in the European Economic Area (i.e., the European Union, Canada, Australia, New Zealand, and most parts of the Middle East).  The Company has sold approximately 900 INVOcell units to date since we commenced sales in the late fall 2008.
Our principal executive offices are located at 100 Cummings Center Suite 421e, Beverly, MA 01915, and our telephone number is (978) 878-9505.  The address of our website is www.INVOBioscience.com.  Information on our website is not part of this prospectus.
The INVOcell Technology
Our product, the INVOcell medical device, is designed to treat infertility at a far lower cost than other treatments available in today’s marketplace, including IVF.  The INVO technology is a fertility treatment where either mild ovarian stimulation or no ovarian stimulation is used.  Using a mild stimulation protocol, 1-10 follicles are retrieved in a physician’s office with the patient under light sedation with or without local anesthesia.  The follicle retrieval is performed using a vaginal probe under ultrasound guidance.  Eggs are identified immediately after retrieval in the follicular fluid.  During the INVO procedure, fertilization and embryo development occurs inside the woman’s vaginal cavity in a disposable single use device -- the INVOcell -- that holds the eggs, sperm and culture medium.
Sperm collection and preparation generally occur before egg retrieval.  Nutrient medium (~1ml) is placed in the inner vessel of the INVOcell.  Eggs and a fraction of motile sperm are placed into the medium and the inner vessel is closed and secured in the protective outer rigid shell.  The INVOcell is placed in the patient’s vaginal cavity for an incubation period of 2-3 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 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.  Obtaining eggs, sperm and media then inserting them into the INVOcell and then placing it in the vagina takes approximately 90 minutes.
After 2-3 days, 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 inner vessel is placed in INVO Bioscience’s patented holding block in a vertical position for 15 minutes.  Embryos are collected in the micro chamber located at the bottom of the inner vessel.  The embryos can be directly viewed in the micro chamber in the holding block by using a microscope.  Embryos can be loaded directly from the device in a transfer catheter from the INVOcell device.  A trained clinician can readily identify the best embryos for transfer.  The embryos to be transferred are aspirated into a standard catheter for transfer into the patient’s uterus.  This second visit should take approximately 45 minutes.  All INVO related medical procedures can be performed in a physician’s office thereby avoiding the requirement of an IVF facility and the associated costs to build and maintain such a facility.
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Our Equity Financing Facility with AGS Capital Group, LLC
On October 28, 2009, we entered into a Reserve Equity Financing Agreement, or REF, with AGS pursuant to which AGS committed to purchase, from time to time over a period of two years, shareslisting of our common stock for cash considerationand 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 $10 million,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 certain conditions and limitations discussed below.delisting. In connectionthe 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 May 23, 2023, we were notified by the Listing Qualifications department (the “Staff”) of Nasdaq that, based upon the Company’s non-compliance with the REF, we also entered into$2.5 million stockholders’ equity requirement for continued listing on The Nasdaq Global Market, as set forth in Nasdaq Listing Rule 5550(b)(1) (the “Rule”), as of May 22, 2023, the Company’s common stock was subject to delisting from Nasdaq unless the Company timely requests a registration rights agreement with AGS, dated October 28, 2009. hearing before the Nasdaq Hearings Panel (the “Panel”).

We have not engaged in prior securities transactions with AGS orrequested a hearing before the Panel, which stays any affiliates of AGS.

The shares of common stockfurther action by Nasdaq at least until the hearing process concludes and any extension that may be issuedgranted by the Panel has expired. At the hearing, we will present a plan to AGS underregain compliance with the REF will be issued pursuant to an exemption from registration underRule and request the Securities Act. Pursuant to the registration rights agreement, we have filed a registration statement,continued listing of which this prospectus is a part, covering the possible resale by AGS of a portion of the shares that we may issue to AGS under the REF. Through this prospectus, the selling shareholder may offer to the public for resale shares of ourits common stock pending the Company’s compliance with the Rule. There can be no assurances however that we may issuethe Panel will agree to AGS pursuant to the REF.
This registration statement covers only a portion of the shares of our common stock issuable pursuant to the REF with AGS. We may file subsequent registration statements covering the resale of additional shares of our common stock issuable pursuant to the REF with AGS beginning approximately 60 days after we have substantially completed the sale to AGS under the REF of the shares subject to this registration statement.
For a period of 24 months from the effectiveness of the registration statement of which this prospectus is a part (the “Registration Statement”), we may, from time to time, at our discretion, and subject to certain conditions that we must satisfy, draw down funds under the REF by selling shares of our common stock to AGS up to an aggregate of $10 million. The purchase price of these shares will be 92% of the “VWAP” of the common stock during the five consecutive trading days after we give AGS a notice of an advance of funds (an “Advance”) under the REF (the “Pricing Period”). “VWAP” generally means, as of any date, the daily dollar volume weighted average price of our common stock as reported by Bloomberg, L.P. or comparable financial news service.  The amount of an Advance will automatically be reduced by 50% if on any day during the Pricing Period, the VWAP for that day does not meet or exceed 85% of the VWAP for the five trading days prior to the notice of Advance (the “Floor Price”).
The REF does not prohibit us from raising additional debt or equity financings, other than financings similar to the REF.
Our ability to require AGS to purchase our common stock is subject to various conditions and limitations. The maximum amount of each Advance is 100% of the average daily trading volume for the five days immediately preceding the notice of Advance, as reported by Bloomberg or comparable financial news service (the “Maximum Advance Amount”).  In addition, unless AGS agrees otherwise, a minimum of five calendar days must elapse between each notice of Advance.
Before AGS is obligated to buy any shares of our common stock pursuant to a notice of Advance, the following conditions, none of which is in AGS’s control, must be met:
·  The Registration Statement (which includes this prospectus) shall have previously become effective and shall remain effective in accordance with and subject to the terms of the registration rights agreement.
·  We shall have obtained all permits and qualifications required by any applicable state in accordance with the registration rights agreement for the offer and sale of the shares of common stock, or shall have the availability of exemptions there from. The sale and issuance of the shares of common stock shall be legally permitted by all laws and regulations to which we are subject.
·  There shall not be any fundamental changes to the information set forth in the Registration Statement which are not already reflected in a post-effective amendment to the Registration Statement.
·  We shall have performed, satisfied and complied in all material respects with all covenants, agreements and conditions required by the REF and the registration rights agreement to be performed, satisfied or complied with by us.
·  No statute, rule, regulation, executive order, decree, ruling or injunction shall have been enacted, entered, promulgated or endorsed by any court or governmental authority of competent jurisdiction that prohibits the consummation of or which would materially modify or delay any of the transactions contemplated by the REF agreement, and no proceeding shall have been commenced that may have the effect of prohibiting the consummation of or materially modify or delay any of the transactions contemplated by the REF.
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·  The common stock is trading on a principal market (as defined in the REF, and including the OTC Bulletin Board). The trading of the common stock is not suspended by the SEC or the principal market. The issuance of shares of common stock with respect to the applicable closing will not violate the shareholder approval requirements of the principal market. We shall not have received any notice threatening the continued quotation of the common stock on the principal market and we shall have no knowledge of any event which would be more likely than not to have the effect of causing the common stock to not be trading or quoted on a principal market.
·  
The amount of an Advance shall not exceed the Maximum Advance Amount. In no event shall the number of shares issuable to AGS pursuant to an Advance cause the aggregate number of shares of common stock beneficially owned by AGS and its affiliates to exceed 4.99% of the then outstanding shares of our common stock (“Ownership Limitation”). Any portion of an Advance that would cause AGS to exceed the Ownership Limitation shall automatically be withdrawn. For the purposes of this provision, beneficial ownership is calculated in accordance with Section 13(d) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).
·  We have no knowledge of any event which would be more likely than not to have the effect of causing such Registration Statement to be suspended or otherwise ineffective at closing.
·  AGS shall have received an Advance notice executed by an officer of ours and the representations contained in such Advance notice shall be true and correct.
There is no guarantee that we will be able to meet the foregoing conditions or any other conditions under the REFrequest or that we will be able to draw downevidence compliance with all applicable Nasdaq listing criteria within any portionextension of time that may be granted by the amounts available underPanel.

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As previously disclosed, the REF.

The Registration Statement covers only 8,790,000 shares of common stock underStaff granted the REF.  The entire share requirement for the full $10 million under the REF would be approximately 32,938,000 based onCompany an assumed VWAP of $0.33 less the 8% discount.  However, we have decidedextension to limit ourselves to 8,790,000 shares available, or $2,668,000, based on current market prices.  If our share price rises, we will be able to draw down in excess of $2,668,000. If we decide to issue more than 8,790,000 shares, we will need to file one or more additional registration statementsevidence compliance with the SEC covering those additional shares. 
The REF contains representations and warranties by us and AGSRule through May 22, 2023. We were unable to do so, which are typical for transactions of this type.
AGS agreed that during the term of the REF, neither AGS nor any of its affiliates, nor any entity managed or controlled by it, will, or cause or assist any person to, enter into or execute any short sale of any shares of our common stock as definedresulted in Regulation SHO promulgated under the Exchange Act.  The REF also contains a variety of covenants by us which are typical for transactions of this type, as well as the obligation, without the prior written consent of AGS, not to enter into any other agreement similar to the REF with a third party during the term of the REF. 
The REF obligates us to indemnify AGS for certain losses resulting from a misrepresentation or breach of any representation or warranty made by us or breach of any obligation of ours. AGS also indemnifies us for similar matters.
We paid no fees, and are not obligated to pay any fees in the future, to AGS in connection with the REF, other than a due diligence fee of $10,000, all of which has been paid as of the date hereof.
We may terminate the REF effective upon fifteen trading days’ prior written notice to AGS; provided that (i) there are no Advances outstanding, and (ii) we have paid all amounts owed to AGS pursuant to the REF. The obligation of AGS to make an Advance to us pursuant to the REF shall terminate permanently if (i) there shall occur any stop order or suspension of the effectiveness of the Registration Statement for an aggregate of 50 trading days, or (ii) we shall at any time fail materially to comply with certain covenants specified in the REF and such failure is not cured within 30 days after receipt of written notice from AGS, subject to exceptions.
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The issuance of our shares of common stock under the REF will have no effect on the rights or privileges of existing holders of common stock except that the economic and voting interests of each stockholder will be diluted as a result of the issuance of our shares.  Although the number of shares of common stock that stockholders presently own will not decrease, these shares will representStaff’s determination.

Notice Regarding Failure to Maintain Minimum Bid Price

On January 11, 2023, we received a smaller percentage of our total shares that will be outstanding after any issuances of shares of common stock to AGS.  If we draw down amounts under the REF when our share price is decreasing, we will need to issue more shares to raise the same amount than if our stock price was higher.  Such issuances will have a dilutive effect and may further decrease our stock price. An example of the effect of issuing shares when our stock price is comparatively low is set forth below.

Under the REF, the purchase price of the shares to be sold to AGS will be at a discount of 8%letter from the volume weighted averagestaff (the “Staff”) of Nasdaq listing qualifications group indicating that, based upon the closing bid price of our common stock for eachthe 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 five trading days followinglisting of our election to sell shares to AGS. The table below illustrates an issuance of shares of common stock, and our common stock will continue to AGStrade on The Nasdaq Capital Market under the REF for a hypothetical draw down amountsymbol “INVO.”

In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have been provided an initial period of $50,000180 calendar days, or until July 10, 2023, to regain compliance with the minimum bid price requirement. If at an assumed volume weighted average price of $0.33, which is equal toany time before July 10, 2023, the closing bid price of our common stock oncloses 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 OTC Bulletin Board on December 11, 2009.

Draw Down        Price to be Paid by  Number of Shares 
Amount  VWAP  % Discount  AGS  to be Issued 
$50,000  $0.33   8%    $0.30   164,690 
By comparison,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 volume weighted averageclosing bid price of our common stock was lower than $0.33, the number of shares that we would be requiredand will consider implementing available options to issue in order to have the same draw down amount of $50,000 would be larger, as shown by the following table:

Draw Down        Price to be Paid by  Number of Shares 
Amount  VWAP  % Discount  AGS  to be Issued 
$50,000  $0.30   8%    $0.276   181,160 
Accordingly, the effect of the second example outlined above from the first example outlined above, would be dilution of an additional 16,470 shares issued due to the lower stock price. In effect, a lower price per share of our common stock means a higher number of shares to be issued to AGS, which equates to greater dilution of existing stockholders. The effect of this dilution may, in turn, cause the price of our common stock to decrease further, both because of the downward pressure on the stock price that would be caused by a large number of sales of our shares into the public market by AGS, and because our existing stockholders may disagree with a decision to sell shares to AGS at a time when our stock price is low, and may in response decide to sell additional numbers of shares, further decreasing our stock price.
There is no limit to the number of shares that we may be required to obtain funds from the REF as it is dependent upon our trading volume and share price, which varies from day to day. This also could cause significant downward pressure on the price of our common stock. The following table shows the effect on the number of shares required for an Advance for the value of the full $10 million REF, in the event the common stock price declines by 25%, 50% and 75% from the trading price.
     Price Decreases By 
  12/11/2009   25%   50%   75% 
VWAP during the Purchase Period (as defined above)         $     0.33   $    0.248   $   0.165   $0.083 
Purchase Price (defined above as 92% of the VWAP)  $     0.304   $    0.228   $    0.152   $  0.076 
Number Subject to the REF if 100% of the REF is Executed.  32,938,076   43,917,435   65,876,152   131,752,306 
We entered into the REFregain compliance with the intention to grow our business, which in turn should increase our value. Because ofminimum bid price requirement under the nature of the REF it appears unlikely thatNasdaq Listing Rules. If we will be able to draw down the full $10 million without significant positive value being added as a result of the aggregate draw downs. In addition, as reflected above, if our share price declines significantly and we still desire to draw down on the REF, in addition to having to file one or more additional registration statements, we may need to amend our charter to increase our authorized shares of common sock, which is currently 200 million shares.
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Placement Agent
We engaged Gilford Securities, Inc. (“Gilford”) to act as placement agent on a non-exclusive basis in connectiondo not regain compliance with the REF.  Gilfordminimum bid price requirement within the allotted compliance periods, we will receive a cash commission equaling six percent (6%) of the total proceeds received by uswritten notification from the sale ofNasdaq that its securities sold to AGS.  In addition, we have issued to Gilford and/or its designees, for a total cost of one dollar, 600,000 shares of our common stock.  If we elect to (and have the ability to) have a closing under the REF on more than $6,000,000, then we shall issue and sell to Gilford and/or its designees, for a total cost of one dollar, an additional 400,000 shares of our common stock.
We agreed to pay all reasonable expenses, not to exceed $10,000, incurred by Gilford in connection with the negotiation, preparation and execution of the definitive documents in connection with the REF, including but not limited to attorneys’ fees and consulting expenses, in two installments.  The first installment of $5,000 was paid in connection with the execution of the definitive documents, and the balance will be due upon the first funding under the REF based on actual expenses.   The placement agent agreement also contains customary mutual indemnification provisions.
The Offering
Common stock offered:
Up to 8,790,000 shares of common stock, $.0001 par value, to be offered for resale by AGS.
Common stock to be outstanding
after this offering:
Approximately 66,800,000 shares.
Use of proceeds:
We will not receive any proceeds from the sale of the shares of common stock offered by AGS. However, we will receive proceeds from the Reserved Equity Financing.  See “Use of Proceeds”.
Risk factors:
An investment in our common stock involves a high degree of risk. See “Risk Factors” beginning on page 6 of this prospectus.
OTC Bulletin Board symbol:
“IVOB.OB”
RISK FACTORS
Investing in our shares of common stock is very risky.  Before making an investment decision, you should carefully consider all of the risks described in this prospectus.  If any of the risks discussed in this prospectus actually occur, our business, financial condition and results of operations could be materially and adversely affected, the price of our shares could decline significantly, and you might lose all or a part of your investment.  The risk factors described below are not the only ones that may affect us.  Our forward-looking statements in this prospectus are also subject to the following risks and uncertainties.  In deciding whether to purchase our shares, you should carefully consider the following factors, among others, as well as information contained in this prospectus.
Risks Relating to Our Company

Our business has posted net operating losses, has limited operating history and our independent certified public accountants have raised doubts about our ability to continue as a going concern.

For the year ended December 31, 2008, our independent auditor issued a report relating to our audited financial statements which contains a qualification with respect to our ability to continue as a going concern because, among other things, our ability to continue as a going concern is dependent upon our ability to generate profits from operations in the future or to obtain the necessary financing to meet our obligations and repay our liabilities when they come due. The financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.  

As reflected in our most recent unaudited condensed consolidated financial statements, we have incurred a net loss for the most recent three months ended September 30, 2009 of $3,409,000 and a cumulative net loss of $6,586,000, a working capital deficiency of $4,677,000, a stockholder deficiency of $4,577,000 and cash used in operations of $673,000 for the nine months ended September 30, 2009.  This raises substantial doubt about our ability to continue as a going concern. The adverse effects of a limited operating history include reduced management visibility into forward sales, marketing costs, and customer acquisition, which could lead to missing targets for achievement of profitability.
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We need additional capital to continue operations; if we do not raise additional capital, we will need to curtail or cease operations.

Since our inception, we have financed our operations primarily through the sale of our common stock and convertible notes and loans from management.  On September 30, 2009, we had $194,405 in cash.  To execute on our business plan successfully, we will need to raise additional money in the future.  Additional financing may not be available on favorable terms, or at all.  The exact amount of funds raised, if any, will determine how quickly we can complete our clinical trials that are required to receive FDA approval to market and sell our products in the United States and how aggressively we can grow our business internationally.  No assurance can be given that we will be able to raise capital when needed or at all, or that such capital, if available, will be on terms acceptable to us.  If we are not able to raise additional capital, we will likely need to curtail or cease operations.  Although we have entered into the REF with AGS, there can be no assurance that we will be successful in raising any capital pursuant to the REF. Other than the REF, we currently have no commitments for funding. If adequate funds are not available when required, we will need to curtail or cease operations.

We are required by the FDA to conduct a clinical trial related to our INVOcell device. As noted above, we need additional capital to undertake the clinical trial.  In addition, the clinical trial may prove unsuccessful.  If unsuccessful, we will not be able to market and sell our product in the United States, which would materially adversely affect our US business.
We are looking to use some of the funds from the REF to conduct a clinical trial related to the INVOcell device. We anticipate that it will take nine months and approximately $1,000,000 of funding to complete the data collection on all required subjects, analyze the data, have an independent audit and submit the full 510(k) to the FDA.  The FDA has 90 days to review the submission from INVO Bioscience.  All preclinical data and testing has been completed and reviewed by FDA.  There is no assurance that our clinical trial will be successful.  An unsuccessful trial would affect the marketability in the U.S. of this product in the future and will prevent the receipt of FDA clearance, which would materially adversely affect our business.
Our business is subject to significant competition, including from more established infertility treatments such as IVF.

The infertility industry is highly competitive and characterized by technological improvements.  New artificial reproductive technology (“ART”) services, devices and techniques may be developed that may render obsolete the INVOcell.  Competition in the areas of infertility 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 continual change.  New health care providers and medical technology companies entering the market may reduce our market share, patient volume and growth rates.  Additionally, increased competitive pressures may require usdelisting. We would then be entitled to commit more resourcesappeal that determination to our marketing efforts, thereby increasing our cost structure and affecting our profitability.a Nasdaq hearings panel. There can be no assurance that we will be able to compete effectively nor can there be assurance that additional competitors will not enterregain compliance during either compliance period, or maintain compliance with the market,other Nasdaq listing requirements.

Available Information

Our principal executive offices 5582 Broadcast Court Sarasota, Florida 34240 and our telephone number is (978) 878-9505.

Our common stock trades on the Nasdaq Capital Market under the symbol “INVO”.

Our principal Internet address is www.invobio.com. Information contained on, or that can be accessed through, our website, is not, and shall not be deemed to be, incorporated in this prospectus supplement or considered a part thereof. We make available free of charge on www.invobio.com our annual, quarterly and current reports, and amendments to those reports, as soon as reasonably practicable after we electronically file such competitionmaterial with, or furnish it to, the SEC. The SEC maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC at www.sec.gov.

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ABOUT THIS OFFERING

This prospectus relates to the offer and resale by the Selling Stockholders of up to 6,241,493 shares of restricted Common Stock and Common Stock issuable upon the exercise of the Warrants and conversion of the Debentures. All of the Warrant Shares and Conversion Shares, if and when sold, will not make it more difficult for usbe sold by the Selling Stockholders. The Selling Stockholders may sell the Warrant Shares and Conversion Shares from time to enter into additional contracts with fertility clinics.

time at prevailing market prices or at privately negotiated prices.

Shares offered by the Selling Stockholders:

Up to 6,241,493 shares of Common Stock consisting of: (i) 5,520,00 shares of Common Stock issuable upon exercise of the March 2023 Warrants: (ii) 195,721 shares of Common Stock upon conversion of the Debentures; (iii) 178,572 shares of Common Stock issuable upon exercise of the February 2023 Warrants; (iv) 50,000 shares of Common Stock issued as a commitment fee under the February 2023 Purchase Agreement; (v) 150,000 shares of Common Stock issued as a commitment fee under the February 2023 Equity Purchase Agreement and (vi) 147,200 shares of Common Stock issuable upon exercise of the Placement Agent Warrants.

Shares of Common Stock outstanding after completion of this offering (assuming full exercise of the Warrants that are exercisable for the Warrant Shares offered hereby and full conversion of the Debenture):

22,579,0731
Use of proceeds:

We will not receive any proceeds from any sale of the Warrant Shares or Conversion Shares by the Selling Stockholders. We will receive proceeds in the event that any of the Warrants are exercised at the exercise prices per share for cash which would result in gross proceeds of approximately $3.7 million. Any proceeds that we receive from the exercise of the Warrants will be used for working capital, capital expenditures, product development, and other general corporate purposes, including investments in sales and marketing in the United States and internationally. See “Use of Proceeds.”

Risk factors:

An investment in the shares of Common Stock offered under this prospectus is highly speculative and involves substantial risk. Please carefully consider the “Risk Factors” section on page 9, other information in this prospectus and in the documents incorporated by reference herein for a discussion of risks. Additional risks and uncertainties not presently known to us or that we currently deem to be immaterial may also impair our business and operations

Nasdaq symbol:INVO

 
We need

1 The number of shares of our Common Stock outstanding after completion of this offering is based on 16,537,580 shares of Common Stock outstanding as of June 23, 2023 and excludes the following as of such date: (a) up to manage growthan aggregate of 729,213 shares of common stock issuable upon exercise of outstanding warrants not being registered in operationsthis prospectus; (b) up to maximize our potential growth.an aggregate of 896,632 shares of common stock issuable upon exercise of outstanding convertible notes not being registered in this prospectus; and (c) an aggregate of 2,477,932 shares of common stock reserved for future issuance under the 2019 Stock Option Plan.

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In order

RISK FACTORS

An investment in the securities offered under this prospectus involves a high degree of risk. You should carefully consider and evaluate all of the information contained in this prospectus and in the documents that we incorporate by reference herein before you decide to maximize potential growthinvest in our currentsecurities. In particular, you should carefully consider and potential markets, we believe that we must expandevaluate the scope of our servicesrisks and uncertainties described under the heading “Risk Factors” in this prospectus and in the bioscience industry.  This expansion will place a significant strain on our management and our operational and sales systems.  We expectdocuments incorporated by reference herein. Investors are further advised that we will need to continue to improve our INVO 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 the revenues we expect.


Our internal growth strategyrisks described below may not be successful whichthe only risks we face. Additional risks that we do not yet know of, or that we currently think are immaterial, may resultalso negatively impact our business operations or financial results. Any of the risks and uncertainties set forth in a negative impact onthis prospectus and in the documents incorporated by reference herein, as updated by annual, quarterly and other reports and documents that we file with the SEC and incorporate by reference into this prospectus, could materially and adversely affect our growth, financial condition,business, results of operations and cash flow.

Onefinancial condition, which in turn could materially and adversely affect the value of our strategies issecurities.

Risks Related to grow internally through increasing the customers we target.  However, many obstacles to this expansion exist, including, but not limited to, increased competition from similar businesses, unexpected costs, costs associated with marketing efforts and maintaining a strong client base.  Therefore, we cannot assure you that we will be able to successfully overcome such obstacles and establish our services in any additional markets.  Proposed Acquisition of the Wisconsin Fertility Institute

Our inability to implement this internal growth strategy successfully may have a negative impact on our growth, future financial condition, resultspotential acquisition of operations 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 four patents, there can be no assurance that any of these patents will not be challenged, invalidated or circumvented, or that any rights granted under these patents will in fact provide competitive advantages to us.  The United States, European Union and other jurisdictions could place restrictions on the patentability of medical devices. Any limitations on the patentability of medical devices may materially adversely affect our business.  We utilize a combination of trade secrets, confidentiality policies, non-disclosure and other contractual arrangements in addition to relying on patent, copyright and trademark laws to protect our intellectual property rights.  However, these measuresWisconsin Fertility Institute may not be adequateclose.

On March 16, 2023, we signed definitive acquisition agreement to prevent or deter infringement or other misappropriation.  Moreover, we may not be ableacquire the Wisconsin Fertility Clinic (“WFI”). This transaction is subject to detect unauthorized use or take appropriate and timely steps to establish and enforce our proprietary rights.  In fact, existing laws of some countries in which we conduct business or intend to conduct business offer only limited protection of our intellectual property rights, if at all.  As the number of market entrantscertain 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 complexityinitial closing payment which may impact our ability to close the transaction. In the event that we are unable to consummate our acquisition of the technology increases, the possibility of functional overlap and inadvertent infringement of intellectual property rights also increases.  Our limited capital resources could put us at a disadvantage if we are required to take legal action to enforce our intellectual property rights.

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We must defend our intellectual property rights from infringement through extensive legal action.

Third parties may assert in the future claims against us alleging that we infringe their intellectual property rights.  Defending such claims may be expensive, time consuming and divert the efforts of our management and/or technical personnel.   As a   result of litigation, we could be required to pay damages and other compensation, develop non-infringing products or enter   into royalty or licensing agreements.  However, we cannot be certain that any such licenses, if available at all,Wisconsin Fertility Institute, it will be available to us on commercially reasonable terms.
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 claims of tort injury claims.  We do not engage in the practice of medicine or assume responsibility for compliance with regulatory requirements directly applicable to physicians.  Although we currently maintain product liability insurance that we believe is adequate as to risk and amount, successful claims could exceed the limits of our insurance and could have a material adverse effect on our business, financial condition or operating results.  Moreover, there canand results of operation.

We may not be no assuranceable to successfully integrate the Wisconsin Fertility Institute into INVO Bioscience and achieve the benefits expected to result from the acquisition.

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

We cannot assure you that we will besuccessfully integrate or profitably manage WFI’s business. Even if we are able to obtain such insurance on commercially reasonable terms inintegrate and profitably manage WFI’s business, we cannot assure you that, following the futuretransaction, 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 such insurance will provide adequate coverage against potential claims.  In addition, a claim asserted against us could be costly to defend, could consume management resources and could adversely affectfuture period.

If we close our reputation and business, regardlessacquisition of the merit or eventual outcomeWisconsin Fertility Institute and fail to make the required $7.5 million in additional payments, our business would be adversely affected.

Following closing of such claim.


Thereour pending acquisition of the Wisconsin Fertility Institute, if consummated, we would be required to make additional payments of approximately $7.5 million, which payments are inherent risks specificsecured the sellers having a lien on the assets purchased to acquire Wisconsin Fertility Institute. If we default on our additional payment obligations to the provision of infertility and ART services.  For example, the long-term effects on womensellers of the administration of fertility medication, integralWisconsin Fertility Institute, such sellers could exercise their rights and remedies under acquisition agreements, which could include seizing the assets sold to most infertility and ART services, are of concernus to certain physicians and others who fearacquire the medication may prove to be carcinogenic or cause other medical problems.  Currently, fertility medication is critical to most infertility and ART services and a ban by the FDA or foreign regulatory or other limitation on its useWisconsin Fertility Institute. Any such action would have a material adverse effect on our business.

business and prospects.

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.

In order to finance our proposed acquisition of the Wisconsin Fertility Institute, 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 any such debt obligation and fail to maintain adequate quality standards for our products, our business maypay such debt obligations in a timely fashion, we would be adversely affectedin default under such debt financing agreement and our reputation harmed.

Our customers are expecting that our products will perform as we claim.  Our manufacturing companiessuch lender could exercise its rights and packaging processes will be relied up on heavily.  A failure to sustain the specified quality requirementsremedies under such debt financing agreements, which could result in the loss of demand for our products.  Delays or quality lapses in our outsourced production lines could result in substantial economic losses to us.  Although we believe that our continued focus on quality throughout the Company adequately addresses these risks, there can be no assurance that we will not experience occasional or systemic quality lapses in our outsourced manufacturing and service operations.  We have limited manufacturing capabilities, and if our manufacturing capabilities are insufficient to produce an adequate supply of products at appropriate quality levels, our growth could be limited and our business could be harmed.  If we experience significant or prolonged quality problems, 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 depend on our key management personnel and the loss of their services could adversely affect our business.

We place substantial reliance upon the efforts and abilitiesinclude seizing all of our executive officers, Kathleen Karloff and Claude Ranoux.  The loss of the services of our executive officers couldassets. Any such action would have a material adverse effect on our business operations, revenuesand prospects.

Risks Related to Our Need for Additional Capital

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

We do not maintain key man life insurance on the lives of these individuals.

Currency exchange fluctuations may affect the results ofexpect that our operations.

We intend to distribute our INVOcell product throughout the world.  We intend to transact our international sales in U.S. dollars, and European, Latin American and Asian currencies.  Our results of operations thuscurrent cash position will be affected by fluctuations in currency exchange rates.  Although we may insufficient to fund our current operations for the future enter into foreign currency exchange forward contracts from time to time to reduce our risk related to currency exchange fluctuation, our results of operations might still be impacted by foreign currency exchange rates.  Becausenext 12 months and we do not anticipate that we will hedge against allhave sufficient funds to consummate our acquisition of our foreign currency exposure, our business will continue to be susceptible to foreign currency fluctuations.

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

the Wisconsin Fertility Institute. Our business is subject to risks in connection with changes in international, national and local economic and market conditions because of global developments.  Beyond the risks of doing business internationally, there is also the potential impact of changes in the international, national and local economic and market conditionsoperating plan may change as a result of global developments, includingmany 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 effects of global financial crisis, effects of terrorist acts and war on terrorism, U.S. and Canadian presence in Iraq and Afghanistan, potential conflictcurrent economic environment may present additional challenges. Even if we believe we have sufficient funds for our current or crisis in North Koreafuture operating plans, we may seek additional capital if market conditions are favorable or Middle East and current global credit crisis, negatively affecting infertile couples’if we have specific strategic considerations.

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Any additional fundraising efforts may divert our management from their day-to-day activities, which may adversely affect our ability to pay for fertility treatment arounddevelop 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 world.

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International sales are expected to account for a significant partany financing may adversely affect the holdings or the rights of our revenue especiallystockholders 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 the ensuing period beforeincreased fixed payment obligations and we obtain FDA clearance, if ever.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 will experience additional risks associatedcould also be required to seek funds through arrangements with these sales including:
• political and economic instability;
• export controls;
• changes in legal and regulatory requirements;
• United States and foreign government policy changes affecting the markets for our products; and
• changes in tax laws and tariffs.
Anycollaborative partners or otherwise at an earlier stage than otherwise would be desirable and we may be required to relinquish rights to some of these factors couldour 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 of operations and financial condition.  We sell our products in certain international markets mainly through independent distributors.  If a distributor fails to meet annual sales goals, it may be difficult and costly to locate an acceptable substitute distributor.  If a change in our distributors becomes necessary, we may experience increased costs, as well as a substantial disruption in operations and a resulting loss of revenue.

We are subject to significant regulation by the government and other regulatory authorities.

Our business is heavily regulated in the United States and internationally.  In addition to the FDA, various other federal, state and local regulations also apply.  If we fail to comply with FDA or other regulatory requirements, we could be subjected to civil and criminal penalties, or even required to suspend or cease operations.  Any such actions could severely curtail our sales.   In addition, more restrictive laws, regulations or interpretations could be adopted, which could make compliance more difficult or expensive or otherwise adversely affect our business.  We devote substantial resources to complying with laws and regulations; however, the possibility cannot be eliminated that interpretations of existing laws and regulations will result in findings that we have not complied with significant existing regulations.  Such a finding could materially harm our business.   Moreover, healthcare reform is continually under consideration by regulators, and we do not know how laws and regulations will change in the future.

Changes in the healthcare industry may require us to decrease the selling price for our products or could result in a reduction in the size of the market for our products, each of which could have a negative impact on our financial performance.
Trends in managed care, healthcare cost containment and other changes in government and private sector initiatives in the U.S. and other countries in which we do business could place increased emphasis on the delivery of more cost-effective medical therapies, which could work in our favor unless more cost-effective devices become available, which could adversely affect the sale and/or the prices of our products.  There are proposed and existing laws and regulations in domestic and international markets regulating pricing and profitability of companies in the healthcare industry.  There have been initiatives by third-party payers to challenge the prices charged for medical products, which could affect our ability to sell products on a competitive basis in the future.  There has been a consolidation among healthcare facilities and purchasers of medical devices in the U.S. who prefer to limit the number of suppliers from whom they purchase medical products, and these entities may decide to stop purchasing our products or demand discounts on our prices.  Both the pressure to reduce prices for our products in response to these trends and the decrease in the size of the market because of these trends could adversely affect our levels of revenues and profitability of sales, which could have a material adverse effect on our business.
We are subject to the reporting requirements of U.S. federal securities laws, which can be expensive.

We are subject to the information and reporting requirements of the Exchange Act and other federal securities laws, including compliance with the Sarbanes-Oxley Act.  The costs of preparing and filing annual and quarterly reports, proxy statements and other information with the SEC and furnishing audited financial statements to stockholders will cause our expenses to be higher than they would be if we had remained privately-held.  In addition, it may be time consuming, difficult and costly for us to develop and implement the internal controls and reporting procedures required by the Sarbanes-Oxley Act.   We may need to hire additional financial reporting, internal controls and other finance personnel in order to develop and implement appropriate internal controls and reporting procedures.  prospects.

If we are unable to comply withobtain 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 internal controls requirementspast 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 the Sarbanes-Oxley Act,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 obtainsecure financing on terms attractive to us, or at all. If we are able to consummate a financing arrangement, the independent accountant certifications required by the Sarbanes-Oxley Act.


Public company complianceamount raised may make it more difficultnot be sufficient to attractmeet 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 retain officers and directors.

The Sarbanes-Oxley Act and new rules subsequently implemented by the SEC have required changes in corporate governance practices of public companies.  As a public entity, we expect these rules and regulations to increase compliance costs and to make certain activities more time consuming and costly.  As a public entity, we also expect that these new rules and regulations may make it more difficult and expensive for us to obtain director and officer liability insurance in the future and it mayour continued viability will 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 persons to serve as directors or as executive officers.
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materially adversely affected.

Risks Related to the REFResale of the Warrant Shares and Conversion Shares and Ownership of Shares of our common stock


WeCommon Stock

The Selling Stockholders may choose to sell the Warrant Shares and the Conversion Shares at prices below the current market price.

The Selling Stockholders are registering an aggregatenot restricted as to the prices at which they may sell or otherwise dispose of 8,790,000the Warrant Shares and Conversion Shares covered by this prospectus. Sales or other dispositions of the Warrant Shares and Conversion Shares below the then-current market prices could adversely affect the market price of our Common Stock.

A large number of shares of common stock toCommon Stock may be issued undersold in the REF. The sale of such shares couldmarket following this offering, which may significantly depress the market price of our common stock.

We are registering an aggregateCommon Stock.

The Warrant Shares and Conversion Shares sold in the offering will be freely tradable without restriction or further registration under the Securities Act. As a result, a substantial number of 8,790,000 shares of common stock under the registration statement of which this prospectus forms a part for issuance pursuant to the REF. The sale of these shares intoCommon Stock may be sold in the public market by AGS could depressfollowing this offering. If there are significantly more shares of Common Stock offered for sale than buyers are willing to purchase, then the market price of our common stock.  As of September 30, 2009, there were 55,247,833 shares of our common stock issued and outstanding.


Assuming we are ableCommon Stock may decline to utilize the maximum amount available under the REF, existing shareholders could experience substantial dilution upon the issuance of common stock.
Our REF contemplates the potential future issuance and sale of up to $10 million of our common stock to AGS subject to certain conditions and limitations. The following table is an example of the number of shares that could be issued at various prices assuming we utilize the maximum amount available under the REF. These examples assume issuances at a market price at which buyers are willing to purchase the offered Common Stock and sellers remain willing to sell Common Stock.

Neither we nor the Selling Stockholders have authorized any other party to provide you with information concerning us or this offering.

You should carefully evaluate all of $0.33 per sharethe information in this prospectus, including the documents incorporated by reference herein and at 5%,10%, 25%therein. We may receive media coverage regarding our Company, including coverage that is not directly attributable to statements made by our officers, that incorrectly reports on statements made by our officers or employees, or that is misleading as a result of omitting information provided by us, our officers or employees. Neither we nor the Selling Stockholders have authorized any other party to provide you with information concerning us or this offering, and 50% below  the discounted $0.30 per share. The following tablerecipients should be read in conjunction with the footnotes immediately following the table.

              
Percent below market price as of 12/11/09
  
Price per share (1)
  
Number of shares issuable (2)
  
Shares outstanding  (3)
  
Percent of
outstanding shares (4)
 
 5%  .288   34,671,659   92,674,422   37%
 10%  .273   36,597,863   94,600,626   39%
 25%  .228   43,917,435   101,920,198   43%
 50%  .152   65,876,153   123,878,916   53%
not rely on this information.

(1)Represents purchase prices equal to 92% of $0.33 and potential reductions thereof of 5%, 10%, 25% and 50%.
(2)Represents the number of shares issuable if the entire $10 million under the REF were drawn down at the indicated purchase prices.
(3)Based on 58,002,763 shares of common stock outstanding at December 11, 2009.
(4)Percentage of the total outstanding shares of common stock after the issuance of the shares indicated, without considering any contractual restriction on the number of shares the selling shareholder may own at any point in time or other restrictions on the number of shares we may issue.10

We may not have access to the full amount under the REF.


The REF provides that the dollar value that we will be permitted to raise from AGS (subject to the conditions and limitations described elsewhere in this prospectus) for each draw down will be 100% of the average daily volume on the OTC Bulletin Board for the five trading days prior to the notice of Advance, multiplied by the average of the five-day VWAP subsequent to the date of our election to sell shares to AGS.  During the nine months ended September 30, 2009, the average market price of our common stock was $0.64 and the average trading volume per day was 127,000. There is no assurance that the market price and/or trading volume of our common stock will be maintained or will increase substantially in the near future.  Assuming we will maintain the market price of our common stock at $0.33, after the 8% discount we will need to issue 32,938,076 shares of common stock to AGS in order to have access to the full amount under the REF.
AGS will pay less than the then-prevailing market price for our common stock.

The common stock to be issued to AGS pursuant to the REF will be purchased at an 8% discount to the VWAP of the common stock during the five consecutive trading days immediately following the date of our notice to AGS of our election to sell shares pursuant to the REF. AGS has a financial incentive to sell our common stock immediately upon receiving the shares to realize the profit equal to the difference between the discounted price and the market price. If AGS sells the shares, the price of our common stock could decrease. If our stock price decreases, AGS may have a further incentive to sell the shares of our common stock that it holds. These sales may put further downward pressure on our stock price.

Our shares of common stock are very 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 ("IVOB”), which permits our shares to be quoted on the OTC Bulletin Board, which is a quotation medium for subscribing members, not an issuer listing service.  However, our shares of common stock are very thinly traded, and 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 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 assurances that there will be any awareness generated.  Consequently, investors may not be able to liquidate their investment or liquidate it at a price that reflects the value of the business.  If a more active market should develop, the price may be highly volatile.  Because there may be a low price for our shares of common stock, many brokerage firms may not be willing to effect transactions in our 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.  Further, many lending institutions will not permit the use of such shares of common stock as collateral for any loans.
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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.  Such patterns include:
o  control of the market for the security by one or a few broker-dealers;
o  manipulation of prices through prearranged matching of purchases and sales and false and misleading statements made by parties unrelated to the issuer;
o  “boiler room" practices involving high pressure sales tactics and unrealistic price projections by inexperienced sales persons;
o  excessive and undisclosed bid-ask differentials and markups by selling broker-dealers; and
o  wholesale dumping of the same securities by promoters and broker-dealers after prices have been manipulated to a desired level, along with the inevitable collapse of those prices with consequent investor losses.
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.

Our controlling stockholders may take actions that conflict with your interests.

Certain of our officers and directors beneficially own approximately 54.1% of our outstanding common stock as of the date hereof.  Our officers and directors will be able to exercise control over all matters requiring stockholder approval, including the election of directors, amendment of our certificate of incorporation and approval of significant corporate transactions, and they will have significant control over our management and policies.  The directors elected by these stockholders will be able to influence decisions affecting our capital structure significantly.  This control may have the effect of delaying or preventing changes in control or changes in management, or limiting the ability of our other stockholders to approve transactions that they may deem to be in their best interest.  For example, our controlling stockholders will be able to control the sale or other disposition of our operating businesses and subsidiaries to another entity.
The market price for our common stock is particularly volatile given our status as a relatively unknown company with a small and thinly traded public float, limited operating history and lack of revenues,profits, which could lead to wide fluctuations in our share price.  The price at which you purchase our common stock may not be indicative of the price that will prevail in the trading market.

The market for our common stock is characterized by significant price volatility when compared to seasoned issuers,the shares of larger, more established companies that have large public floats, and we expect that our share price will continue to be more volatile than a seasoned issuerthe shares of such larger, more established companies for the indefinite future.  In fact,future, although such fluctuations may not reflect a material change to our financial condition or operations during the period from January 1, 2009 until September 30, 2009, the high and low sale prices of a share of our common stock were $0.05 and $5.50, respectively. Theany such period. Such volatility in our share price iscan be attributable to a number of factors. First, as noted above, our common stock is, compared to the shares of our common stock aresuch larger, more established companies, sporadically and/orand thinly traded.  As a consequence of this lack of liquidity, the trading of relatively small quantities of shares by our shareholders may disproportionately influence the price of those shares in either direction. The price for our sharescommon stock could, for example, decline precipitously in the event that a large number of shares of our common stockshares are sold on the market without commensurate demand, as compared to a seasoned issuer which could better absorb those sales without adverse impact on its share price.


demand. Secondly, we are a speculative or “risky” investment due to our limited operating history and lack of meaningful revenues and profits to date, and uncertainty of future market acceptance for our products and services.date. As a consequence of this enhanced risk, more risk-adverse investors may, under the fear of losing all or most of their investment in the event of negative news or lack of progress, be more inclined to sell their shares on the market more quickly and at greater discounts than would be the case with the stock of a seasoned issuer.

You may be unable to sell your common stock at or above your purchase price, which may result in substantial losses to you.

The following factors may add to the volatility in the price of our common stock: uncertainty regarding the amount and price of sales of our common stock to AGS under the REF; actual or anticipated variations in our quarterly or annual operating results; government regulations, announcements of significant acquisitions, strategic partnerships or joint ventures; our capital commitments; and additions or departures of our key personnel.larger, more established company that has a large public float. Many of these factors are beyond our control and may decrease the market price of our common stock regardless of our operating performance.

In addition to being highly volatile, our common stock could be subject to wide fluctuations in response to a number of factors that are beyond our control, including, but not limited to:

●variations in our revenues and operating expenses;
●

actual or anticipated changes in the estimates of our operating results or changes in stock market analyst recommendations regarding our common stock, other comparable companies or our industry generally;

●market conditions in our industry, the industries of our customers and the economy as a whole;
●actual or expected changes in our growth rates or our competitors’ growth rates;
●developments in the financial markets and worldwide or regional economies;
●announcements of innovations or new products or services by us or our competitors;
●announcements by the government relating to regulations that govern our industry;
●sales of our common stock or other securities by us or in the open market;
●changes in the market valuations of other comparable companies; and
●

other events or factors, many of which are beyond our control, including those resulting from such events, or the prospect of such events, including war, terrorism and other international conflicts, public health issues including health epidemics or pandemics, such as the COVID-19 pandemic, and natural disasters such as fire, hurricanes, earthquakes, tornados or other adverse weather and climate conditions, whether occurring in the United States or elsewhere, could disrupt our operations, disrupt the operations of our suppliers or result in political or economic instability.

In addition, if the market for healthcare stocks or the stock market in general experiences loss of investor confidence, the trading price of our common stock could decline for reasons unrelated to our business, financial condition or operating results. The trading price of our shares might also decline in reaction to events that affect other companies in our industry, even if these events do not directly affect us. Each of these factors, among others, could harm the value of our common stock. In the past, following periods of volatility in the market, securities class-action litigation has often been instituted against companies. Such litigation, if instituted against us, could result in substantial costs and diversion of management’s attention and resources, which could materially and adversely affect our business, operating results and financial condition.

We cannot makehave 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.

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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 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 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.

On May 23, 2023, we were notified by the Listing Qualifications department (the “Staff”) of Nasdaq that, based upon the Company’s non-compliance with the $2.5 million stockholders’ equity requirement for continued listing on The Nasdaq Global Market, as set forth in Nasdaq Listing Rule 5550(b)(1) (the “Rule”), as of May 22, 2023, the Company’s common stock was subject to delisting from Nasdaq unless the Company timely requests a hearing before the Nasdaq Hearings Panel (the “Panel”).

We have requested a hearing before the Panel, which stays any predictionsfurther action by Nasdaq at least until the hearing process concludes and any extension that may be granted by the Panel has expired. At the hearing, we will present a plan to regain compliance with the Rule and request the continued listing of its common stock pending the Company’s compliance with the Rule. There can be no assurances however that the Panel will hear our request or projectionsthat we will be able to evidence compliance with all applicable Nasdaq listing criteria within any extension of time that may be granted by the Panel.

As previously disclosed, the Staff granted the Company an extension to evidence compliance with the Rule through May 22, 2023. We were unable to do so, which resulted in the issuance of the Staff’s determination.

In addition, 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).

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 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 whatcomply with either the prevailingStockholders’ 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 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, willand it would likely be at any time, including asmore difficult to whetherobtain coverage by securities analysts and the news media, which could cause the price of our common stock will sustain itsto decline further. Also, it may be difficult for us to raise additional capital if we are not listed on a national exchange.

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In the event that our Common Stock is delisted from Nasdaq, U.S. broker-dealers may be discouraged from effecting transactions in shares of our Common Stock because they may be considered penny stocks and thus be subject to the penny stock rules.

The SEC has adopted a number of rules to regulate “penny stock” that restricts transactions involving stock which is deemed to be penny stock. Such rules include Rules 3a51-l, 15g-l, 15g-2, 15g-3, 15g-4, 15g-5, 15g-6, 15g-7, and 15g-9 under the Exchange Act. These rules may have the effect of reducing the liquidity of penny stocks. “Penny stocks” generally are equity securities with a price of less than $5.00 per share (other than securities registered on certain national securities exchanges or quoted on Nasdaq if current price and volume information with respect to transactions in such securities is provided by the exchange or system). Our shares have in the past constituted, and may again in the future constitute, “penny stock” within the meaning of the rules. The additional sales practice and disclosure requirements imposed upon U.S. broker-dealers for sales of penny stocks may discourage such broker-dealers from effecting transactions in shares of our Common Stock, which could severely limit the market price,liquidity of such shares and impede their sale in the secondary market.

A U.S. broker-dealer selling penny stock to anyone other than an established customer or as“accredited investor” (generally, an individual with a net worth in excess of $1,000,000 or an annual income exceeding $200,000, or $300,000 together with his or her spouse) must make a special suitability determination for the purchaser and must receive the purchaser’s written consent to what effect that the transaction prior to sale, of sharesunless the broker-dealer or the availabilitytransaction is otherwise exempt. In addition, the “penny stock” regulations require the U.S. broker-dealer to deliver, prior to any transaction involving a “penny stock”, a disclosure schedule prepared in accordance with SEC standards relating to the “penny stock” market, unless the broker-dealer or the transaction is otherwise exempt. A U.S. broker-dealer is also required to disclose commissions payable to the U.S. broker-dealer and the registered representative and current quotations for the securities. Finally, a U.S. broker-dealer is required to submit monthly statements disclosing recent price information with respect to the “penny stock” held in a customer’s account and information with respect to the limited market in “penny stocks”.

Stockholders should be aware that, according to the SEC, the market for “penny stocks” has suffered in recent years from patterns of fraud and abuse. Such patterns include: (i) control of the market for the security by one or a few broker-dealers that are often related to the promoter or issuer; (ii) manipulation of prices through prearranged matching of purchases and sales and false and misleading press releases; (iii) “boiler room” practices involving high-pressure sales tactics and unrealistic price projections by inexperienced sales persons; (iv) excessive and undisclosed bid-ask differentials and markups by selling broker-dealers; and (v) the wholesale dumping of the same securities by promoters and broker-dealers after prices have been manipulated to a desired level, resulting in investor losses. Our management is aware of the abuses that have occurred historically in the penny stock market. Although we do not expect to be in a position to dictate the behavior of the market or of broker-dealers who participate in the market, management will strive within the confines of practical limitations to prevent the described patterns from being established with respect to our securities.

You may experience future dilution as a result of future equity offerings and other issuances of our common stock for sale at any time will have on the prevailing market price.

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Shares eligible for future sale by our current shareholderscommon stock or other securities may adversely affect our common stock price.

To date,

In order to raise additional capital, we have had a limited trading volumemay in the future offer additional shares of our common stock.  As longstock or other securities convertible into or exchangeable for our common stock at prices that may not be the same as the price per share in this condition continues,offering. We may not be able to sell shares or other securities in any other offering at a price per share that is equal to or greater than the saleprice per share paid by the investor in this offering, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders. The price per share at which we sell additional shares of a significant numberour common stock or securities convertible into common stock in future transactions may be higher or lower than the price per share in this offering. You will incur dilution upon exercise of any outstanding stock options, warrants or upon the issuance of shares of common stock at any particular time could be difficult to achieve at the market prices prevailing immediately before such shares are offered.under our stock incentive programs. In addition, the sale of shares in this offering and any future sales of a substantial amountsnumber of shares of our common stock including shares issued uponin the exercise of outstanding options and warrants, under SEC Rule 144public market, or otherwisethe perception that such sales may occur, could adversely affect the price of our common stock. We cannot predict the effect, if any, that market sales of those shares of common stock or the availability of those shares for sale will have on the market price of our common stock.

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Future sales, or the perception of future sales, by us or our stockholders in the public market could cause the market price of our common stock to decline, and any issuance of additional common stock, or securities convertible into common stock, could dilute common stockholders. We may issue additional common stock, or securities convertible into common stock, pursuant to our shelf registration statement (including our at-the-market facility), upon exercise of outstanding warrants, for additional financing purposes, in connection with strategic transactions such as acquisitions or collaboration agreements, or otherwise, any of which could result in dilution to existing stockholders.

The sale of shares of our common stock in the public market, or the perception that such sales could occur, could harm the prevailing market price of shares of our common stock. These sales, or the possibility that these sales may occur, also might make it more difficult for us to sell equity securities in the future at a time and at a price that we deem appropriate.

Shares of our common stock held by certain other of our stockholders are eligible for resale, subject to volume, manner of sale and other limitations under Rule 144 under the Securities Act (“Rule 144”). By exercising their registration rights and selling a large number of shares, these stockholders could cause the prevailing market price of our common stock to decline.

As restrictions on resale end or if these stockholders exercise their registration rights, the market price of shares of our common stock could drop significantly if the holders of these shares sell them or are perceived by the market as intending to sell them. These factors could also make it more difficult for us to raise additional funds through future offerings of shares of our common stock or other securities.

In addition, the shares of our common stock reserved for future issuance under our equity incentive plans will become eligible for sale in the public market once those shares are issued, subject to provisions relating to various vesting agreements, lock-up agreements and, in some cases, limitations on volume and manner of sale applicable to affiliates under Rule 144, as applicable. We have filed registration statements on Form S-8 under the Securities Act to register shares of our common stock issuable pursuant to our equity incentive plan and our employee stock purchase plan and may in the future file one or more additional registration statements on FormS-8 for the same or similar purposes. Any such Form S-8 registration statements will automatically become effective upon filing. Accordingly, shares registered under such registration statements will be available for sale in the open market.

Substantial future sales of shares of our common stock could cause the market price of our common stock to decline.

We expect that significant additional capital will be needed in the near future to continue our planned operations. Sales of a substantial number of shares of our common stock in the public market, or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital at that time through the sale of additional equity securities. We are unable to predict the effect that such sales may have on the prevailing market price of our securities.  On December 11, 2009, approximately 39,500,000 sharesshares.

We have financed our operations, and we expect to continue to finance our operations, acquisitions, if any, and the development of strategic relationships by issuing equity, warrants and/or convertible securities, which could significantly reduce the percentage ownership of our existing stockholders. Further, any additional financing that we secure may require the granting of rights, preferences or privileges senior to, or pari passu with, those of our common stock. Additionally, we may finance strategic alliances and/or acquisitions by issuing our equity or equity-linked securities, which may result in additional dilution. Any issuances by us of equity securities may be at or below the prevailing market price of our common stock became subjectand in any event may have a dilutive impact on your ownership interest, which could cause the market price of our common stock to resale under Rule 144decline. We may also raise additional funds through the incurrence of debt or the issuance or sale of other securities or instruments senior to our shares of common stock. The holders of any securities or instruments we may issue may have rights superior to the rights of our holders of our common stock. If we experience dilution from issuance of additional securities and we grant superior rights to new securities over common stockholders, it may negatively impact the trading price of our shares of common stock.

We will have broad discretion as to the proceeds that we receive from the cash exercise by any holder of the Warrants, and we may not use the proceeds effectively.

We will not receive any of the proceeds from the sale of the Warrant Shares by the Selling Stockholders pursuant to this prospectus. We may receive up to approximate $3.6 million in aggregate gross proceeds from cash exercises of the Warrants, based on the per share exercise price of the Warrants, and to the extent that we receive such proceeds, we intend to use the net proceeds from cash exercises of the Warrants for working capital, capital expenditures, product development, and other general corporate purposes, including investments in sales and marketing in the United States and internationally. We have considerable discretion in the application of the such proceeds. You will not have the opportunity, as part of your investment decision, to assess whether such proceeds are being used in a manner agreeable to you. You must rely on our judgment regarding the application of the net proceeds from cash exercises of the Warrants, which may be used for corporate purposes that do not improve our profitability or increase the price of our shares of Common Stock. Such proceeds may also be placed in investments that do not produce income or that lose value. The failure to use such funds by us effectively could have a material adverse effect on our business, financial condition, operating results and cash flow.

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You may experience future dilution as a result of the expirationissuance of the one-year period followingWarrant Shares and Conversion Shares, future equity offerings by us and other issuances of our filingCommon Stock or other securities. In addition, the issuance of the From 8-K reportingWarrant Shares and Conversion Shares and future equity offerings and other issuances of our Common Stock or other securities may adversely affect our Common Stock price.

In order to raise additional capital, we may in the future offer additional shares of our Common Stock or other securities convertible into or exchangeable for our Common Stock at prices that may not be the same as the price per share exchange. Salesas prior issuances of Common Stock. We may not be able to sell shares or other securities in any other offering at a price per share that is equal to or greater than the price per share previously paid by investors, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders. The price per share at which we sell additional shares of our Common Stock or securities convertible into Common Stock in future transactions may be higher or lower than the prices per share per share. ln addition, the exercise price of the Warrants for the Warrant Shares may be or greater than the price per share previously paid by certain investors. You will incur dilution upon exercise of any outstanding stock options, warrants or upon the issuance of shares of Common Stock under our stock incentive programs. In addition, the issuance of the Warrant Shares and any future sales of a substantial number of shares of our Common Stock in the public market, or the perception that such sharessales may occur, could adversely affect the price of our stock price.


Common Stock. We entered intocannot predict the REF on October 28, 2009 with AGS. The perceived risk of dilution fromeffect, if any, that market sales of those shares of Common Stock or the availability of those shares for sale will have on the market price of our commonCommon Stock.

We could issue “blank check” preferred stock to or by AGS in connectionwithout stockholder approval with the REF may cause holderseffect of our common stock to selldiluting then current stockholder interests and impairing their shares, or it may encourage short selling by market participants, which could contribute to a declinevoting rights; and provisions in our stock price. The registration rights agreement entered into in connection with the REF requirescharter documents could discourage a takeover that we use commercially reasonable efforts to ensure that the registration statement in connection with the REF remains effective for the termstockholders may consider favorable.

Our Articles of such agreement.  As of the date hereof, we have not drawn down funds and have not issued shares of our common stock under our REF. Our ability to draw down funds and sell shares under the REF requires the continued effectiveness of and the ability to use the registration statement that we filed registering the resale of any shares issuable to AGS under the REF.


Our directors have the right to authorizeIncorporation authorizes the issuance of shares of our“blank check” preferred stock with designations, rights and additional shares of our common stock.

Our directors, within the limitations and restrictions contained in our Articles of Incorporation and without further action by our shareholders, have the authority to issue shares of preferred stockpreferences as may be determined from time to time in one or moreby the Board. The Board is empowered, without stockholder approval, to issue a series and to fix the number of shares and the relative rights, conversion rights, 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 atwith dividend, liquidation, conversion, voting or other rights which could dilute the present time, we continue to seek to raise capital throughinterest of, or impair the salevoting power of, our securities and may issue shares of preferred stock in connection with a particular investment.  Anycommon stockholders. The issuance of sharesa series of preferred stock could adversely affectbe used as a method of discouraging, delaying or preventing a change in control. For example, it would be possible for the Board to issue preferred stock with voting or other rights or preferences that could impede the success of holdersany attempt to change control of our common stock.

Should we issue additionalCompany.

We do not intend to pay dividends on shares of our common stock at a later time, each investor’s ownership interest in our stock would be proportionally reduced.  No investor will have any preemptive right to acquire additional shares of our common stock, or any of our other securities.


If we fail to remain current on our reporting requirements, we could be removed from the OTC Bulletin Board, which would limit the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market.

Companies trading on the OTC Bulletin Board, such as INVO Bioscience, must be reporting issuers under Sections 13 or 15(d) of the Exchange Act, and must be current in their reports under Section 13 of the Exchange Act, in order to maintain price quotation privileges on the OTC Bulletin Board.  If we fail to remain current on our reporting requirements, we could be removed from the OTC Bulletin Board.  As a result, the market liquidity for our securities could be adversely affected by limiting the ability of broker-dealers to sell our securities and the ability of shareholders to sell their securities in the secondary market.

Our common stock is subject to the “penny stock” rules of the SEC, and the trading market in our common stock is limited, which makes transactions in our stock cumbersome and may reduce the investment value of our stock.

Our shares of common stock are “penny stocks” because they are not registered on a national securities exchange or listed on an automated quotation system sponsored by a registered national securities association, pursuant to Rule 3a51-1(a) under the Exchange Act.  For any transaction involving a penny stock, unless exempt, the rules require, among other things:

o  That a broker or dealer approve a person’s account for transactions in penny stocks;
o  That the broker or dealer receives from the investor a written agreement to the transaction, setting forth the identity and quantity of the penny stock to be purchased;
o  The broker or dealer must also deliver, prior to any transaction in a penny stock, a disclosure schedule prescribed by the SEC relating to the penny stock market, which, in highlight form, sets forth the basis on which the broker or dealer made the suitability determination; and

Generally, brokers may be less willing to execute transactions in securities subject to the “penny stock” rules.  This may make it more difficult for investors to dispose of our common stock and cause a decline in the market value of our stock.
Disclosure also has to be made about the risks of investing in penny stocks in both public offerings and in secondary trading and about the commissions payable to both the broker-dealer and the registered representative, current quotationsCommon Stock for the securities and the rights and remedies available to an investor in cases of fraud in penny stock transactions.  Finally, monthly statements have to be sent disclosing recent price information for the penny stock held in the account and information on the limited market in penny stocks.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus includes forward-looking statements.  All statements, other than statements of historical fact, contained in this prospectus constitute forward-looking statements.  In some cases, you can identify forward-looking statements by terms such as “may,” “intend,” “might,” “will,” “should,” “could,” “would,” “expect,” “believe,” “estimate,” “anticipate,” “predict,” “project,” “potential,” or the negative of these terms and similar expressions intended to identify forward-looking statements.
Forward-looking statements are based on assumptions and estimates and are subject to risks and uncertainties.  foreseeable future.

We have identified in this prospectus some of the factors that may cause actual results to differ materially from those expressed or assumed in any of our forward-looking statements.  There may be other factors not so identified.  You should not place undue reliance on our forward-looking statements.  As you read this prospectus, you should understand that these statements are not guarantees of performance or results.  Further, any forward-looking statement speaks only as of the date on which it is made and, except as required by law, we undertake no obligation to update any forward-looking statement to reflect events or circumstances after the date on which it is made or to reflect the occurrence of anticipated events or circumstances.  New factors emerge from time to time that may cause our business not to develop as we expect and it is not possible for us to predict all of them.  Factors that may cause actual results to differ materially from those expressed or implied by our forward-looking statements include, but are not limited to, those described under the heading “Risk Factors” beginning on page 6.

USE OF PROCEEDS
We will not receive any proceeds from the sale of common stock offered by AGS pursuant to this prospectus. However, we will receive proceeds from the sale of our common stock to AGS pursuant to the REF. The proceeds from our rights to sell shares pursuant to the REF will be used for working capital and general corporate expenses.

We propose to expend these proceeds as follows:
  
Proceeds if 100%, or 8,790,000 shares, are sold
At an assumed price of $0.304
  Proceeds if 50% of 8,790,000 shares sold 
Gross proceeds $2,669,000  $1,334,500 
Offering expenses:        
  Legal fees  30,000   30,000 
  Accounting and auditing fees  10,000   10,000 
  State securities fees  2,000   2,000 
  Transfer agent fees  10,000   10,000 
  Broker’s fees  160,100   80,100 
         
  Miscellaneous expenses  5,000   5,000 
Total offering expenses  217,100   137,100 
Net proceeds $2,451,900  $1,197,400 

We expect to use the net proceeds, if any, from sales of our common stock to AGS under the REF for working capital needs, including paying accounts payable, notes payable, inventory, FDA medical device clinical trials, as well as accrued but unpaid salaries of our employees.  The amounts and timing of the expenditures will depend on numerous factors, such as the timing and progress of our clinical trial for FDA approval and the competitive environment. As of the date of this prospectus, we cannot specify with certainty all of the particular uses for the net proceeds to us from the sale of shares to AGS. Accordingly, we will retain broad discretion over the use of proceeds.
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MARKET FOR COMMON EQUITY AND RELATED SHAREHOLDER MATTERS
Our common stock has been traded on the OTC Bulletin Board since February 17, 2009 under the symbol "IVOB".  Prior to that date, our common stock was traded under the symbol of “EMYS” in the public market on the OTC Bulletin Board as well.  The following table sets forth, for the periods indicated, the high and low bid prices for our common stock on the OTC Bulletin Board. The quotations do not reflect adjustments for retail mark-ups, mark-downs, or commissions and may not necessarily reflect actual transactions.
 
 
 Price
  High  Low
2009       
First Quarter $5.50  $0.40 
Second Quarter $1.01  $0.05 
Third Quarter $0.46  $0.08 
On December 11, 2009 the high and low bid prices of our common stock on the OTC Bulletin Board were $0.33 and $0.31 per share, respectively, and there were approximately 98 holders of record of our common stock with 58,002,763 shares issued and outstanding.

To date, we have never declared or paid any cash dividends on shares of our capital stock.  We currentlyCommon Stock and do not intend to retainpay any future earnings for funding growth and therefore, do not expect to pay anycash dividends in the foreseeable future.
CAPITALIZATION
The following table sets forth our capitalization as of September 30, 2009:

·  on an actual basis; and
·  as adjusted to reflect the sale of 8,790,000 shares of common stock offered by this prospectus, at an assumed initial price of $0.304 per share, after deducting estimated offering expenses payable by us.

This information should be read in conjunction with our Management’s Discussion and Analysis or Plan of Operation and our consolidated financial statements and the related notes appearing elsewhere in this prospectus.

We had a net loss of ($4,499,000) for the nine months ended September 30, 2009 and a total net loss of $6,586,000 from January 5, 2007, (inception) through September 30, 2009, included in the accumulated deficit in the table below:
  September 30, 2009   
  Actual  Adjusted   
Capitalization:        
Preferred Stock, $.0001 par value; 100,000,000 shares authorized; no shares issued and outstanding  -   -   
Common Stock, $0.0001 par value; 200,000,000 share authorized; 55,247,833 issued
and outstanding and 66,792,763(1) issued and outstanding as adjusted.
 $2,213,878  $4,665,768  (1) 
Stock subscription receivable  (205,000)  (205,000)  
Accumulated deficit during the development stage  (6,586,312)  (6,586,312)  
 Total Capitalization $(4,577,434) $(2,125,544)  
  (1)  Reflects the sale of the 8,790,000 shares included in this prospectus, at a price of $0.304 per share.
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SELECTED CONSOLIDATED FINANCIAL DATA

The following consolidated selected financial data as of December 31, 2008 and for the years ended December 31, 2008 and 2007 are derived from our consolidated financial statements. The following selected financial data as of September 30, 2009 is derived from unaudited financial statements that, in our opinion, reflect all adjustments (consisting of normal recurring adjustments) necessary for a fair presentation of the financial position as of such date and results of operations for these periods.  Operating results for the nine-month period ended September 30, 2009 are not necessarily indicative of the results that may be expected for the entire year ending December 31, 2009. The data set forth below should be read in conjunction with our financial statements and notes thereto included elsewhere in this prospectus and with “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
  For the Nine  Year  From January 5, 2007 
  Months Ended  Ended  (Inception) to 
  September 30, 2009  December 31, 2008  December 31, 2007 
Revenue:         
Product Revenue $56,298  $37,955  $- 
Cost of Goods Sold:            
Product Costs  30,528   10,088    - 
             
Gross Margin:  25,770   27,907    - 
             
Operating Expenses:            

  Research and development  4,950   51,761   33,350 
  Selling, general and administrative  1,394,592   1,837,606   77,170 
   Total Operating Expenses  1,399,542   1,889,367   210,520 
             
Loss from operations  (1,373,772)  (1,861,460)  (210,520)
             
Other Expenses:            
  Change in fair value of derivative liability
  380,036   -   - 
   Interest and financing expenses  2,745,010   11,945   3,569 
   Total other expenses  3,125,046   11,945   3,569 
             
Loss before income taxes  (4,498,818)  (1,873,405)  (214,089)
             
Provisions for income taxes  -   -   - 
             
Net Loss $(4,498,818) $(1,873,405) $(214,089)
             
Basic and diluted net loss per weighted average shares of common stock $(0.08) $(0.05) $(0.01) 
Basic and diluted Weighted average number of shares of common stock  53,849,481   36,691,176   24,649,031 
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MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion of our financial condition and results of operations should be read in conjunction with the financial statements and the notes to those statements included in this prospectus. This discussion includes forward-looking statements that involve risk and uncertainties. As a result of many factors, such as those set forth in this prospectus under “Risk Factors,” actual results may differ materially from those anticipated in these forward-looking statements.
Overview
We are a development stage company that has recently begun to commercialize our proven and patented technology that we believe will revolutionize the treatment of infertility.  Our device, the INVOcell, and the INVO procedure are designed to provide an alternative infertility treatment for the patient and the clinician; it is less expensive and simpler to perform than current infertility treatments.  The simplicity of the INVO procedure relates to the ability to potentially perform the infertility procedure in a physician’s practice rather than in a specialized facility at a much lower cost overall than current infertility treatments, including in vitro fertilization (“IVF”).  Therefore, we believe that the INVO procedure will be available in many more locations than conventional IVF especially outside the United States.  INVO also allows conception and embryo development to take place inside the woman's body; an attractive feature for most couples.
Our primary focus is the sale of the INVOcell device and the INVO technology to assist infertile couples in having a baby.  Our patented and proven INVOcell technology is an effective low cost alternative to current treatments.  Along with being offered as an option in traditional IVF clinics, the INVO technique may be provided in a physician’s office or a small lab and, therefore, may be offered by physicians around the world to couples who do not have access to IVF facilities.  INVO uses a device, the INVOcell, which we currently sell to distributors around the world (outside of the U.S.) at prices ranging from $75 to $400.  Currently, we are only authorized to sell the INVOcell device in certain international markets. We do not expect to be able to sell the device in the United States until the first quarter of 2011, assuming we receive the necessary capital to complete our clinical trial and receive FDA clearance by such date.  We are establishing agreements with distributors and beginning to train physicians around the world in places such as South America, Europe, Africa and the Middle East.  While we penetrate the infertility markets in Europe and Canada along with certain developing countries, we anticipate pursuing the completion of the U.S. Federal Food and Drug Administration’s (“FDA”) “510(k)” process.  We have completed the first step for medical device companies who manufacture Class 2 devices and the filing of a Premarket Notification with the FDA (i.e., an FDA 510(k) submission).  Technically, the FDA does not “approve” Class 1 and 2 medical devices for sale in the U.S. they give “clearance” for them to be sold.  We are hoping to receive clearance to market in the U.S. by the end of 2010 upon completion of our clinical trial, which we will commence sometime after the start of funding from our REF with AGS Capital Group, LLC.  However, there can be no assurance that we will receive such clearance by that date or ever.
We operate by outsourcing many key operational functions in the development and manufacturing of the INVOcell device to keep fixed costs to a minimum.  Our most critical management and leadership functions are carried out by our core team.  We have contracted out the following functions: manufacturing, packaging/labeling and sterilization of the device to a certified manufacturer to mold the parts; to a medical manufacturing company to assemble packages and label the product and to a sterilization specialist to perform the gamma sterilization process.  This expedites production and eliminates the need for in-house capital equipment expenditures.
We anticipate that we will experience significant quarterly fluctuations in our sales and revenues as a resultretain all of our efforts to expand the sales of the INVO technology to new markets.  Operating results will depend upon and upon the timing of signing of new distributor contracts and the training of physicians and their staffsfuture earnings for use in the INVO procedure.  International sales will continue to be our only sourcedevelopment of revenue for the coming year.  We are aware of many significant international opportunities, and we expect international revenues to continue to grow.  International sales are, however, difficult to forecast.  Subject to having available financial resources, we are committed in our ongoing sales, marketing and development activities to sustain and grow our sales and revenues from our products and services.  
During the last year, we continued to market our products in strategic markets utilizing our limited resources in the most economical fashion possible. We focused our efforts on South America and parts of Europe as we see these as our best opportunities to introduce the INVO procedure to many willing physicians quickly.  During this period, we reduced our travel and planned trips further in advance to benefit from travel discounts, which reduced our travel expenses considerably.  We had a presence at the World Congress of Gynecology and Obstetrics held in Cairo, Egypt in October 2009, as we continued to introduce the INVOcell across new regions of the Middle East and Africa.  This annual meeting is the largest infertility conference of physicians in Northern Africa and was felt to be an essential component in gaining name recognition and traction in this part of the world.
The INVOcell is cleared for use within a particular country by its CE mark, but still must undergo a registration process in certain countries because it is a Class II medical device.  In some countries, the process is relatively quick - approximately three to six weeks - while we have discovered in other countries it may take months.  While we are continuing to tend to the needs of the regional health organizations for registering the INVOcell, INVO Bioscience has continued to actively train physicians and teach distributors in the INVOcell technology.  Physicians have demonstrated that their patients would like to see current success rates within their own geographic and cultural areas and therefore we are assisting them in sponsoring clinical marketing trials. As of September 30, 2009, we have the necessary approvals to sell the INVOcell device in the following countries: Canada, Colombia, Guatemala,Belgium, Greece, Bulgaria, Turkey, Poland, Spain, Switzerland, Cyprus, Pakistan, Cameroon, Nigeria, South Africa and India. We have started the registration process in the following countries as well: Peru, Argentina, Venezuela, Egypt, Russia and Taiwan,
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Because of the registration process and delays to wait for “local results” in certain geographic and cultural areas, along with limited resources to assist in moving things forward in some countries, revenues were significantly less than anticipated for the quarter.  However, we are starting to receive registration notifications as well as receiving favorable initial local results that will be used for regional marketing campaigns.   In addition to these developments, we are continuing to plan sales and training trips actively.  We believe that we will begin increasing revenues in the future; however, our growth is limited by both the registration processes that we must undertake as well as our limited capital resources, and therefore we anticipate that revenues will continue to be lower than originally anticipated for the next few quarters.  The registration process differs from a clinical approval, which the INVOcell has in the form of the CE mark; instead, the process is more akin to a governmental tracking to monitor what products are sold and used within its borders.
Our most significant challenge in growing our business has been our limited resources.  As of September 30, 2009, we generally require approximately $175,000 per monthand for general corporate purposes. Any determination to fund our planned operations.  This amount may increase as we expand our sales and marketing efforts and develop new products and services; however, if we do not raise additional capital in the near future we will have to curtail our spending and downsize our operations.  Our cash needs are primarily attributable to funding our clinical trial, sales and marketing efforts, strengthening our training capabilities, satisfying existing obligations and building an administrative infrastructure, including costs and professional fees associated with being a public company. 
We believe we are taking the necessary steps to provide the capital resources we need to execute our business plan and grow the business as expected, including through the REF with AGS Capital Group, LLC, although no assurances can be made that we will be able to draw down on the REF.  We also seek other sources of capital through private placements of our securities. The exact amount of funds raised, if any, will determine how aggressively we can grow and what additional projects we will be able to undertake, such as initiating the final required FDA clinical trial.  No assurance can be given that we will be able to raise additional capital when needed.  If we are unable to raise additional capital, we will be required to substantially curtail or cease operations.
Our registered independent certified public accountants have stated in their report dated April 15, 2009, filed with the Company’s Annual Report on Form 10-K that we have a generated negative cash outflows from operating activities, experienced recurring net operating losses, and we are dependent on securing additional equity and debt financing to support our business efforts.  These factors among others raise substantial doubt about our ability to continue as a going concern.
Results of Operations
Nine months ended September 30, 2009, compared to the nine months ended September 30, 2008
Net Sales and Revenues
Net sales and revenue for the nine months ending September 30, 2009 were $56,300 compared to no revenue for the same period in 2008.  The increase was due to starting international shipments of small orders to our newly signed distributors as well as direct shipments to physicians who want to use the INVOcell.  We expect this trend to continue as we introduce the INVO technology into our targeted countries over the next few months while continuing to assist our current customer base in the Mid-East and South America. As noted above, our ability to generate revenues is also impacted by our ability to obtain appropriate approvals/registrations in local jurisdictions, as well as our success in raising additional capital to fund sales and marketing efforts.
Cost of Sales and Revenues
Cost of sales as a percentage of revenues for the nine months ended September 30, 2009 was 54%.  This is significantly higher than we expectpay dividends in the future as we are producing small lot quantities and have higher shipping costs per unit as a result ofwill be at the small volume shipments.  There were no sales or costs for the comparative period of 2008 with which to compare our results.  As our products become an accepted method of assisting couples with infertility and subject to raising additional capital, we expect to be manufacturing larger quantitiesdiscretion of our devices,Board. Accordingly, investors must rely on sales of their Common Stock after price appreciation, which inmay never occur, as the only way to realize any future gains on their investments.

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FEBRUARY 2023 CONVERTIBLE DEBENTURE AND WARRANT FINANCING

On February 3, 2023, we expect will reduce our cost of sales.  Further, shipping larger quantities to distributors via common carriers will reduce our shipping costs.  Collectively, we anticipate that eventually these volume discounts would reduce our cost of sales by approximately 50%, or approximately 25% of revenues. 

Selling, General and Administrative Expenses
Selling, general and administrative expenses for the nine months ended September 30, 2009 and 2008 were $1,395,000 and $661,000, respectively.  Our higher general and administrative expenses in 2009 were due to expanding the marketing of our products and technology across the world outside of the United States.  During the initial six months of 2008, we had three senior employees who did not take a salary.  In 2009, we grew to six employees, all earning a salary as well as all the associated expenses that relate to them, including benefits and travel.  Salaries and benefits for the period were $680,000 compared to $375,000 for the same period ending September 30, 2008.  We incurred considerable travel costs as our employees continued to travel internationally to introduce the INVOcell and the INVO process to physicians and distributors in Europe, Mid-East, Asia and South America. Travel related expenses for the nine months ending September 30, 2009 were $131,000 compared to $32,000sold convertible debentures in the same period in 2008.  We continued to protect our patent rights around the world with legal and filing fees totaling $31,000 for the nine months ended September 30, 2009 compared to $23,000 for the nine months ended September 30, 2008.  Some of  the new expenses incurred by us during the nine months ended September 30, 2009 relate to being a public entity, including investor relations, insurance, accounting and legal costs,  which together were $242,000 versus $77,000 for the nine months ended September 30, 2008. 
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Research and Development Expenses
Research and development expenses increased to $5,000 for the nine months ended September 30, 2009, as compared to $0 spent in the nine months ended September 30, 2008.  The increase in research and development expense was for a new product model.  We do not anticipate much spending in R&D in the next 6-12 months as we focus our resources on launching and training doctors on our current products.
Interest Income and Expense and Financing Fees
During the nine-month period ended September 30, 2009, we incurred significant non-cash financing liability expense related to the convertible loans with detachable warrants that we issued to raise capital during the period.  We incurred $3,100,000 in non-cash expense primarily from the common stock market price appreciation compared to the conversion feature of $0.10 per share and warrant price per share of $0.20.  We had net interest expense of $24,600 for the nine months ended September 30, 2009, as compared to $5,900 for the nine months ended September 30, 2008 as a result of having higher loans including the convertible loans in 2009 versus 2008.
Income Taxes
Our aggregate unused net operating losses approximate $3,400,000, which expire at various times through 2029, subject to limitations of Section 382 of the Internal Revenue Code of 1986, as amended.  The deferred tax asset related to the carry forward is approximately $540,000.  We have provided a valuation reserve against the full amount of the net operating loss benefit, since in the opinion$300,000 for an aggregate purchase price of management based upon our earnings history, it is more likely than not that we will not realize the net operating loss benefits.
Year ended December 31, 2008 and December 31, 2007

Net Sales and Revenues

Net sales and revenues for 2008 increased 100%$270,000 with warrants (after giving effect to $38,000 comparedanti-dilution adjustments) to no revenues in 2007.  The increase was due to starting international shipments of small orders to our newly signed distributors as well as direct shipments to physicians who wanted to use the INVOcell.

Cost of Sales and Revenues

Cost of sales as a percentage of revenues was 27% for 2008   This is slightly higher than we expect in the future as we are producing small lot quantities and have higher shipping cost per unit as a result of the small volume shipments.  There were no sales or costs in 2007 to compare to.
Selling, General and Administrative Expenses

Selling, general and administrative expenses were $1,837,600 in 2008 as compared to $177,200 in 2007.  We experienced higher general and administrative costs in 2008 due to hiring our first employees and all the associated expenses that relate to them, including benefits, a stock compensation charge for common stock grants and travel, which costs totaled approximately $1,070,000.  During the year ended December 31, 2008, we also incurred considerable travel costs as our employees started to travel internationally to introduce the INVOcell and the INVO process to physicians and distributors in Europe, the Mid-East, Asia and South America. Such travel related expenses totaled $150,000 during 2008.  We continued to protect our patent rights throughout the world, resulting in legal and filing fees totaling $54,000 in 2008.  Also, in December 2008, we completed our share exchange and the accounting and legal costs in preparing for and completing that transaction was approximately $375,000.

Research and Development Expenses

Research and development expenses increased to $51,800 in 2008 from $33,400 in 2007.  The increase in research and development expense was a result of our efforts to continually understand the regulations and guidelines for selling the INVOcell in foreign countries.

Interest Income and Expense, Net

We had net interest expense of $11,900 in 2008 as compared to $3,600 in 2007 as a result of having our loans for all of 2008 versus only part of 2007.

Income Taxes

Our aggregate unused net operating losses as of the end of 2008 approximated $1,800,000 and expire at various times through 2028 and are subject to limitations of Section 382 of the Internal Revenue Code, as amended.  The deferred tax asset related to the carry forward is approximately $540,000.  We have provided a valuation reserve against the full amount of the net operating loss benefit, since in the opinion of management based upon our earnings history, it is more likely than not that the benefits will not be realized.
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Liquidity and Capital Resources
Our lack of financial resources continues to be our major challenge.  As of September 30, 2009, we had $194,400 in cash and no cash equivalents.  Net cash used by operating activities was $673,000 for the nine months ended September 30, 2009, compared to net cash used by operating activities of $375,000 for the nine months ended September 30, 2008.  The increase in net cash used was due to the significant costs of staffing, compliance and introducing our products into new markets.  In addition, all of the current employees have assisted INVO Bioscience in its funding requirements by deferring their salaries ($377,000, as of September 30, 2009) for the last seven months ending September 30, 2009.
No cash was used during the first nine months of 2009 in investing activities, compared to $44,000 cash used by investing activities for the same period of 2008.  The cash used during 2008 was for the purchase of patents to protect our proprietary products.  During 2009, we maintained our current patents across the globe and currently do not believe it is necessary to expand any of them at this time.  Also during 2008, we purchased manufacturing molds and a telephone system.
Net cash provided by financing activities was $852,000 for the nine months ended September 30, 2009. Of that amount, $88,000 was provided by a short term 5% loan by Kathleen Karloff, our CEO.  In addition, on September 15, 2009, we completed a bridge offering of $545,000 principal amount of 10% convertible notes (the “Notes”).  Each Note bears interest, payable in150,000 shares of common stock at an initial exercise price of $0.75 and 50,000 shares of our common stock. As a rate equal to 9-12% per annum from the date of issuanceresult of the Note until paid in full onlower exercise price for the Maturity DatePrivate Placement Warrants (defined below). The initial investor’s Notes have a 12% interest rate. All outstanding principal and accrued interest under each Note is payable on the first to occur of (i) one year following the original issue date (as defined below), or (ii) a follow-on financing of at least $2,500,000 (the “Maturity Date”).  We can prepay the Notes at any time without penalty or premium. The Notesthese warrants are secured by all of our assets and carry detachable common stock purchase warrants.  The Notes rank junior to our SBA $50,000 Century Bank Line of Credit Loan and rank senior in all respects to all other existing and future indebtedness. The Notes are convertible into our common stock at a conversion price of $0.10 per share. The investors have the option to convert all or any portion of the principal amount of the Notes outstanding at any time, together with any accrued and unpaid interest hereunder intonow exercisable for 178,572 shares of common stock at an exercise price of $0.63 per share. The debentures are initially convertible into Common Stock at an initial fixed conversion 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; provided, however, the adjustment for issuances of additional securities has a floor price as set forth in the Debenture. The debentures accrue interest at a rate of 8% and are payable on maturity dates of February 3, 2024.

The debentures may not be converted and shares of Common Stock may not be issued under the debentures if, after giving effect to the conversion price.or issuance, the holder together with its affiliates would beneficially own in excess of 9.99% of the outstanding Common Stock. In addition as additional consideration forto the investmentbeneficial ownership limitations in the Notes, we issued todebentures, the initial investor in the Notes a warrant to purchasesum of the number of shares of common stockCommon Stock that may be issued under that certain securities purchase agreement (including the debenture and warrant and commitment shares issued thereunder) and the equity purchase agreement entered into by the Company both dated February 3, 2023 with the securities purchase agreement dated February 17, 2023, is limited to 19.99% of the outstanding Common Stock as of February 3, 2023 (the “Exchange Cap”, which is equal to 100%2,436,045 shares of Common Stock, subject to adjustment as described in the Purchase Agreement), unless shareholder approval (as defined in the Purchase Agreement) (“Shareholder Approval”) is obtained by the Company to issue more than the Exchange Cap. The Exchange Cap shall be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction.

While any portion of the quotientdebentures are outstanding, if we receive cash proceeds of more than $2,000,000.00 (the “Minimum Threshold”) in the aggregate from any source or series of related or unrelated sources, including but not limited to the issuance of equity or debt (except with respect to the issuance of equity or debt to officers and directors of the principal amount of the Note issued to such investor divided by the Conversion Price, as set forth in such Note, which Conversion Price equals $0.10 per share andCompany), the exercise price of outstanding warrants for cash, the Warrants equals $0.20 per share.  The purchase agreement for the Notes also includes certain negative covenantsissuance of the company, including, without limitation, limitations on:  incurring additional indebtedness and liens, transactions with affiliates and payment of dividends.

The remaining $245,000 of net cash provided by financing activities was from Lionshare Ventures, per a subscription receivable agreement dated December 5, 2008, and revised on June 10, 2009, for the previous sale of common stocksecurities pursuant to Lionshare Ventures.  As of September 30, 2009, $205,000 is still due to us from Lionshare Ventures.
We maintain a $50,000 working capitalan equity line of credit, with Century Bank.  Interest is payable monthly ator the ratesale of 0.24%assets (for the avoidance of doubt, each time that the Company receives cash proceeds from any of the aforementioned sources, then such amount shall be aggregated together), we shall, within two (2) business days of our receipt of such proceeds, inform the Buyer of such receipt, following which the holders of debentures shall have the right in their sole discretion to require us to immediately apply up to 50% of all proceeds received by us above the bank’s prime lending rate.  As of September 30, 2009,Minimum Threshold to repay the rate was 3.74%.  This line of credit matures on May 31, 2010.  At September 30, 2009 and December 31, 2008, the balance outstanding on the line of credit was $50,000.
Our registered independent certified public accountants have stated in their report dated April 15, 2009, that we have generated negative cash outflows from operating activities, experienced recurring net operating losses, and are dependent on securing additional equity and debt financing to support our business efforts.  These factors among others may raise substantial doubt about our ability to continue as a going concern.
Our existing cash resources, cash flow from operations and short-term borrowings on the existing credit line or from management will not provide adequate resources for supporting operations during fiscal 2009 and 2010.  We are actively seeking the funding we need to continue to execute our business plan.  We intend to achieve additional funding through additional sales of our securities, including in connection with the $10 million REF described elsewhere in this prospectus.  Although there can be no assurance that an additional source of funding will materialize, we currently believe that we will be able to obtain the funding we need to continue to grow our business.  However, if we do not raise additional capital in the near future we will have to further curtail our spending and downsize or cease our operations.
Critical Accounting Policies
The preparation of financial statements and related disclosures in conformity with accounting principles generally accepted in the United States requires us to make judgments, assumptions and estimates that affect the amounts reported. Note 1 of Notes to Financial Statements describes the significant accounting policies used in the preparation of the financial statements. Certain of these significant accounting policies are considered to be critical accounting policies, as defined below.
A critical accounting policy is defined as one that is both material to the presentation of our financial statements and requires management to make difficult, subjective or complex judgments that could have a material effect on our financial condition and results of operations. Specifically, critical accounting estimates have the following attributes: 1) we are required to make assumptions about matters that are highly uncertain at the time of the estimate; and 2) different estimates we could reasonably have used, or changes in the estimate that are reasonably likely to occur, would have a material effect on our financial condition or results of operations.
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Estimates and assumptions about future events and their effects cannot be determined with certainty. We base our estimates on historical experience and on various other assumptions believed to be applicable and reasonableowed under the circumstances. These estimates may change as new events occur, as additional information is obtained and as our operating environment changes. These changes have historically been minor and have been included in the consolidated financial statements as soon as they became known. Based on a critical assessment of our accounting policies and the underlying judgments and uncertainties affecting the application of those policies, management believes that our financial statements are fairly stated in accordance with accounting principles generally accepted in the United States, and present a meaningful presentation of our financial condition and results of operations.
In preparing our financial statements to conform to accounting principles generally accepted in the United States, we make estimates and assumptions that affect the amounts reported in our financial statements and accompanying notes. These estimates include useful lives for fixed assets for depreciation calculations and assumptions for valuing options and warrants. Actual results could differ from these estimates.
We are a development stage company, as defined by Accounting Standards Codification (“ASC”) Topic 915, “Accounting and Reporting by Development Stage Enterprise” formerly (“SFAS”) No. 7.  The Company’s activities during our development stage to date has included developing the business plan, seeking regulatory clearance in the European Union and the United States, raising capital, conducting beta tests, sales and marketing of the INVOcell device and offering instructions in the INVO technique to doctors in numerous foreign countries.
Through September 30, 2009, we have generated minimal sales revenues, have incurred significant expenses and have sustained losses.  Consequently, our operations are subject to all of the risks inherent in the establishment of a new business enterprise.
We consider that the following are critical accounting policies:

debentures.

Derivatives REGISTERED DIRECT OFFERING AND CONCURRENT PRIVATE PLACEMENT— In June 2008, the FASB ratified EITF Issue No. 07-5, “Determining Whether an Instrument (or Embedded Feature) Is Indexed to an Entity’s Own Stock” (EITF 07-5, included in ASC 815-40). EITF 07-5 mandates a two-step process for evaluating whether an equity-linked financial instrument or embedded feature is indexed to the entity’s own stock. It is effective for fiscal years beginning on or after December 15, 2008.  We recently adopted EITF 07-5 and had a significant effect on our consolidated condensed financial statements.

Fair Value Measurements —

On January 1, 2008, we adopted FASB ASC 820-10, “Fair Value Measurements and Disclosures.” FASB ASC 820-10 defines fair value, and establishes a three-level valuation hierarchy for disclosures of fair value measurement that enhances disclosure requirements for fair value measures. The carrying amounts reported in the consolidated balance sheets for receivables and current liabilities each qualify as financial instruments and are a reasonable estimate of their fair values because of the short period of time between the origination of such instruments and their expected realization and their current market rate of interest. The three levels of valuation hierarchy are defined as follows:

·Level 1 inputs to the valuation methodology are quoted prices for identical assets or liabilities in active markets.

·Level 2 inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the financial instrument.

·Level 3 inputs to the valuation methodology are unobservable and significant to the fair value measurement.

Management analyzes all financial instruments with features of both liabilities and equity under FASB ASC 480, “Distinguishing Liabilities From Equity” and FASB ASC 815, “Derivatives and Hedging.” Derivative liabilities are adjusted to reflect fair value at each period end, with any increase or decrease in the fair value being recorded in results of operations as adjustments to fair value of derivatives. The effects of interactions between embedded derivatives are calculated and accounted for in arriving at the overall fair value of the financial instruments. In addition, the fair values of freestanding derivative instruments such as warrant and option derivatives are valued using the Black-Scholes model.
Stock Based Compensation — We account for stock-based compensation under the provisions of FASB ASC 718 “Compensation-Stock Compensation.”  This statement requires 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 in exchange for the award, which is usually the vesting period.
Revenue Recognition — We will recognize revenue on arrangements in accordance with Securities and Exchange Commission Staff Accounting Bulletin No. 101, “Revenue Recognition in Financial Statements” and No. 104, “Revenue Recognition”.  In all cases, revenue is recognized only when the price is fixed and determinable, persuasive evidence of an arrangement exists, the service is performed and collectability of the resulting receivable is reasonably assured.
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Recently Issued Accounting Pronouncements
On July 1, 2009, the Financial Accounting Standards Board (“FASB”) launched the FASB Accounting Standards Codification (“ASC”) 105, Generally Accepted Accounting Principles (“ASC 105” and formerly referred to as FAS 168). ASC 105, establishes the FASB Accounting Standards Codification as the source of authoritative accounting principles recognized by the FASB to be applied by nongovernmental entities in the preparation of financial statements in conformity with GAAP. Rules and interpretive releases of the Securities and Exchange Commission (SEC) under authority of federal securities laws are also sources of authoritative GAAP for SEC registrants. ASC 105 is effective for financial statements issued for interim and annual periods ending after September 15, 2009.
 GAAP is not intended to be changed as a result of the FASB’s Codification project, but it will change the way the guidance is organized and presented. As a result, these changes will have a significant impact on how companies reference GAAP in their financial statements and in their accounting policies for financial statements issued for interim and annual periods ending after September 15, 2009.
In June 2009, the FASB issued SFAS No. 167, Amendments to FASB Interpretation No. 46(R) (“SFAS 167”).  SFAS 167, which amends ASC 810-10, Consolidation  (“ASC 810-10”), prescribes a qualitative model for identifying whether a company has a controlling financial interest in a variable interest entity (“VIE”) and eliminates the quantitative model prescribed by ASC 810-10.  The new model identifies two primary characteristics of a controlling financial interest: (1) provides a company with the power to direct significant activities of the VIE, and (2) obligates a company to absorb losses of and/or provides rights to receive benefits from the VIE.  SFAS 167 requires a company to reassess on an ongoing basis whether it holds a controlling financial interest in a VIE.  A company that holds a controlling financial interest is deemed to be the primary beneficiary of the VIE and is required to consolidate the VIE.  SFAS 167, which is referenced in ASC 105-10-65, has not yet been adopted into the Codification and remains authoritative.  This statement is effective for fiscal years beginning after November 15, 2009.  We plan to adopt SFAS 167 effective January 1, 2010.  The adoption of SFAS 167 is not expected to have a material impact on our financial position and results of operations.
In June 2009, the FASB issued SFAS No. 166, Accounting for Transfers of Financial Assets (“SFAS 166”).  SFAS 166 removes the concept of a qualifying special-purpose entity from ASC 860-10,  Transfers and Servicing (“ASC 860-10”), and removes the exception from applying ASC 810-10.  This statement also clarifies the requirements for isolation and limitations on portions of financial assets that are eligible for sale accounting.  SFAS 166, which is referenced in ASC 105-10-65, has not yet been adopted into the Codification and remains authoritative.  This statement is effective for fiscal years beginning after November 15, 2009.  We plan to adopt SFAS 166 effective January 1, 2010.  The adoption of SFAS 166 is not expected to have a material impact on our financial position and results of operations.    
BUSINESS
COMPANY BACKGROUND
March 23, 2023, INVO Bioscience, was formed in January 2007 under the laws of the Commonwealth of Massachusetts under the name “Bio X Cell, Inc.,” which was the business successor to Medelle Corporation (“Medelle”).  Dr. Claude Ranoux was the founder and vice president of Medelle and Kathleen Karloff was a vice president of Medelle. Between 2001 and 2006, Medelle raised $8 million in venture capital, which was used to develop and validate a device called the “INVOcell.”  Medelle conducted pre-clinical safety testing and performed a human efficacy clinical study.  Due to a delay in obtaining U.S. Food and Drug Administration (“FDA”) clearance for the INVOcell, venture capital investments ceased and, by the end of 2006, Medelle ceased operations.  Medelle assigned all of its assets to a trustee who liquidated those assets and distributed the proceeds to creditors.  In that process, Dr. Ranoux purchased all of the assets of Medelle for $20,000 and contributed those assets to Bio X Cell, Inc. upon its formation in January 2007, including four patents related to the INVOcell technology.
On December 5, 2008, Bio X Cell, Inc., doing business as INVO Bioscience, and each of the shareholders of INVO Biosciencea Nevada corporation (the “INVO Bioscience Shareholders”) entered into a share exchange agreement (the “Share Exchange Agreement”) and consummated a share exchange (the “Share Exchange”) with our predecessor Emy’s Salsa Aji Distribution Company, Inc. (“Emy’s”). Upon the closing of the Share Exchange on December 5, 2008 (the “Closing”“Company”), the INVO Bioscience Shareholders transferred all of their shares of common stock in INVO Bioscience to Emy’s.  In exchange, Emy’s issued to the INVO Bioscience Shareholders an aggregate of 38,307,500 shares of Emy’s common stock, representing 71.9% of the shares issued and outstanding immediately after the Closing.  As a result of the Share Exchange, INVO Bioscience became a wholly-owned subsidiary of Emy’s.  After the Closing, the Company had 53, 245,000 shares of common stock outstanding.

At Closing, Emy’s officers and directors resigned from their positions.  Kathleen Karloff was appointed as Chief Executive Officer, Secretary and Director and Dr. Claude Ranoux was appointed as President, Treasurer and Director.
Immediately following the Closing, the Company entered into a securities purchase agreement (the “Securities Purchase“Purchase Agreement”) with GRQ Consulting,certain institutional investors, pursuant to which the Company agreed to issue and sell to such investors (i) in a registered direct offering, 1,380,000 shares (the “Shares”) of common stock, par value $0.0001 per share (the “Common Stock”), of the Company, 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 of Common Stock, and (ii) in a concurrent private placement, common stock purchase warrants (the “Private Placement Warrants”), exercisable for an aggregate of up to 5,520,000 shares of Common Stock, at an exercise price of $0.63 per share of Common Stock. 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 Securities and Exchange Commission (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.

The Private Placement Warrants (and the shares of Common Stock issuable upon the exercise of the Private Placement 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 Private Placement Warrants are immediately exercisable upon issuance, will expire eight years from the date of issuance, and in certain circumstances may be exercised on a cashless basis.

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 Private Placement Warrants are exercised for cash, the Company would receive additional gross proceeds of approximately $3.5 million. The Company may use a portion of the net proceeds of the offering to repay the outstanding principal amount (at 105%) of those convertible debentures in the original principal amount of $500,000 issued to accredited investors in February 2023 (the “February Investors”) if requested by such February Investors as permitted under the terms of such convertible debentures. In addition, the Company may use a portion of the proceeds to pay the down payment for the acquisition of Wisconsin Facility Institute. The remainder of the net proceeds will be used for working capital, capital expenditures, and other general corporate purposes.

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Under the 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 issued and issuable upon the exercise of the Private Placement 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 investor owns any Private Placement Warrants or shares issuable upon exercise thereof.

Also in connection with the offering, on March 23, 2023, the Company entered into a placement agency agreement (the “Placement Agency Agreement”) with Maxim Group LLC (the “Placement Agent”), pursuant to which (i) the Placement Agent agreed to act as placement agent on a “best efforts” basis in connection with the offering and Whalehaven Capital Fund Limited.(ii) the Company agreed to pay the Placement Agent an aggregate fee equal to 5.0% of the gross proceeds raised in the offering and warrants to purchase up to 147,200 shares of Common Stock at an exercise price of $0.8965 (the “Placement Agent Warrants”). The Placement Agent Warrants (and the shares of Common Stock issuable upon the exercise of the Placement Agent 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 Placement Agency Agreement and the Purchase Agreement contain customary representations, warranties and agreements by the Company, customary conditions to closing, indemnification obligations of the Company, the Placement Agent, or the investors, as the case may be, other obligations of the parties and termination provisions. Pursuant to the Securitiesterms of the Purchase Agreement, from the date hereof until 45 days after the after the effective date of the Resale Registration Statement, subject to certain exceptions, we may not issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of common stock or common stock equivalents, or file any registration statement or any amendment or supplement thereto, other than (A) this prospectus supplement and (B) a Resale Registration Statement. In addition, from the date of this prospectus supplement until the one year anniversary of the closing date of the offering, we are prohibited from effecting or entering into an agreement to effect any issuance of common stock or common stock equivalents involving a variable rate transaction (as defined in the securities purchase agreement); provided, that an “at the market offering” shall not constitute a variable rate transaction.

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 purchaser under the Purchase Agreement: 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

17

SELLING STOCKHOLDERS

The Warrant Shares being offered by the Selling Stockholders are those issuable upon the exercise of the Warrants and the Conversion Shares being offered by the Selling Stockholders upon conversion of the Debenture. For additional information regarding the issuance of these securities, see “February 2023 Convertible Debenture and Warrant Financing” and “Registered Direct Offering and Concurrent Private Placement” on page 16 of this prospectus. We are registering the Warrant Shares issuable upon exercise of the Warrants, the Conversion Shares issuable upon conversion of the Debenture and the Shares of Common Stock issuable as commitment shares in order to permit the Selling Stockholders to offer such shares for resale from time to time. Except for the ownership of the Warrants, the Debenture and the shares of Common Stock issued as commitment shares, none of the Selling Stockholders have had any material relationship with us within the past three (3) years.

The following table sets forth certain information with respect to each Selling Stockholder, including (i) the shares of Common Stock beneficially owned by the Selling Stockholder prior to this offering, (ii) the number of Warrant Shares, Conversion Shares and Shares of Common Stock being offered by the Selling Stockholder pursuant to this prospectus and (iii) the Selling Stockholder’s beneficial ownership after completion of this offering. The registration of the Warrant Shares issuable to the Selling Stockholders upon the exercise of the Warrants, the Conversion Shares issuable to the Selling Stockholders upon conversion of the Debenture and the shares of Common Stock issued as commitment shares does not necessarily mean that the Selling Stockholders will sell all or any of such shares, but the number of shares of Common Stock and percentages set forth in the final two columns below assume that all shares of Common Stock being offered by the Selling Stockholders are sold. The final two columns also assume the exercise of all of the Warrants and conversion of the Debenture held by the Selling Stockholders as of June 23, 2023, without regard to any limitations on exercise described in this prospectus or in the Warrants. See “Plan of Distribution”.

The table is based on information supplied to us by the Selling Stockholders, with beneficial ownership and percentage ownership determined in accordance with the rules and regulations of the SEC and includes voting or investment power with respect to shares of Common Stock. This information does not necessarily indicate beneficial ownership for any other purpose. In computing the number of shares of Common Stock beneficially owned by a Selling Stockholder and the percentage ownership of that Selling Stockholder, shares of Common Stock subject to warrants held by that Selling Stockholder that are exercisable for shares of Common Stock within 60 days after June 23, 2023, are deemed outstanding. Such shares, however, are not deemed outstanding for the purposes of computing the percentage ownership of any other stockholder.

This prospectus covers the resale of up to an aggregate of 6,241,493, shares of Common Stock consisting of: (i) 5,520,000 shares of Common Stock issuable upon exercise of the March 2023 Warrants; (ii) 195,721 shares of Common Stock issuable upon conversion of the Debentures; (iii) 178,572 shares of Common Stock issuable upon exercise of the February 2023 Warrants; (iv) 50,000 shares of Common Stock issued as a commitment fee under the February 2023 Purchase Agreement; (v) 150,000 shares of Common Stock issued as a commitment fee under the February 2023 Equity Purchase Agreement and (vi) 147,200 shares of Common Stock issuable upon exercise of the Placement Agent Warrants .. See “February 2023 Convertible Debenture and Warrant Financing” and “Registered Direct Offering and Concurrent Private Placement” in this prospectus for further details relating to the Warrant Shares, the Warrants, the Conversion Shares, the Debenture and the commitment shares.

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Name of Selling Stockholder

 Number of Shares of Common Stock Beneficially Owned Prior to Offering(1)  

Maximum Number of Shares of Common Stock

to be Sold Pursuant to this Prospectus(2)

  Number of Shares of Common Stock Beneficially Owned After Offering(3)  Percentage Beneficially Owned After Offering(3) 
Armistice Capital, LLC(4)  5,520,000(7)  5,520,000   0   *
Peak One Opportunity Fund, LP (5)  195,721(8)  195,721   0   *
Peak One Investments, LLC (5)  378,572(9)  378,572   0   * 
Maxim Partners, LLC (6)  147,200(10)  147,200         0          * 
TOTAL  6,241,493   6,241,493   0   * 

*Less than 1%

(1)All of the Warrants that are exercisable for the Warrant Shares offered hereby contain certain beneficial ownership limitations, which provide that a holder of the Warrants will not have the right to exercise any portion of its Warrants if such holder, together with its affiliates, would beneficially own in excess of 4.99% or 9.99%, as applicable, of the number of shares of Common Stock outstanding immediately after giving effect to such exercise, provided that upon at least 61 days’ prior notice to us, a holder may increase or decrease such limitation up to a maximum of 9.99% of the number of shares of Common Stock outstanding (each such limitation, a “Beneficial Ownership Limitation”). As a result, the number of shares of Common Stock reflected in this column as beneficially owned by each Selling Stockholder includes (i) any outstanding shares of Common Stock held by such Selling Stockholder, and (ii) if any, the number of shares of Common Stock subject to the Warrants exercisable for the Warrant Shares offered hereby and any other warrants that may be held by such Selling Stockholder, in each case which such Selling Stockholder has the right to acquire as of February 3, 2023 or within 60 days thereafter and without it or any of its affiliates beneficially owning more than 4.99% or 9.99%, as applicable, of the number of outstanding shares of Common Stock as of February 3, 2023.

(2)Represents shares of Common Stock owned by the Selling Stockholders upon full exercise of the Warrants and conversion of the Debenture offered hereby.

(3)The number of shares owned and the percentage of beneficial ownership after this offering set forth in these columns are based on 22,579,073 shares of Common Stock outstanding on June 23, 2023, which includes 16,537,580 shares of Common Stock outstanding as of such date and assumes full exercise of the Warrants that are exercisable for the 5,845,772 Warrant Shares offered hereby and full conversion of the Debenture that is convertible into 195,721 Conversion Shares. The calculation of beneficial ownership reported in such columns takes into account the effect of the Beneficial Ownership Limitations in any warrants held by the Selling Stockholders after this offering. We do not know when or in what amounts a Selling Stockholder may offer shares for sale. The Selling Stockholders may choose not to sell any or all of the shares offered by this prospectus. Because the Selling Stockholders may offer all or some of the Shares pursuant to this offering, we cannot estimate the number of the Shares that will be held by the Selling Stockholders after completion of the offering. However, for purposes of this table, we have assumed that, after completion of the offering, all of the Shares covered by this prospectus will be sold by the Selling Stockholders and that the Selling Stockholders do not acquire beneficial ownership of any additional shares.

(4)The securities are directly held by Armistice Capital Master Fund Ltd., a Cayman Islands exempted company (the “Master Fund”), and may be deemed to be indirectly beneficially owned by: (i) Armistice Capital, LLC (“Armistice”), as the investment manager of the Master Fund; and (ii) Steven Boyd, as the Managing Member of Armistice Capital. The warrants are subject to a beneficial ownership limitation of 4.99%, which such limitation restricts the Selling Stockholder from exercising that portion of the warrants that would result in the Selling Stockholder and its affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The address of Armistice Capital Master Fund Ltd. is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022.

(5)Jason Goldstein exercises voting and dispositive power with respect to the shares of our common stock that are beneficially owned by Peak One and Peak One Investments.

(6)MJR Holdings LLC owns a majority of the outstanding membership interest of Maxim Partners. Mr. Michael Rabinowitz is the managing member of MJR Holdings LLC. As such, each of Maxim Partners, MJR Holdings LLC and Mr. Rabinowitz may be deemed to have beneficial ownership of the shares of common stock held directly by INVO Bioscience, Inc. Each such entity or person disclaims any beneficial ownership of the reported shares other than to the extent of any pecuniary interest they may have therein, directly or indirectly. The business address for this Selling Securityholder is c/o Maxim Group LLC, 300 Park Avenue, 16th Floor, New York, New York, 10022.

(7)Consists of 5,520,000 shares of Common Stock issuable upon the exercise of a Common Stock Warrant, without giving effect to the blocker provision described above, which will become exercisable on September 6, 2022.

(8)Consists of 195,721 shares of Common Stock issuable upon the conversion of the Debenture.

(9)Consist of (i) 200,000 shares of Common Stock held direct; and (iii) 178,572 shares of Common Stock issuable upon exercise of a Common Stock Warrant, without giving effect to the blocker provision described above.

(10)Consist of 147, 200 shares of Common Stock issuable upon exercise of the Placement Agent Warrants.

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USE OF PROCEEDS

We will not receive any of the proceeds from the sale of the Warrant Shares or Conversion Shares by the Selling Stockholders pursuant to this prospectus. We may receive up to approximately $3.7 million in aggregate gross proceeds from cash exercises of the Warrants, based on the per share exercise price of the Warrants. We intend to use any net proceeds we receive for working capital, capital expenditures, product development, and other general corporate purposes, including investments in sales and marketing in the United States and internationally. We have not allocated specific amounts of net proceeds for any of these purposes; however, we are required pursuant to the terms of the February 2023 Purchase Agreements to direct 50% of the gross proceeds we may receive from any cash exercises of the Warrants to repay a portion of the Debentures, unless the February 2023 investors invested $375,000elect to waive such repayment.

The Selling Stockholders will pay any agent’s commissions and expenses they incur for brokerage, accounting, tax or legal services or any other expenses that they incur in disposing of the shares of Common Stock. We will bear all other costs, fees and expenses incurred in effecting the registration of the shares of Common Stock covered by this prospectus and any prospectus supplement. These may include, without limitation, all registration and filing fees, SEC filing fees and expenses of compliance with state securities or “blue sky” laws.

We cannot predict when or if the Warrants will be exercised, and it is possible that the Warrants may expire and never be exercised, nor can we predict when the Debenture will be converted, if at all. In addition, the Warrants are exercisable on a cashless basis after six (6) months from the date of issuance if at the time of exercise there is no effective registration statement registering, or the prospectus contained therein is not available for, the issuance of the Warrant Shares. As a result, we may never receive meaningful, or any, cash proceeds from the exercise of the Warrants, and we cannot plan on any specific uses of any proceeds we may receive beyond the purposes described herein.

See “Plan of Distribution” elsewhere in this prospectus for more information.

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DIVIDEND POLICY

We have never declared or paid any dividends on our Common Stock. We currently intend to retain all available funds and any future earnings for the operation and expansion of our business and, therefore, we do not anticipate declaring or paying dividends in the foreseeable future. The payment of dividends will be at the discretion of our Board and will depend on our results of operations, capital requirements, financial condition, prospects, contractual arrangements, any limitations on payment of dividends present in our future debt agreements, and other factors that our Board may deem relevant.

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SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT

The following table and notes set forth the beneficial ownership of the common stock of the Company as of June 23, 2023, 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, to our knowledge, all persons listed below have sole voting and dispositive power with respect 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 c/o INVO Bioscience, Inc., 5582 Broadcast Court Sarasota, Florida, 34240.

The following table sets forth the beneficial ownership of our common shares as of June 23, 2023 for:

●each person, or group of affiliated persons, who is known by us to beneficially own more than 5% of our common shares;
●each of our named executive officers;
●each of our directors; and
●all of our current executive officers and directors as a group.

The percentage ownership information is based upon 16,537,580 common shares outstanding as of June 23, 2023. The percentage ownership information shown in the table after this offering is based upon 22,579,073 shares of Common Stock (assuming full exercise of the Warrants to purchase 5,845,772 Warrant Shares and full conversion of the Debenture into 195,721 shares). 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. Unless otherwise indicated the address for persons listed in the table is c/o INVO Bioscience, Inc., 5582 Broadcast Court, Sarasota, FL 34240.

Name and Address of Beneficial Owner (1) 

Number

of Shares

  Percentage of Common Stock  Percentage of Common Stock Beneficially Owned After this Offering 
5% Stockholders:            
None  -   -   - 
             
Officers and Directors            
Andrea Goren  377,185(3)  2.25%  1.65%
Michael Campbell  361,929(4)  2.15%  1.58%
Steve Shum  323,222(5)  1.93%  1.42%
Matthew Szot  112,670(6)  0.68%  0.50%
Trent Davis  104,003(7)  0.63%  0.46%
Barbara Ryan  100,405(8)  0.60%  0.44%
Rebecca Messina  81,822(9)  0.49%  0.36%
All directors and executive officers as a group (7 persons)  1,461,236   8.73%  6.42%

(1)Unless otherwise indicated, the business address of each current director or executive officer is INVO Bioscience, Inc. 5582 Broadcast Court Sarasota, Florida 34240.
(2)The address is 88 Chestnut Street, Winchester, MA 01889.
(3)Includes: 227,990 shares of common stock under options (either presently exercisable or within 60 days of June 23, 2023).
(4)Includes: 293,785 shares of common stock under options (either presently exercisable or within 60 days of June 23, 2023).
(5)Includes: 204,858 shares of common stock under options (either presently exercisable or within 60 days of June 23, 2023).
(6)Includes: 73,495 shares of common stock under options (either presently exercisable or within 60 days of June 23, 2023).
(7)Includes: 70,381 shares of common stock under options (either presently exercisable or within 60 days of June 23, 2023).
(8)Includes: 68,826 shares of common stock under options (either presently exercisable or within 60 days of June 23, 2023).
(9)Includes: 58,837 shares of common stock under options (either presently exercisable or within 60 days of June 23, 2023).

DESCRIPTION OF SECURITIES THAT THE SELLING STOCKHOLDERS ARE OFFERING

The Selling Stockholders are offering for resale up to an aggregate of 6,241,493 shares of Common Stock consisting of: (i) 5,520,000 shares of Common Stock issuable upon exercise of the March 2023 Warrants: (ii) 195,721 shares of Common Stock issuable upon conversion of the Debentures; (iii) 178,572 shares of Common Stock issuable upon exercise of the February 2023 Warrants; (iv) 50,000 shares of Common Stock issued as a commitment fee under the February 2023 Purchase Agreement; (v) 150,000 shares of Common Stock issued as a commitment fee under the February 2023 Equity Purchase Agreement and (vi) 147,200 shares of Common Stock issuable upon exercise of the Placement Agent Warrants. The following summary of the terms of our shares of Common Stock is based upon our Articles of Incorporation and our bylaws. The summary is not complete and is qualified by reference to our Articles of Incorporation and our bylaws, which were filed as exhibits to our Annual Report on Form 10-K for the fiscal year ended December 31, 2022. For a description of our Common Stock, see our Registration Statement on Form 8-A, filed with the SEC on November 12, 2020 under Section 12(b) of the Exchange Act, including any amendments or reports filed for the purpose of updating such description and (ii) Exhibit 4.1-Description of Securities, to our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on April 17, 2023.

Our Articles of Incorporation authorizes the issuance of up to 125,000,000 shares of Common Stock, par value $0.0001 per share, and up to 100,000,000 shares of blank check preferred stock, par value $0.0001 per share. Our Board may establish the rights and preferences of the preferred stock from time to time.

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PLAN OF DISTRIBUTION

The Selling Stockholders and any of their respective pledgees, assignees and successors-in-interest may, from time to time, sell any or all of their securities covered hereby on any trading market, stock exchange or other trading facility on which the securities are traded or in private transactions. These sales may be at fixed or negotiated prices. The Selling Stockholders may use any one or more of the following methods when selling securities:

●ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;

●block trades in which the broker-dealer will attempt to sell the securities as agent but may position and resell a portion of the block as principal to facilitate the transaction;

●purchases by a broker-dealer as principal and resale by the broker-dealer for its account;

●an exchange distribution in accordance with the rules of the applicable exchange;

●privately negotiated transactions;

●settlement of short sales;

●in transactions through broker-dealers that agree with the Selling Stockholders to sell a specified number of such securities at a stipulated price per security;

●through the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;

●a combination of any such methods of sale; or

●any other method permitted pursuant to applicable law.

The Selling Stockholders may also sell securities under Rule 144 under the Securities Act, if available, rather than under this prospectus.

Broker-dealers engaged by the Selling Stockholders may arrange for 375,000other brokers-dealers to participate in sales. Broker-dealers may receive commissions or discounts from the Selling Stockholders (or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser) in amounts to be negotiated, but, except as set forth in a supplement to this prospectus, in the case of an agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2440; and in the case of a principal transaction a markup or markdown in compliance with FINRA IM-2440.

In connection with the sale of the securities covered hereby, the Selling Stockholders may enter into hedging transactions with broker-dealers or other financial institutions, which may in tum engage in short sales of the securities in the course of hedging the positions they assume. The Selling Stockholders may also sell securities short and deliver these securities to close out their short positions, or loan or pledge the securities to broker-dealers that in tum may sell these securities. The Selling Stockholders may also enter into option or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the delivery to such broker-dealer or other financial institution of securities offered by this prospectus, which securities such broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).

The Selling Stockholders and any broker-dealers or agents that are involved in selling the securities may be deemed to be “underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts under the Securities Act. We are requesting that each Selling Stockholder inform us that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the securities. We will pay certain fees and expenses incurred by us incident to the registration of the securities.

Because the Selling Stockholders may be deemed to be “underwriters” within the meaning of the Securities Act, they will be subject to the prospectus delivery requirements of the Securities Act, including Rule 172 thereunder. In addition, any securities covered by this prospectus which qualify for sale pursuant to Rule 144 under the Securities Act may be sold under Rule 144 rather than under this prospectus. We are requesting that each Selling Stockholder confirm that there is no underwriter or coordinating broker acting in connection with the proposed sale of the resale securities by the Selling Stockholder.

We intend to keep this prospectus effective until the earlier of (i) the date on which the securities may be resold by the Selling Stockholders without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for us to be in compliance with the current public information requirement under Rule 144 under the Securities Act or any other rule of similar effect or (ii) all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The resale securities will be sold only through registered or licensed brokers or dealers if required under applicable state securities laws. In addition, in certain states, the resale securities covered hereby may not be sold unless they have been registered or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is complied with.

Under applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously engage in market making activities with respect to the Common Stock for the applicable restricted period, as defined in Regulation M, prior to the commencement of the distribution. In addition, the Selling Stockholders will be subject to applicable provisions of the Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the Common Stock by the Selling Stockholders or any other person. We will make copies of this prospectus available to the Selling Stockholders and are informing the Selling Stockholders of the need to deliver a copy of this prospectus to each purchaser at or prior to the time of the sale (including by compliance with Rule 172 under the Securities Act).

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DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITY

Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling the registrant pursuant to the foregoing provisions, the registrant has been informed that in the opinion of the SEC such indemnification is against public policy as expressed in the Securities Act and is, therefore, unenforceable.

LEGAL MATTERS

The validity of the issuance of the securities offered hereby will be passed upon for us by Sheppard Mullin Richter & Hampton LLP of New York, New York.

EXPERTS

The consolidated financial statements of INVO Bioscience, Inc. as of December 31, 2022 and 2021 and for each of the two years in the period ended December 31, 2022, incorporated into this prospectus and the Registration Statement on Form S-1 of which it forms a part by reference to the Annual Report on Form 10-K for the year ended December 31, 2022, have been so incorporated in reliance on the report (which contains an explanatory paragraph relating to the Company’s ability to continue as a going concern as described in Note 1 to the consolidated financial statements) of M&K CPAs, an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting. The combined financial statements of Wisconsin Fertility and Reproductive Surgery Associates, S.C. and Fertility Labs of Wisconsin, LLC as of December 31, 2022 and 2021 and for each of the two years in the period ended December 31, 2022 incorporated into this prospectus and the Registration Statement on Form S-1 of which it forms a part by reference to the Current Report on Form 8-K/A filed with the Securities and Exchange Commission on June 21, 2023, have been so incorporated in reliance on the report of M&K CPAs, an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting .

WHERE YOU CAN FIND MORE INFORMATION

This prospectus constitutes a part of a registration statement on Form S-1 filed under the Securities Act. As permitted by the SEC’s rules, this prospectus and any prospectus supplement, which form a part of the registration statement, do not contain all the information that is included in the registration statement. You will find additional information about us in the registration statement and its exhibits. Any statements made in this prospectus or any prospectus supplement concerning legal documents are not necessarily complete and you should read the documents that are filed as exhibits to the registration statement or otherwise filed with the SEC for a more complete understanding of the document or matter.

You can read our electronic SEC filings, including such registration statement, on the internet at the SEC’s website at www.sec.gov. We are subject to the information reporting requirements of the Exchange Act, and we file reports, proxy statements and other information with the SEC. These reports, proxy statements and other information will be available at the website of the SEC referred to above. We also maintain a website at www.wisatechnologies.com, at which you may access these materials free of charge as soon as reasonably practicable after they are electronically filed with, or furnished to, the SEC. However, the information contained in or accessible through our website is not part of this prospectus or the registration statement of which this prospectus forms a part, and investors should not rely on such information in making a decision to purchase our securities in this offering.

INCORPORATION OF DOCUMENTS BY REFERENCE

We incorporate by reference the filed documents listed below (excluding those portions of any Current Report on Form 8-K that are not deemed “filed” pursuant to the General Instructions of Form 8-K), except as superseded, supplemented or modified by this Prospectus Supplement or any subsequently filed document incorporated by reference herein as described below:

●our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed with the SEC on April 17, 2023 and our Annual Report on Form 10-K/A for the fiscal year ended December 31, 2022 filed with the SEC on April 27,2023;
●our Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2023, filed with the SEC on May 15, 2023;
●our Current Reports on Forms 8-K filed with the SEC on January 5, 2023,January 5, 2023, January 12, 2023, January 23, 2023, February 9, 2023, February 23, 2023, March 20, 2023, March 20, 2023, March 23, 2023, March 28, 2023, March 30, 2023, April 4, 2023, May 30, 2023; June 21, 2023 and June 30, 2023 (except for Item 2.02 and Item 7.01 of any Current Report on Form 8-K which are not deemed “filed” for purposes of Section 18 of the Exchange Act and are not incorporated by reference in this prospectus); and
●the description of the Registrant’s securities, which is contained in the Registrant’s Registration Statement on Form 8-A filed with the SEC on November 12, 2020 under Section 12(b) of the Exchange Act, including any amendments or reports filed for the purpose of updating such description, as amended and Exhibit 4.1 to the Registrant’s Annual Report on Form 10-K form 10-K for the year ended December 31, 2022 filed on April 17, 2023.

We also incorporate by reference in this prospectus supplement and the accompanying prospectus any future filings we make with the SEC under Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act after the date hereof but before the completion or termination of this offering (excluding any information not deemed “filed” with the SEC).

Any statement contained in a document incorporated by reference herein or therein shall be deemed to be modified or superseded for all purposes to the extent that a statement contained in this Prospectus Supplement and the Base Prospectus or in any other subsequently filed document which is also incorporated or deemed to be incorporated by reference herein or therein, modifies or supersedes such statement. Any statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this Prospectus Supplement and the Base Prospectus. You may request a copy of these filings (other than an exhibit to a filing unless that exhibit is specifically incorporated by reference into that filing) at no cost by writing, telephoning or e-mailing us at the following address, telephone number or e-mail address:

INVO Bioscience, Inc.

5582 Broadcast Court

Sarasota, Florida 34240

(978) 878-9505

legal@invobio.com

Copies of these filings are also available through the “Investor Relations” section of our website at www.invobio.com. For other ways to obtain a copy of these filings, please refer to “Where You Can Find More Information” above.

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A picture containing text, font, logo, graphics Description automatically generated

INVO Bioscience, Inc.

Up to 6,241,493 Shares of Common Stock underlying Warrants

PROSPECTUS

The date of this prospectus is , 2023.

PART II - INFORMATION NOT REQUIRED IN PROSPECTUS

Item 13. Other Expenses of Issuance and Distribution.

The following table sets forth an estimate of the fees and expenses relating to the issuance and distribution of the securities being registered hereby, other than underwriting discounts and commissions, all of which shall be borne by the registrant. All of such fees and expenses, except for the SEC registration fee, are estimated:

SEC registration fee $120.02 
Transfer agent and registrar fees and expenses $5,000.00 
Legal fees and expenses $20,000.00 
Printing fees and expenses $5,000.00 
Accounting fees and expenses $10,000.00 
Miscellaneous fees and expenses $5,000.00 
Total $45,120.02 

Item 14. Indemnification of Officers and Directors.

We are a Nevada corporation and generally governed by the Nevada Private Corporations Code, Title 78 of the Nevada Revised Statutes (the “NRS”).

Section 78.138 of the NRS provides that, unless the corporation’s articles of incorporation provide otherwise, a director or officer will not be individually liable unless it is proven that (i) the director’s or officer’s acts or omissions constituted a breach of his or her fiduciary duties, and (ii) such breach involved intentional misconduct, fraud, or a knowing violation of the law. Our articles of incorporation provide the personal liability of our directors is eliminated to the fullest extent permitted under the NRS.

Section 78.7502 of the NRS permits a company to indemnify its directors and officers against expenses, judgments, fines, and amounts paid in settlement actually and reasonably incurred in connection with a threatened, pending, or completed action, suit, or proceeding, if the officer or director (i) is not liable pursuant to NRS 78.138, or (ii) acted in good faith and in a manner the officer or director reasonably believed to be in or not opposed to the best interests of the corporation and, if a criminal action or proceeding, had no reasonable cause to believe the conduct of the officer or director was unlawful. Section 78.7502 of the NRS requires a corporation to indemnify a director or officer that has been successful on the merits or otherwise in defense of any action or suit. Section 78.7502 of the NRS precludes indemnification by the corporation if the officer or director has been adjudged by a court of competent jurisdiction, after exhaustion of all appeals, to be liable to the corporation or for amounts paid in settlement to the corporation, unless and only to the extent that the court determines that in view of all the circumstances, the person is fairly and reasonably entitled to indemnity for such expenses and requires a corporation to indemnify its officers and directors if they have been successful on the merits or otherwise in defense of any claim, issue, or matter resulting from their service as a director or officer.

Section 78.751 of the NRS permits a Nevada company to indemnify its officers and directors against expenses incurred by them in defending a civil or criminal action, suit, or proceeding as they are incurred and in advance of final disposition thereof, upon determination by the stockholders, the disinterested board members, or by independent legal counsel. If so provided in the corporation’s articles of incorporation, bylaws, or other agreement, Section 78.751 of the NRS requires a corporation to advance expenses as incurred upon receipt of an undertaking by or on behalf of the officer or director to repay the amount if it is ultimately determined by a court of competent jurisdiction that such officer or director is not entitled to be indemnified by the company. Section 78.751 of the NRS further permits the company to grant its directors and officers’ additional rights of indemnification under its articles of incorporation, bylaws, or other agreement.

Section 78.752 of the NRS provides that a Nevada company may purchase and maintain insurance or make other financial arrangements on behalf of any person who is or was a director, officer, employee, or agent of the company, or is or was serving at the request of the company as a director, officer, employee, or agent of another company, partnership, joint venture, trust, or other enterprise, for any liability asserted against him and liability and expenses incurred by him in his capacity as a director, officer, employee, or agent, or arising out of his status as such, whether or not the company has the authority to indemnify him against such liability and expenses.

Our articles of incorporation provide for indemnification of our officers and directors to the fullest extent permissible under Nevada General Corporation Law, in accordance with the Company’s Bylaws. Our Bylaws provide for indemnification of our officers and directors to the fullest extent not prohibited by the Nevada; provided however, that the Company may modify the extent of such indemnification by individual contracts with its directors and officers; and provided, further, that the Company shall not be required to indemnify any director or officer in connection with any proceeding (or part thereof) initiated by such person unless (i) such indemnification is expressly required to be made by law; (ii) the proceeding was authorized by the board of directors; (iii) such indemnification is provided by the Company, in its sole discretion, pursuant to the powers vested in the corporation under the Nevada General Corporation Law or; (iv) such indemnification is a result of the enforcement of a contractual right.

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See “Item 17. Undertakings” for a description of the SEC’s position regarding such indemnification provisions.

Item 15. Recent Sales of Unregistered Securities.

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.

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.

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.

During 2021, we issued 97,500 shares of our common stock to consultants and employees in consideration of services rendered. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. We did not receive any proceeds from this issuance.

In November 2021, we issued 30,000 shares of our common stock in consideration for purchasing Effortless IVF with a fair value of $117,600. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. We did not receive any proceeds from this issuance.

In December 2021, we issued 78,125 shares of our common stock upon conversion of $250,000 of a convertible promissory note. 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.

In January 2022, the Company issued 94,623 shares of common stock to Paradigm Opportunities Fund, LP (“Paradigm”). The shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company received $315,000 in proceeds from this issuance.

In February 2022, we issued 3,000 shares of common stock to consultants in consideration of services rendered. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. We did not receive any cash proceeds from this issuance.

In February 2023, we issued 233,333 shares of common stock to consultants in consideration of services rendered. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. We did not receive any cash proceeds from this issuance.

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On March 27, 2023, we issued common stock purchase warrants to purchase 5,520,000 shares of our common stock at aan exercise price of $1.00$0.63 per share subject to anti-dilution protection. Aftercertain institutional investors in a concurrent private placement along with a registered direct offering. The warrants were issued pursuant to the Closing,exemption from registration provided by Regulation D of the Company had 53, 245,000Securities Act of 1933, as amended. We did not receive any cash proceeds from this issuance.

On March 27, 2023, we issued common stock purchase warrants to purchase 147,200 shares of our common stock at an exercise price of $0.8965 per share to the placement agent for our registered direct offering and concurrent private placement as consideration for their services. The warrants were issued pursuant to the exemption from registration provided by Regulation D of the Securities Act of 1933, as amended. We did not receive any cash proceeds from this issuance.

In May 2023, we issued 122,283 shares of common stock outstanding.

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COMPANY OVERVIEW
We are a development stage company that has recently begunservices rendered. These shares were issued pursuant to commercialize our proven and patented technology that we believe will revolutionize the treatment of infertility.  Our device, the INVOcell, and the INVO procedure are designed to provide an alternative infertility treatment for the patient and the clinician; it is less expensive and simpler to perform than current infertility treatments.  The simplicityexemption from registration provided by Section 4(a)(2) of the INVO procedure relatesSecurities Act of 1933, as amended. We did not receive any cash proceeds from this issuance.

Item 16. Exhibits.

The list of exhibits in the Exhibit Index to this registration statement is incorporated herein by reference.

Item 17. Undertakings.

The undersigned registrant hereby undertakes:

(1)To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:

(i)To include any prospectus required by Section 10(a)(3) of the Securities Act of 1933, as amended;

(ii)To reflect in the prospectus any facts or events arising after the effective date of this registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in this registration statement. Notwithstanding the foregoing, any increase or decrease in the volume of securities offered (if the total dollar value of the securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Securities and Exchange Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and

(iii)To include any material information with respect to the plan of distribution not previously disclosed in this registration statement or any material change to such information in this registration statement;

provided, however, that the undertakings set forth in paragraphs (1)(i), (1)(ii) and (1)(iii) above do not apply if the information required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the abilitySecurities and Exchange Commission by the registrant pursuant to potentially performSection 13 or Section 15(d) of the infertility procedureSecurities Exchange Act of 1934, as amended, that are incorporated by reference in this registration statement or is contained in a physician’s practice rather than in a specialized facility at a much lower cost overall than current infertility treatments, including in vitro fertilization (“IVF”).  Therefore, we believeform of prospectus filed pursuant to Rule 424(b) that the INVO procedure will be available in many more locations than conventional IVF especially outside the United States.  INVO also allows conception and embryo developmentis part of this registration statement;

(2)That, for the purpose of determining any liability under the Securities Act of 1933, as amended, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof;

(3)To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering;

(4)That, for the purpose of determining liability under the Securities Act of 1933, as amended, to any purchaser:

(i)Each prospectus filed by the registrant pursuant to Rule 424 (b)(3) shall be deemed to be part of this registration statement as of the date the filed prospectus was deemed part of and included in this registration statement; and

(ii)Each prospectus required to be filed pursuant to Rule 424 (b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance on Rule 430B relating to an offering made pursuant to Rule 415(a)(l)(i), (vii) or (x) for the purpose of providing the information required by Section 10(a) of the Securities Act of 1933, as amended, shall be deemed to be part of and included in the registration statement as of the earlier of the date such prospectus is first used after effectiveness or the date of the first contract of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof; provided, however, that no statement made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration statement or made in any such document immediately prior to such effective date;

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(5)That, for the purpose of determining liability of the registrant under the Securities Act of 1933, as amended, to any purchaser in the initial distribution of the securities, the undersigned registrant undertakes that in a primary offering of securities of the undersigned registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:

(i)Any preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant to Rule 424;

(ii)Any free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred to by the undersigned registrant;

(iii)The portion of any other free writing prospectus relating to the offering containing material information about the undersigned registrant or its securities provided by or on behalf of the undersigned registrant; and

(iv)Any other communication that is an offer in the offering made by the undersigned registrant to the purchaser;

(6)That, for purposes of determining any liability under the Securities Act of 1933, as amended, each filing of the registrant’s annual report pursuant to Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934, as amended (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934, as amended) that is incorporated by reference in the registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof;

(7)Insofar as indemnification for liabilities arising under the Securities Act of 1933, as amended, may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act of 1933, as amended, and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Securities Act of 1933, as amended, and will be governed by the final adjudication of such issue.

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SIGNATURES

Pursuant to take place inside the woman's body; an attractive feature for most couples.


In May 2008, we received notice that the INVOcell product meets all the essential requirements of the relevant European Directive(s), and received CE Marking.  The CE marking (also knownSecurities Act of 1933, as CE mark) is a mandatory conformity markamended, the registrant has duly caused this Amendment No. 1 to registration statement to be signed on many products placed onits behalf by the single marketundersigned, thereunto duly authorized, in the European Economic Area (EEA).  The CE marking (an acronym for the French “Conformité Européenne”) certifies that a product has met EU health, safety and environmental requirements, which ensure consumer safety.  With CE marking, we possess the regulatory authority to distribute its product in the European Economic Area, provided we comply with local registration requirements as discussed herein (i.e., the European Union, Canada, Australia, New Zealand and most partsCity of the Middle East).  We have sold approximately 900 INVOcell units through September 30, 2009.
THE INVOCELL TECHNOLOGY
Our product, the INVOcell medical device, is designed to treat infertility at a far lower cost than other treatments available in today’s marketplace, including IVF.  The INVOcell technology is a fertility treatment where either mild ovarian stimulation or no ovarian stimulation is used.  Using a mild stimulation protocol, 1-10 follicles are retrieved in a physician’s office with the patient under light sedation with or without local anesthesia.  The follicle retrieval is performed using a vaginal probe under ultrasound guidance.  Eggs are identified immediately after retrieval in the follicular fluid.  During the INVO procedure, fertilization and embryo development occurs inside the woman’s vaginal cavity in a disposable single use device -- the INVOcell -- that holds the eggs, sperm and culture medium.
Sperm collection and preparation generally occur before egg retrieval.  Nutrient medium (~1ml) is placed in the inner vesselSarasota, State of the INVOcell.  Eggs and a fraction of motile sperm are placed into the medium and the inner vessel is closed and secured in the protective outer vessel.  The INVOcell is placed in the patient’s vaginal cavity for an incubation period of 2-3 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 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.  Obtaining eggs, sperm and media then inserting them into the INVOcell and then placing it in the vagina takes approximately 90 minutes.
After 2-3 days, the patient returnsFlorida, on July 3, 2023.

INVO BIOSCIENCE, INC.
By:/s/ Steven Shum
Steven Shum
Chief Executive Officer

Pursuant to the physician’s office where the retention system and the INVOcell are removed.  The protective outer vessel is discarded and the inner vessel is placed in INVO Bioscience’s patented holding block in a vertical position for 15 minutes.  Embryos are collected in the micro chamber located at the bottom of the inner vessel.  The embryos can be directly viewed in the micro chamber in the holding block by using a microscope.  Embryos can be loaded directly from the device in a transfer catheter from the INVOcell device.  A trained clinician can readily identify the best embryos for transfer.  The embryos to be transferred are aspirated into a standard catheter for transfer into the patient’s uterus.  This second visit should take approximately 45 minutes.  All INVO related medical procedures can be performed in a physician’s office thereby avoiding the requirement of an IVF facility and the associated costs to build and maintain such a facility.

SUMMARY OF OPERATIONS
INVO Bioscience operates by outsourcing many key operational functions in the development and manufacturing of the INVOcell device to keep fixed costs to a minimum.  Our most critical management and leadership functions are carried out by our core team.  We have contracted out the following functions: manufacturing, packaging/labeling and sterilization of the device to a certified manufacturer to mold the parts; to a medical manufacturing company to assemble packages and label the product and to a sterilization specialist to perform the gamma sterilization process.  This expedites production and eliminates the need for in-house capital equipment expenditures.
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To date, we have completed a series of important steps in the development and manufacturing of the INVOcell:
·  
Manufacturing:  All parts and processes have been validated.  Manufacturing of inventory is ongoing.  To date, we have 400 INVOcell devices ready for sale.  We have an additional 9,000 devices molded and ready for sterilization and packaging.
·  
CE Mark:  INVO Bioscience has obtained a CE Mark that will allow sales of INVO in Europe, Canada and many other countries, subject to local registration requirements.
·  
Clinical Trials:  Safety and efficacy of the INVOcell device has been demonstrated and accepted by both the CE Mark governing body and the FDA.
·  
Support of Practitioners:  Clinicians and laboratory directors having used the INVO method are enthusiastic about the fact that it is a patient-friendly procedure, easy to perform, simple and efficacious.
·  
Initiate FDA Clearance: In parallel to the sale of products outside of the United States in Europe, Canada, Mid-East  and South America, INVO Bioscience intends to complete, subject to receipt of additional funding, all clinical and non-clinical studies by 2010 and thereafter intends to finalize its FDA 510 (k) filing and hopefully receive FDA clearance in early 2011.
·  
Marketing Trials/Studies: Currently clinical studies are underway in South America, the Mid-East and soon to commence in India by doctors currently using the INVOcell to have “local” data on patient efficacy and experience for marketing collateral and advertising.
CURRENT MARKET OPPORTUNITY
According to the European Society for Human Reproduction (“ESHRE”) in 2007, there are more than 100 million infertile couples in the world.  While there have been large increases in the use of IVF, only about one million IVF cycles were performed in 2006, which amounts to a treatment of less than 1% of the infertile couples worldwide.  Knowing that an average of 2-3 cycles of IVF is performed per infertile couple, there are only 300,000-500,000 couples treated by IVF.  A survey by “Resolve: The National Infertility Association,” the number one reason couples do not use IVF is cost and geographical availability.  We can provide a locally available treatment option at less than half the cost of IVF that will help millions of infertile couples throughout the world where IVF is not currently available.
IVF is an effective treatment option for many infertile couples.  Our patented and proven INVO technology is a low cost, unique fertility treatment option that is much simpler to perform than IVF.  The procedure can be provided without an IVF center and therefore can be available in many more locations than IVF.  We believe we are well positioned to capture a significant share of the unmet market needs.  With the INVOcell device and technique, fertilization and early embryo development is done within the vaginal cavity rather than an incubator.  Oocytes and sperm are fertilized and developed into embryos within the INVO device while contained by the woman’s vaginal cavity.
Currently, according to European Society for Human Reproduction (ESHRE, 2007) the 1% of infertile couples who receive infertility treatment, including IVF, intra uterine insemination (“IUI”) and other fertility treatment, represents a $6 billion worldwide market.  This leaves 99% of the infertile couples untreated with an estimated unmet market opportunity of $594 billion, a portion of which, we believe will be met by the INVO device.  Much of the unmet market is located in developing countries where many patients cannot afford, and have limited access to, IVF.  We believe that developing countries offer a large and ready market for the INVOcell.
In May 2008, we received notice that the INVOcell device meets all of the essential requirements of the relevant European Directive,Securities Act of 1933, the following persons in the capacities and received CE marking.  The CE marking (also known as a CE mark) is a mandatory conformity mark on many products placed on the single medical device market in the European Economic Area ( i.e., Europe, Canada, Australia, New Zealand and most parts of the Middle East) (“EEA”).  The CE marking (an acronym for the French "Conformité Européenne") certifies that a product has met European health, safety and environmental requirements, which ensure consumer safety.   Manufacturers in Europe and abroad must meet CE marking requirements where applicable in orderdates indicated have signed this Amendment No. 1 to market their products in Europe.  With CE marking, we now have the necessary regulatory authority to distribute our INVOcell device in the EEA, subject to local registration regulations.  
Currently, we are continuing to establish agreements with distributors and train physicians in the areas outside of the US they include Canada, South America, Latin America, Europe, the Middle East and Africa.  While we penetrate the infertility markets in Europe and Canada along with the certain developing countries, we anticipate also pursuing the completion of the FDA ’ s “510(k)” process.  We have completed the first step for medical device companies who manufacture Class 2 devices (and a small number of Class 1 and 3 devices), the filing of a Premarket Notification with the FDA (i.e., an FDA 510(k) submission).  Technically, the FDA does not "approve" Class 1 and 2 medical devices for sale in the U.S. they give "clearance" for them to be sold.  We believe we are presently halfway completed with our clinical trial and anticipate its completion by the end of 2010, subject to funding through the AGS REF or other sources.  However, there can be no assurance that our trial will be successful and that we will receive FDA clearance thereafter.
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COMPETITION
The infertility industry is highly competitive and characterized by technological improvements.  New artificial reproductive technology (“ART”) services, devices and techniques may be developed that may render the INVOcell obsolete.  Competition in the areas of infertility 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.  The INVO procedure will offer an alternative treatment to couples who currently do not have access to treatments because of cost or location.  Infertility clinics can expand their businesses by offering INVO in satellite centers that can be opened at a substantially lower cost than an IVF center.  We are not aware of any direct competitors to INVO Bioscience or the INVO process using the INVOcell device.  However, there are existing infertility treatment regimes that the INVOcell will compete with when the 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.
Competing Treatments
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 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.  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 by a subset of 5,000 of the 40,000 fertility doctors in the U.S. as well as by IVF providers.  In Europe, at least 550,000 IUI cycles are performed annually.  The cost of a single IUI treatment can range from $500 to $4,000 per cycle in the U.S. and $500 to $2,000 in Europe.  The intra-country differences in cost depend on the stimulation protocol and the accuracy of the ovulation monitoring used by physician.
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 and 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, they are transferred to the uterine cavity.  The transfer of several embryos allows an average success rate for IVF of 27%, but it is also responsible for a high multiple birth rate of approximately 40% of IVF pregnancies.  Multiple births bring risks to mother and babies and significant expenses for third party payers.  In addition, due to the high number of embryos produced in IVF, cryo-preservation of excess embryos occurs in more than 30% of the cycles.  In the U.S., there are approximately 1,000 reproductive endocrinologists who collectively perform more than 125,000 IVF cycles per year at 430 specialized facilities.  In Europe, nearly 300,000 IVF cycles are reportedly performed at more than 1,000 facilities.
The cost to the patient for a single IVF cycle (including drugs) averages $12,400 in the U.S. and can go as high as $20,000 depending on the IVF center.  The cost of drugs for an IVF cycle ranges from $2,500 to $3,500.  The average cost per live birth using IVF can exceed $50,000 since the successful patient generally requires more than one cycle.  Many patients who would be good candidates for IVF are unable to access it 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.  In addition, some couples experience concerns regarding IVF such as the possibility of laboratory errors resulting in receiving another person’s embryo.
Competitors
We operate in a highly competitive industry, which is subject to competitive pricing and rapid technological change.  The market for fertility treatment and devices are 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.  Our competitors may implement new technologies before we do, allowing them to offer more attractively priced or enhanced products, services or solutions than we provide.  Most of our competitors may have greater resources in certain business segments or geographic markets than we do.  We may also encounter increased competition from new market entrants or alternative ART technologies.  Our operating results significantly depend on our ability to compete in this market environment, in particular on our ability to adapt to economic or regulatory changes, to introduce new products to the market and to enhance the functionality while reducing the cost of new and existing products.
Our principal ART medical-device competitor is Anecova, a Swiss start-up life sciences company with an intrauterine device under development 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 inside the woman’s uterus for early embryo development.  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.  The precision manufacturing of the Anecova device will drive its cost close to $1,500, which is higher than our price.  If the Anecova device is shown to be effective, it is likely that the device would only be available in hospitals and IVF Centers at a significantly higher cost than the INVOcell.  This procedure still needs the complex equipment of an IVF center.
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Competitive Advantages
We believe that the INVOcell has the following competitive advantages:
Lower cost than IVF with similar efficacy:  The INVOcell is substantially less expensive than IVF due to the shorter time to execute the procedure, lower costs of supplies, labor, capital equipment and overhead.  An IVF center requires at least $500,000 of laboratory capital equipment and highly trained personnel.  In contrast, the cost of laboratory capital equipment to set-up an INVOcell procedure is approximately $30,000 and does not require highly trained specialists beyond the traditional obstetrician and gynecological practice.  The global success rate for IVF varies dramatically from 13.6% to 40.5% with an average of 27% per cycle (ESHRE, ICMART Committee, June 21, 2006).  We foresee INVO will be offered at approximately $5,000 per cycle with a pregnancy rate comparable to traditional IVF (20% versus 27%, INVO to IVF, respectively).  In Europe, IUI currently averages $1,000 per cycle and IVF averages $5,000.  INVO in Europe will be offered at approximately $2,500 per cycle.  In Europe, the average cost per pregnancy for IVF is $21,354.
Similar cost than IUI with greater efficacy: In the U.S. currently, IUI averages $1,500 per cycle with <10% pregnancy rate while IVF averages $12,400 per cycle with an average of 27% pregnancy rate.  With INVO, we believe that the Ob/Gyn or reproductive endocrinologist practitioners will benefit by providing a superior product than IUI with good financial margins, efficacy rates more than double IUI while treating the full range of infertility indications.  In Europe, the average cost per pregnancy using IUI is $12,000.  The average cost per pregnancy for IVF is $21,354 while for INVO it is only $13,888: a savings of more than $7,000 per pregnancy.  Using INVO could reduce annual infertility costs in Europe by more than $650 million.
Greater geographic availability:   In Europe, there are more than 1,000 IVF centers, and there are approximately 430 IVF centers in the U.S.  In addition, by having INVO geographically available in Ob/Gyn offices, couples will not have the travel costs and absence from work associated with IVF treatments.  The medical staff at these centers could easily learn INVO and offer it as a lower cost treatment option for their patients through satellite centers.  There are also 5,000 Ob/Gyn physicians in the U.S. who offer infertility services (IUI).  Since INVO does not require a specialized lab facility, large costly equipment or highly specialized staff, it may possible be offered in a doctors’ office setting.  Therefore, in the U.S. alone, INVO could be 10 times more available than conventional IVF.  This also allows Ob/Gyn offices worldwide to offer INVO as an alternative or follow up treatment to IUI and generate a significant new revenue stream.
Greater patient involvement: With INVO, the patient uses her own body as the incubation environment.  This creates a greater sense of involvement, comfort and participation for patients who know that the fertilization is happening within their own bodies.  In some cases, this frees the couples from ethical or religious concerns, or fears of laboratory mix-ups that could result in a patient receiving another couple’s embryo(s).
SALES AND MARKETING
Product Pricing
We anticipate employing the following pricing system for the INVOcell technology.  These prices were determined through discussions with our advisory board of physicians and potential strategic partners and reflect the innovative features of the device, the savings in physician’s laboratory fixed costs and the amount that a physician will receive from patients to perform INVO. Our goal is to have the INVO procedure be a lower cost alternative, with comparable success rates.
INVOcell device:    We expect to sell the INVOcell device and its retention system for between $75 and $400 per unit.  IVF centers or Ob/Gyn groups purchasing a large number of devices and promoting the INVO process will receive discounted prices and a limited amount of free advertising of their facility on our website.  It is expected that the INVOcell will sell for $400 in the U.S., which grants a single-use license under our patents. In Central and South America and Europe, the price of the device will be reduced to between $100-$300 to reflect a generally lower cost of infertility procedures in most of these countries and to make INVOcell available to populations with lower incomes.
Holding/Warming Blocks:  The holding blocks will be sold as a tool for viewing and retrieving the embryos from the inner chamber.  Each physician will need a minimum of two blocks depending on the number of cycles he/she performs.  The blocks cost $100 per block and will sell for $200 and will constitute an additional revenue stream.
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.  We have had initial discussions with an equipment supplier that has a mobile bench and hood with all the required equipment.  We intend to establish an agreement with this company to provide our customers with a discount and financing to facilitate new customer entry into the INVO market in the future, however, there can be no assurance that we will be successful in this effort.  The complete set up for the INVO procedure is approximately $33,000 in Europe and $50,000 in the U.S.
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Our Sales Team
As of the date of this prospectus, we employ two sales and marketing individuals who are charged with all of our sales efforts.  We anticipate growing our sales team to eight in 2010, subject to raising additional capital.  Our sales efforts follow two approaches:
Direct Physician Sales through Distributors -- In many countries, we intend to establish local distributors to access the countries’ markets.  With the distributor-to-physician model, the distributors will be selling to IVF centers, medical practices and physicians directly.  We will support the distributor’s efforts with training, both to the distributor’s trainers as well as to the physicians directly.  We current maintain distribution agreements in the following countries: Canada, Colombia, Venezuela, Ecuador, Panama, Argentina, Peru, Pakistan, Turkey and Taiwan. Additionally we are in discussions with potential distributors for Spain, Greece, Cyprus, Bulgaria, Poland, Russia, Egypt, India, and South Africa
Direct Sales to Physicians -- We are also following a parallel path directly to leading infertility doctors in regions where there is demand but either distributors do not exist such as in Western Africa or we have not yet signed distribution agreements.  
Target Markets
Currently and through 2010, we anticipate that we will launch the sale of the INVOcell device in Europe, Canada, South America and the Middle East.  During 2011, or at such time that we receive FDA approval, we anticipate launching the INVOcell in the U.S.  In 2010, we also anticipate the launch of the INVOcell device in India and Russia.  In 2011, we anticipate the launch of the INVOcell device in China and other countries where an alternative treatment is needed.  With the cost of the INVO procedure being less than half the cost of IVF, we expect to penetrate 5% of the currently untreated infertility market, although no assurances can be made in this regard.
Worldwide -- According to the European Society for Human Reproduction (ESHRE, 2007) there are more than 100 million infertile couples in the world.  About one million IVF cycles were performed in 2006, which is less than 1% of the infertile couples worldwide.  More than 99 million infertile couples remain untreated due to cost, availability, awareness and other factors.
U.S. -- According to the Centers for Disease Control, 7.3 million people in the U.S. have difficulty conceiving.  With only 350,000 couples receiving fertility treatment, more than six million couples receive no treatment.  According to Integramed, Inc., a U.S. based network of fertility centers, 97% of the untreated infertile couples do not receive treatment due to cost.  Working with our advisory board, we estimate that an INVO procedure in the U.S. will cost approximately $5,000 dollars.  
Europe -- Europe has approximately 10 million infertile couples, of which 137,000 are estimated to have received IVF treatment and 183,000 received IUI (ESHRE) leaving 9.5 million infertile couples untreated.
Preliminary Sales Strategy
We have received the CE Mark that allows us to sell product in Europe, Canada and other countries in South America, the Middle East, and Africa along with Russia, and India subject to local registration requirements.  Our strategy is to launch the product in the developing world first because of the high demand and relatively low availability of IVF procedures. 
Launching INVO in the U.S. market requires 510(k) clearance, which we anticipate receiving in early 2011 upon completion of our clinical trials estimated for 2010 based on adequate funding from the REF.  We have completed the required human confirmatory study.  The births of normal babies have been confirmed in this study using the INVOcell.  It will take nine months and approximately $1,000,000 of funding to complete the data collection on all required subjects, analyze the data, have an independent audit and submit the full 510(k) to the FDA.  The FDA has 90 days to review the submission from INVO Bioscience.  All preclinical data and testing has been completed and reviewed by FDA.  We expect to receive approval to sell the INVOcell without further studies at that time.  However, there is no assurance that will be the case.  We intend to launch INVOcell through key IVF centers in the U.S. once FDA clearance is achieved.  Our U.S. based board of advisors and participants in our clinical trials have indicated a desire to be among the first to offer the INVOcell to their patients.  The success of these IVF centers with the INVOcell will assist in expanding our share of the market in the U.S.  We will also target the 5,000 Ob/Gyn doctors with experience in infertility treatment.
Insurance Reimbursement for Infertility Treatment
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 UK covers 20% of most costs for infertility treatment.  However, that standard is not applied universally throughout the country and some counties provide almost none.  In the U.S., fifteen states mandate some form of insurance reimbursement for infertility treatment.  Three states mandate reimbursement for IVF, while other states cover some form of infertility treatment, but they may also specifically exclude IVF due to cost.  In addition, fifteen other states are considering mandating some form of coverage for infertility treatment.  Finally, there are bills under consideration in the U.S. Congress for a federal mandate to provide insurance coverage for infertility treatments universally across the nation.
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We believe that the INVOcell process will be treated favorably by insurance companies because it lowers cost and has a high efficacy rate.  In Europe, the average cost per pregnancy using IUI is $12,000 and IUI is appropriate for only 40% of the infertile population.  However, for INVO, which is marginally more expensive at $13,888 per pregnancy, is a more effective treatment for a majority of infertile couples.  The average cost per pregnancy for IVF is $21,354.  Therefore, there is a savings of more than $7,000 (over 33%) per pregnancy by using INVO versus IVF.  Using INVO could reduce infertility costs in Europe by more than $650 million.
Currently, many third-party payers require that an infertile patient have at least three cycles of IUI before going on to IVF.  The aggregate success rate of three IUI’s is 25%.  Therefore, up to 75% of those patients are often referred to IVF.  In the future, third-party insurance payers could save more than $7,000 per pregnancy by requiring the patient to try INVOcell first.
Branding and Promotion
We have a new logo refined for the infertility market.  We have trademarked the logo, device and technology.  At the same time, we are developing a website that includes special pages for clinicians and patients.  Subject to available capital, the next generation website will include materials that medical professionals and patients can print, including status reports and news items.  It will include a training videos for potential customers both physician and patients who want to learn exactly how the INVOcell works.
REGULATION
Domestic Regulations
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 and the regulations promulgated there under.  We are subject to the standards and procedures with respect to the manufacture of medical devices and are subject to inspection by the FDA for compliance with such standards and procedures.  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.  The INVOcell device and process must secure a 510(k) pre-market notification clearance before it can be introduced into the United States market.  The process of obtaining 510(k) clearance typically takes several months and may involve the submission of limited clinical data supporting assertions that the product is substantially equivalent to an already approved device or to a device that was on the market before the enactment of the Medical Device Amendments of 1976.
Every company that manufactures or assembles medical devices is required to register with the FDA and adhere to certain “good manufacturing practices” in accordance with the FDA’s Quality System Regulation, which regulates the manufacture of medical devices, prescribes record-keeping procedures and provides for the routine inspection of facilities for compliance with such regulations.  The FDA also has broad regulatory powers in the areas of clinical testing, marketing and advertising of medical devices.
Medical device manufacturers are routinely 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, it can:
statement below.

·  Signatureplace the company under observation and re-inspect the facilities;TitleDate
·  issue a warning letter apprising of violating conduct;
·  detain or seize products;
·  mandate a recall;
·  enjoin future violations; and
·  assess civil and criminal penalties against the company, its officers or its employees.
At present, we believe are more than halfway completed with the clinical trials requested by the FDA through our predecessor company.  Subject to available capital, we anticipate completing those clinical trials by the end of 2010.  Thus, we believe that we will receive FDA clearance by 2011, though there can be no assurance that we will be successful in doing so on a timely basis, if at all.
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International Regulations
We are also 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 social security 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 do not have a formal approval process of their own but rely on either FDA clearance or the European approval, CE Mark, they follow that up with a registration process of listing the INVOcell with the governing body.
Our activities during our development stage have included developing the business plan, seeking regulatory clearance in Europe and the United States and raising capital.  In May 2008, we received notice that the INVOcell product met all the essential requirements of the relevant European Directive(s), and received CE marking.  The CE mark is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA).  The CE mark (an acronym for the French "Conformité Européenne") certifies that a product has met EU health, safety and environmental requirements, which ensure consumer safety.
With CE marking, we now have the ability and necessary regulatory authority to distribute our product after registration in the European Economic Area (i.e., Europe, Canada, Australia, New Zealand, along with most parts of the Middle East and South America). Every country is different we have completed registrations in some, are in process with others, upon funding from the REF we will be submitting additional registrations and for a few others we have to wait until we have FDA clearance. We are registering the product based on the size of the market and our ability to service it given our resources.
INTELLECTUAL PROPERTY
More than 800 cases of an INVO procedure have been documented in peer-reviewed journals since the 1980s, using an incubation device not specifically designed for the process but functionally capable of demonstrating success rates equivalent to IVF at that time.  The INVOcell device was specially developed and manufactured to optimize the ease of use and effectiveness of the procedure at an affordable price.  This product development process has resulted in five active patents worldwide covering both the INVOcell device and the INVO process.  
LEGAL PROCEEDINGS
We are not involved in any lawsuit outside the ordinary course of business, the disposition of which would have a material effect upon either our results of operations, financial position or cash flows.
PROPERTY
We currently do not own any property.  Our principal executive office is located at 100 Cummings Center, Suite 421E, Beverly, Massachusetts 01915, pursuant to a lease entered into by INVO Bioscience in January 2007 for 3,294 square feet of general office space.  The lessor is Cummings Properties, LLC and the lease commenced in January 2007 and concludes on December 31, 2010.  The lease is subject to a cost of living increase equal to the Boston, Massachusetts Consumer Price Index at the beginning of each calendar year.  
EMPLOYEES
As of September 30, 2009, we have 5 full-time employees.  We consider our relationship with our employees to be good.
MANAGEMENT
The following table sets forth the names and positions of our directors and executive officers and other key personnel as of September 30, 2009:
 

/s/ Steven Shum

Chief Executive Officer and Director

July 3, 2023
Steven Shum(principal executive officer)

*

Chief Financial Officer

July 3, 2023
Andrea Goren(principal financial officer)

*

Director

July 3, 2023
Trent Davis    
     
Name

*

 Age

Director

 PositionJuly 3, 2023
Kathleen T. Karloff
Matthew Szot
54
Chief Executive Officer, Secretary and Director
Dr. Claude Ranoux
58
President, Treasurer, Chief Scientific Officer and Director
Robert J. Bowdring
52
Chief Financial Officer
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Each Director holds office until the next annual meeting of the shareholders or until his successor is elected and duly qualified. Executive officers are appointed by and serve at the pleasure of the Board of Directors. The following sets forth biographical information concerning our directors, and executive officers for the past three years:
Kathleen T. Karloff, Chief Executive Officer, secretary and member of the Board of Directors, co-founded INVO Bioscience in January 2007.  Since that time, Ms. Karloff has obtained ISO certification and the CE mark for the INVOcell device and has implemented manufacturing and distribution systems.  From 2000 through 2003, Ms. Karloff was the Vice President of Operations for a start-up company called Control Delivery Systems, which was developing an intra-ocular drug therapy for Uveitus and Diabetic Macular Edema.  That company was acquired by Psivida LTD in December 2005.  From 2004 until September 2006, Ms. Karloff was the Vice President of Operations for Medelle Corporation.  Prior to that, she has held various positions at Boston Scientific during 13 years of dynamic growth from 1983 to 1997 her last position being the Director of Manufacturing.  Since leaving Boston Scientific, she has been Vice President of Operations on start-up teams of three device/pharmaceutical companies.  Ms. Karloff earned her B.S. in microbiology from Montana State University and attended Northeastern University for MBA coursework.

Dr. Claude Ranoux, President, Treasurer and member of the Board of Directors, co-founded INVO Bioscience in January 2007.  He has more than 30 years of experience in the research and treatment of infertility; he is the inventor and developer of the INVO™ procedure and INVOcell device.  From 2000 through 2005, Dr. Ranoux was president of Medelle Corporation and worked on development of the INVOcell.  Dr. Ranoux has built and run 12 IVF centers worldwide and has established 12 reproductive centers worldwide.  Before founding INVO Bioscience and recruiting the highly experience management team, Dr. Ranoux had 6 years of experience in creating  and finding financing for a start-up company.  He has been scientific consultant for a new instrument (Immuno1) from Bayer Corporation.  During this collaboration, the North West area became the first area for the sales of the instrument 2 years in a row. Dr. Ranoux was the founder of several non-profit organizations and foreign trade advisor in the New England area.  Dr. Ranoux earned his M.D. and his M.S. in Reproductive Biology from the Medical University of Paris (V & XI) where he was an Associate Professor.  Dr. Ranoux has served as a scientific consultant for eight other centers and is  the author of numerous scientific publications as first author.  He has given numerous invited lectures, conferences and workshops and is the author of five medical and scientific theses and mentor for several others.  He is co-author of six scientific and medical films.  He received a prize for the one of the best scientific presentation at the Fifth World Congress in IVF, in Norfolk, VA, and is the recipient of several other awards.  Dr. Ranoux is the main inventor in six international patents.
Robert J. Bowdring, Chief Financial Officer, Mr. Bowdring joined the Company as its Corporate Controller in October 2008.  In January 2009, the Company appointed Mr. Bowdring as its Chief Financial Officer.  From April 2003 to August 2008, Mr. Bowdring served as Vice President of Finance and Administration for Cyphermint, Inc., a software development firm.  For the fourteen prior years, he was the Controller and Vice President of Lifeline Systems Inc., a public manufacturing and service company (NASDAQ: LIFE) in the personal emergency response market.  Mr. Bowdring has a strong history in senior financial management with more than 25 years experience serving in capacities such as chief financial officer, vice president of finance and controller.  Rob has been in both public and private manufacturing and service companies throughout his career.  Mr. Bowdring has a Bachelors degree in Accounting from the University of Massachusetts in Amherst.
Board of Directors
Currently, we only have two board members, Claude Ranoux and Kathleen Karloff, who are also our CEO and President.  We expect to add three independent members to expand our Board of Directors to five in 2010, depending upon our ability to reach and maintain financial stability.
Committees of the Board of Directors
We do not currently have an Audit Committee, Compensation Committee, Nominating Committee, or any other committee of the Board of Directors. The responsibilities of these committees are fulfilled by our Board of Directors and all of our directors participate in such responsibilities. In addition, we do not currently have an "audit committee financial expert" as such term is defined in the Securities Act, as our financial constraints have made it extremely difficult to attract and retain qualified outside Board members. We hope to add qualified independent members of our Board of Directors in 2010, depending upon our ability to reach and maintain financial stability.
Compensation Committee Interlocks and Insider Participation
We do not have a Compensation Committee or any other committee of the Board of Directors performing similar functions during the years ended September 30, 2009. Kathleen Karloff, our Chief Executive Officer, Claude Ranoux, President and Robert Bowdring CFO make decisions relating to compensation.
Code of Ethics
We have adopted a Code of Ethics that applies to all employees including our officers, our principal executive officer, our president and principal financial & accounting officer.
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EXECUTIVE COMPENSATION
Compensation Discussion and Analysis

Compensation before the Share Exchange

Prior to the closing of the Share Exchange, the named executive officers received stock awards as their compensation from February 2007 until June 2008.  In July 2008 through the year end of December 31, 2008, which included the closing of the Share Exchange, our officers drew an annualized salary of $175,000 each.  The named executive officers’ salaries did not change as a result of the Share Exchange. The Board of Directors, who are also named executive officers, determined the compensation for themselves and the other executive officers and employees of INVO Bioscience. The members of the Board of Directors do not receive separate compensation for serving as directors, although it is anticipated that any non-employee directors who may be appointed to the Board will be compensated in a manner to be determined by the Board at such time as new directors are appointed.

Compensation after the Share Exchange

From January 1, 2009 to present the named executive officers compensation consisted solely of each executive officer’s salary; no cash bonuses were paid or accrued.  On January 2, 2009, Mr. Robert J. Bowdring was promoted to the position of Chief Financial Officer by the Board of Directors, thus making him a named executive as of that date.  From March 1, 2009 until present, the named executive officers’ salaries have been accrued, but not paid, to financially assist the Company during this period.  The Board of Directors of INVO Bioscience believes that the salaries paid and accrued to our executive officers during 2008 and 2009 are indicative of the objectives of its compensation program as this stage of our development.
Salary is designed to attract, as needed, individuals with the skills necessary for us to achieve our business plan, to motivate those individuals, to reward those individuals fairly over time, and to retain those individuals who continue to perform at or above the levels that we expect.  When setting and adjusting individual executive salary levels, we consider the relevant established salary range, the named executive officer’s responsibilities, experience, potential, individual performance and contribution.  We also consider other factors such as our overall corporate budget for annual merit increases, unique skills, demand in the labor market and succession planning.  We determine the levels of salary as measured primarily by the local market in Boston/New England, which determinations are made based on anecdotal evidence rather than compensation studies or surveys.  

Corporate performance goals include sales, margin and net profit targets.  Additional key areas of corporate performance taken into account in setting compensation policies and decisions are new business development, cost control, and innovation.  The key factors may vary depending on which area of business a particular executive officer’s work is focused.  Individual performance goals include subjective evaluation, based on an employee’s team-work, creativity and management capability, and objective goals such as sales targets.  We have not paid bonuses to our executive officers in the past.  If we are successful in raising capital and building our business, we intend to establish a bonus program for all of our employees including our named executive officers.  Although no such program has been designed, the program is expected to be based on both corporate and individual performance goals.    
Our intention is to establish a compensation committee comprised of both non-employee and employee directors, once we expand the Board.  The compensation committee will perform, at least annually, a strategic review of the compensation program for our executive officers to determine whether it provides adequate incentives and motivation to our executive officers and whether it adequately compensates our executive officers relative to comparable officers in other companies with which we compete for executives.  Those companies may or may not be public companies or companies located in the Boston area or even, in all cases, companies in a similar business.   We would like to establish a compensation program for executive officers that is designed to attract, as needed, individuals with the skills necessary for us to achieve our business plan, to motivate those individuals, to reward those individuals fairly over time, and to retain those individuals who continue to perform at or above the levels that we expect.  

We also intend to expand the scope of our compensation, such as the possibility of granting options or other stock-based awards to executive officers and tying compensation to predetermined performance goals.  We intend to adopt an equity incentive plan in the near future and issue stock-based awards under the plan to aid our long-term performance, which we believe will create an ownership culture among our named executive officers that fosters beneficial, long-term performance by our company.  We do not currently have a general equity grant policy with respect to the size and terms of grants that we intend to make in the future, but we will evaluate our achievements for each fiscal year based on performance factors and results of operations such as revenues generated, cost of revenues, and net income. No such goals have been determined for this fiscal year.

The following Summary Compensation Table sets forth, for the years indicated, all cash compensation paid, distributed or accrued for services, including salary and bonus amounts, rendered in all capacities by the Company’s chief executive officer,  president and chief financial officer who received or was entitled to receive remuneration in excess of $100,000 during the stated periods.  As reflected below, none of our officers received cash compensation during fiscal 2007.
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SUMMARY COMPENSATION TABLE
Name and Principal Position Year Salary  Bonus ($)  
Stock Award
($)
  Option Award ($)  Non-Equity Incentive Plan Compensation Earnings ($)  Non-Qualified Deferred Compensation Earnings ($)  All other Compensation ($)  
Total ($)
 
                           
Kathleen Karloff, CEO/Director(1) (2) 2009 $131,252   -   -   -   -   -   -  $131,252 
  2008 $93,074   -   -   -   -   -   -  $93,074 
   2007 $-   -  $4,498   -   -   -   -  $4,498 
                                   
Claude Ranoux, President/Director(2) (3) 2009 $ 131,252   -   -   -   -   -   -  $131,252 
  2008 $91,974   -   -   -   -   -   -  $91,974 
  2007 $-   -  $19,731   -    -    -   -  $19,731 
                                   
Robert Bowdring, CFO (2)  2009 $108,750   -   -   -   -   -   -  $108,750 
  2008 $24,518   -   -   -   -   -   -  $24,518 
  2007 $-   -   -   -   -   -   -  $- 
(1)Kathleen Karloff was elected as the Chief Executive Officer, Secretary and member of the Board of Directors of the Company effective upon the resignation of Andrew Uribe in connection with the Share Exchange between INVO Bioscience and Emys on December 5, 2008.  During 2007, Ms. Karloff received shares of common stock valued at $.2857/share.
(2)2009 salary includes both paid and accrued salary for all officers.
(3)Claude Ranoux was elected as the President, Treasurer and member of the Board of Directors effective upon the resignation of Andrew Uribe, in connection with the Share Exchange between INVO Bioscience and Emys on December 5, 2008.  During 2007, Dr. Ranoux received shares of common stock valued at $.2857/share.
Stock Option Grants
Since January 1, 2008, we have signed agreements to compensate certain officers, employees and service providers with common stock or options to acquire common stock.  As of December 31, 2008, a total of 857,000 shares of common stock and options to purchase an additional 440,000 shares of common stock were agreed to be issued.  As of September 30, 2009, we have issued the 857,000 shares of common stock against its previously recorded accrued liability.  However, as of September 30, 2009, we terminated 70,000 of the options and agreed to issue an additional 300,000 to two employees hired during 2009 bringing the total options to 670,000 as of this date.  We have not yet adopted a formal stock option plan and, consequently, the options to purchase 670,000 shares of common stock are deemed not yet issued. 
Long-Term Incentive Compensation:  We are looking to establish a program that will provide long-term incentive compensation through awards of stock options, restricted stock, and/or stock awards.  Our equity compensation program is intended to align the interests of the officers with those of our shareholders by creating an incentive for our officers to maximize shareholder value.  The equity compensation program will be designed to encourage officers to remain employed with us despite a competitive labor market, and the fact that we are a development stage company and have a limited operating history and limited revenue to date, and may not necessarily be able to sustain a market rate base salary.  Stock options, stock grants, warrants and other incentives are based on combination of factors including the need and urgency for such an executive, the experience level of the executive and the balance of such incentives with a lower than market base salary or fees that is paid in cash. Employees and consultants are granted such incentives from time to time to maintain their continuing services, sometimes without increases in salaries or fees.
Deferred Compensation Benefits:  We do not have a deferred compensation program at this time.
Retirement Benefits:  We do not have a 401(k) plan or other retirement program at this time.
Executive Perquisites and Generally Available Benefits:  We have no executive perquisite program at this time.
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Employment Agreements; Termination of Employment and Change of Control Arrangements
Kathleen T. Karloff, Chief Executive Officer, Secretary and member of the Board of Directors, has executed an employment agreement with INVO Bioscience effective as of February 1, 2008.  The agreement provides for an annual salary of $175,000 and health and life insurance and retirement plan along with the reimbursement of expenses.  In the event that Ms. Karloff’s employment is terminated other than for good cause (as defined in the employment agreement), she will receive her salary and full medical benefits for twelve (12) months thereafter.  
Dr. Claude Ranoux, President, Treasurer and member of the Board of Directors, has executed an employment agreement with INVO Bioscience effective as of February 1, 2008.  The agreement provides for an annual salary of $175,000 and health and life insurance and retirement plan along with the reimbursement of expenses.  In the event that Dr. Ranoux’s employment is terminated other than for good cause (as defined in the employment agreement), he will receive his salary and full medical benefits for twelve (12) months thereafter.  
Robert J. Bowdring, Chief Financial Officer, has executed an employment agreement with INVO Bioscience effective as of October 27, 2008.  The agreement provides for an annual salary of $150,000 and health and life insurance and retirement plan along with the reimbursement of expenses.  In the event that Mr. Bowdring’s employment is terminated other than for cause (as defined in the employment agreement), he will receive a severance package of two months of salary and full medical benefits per service year
Outstanding Equity Awards
The Company has not yet adopted a formal stock option plan.  Accordingly, there are no outstanding equity awards as of September 30, 2009.
CERTAIN RELATIONSHIPS AND RELATED PARTY TRANSACTIONS

On September 18, 2008, we entered into a related party transaction with Dr. Claude Ranoux, the President, Director and Chief Scientific Officer of the Company.  Dr. Ranoux had loaned funds to the Company to sustain its operations since January 5, 2007 (inception).  Dr. Ranoux’s total cumulative loans at September 30, 2009 were $70,462.  On March 26, 2009, the Company and Dr. Ranoux agreed to amend the agreement to a non-convertible note payable bearing interest at 5% per annum and extended the repayment date to March 31, 2010.  The Company and Dr. Ranoux can jointly decide to repay the loan earlier without prepayment penalties.  During the three months and nine months ended September 30, 2009, $26,000 was repaid on the principal of the loan.
On March 5, 2009, we entered into a related party transaction with Kathleen Karloff, the Chief Executive Officer and a Director of the Company.  Ms. Karloff provided a short-term loan in the amount of $75,000 bearing interest at 5% per annum to the Company to fund operations.  In May 2009, Ms. Karloff loaned to the Company an additional $13,000, making her total cumulative loan $88,000 as of September 30, 2009.  This note was due on September 15, 2009, which has since been extended to March 4, 2010. 
PRINCIPAL SHAREHOLDERS
The following table sets forth certain information regarding the beneficial ownership of our common stock as of December 11, 2009, (i) by each of our directors; (ii) by each person known by us to own beneficially more than five percent of our common stock; (iii) by the executive officer named in the Summary Compensation Table set forth in "Executive Compensation" and (iv) by all of our directors and executive officers as a group. Beneficial ownership is determined in accordance with Rule 13d-3(d) promulgated by the SEC under the Securities Exchange Act of 1934, as amended. Unless otherwise noted, each person or group identified possesses sole voting and investment power with respect to the shares, subject to community property laws where applicable. The percentage of shares beneficially owned prior to the offering is based on 58,002,763 shares of our common stock actually outstanding as of December 11, 2009.
Name of Principal Shareholder Number of Shares Owned  
Percent of Shares
Outstanding
 
Dr. Claude Ranoux  25,501,473   44.0%
Kathleen Karloff  5,862,159   10.1%
Christopher Esposito  3,931,763   6.8%
Phillip Warren  3,457,778   6.0%
         
All Officers and Directors as a Group (two persons)  31,363,632   54.1%
We have 58,002,763 shares issued and outstanding as of December 11, 2009.
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SELLING SHAREHOLDER
This prospectus relates to the possible resale by the selling stockholder, AGS Capital, LLC, of shares of common stock that we may issue pursuant to the Reserve Equity Financing Agreement, or REF, that we entered into with AGS on October 28, 2009. We are filing the registration statement of which this prospectus is a part pursuant to the provisions of the registration rights agreement we entered into with AGS on October 28, 2009.
The selling stockholder may from time to time offer and sell pursuant to this prospectus any or all of the shares that it acquires under the REF.
The following table presents information regarding AGS and the shares that it may offer and sell from time to time under this prospectus. This table is prepared based on information supplied to us by the selling stockholder. As used in this prospectus, the term “selling stockholder” includes AGS and any donees, pledgees, transferees or other successors in interest selling shares received after the date of this prospectus from a selling stockholder as a gift, pledge or other non-sale related transfer. The number of shares in the column “Number of Shares Being Offered” represents all of the shares that the selling stockholder may offer under this prospectus. The selling stockholder may sell some, all or none of its shares. We do not know how long the selling stockholder will hold the shares before selling them, and we currently have no agreements, arrangements or understandings with the selling stockholder regarding the sale of any of the shares.
Beneficial ownership is determined in accordance with Rule 13d-3(d) promulgated by the SEC under the Securities Exchange Act of 1934, as amended. Unless otherwise noted, each person or group identified possesses sole voting and investment power with respect to the shares, subject to community property laws where applicable. The percentage of shares beneficially owned prior to the offering is based both on 58,002,763 shares of our common stock actually outstanding as of December 11, 2009 and on the assumption that all shares of common stock issuable under the REF we entered into with AGS are outstanding as of that date.
              
 
Name of Beneficial Owner
 
Shares Beneficially Owned
Prior to the Offering
 
Number of
Shares Offered
  
Shares Beneficially Owned
After the Offering
 
 Number Percent Number  Percent 
AGS Capital Group, LLC(1)  8,790,000(2) %  8,790 ,000   —   — 
(1) The address of AGS is:   2 Water Street, 17th Floor, New York, New York
(2) Consists of 8,790,000 shares of common stock issuable under the REF we entered into with AGS on October 28, 2009. For the purposes hereof, we assumed the issuance of the 8,790,000 shares of common stock issuable pursuant to the REF, but no additional shares of common stock potentially issuable pursuant to the REF. We will file subsequent registration statements covering the resale of any additional shares of common stock beginning approximately 60 days after we have substantially completed the sale to AGS under the REF of the shares subject to this registration statement. Allen Silberstein has voting and investment control of the securities held by AGS.
DESCRIPTION OF CAPITAL STOCK
Our authorized capital stock consists of 200,000,000 shares of common stock, $0.0001 par value and 100,000,000 shares of preferred stock, $0.0001 par value. As of December 11, 2009, there were 58,002,763 shares of our common stock outstanding that were held of record by approximately 98 stockholders, and options and warrants to purchase 9,100,000 shares of common stock were outstanding.
The following description is only a summary. You should also refer to our amended and restated certificate of incorporation and bylaws, both of which have been filed with the SEC as exhibits to our registration statement of which this prospectus forms a part.  
Common Stock

Each holder of common stock is entitled to one vote for each share on all matters submitted to a vote of the stockholders, including the election of directors, and each holder does not have cumulative voting rights. Accordingly, the holders of a majority of the shares of common stock entitled to vote in any election of directors can elect all of the directors standing for election, if they so choose.
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Subject to preferences that may be applicable to any then outstanding preferred stock, holders of common stock are entitled to receive ratably those dividends, if any, as may be declared from time to time by the board of directors out of legally available funds. In the event of our liquidation, dissolution or winding up, holders of common stock will be entitled to share ratably in the net assets legally available for distribution to stockholders after the payment of all of our debts and other liabilities and the satisfaction of any liquidation preference granted to the holders of any outstanding shares of preferred stock.
Holders of common stock have no preemptive or conversion rights or other subscription rights, and there are no redemption or sinking fund provisions applicable to the common stock. All outstanding shares of common stock are, and the shares of common stock offered by us in this offering, when issued and paid for, will be fully paid and nonassessable. The rights, preferences and privileges of the holders of common stock are subject to, and may be adversely affected by, the rights of the holders of shares of any series of preferred stock which we may designate in the future.
Preferred Stock

The board of directors is authorized, subject to any limitations prescribed by law, without stockholder approval, to issue up to an aggregate of 100,000,000 shares of preferred stock in one or more series and to fix the rights, preferences, privileges and restrictions granted to or imposed upon the preferred stock, including voting rights, dividend rights, conversion rights, redemption privileges and liquidation preferences. The rights of the holders of common stock will be subject to, and may be adversely affected by, the rights of holders of any preferred stock that may be issued in the future. Issuance of preferred stock, while providing flexibility in connection with possible acquisitions and other corporate purposes, could have the effect of delaying, deferring or preventing a change in control of INVO Bioscience. We have no present plans to issue any shares of preferred stock.
Registration Rights

Registration rights with respect to shares covered by this registration statement and prospectus –shares sold in connection with the Reserve Equity Financing Agreement, or REF, with AGS Capital Group, LLC. In connection with establishing the REF with AGS, we entered into a registration rights agreement with AGS. Pursuant to the registration rights agreement, we filed a registration statement, of which this prospectus forms a part, with the Securities and Exchange Commission. We have agreed to use our commercially reasonable efforts to cause this registration statement to be declared effective by the Securities and Exchange Commission. The effectiveness of this registration statement is a condition precedent to our ability to sell the shares of common stock subject to this registration statement to AGS under the REF. This registration statement covers only a portion of the shares of our common stock issuable pursuant to the REF. We will file subsequent registration statements covering the resale of additional shares of our common stock issuable pursuant to the REF beginning approximately 60 days after we have substantially completed the sale to AGS under the REF of the shares subject to this registration statement. These subsequent registration statements are subject to our ability to prepare and file them, and may be subject to review and comment by the Staff of the Securities and Exchange Commission, as well as consent by our independent registered accounting firm. Therefore, the timing of effectiveness of these subsequent registration statements cannot be assured. The effectiveness of these subsequent registration statements is a condition precedent to our ability to sell the shares of common stock subject to these subsequent registration statements to AGS under the REF.
Transfer Agent and Registrar
We have engaged the services of Island Stock Transfer as our transfer agent and registrar.
PLAN OF DISTRIBUTION
We are registering 8,790,900 shares of common stock under this prospectus on behalf of AGS. Except as described below, to our knowledge, the selling stockholder has not entered into any agreement, arrangement or understanding with any particular broker or market maker with respect to the shares of common stock offered hereby, nor, except as described below, do we know the identity of any brokers or market makers that may participate in the sale of the shares.
The selling stockholder may decide not to sell any shares. The selling stockholder may from time to time offer some or all of the shares of common stock through brokers, dealers or agents who may receive compensation in the form of discounts, concessions or commissions from the selling stockholder and/or the purchasers of the shares of common stock for whom they may act as agent. In effecting sales, broker-dealers that are engaged by the selling stockholder may arrange for other broker-dealers to participate. AGS is an “underwriter” within the meaning of the Securities Act. Any brokers, dealers or agents who participate in the distribution of the shares of common stock may also be deemed to be “underwriters,” and any profits on the sale of the shares of common stock by them and any discounts, commissions or concessions received by any such brokers, dealers or agents may be deemed to be underwriting discounts and commissions under the Securities Act. AGS has advised us that it may effect resales of our common stock through any one or more registered broker-dealers. Because the selling stockholder is deemed to be an underwriter, the selling stockholder will be subject to the prospectus delivery requirements of the Securities Act and may be subject to certain statutory liabilities of, including but not limited to, Sections 11, 12 and 17 of the Securities Act and Rule 10b-5 under the Securities Exchange Act of 1934, as amended, or the Exchange Act.
33
The selling stockholder will act independently of us in making decisions with respect to the timing, manner and size of each sale. Such sales may be made, on the over-the-counter market, otherwise or in a combination of such methods of sale, at then prevailing market prices, at prices related to prevailing market prices or at negotiated prices. The shares of common stock may be sold according to one or more of the following methods:
a block trade in which the broker or dealer so engaged will attempt to sell the shares of common stock as agent but may position and resell a portion of the block as principal to facilitate the transaction;
purchases by a broker or dealer as principal and resale by such broker or dealer for its account pursuant to this prospectus;
an over-the-counter distribution in accordance with the FINRA rules;
ordinary brokerage transactions and transactions in which the broker solicits purchasers;
privately negotiated transactions;
a combination of such methods of sale; and
any other method permitted pursuant to applicable law.
Any shares covered by this prospectus which qualify for sale pursuant to Rule 144 of the Securities Act may be sold under Rule 144 rather than pursuant to this prospectus. In addition, the selling stockholder may transfer the shares by other means not described in this prospectus.
Any broker-dealer participating in such transactions as agent may receive commissions from AGS (and, if they act as agent for the purchaser of such shares, from such purchaser). Broker-dealers may agree with AGS to sell a specified number of shares at a stipulated price per share, and, to the extent such a broker-dealer is unable to do so acting as agent for AGS, to purchase as principal any unsold shares at the price required to fulfill the broker-dealer commitment to AGS. Broker-dealers who acquire shares as principal may thereafter resell such shares from time to time in transactions (which may involve crosses and block transactions and which may involve sales to and through other broker-dealers, including transactions of the nature described above) on the Nasdaq Capital Market, on the over-the-counter market, in privately-negotiated transactions or otherwise at market prices prevailing at the time of sale or at negotiated prices, and in connection with such resales may pay to or receive from the purchasers of such shares commissions computed as described above. To the extent required under the Securities Act, an amendment to this prospectus, or a supplemental prospectus will be filed, disclosing:
the name of any such broker-dealers;
the number of shares involved;
the price at which such shares are to be sold;
the commission paid or discounts or concessions allowed to such broker-dealers, where applicable;
that such broker-dealers did not conduct any investigation to verify the information set out or incorporated by reference in this prospectus, as supplemented; and
other facts material to the transaction.
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Underwriters and purchasers that are deemed underwriters under the Securities Act may engage in transactions that stabilize, maintain or otherwise affect the price of the securities, including the entry of stabilizing bids or syndicate covering transactions or the imposition of penalty bids. AGS and any other persons participating in the sale or distribution of the shares will be subject to the applicable provisions of the Exchange Act and the rules and regulations thereunder including, without limitation, Regulation M. These provisions may restrict certain activities of, and limit the timing of, purchases by the selling stockholder or other persons or entities. Furthermore, under Regulation M, persons engaged in a distribution of securities are prohibited from simultaneously engaging in market making and certain other activities with respect to such securities for a specified period of time prior to the commencement of such distributions, subject to special exceptions or exemptions. Regulation M may restrict the ability of any person engaged in the distribution of the securities to engage in market-making and certain other activities with respect to those securities. In addition, the anti-manipulation rules under the Exchange Act may apply to sales of the securities in the market. All of these limitations may affect the marketability of the shares and the ability of any person to engage in market-making activities with respect to the securities.
We have agreed to pay the expenses of registering the shares of common stock under the Securities Act, including registration and filing fees, printing expenses, administrative expenses and certain legal and accounting fees. The selling stockholder will bear all discounts, commissions or other amounts payable to underwriters, dealers or agents, as well as transfer taxes and certain other expenses associated with the sale of securities.
Under the terms of the AGS common stock purchase agreement and the registration rights agreement, we have agreed to indemnify the selling stockholder and certain other persons against certain liabilities in connection with the offering of the shares of common stock offered hereby, including liabilities arising under the Securities Act or, if such indemnity is unavailable, to contribute toward amounts required to be paid in respect of such liabilities.
At any time a particular offer of the shares of common stock is made, a revised prospectus or prospectus supplement, if required, will be distributed. Such prospectus supplement or post-effective amendment will be filed with the SEC, to reflect the disclosure of required additional information with respect to the distribution of the shares of common stock. We may suspend the sale of shares by the selling stockholder pursuant to this prospectus for certain periods of time for certain reasons, including if the prospectus is required to be supplemented or amended to include additional material information.
LEGAL MATTERS
The validity of the issuance of the common stock offered hereby will be passed upon for us by Shulman, Rogers, Gandal Pordy & Ecker, P.A..
EXPERTS
The financial statements for the two most recent fiscal years ended December 31, 2007 and 2008, have been audited by Webb & Company, P.A. and RBSM, LLP respectively, independent registered public accounting firms, to the extent and for the periods set forth in their report, which contains an explanatory paragraph regarding our ability to continue as a going concern, appearing elsewhere herein and in the registration statement, and are included in reliance upon such report given upon the authority of said firms as experts in auditing and accounting.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
We have filed with the SEC a registration statement on Form S-1 under the Securities Act that registers the shares of our common stock to be sold in this offering. The registration statement, including the attached exhibits and schedules, contains additional relevant information about us and our capital stock. The rules and regulations of the SEC allow us to omit from this prospectus certain information included in the registration statement. For further information about us and our common stock, you should refer to the registration statement and the exhibits and schedules filed with the registration statement. With respect to the statements contained in this prospectus regarding the contents of any agreement or any other document, in each instance, the statement is qualified in all respects by the complete text of the agreement or document, a copy of which has been filed as an exhibit to the registration statement.
We file reports, proxy statements and other information with the SEC under the Securities Exchange Act of 1934. You may read and copy this information from the Public Reference Room of the SEC, 100 F Street, N.E., Room 1580, Washington, D.C. 20549, at prescribed rates. You may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC also maintains an Internet website that contains reports, proxy statements and other information about issuers, like us, that file electronically with the SEC. The address of that website is www.sec.gov.
You should rely only on the information provided in this prospectus or any prospectus supplement. We have not authorized anyone else to provide you with different information.  We are not making an offer to sell, nor soliciting an offer to buy, these securities in any jurisdiction where that would not be permitted or legal.  Neither the delivery of this prospectus nor any sales made hereunder after the date of this prospectus shall create an implication that the information contained herein or our affairs have not changed since the date hereof.
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INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
INDEX to FINANCIAL STATEMENTS
For the nine months ended September 30, 2009
Condensed Consolidated Balance Sheets as of September 30, 2009 (unaudited) and December 31, 2008
F-2
Condensed Consolidated Statements of Operations for the three months ended September 30, 2009 and 2008 (unaudited)
F-3
Condensed Consolidated Statements of Operations for the nine months ended September 30, 2009 and 2008 (unaudited)
F-4
Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2009 and 2008 (unaudited)
F-5
Notes to the Condensed Consolidated Financial Statements (unaudited)
F-6
For the years ended December 31, 2008 and 2007
Reports of Independent Registered Public Accounting Firms
F-19
Consolidated Balance Sheets as of December 31, 2008 and 2007
F-21
Consolidated Statements of Operations for the Years Ended December 31, 2008 and for the period January 5, 2007 (Inception) to December 31, 2007 
and for the period from January 5, 2007 (Inception) through December 31, 2008
F-22
Consolidated Statement of Changes in Shareholders’ Deficit for the Period from January 5, 2007 (Inception) through  December 31, 2008
 F-23
Consolidated Statements of Cash Flows for the Years Ended December 31, 2008 and for the period January 5, 2007 (Inception) to December 31, 2007
and for the period from January 5, 2007 (Inception) through December 31, 2008
F-24
Notes to Consolidated Financial StatementsF-25

F-1
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED BALANCE SHEETS
  
As of
September 30,
2009
 
As of
December 31,
2008
  (unaudited)  
Assets 
Current Assets:      
  Cash $194,405  $15,716 
  Accounts receivable, net  66,889   34,195 
  Other receivable  -   7,500 
  Inventory  66,545   70,722 
  Prepaid expenses  11,250   73,785 
Total current assets  339,089   201,918 
Property and equipment, net  34,939   41,245 
Other Assets:        
  Capitalized patents, net  64,167   68,392 
 Total other assets  64,167   68,392 
  Total assets $438,195  $311,555 
         
Liabilities and Stockholders' Deficiency 
Current Liabilities:        
  Accounts payable $650,193  $226,861 
  Accrued expenses and salaries  561,583   614,799 
  Notes payable- related party  158,462   - 
  Line of credit  50,000   50,000 
  Convertible notes, net of debt discount of  $543,023 and $0, respectively  1,977   - 
  Derivative liabilities  3,593,414   - 
 Total current liabilities  5,015,629   891,660 
         
         
Long Term Liabilities:        
               Note payable - related party  -   96,462 
Total long term liabilities  -   96,462 
Total liabilities  5,015,629   988,122 
         
Commitments and Contingencies        
Stockholders' Deficiency:        
Preferred Stock, $.0001 par value; 100,000,000 shares authorized; no shares issued and outstanding  -   - 
Common Stock, $.0001 par value; 200,000,000 shares authorized; 55,247,833 and
53,620,000 issued and outstanding as of September 30, 2009 and December 31, 2008, respectively.
  5,525   5,362 
Additional paid-in capital  2,208,353   1,855,565 
Stock subscription receivable  (205,000)   (450,000) 
Accumulated deficit during the development stage  (6,586,312)  (2,087,494)
 Total stockholders' deficiency  (4,577,434)  (676,567)
Total liabilities and stockholders' deficiency $438,195  $311,555 
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

F-2
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
 CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(unaudited)
   
Three
 months ended
September 30, 2009
  
Three
months ended
September 30, 2008
  
From January 5, 2007 (Inception) to
September 30, 2009
 
Revenue:         
Product Revenue $2,852  $-  $94,292 
Cost of Goods Sold:            
Product Costs  3,682   1,765   40,616 
Gross Margin:  (830)   (1,765)   53,676 
Operating Expenses:            
Research and development     (17,500)   90,061 
Selling, general and administrative  293,588   365,121   3,409,367 
              Total Operating Expenses  293,588   347,621   3,499,428 
Loss from operations  (294,418)  (349,386)  (3,445,752)
Other Expenses:            
             
Change in fair value of derivative liability  380,036       380,036 
             
Interest and financing expenses  2,734,579   1,907   2,760,524 
             
               Total other expenses  3,114,615   1,907   3,140,560 
Loss before income taxes  (3,409,033)  (351,293)  (6,586,312)
Provisions for income taxes  -   -   - 
Net Loss $(3,409,033) $(351,293) $(6,586,312)
Basic and diluted net loss per weighted average shares of common stock $(0.06) $(0.01)    
Basic and diluted Weighted average number of shares of common stock  54,114,000   36,419,937   - 
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

F-3
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
 CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(unaudited)
   Nine months ended September 30, 2009  Nine months ended September 30, 2008  
From January 5, 2007
(Inception) to
September 30, 2009
 
Revenue:         
Product Revenue $56,298  $-  $94,292 
Cost of Goods Sold:            
Product Costs  30,528   1,765   40,616 
             
Gross Margin:  25,770   (1,765)   53,676 
Operating Expenses:            
Research and development  4,950   -   90,061 
Selling, general and administrative  1,394,592   660,875   3,409,367 
               Total Operating Expenses  1,399,542   660,875   3,499,428 
Loss from operations  (1,373,772)  (662,640)  (3,445,752)
             
Other Expenses:            
Change in fair value of derivative liability  380,036       380,036 
 Interest and financing expenses  2,745,010   5,933   2,760,524 
             Total other expenses  3,125,046   5,933   3,140,560 
             
Loss before income taxes  (4,498,818)  (668,573)  (6,586,312)
             
Provisions for income taxes  -   -   - 
             
Net Loss $(4,498,818) $(668,573) $(6,586,312)
             
Basic and diluted net loss per weighted average shares of common stock $(0.08) $(0.02)    
Basic and diluted Weighted average number of shares of common stock  53,849,481   32,493,732     
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
F-4
INVO BIOSCIENCE, INC
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
   
For the nine months ended
September 30, 2009
  
For the nine months ended
September 30, 2008
  
From
January 5, 2007
(Inception) to
September 30, 2009
 
             
Net Loss $(4,498,818) $(668,573) $(6,586,312)
Adjustments to reconcile net loss to net cash used in operating activities:            
Non-cash stock compensation issued for services  352,950   13,051   404,535 
In kind contribution to employees                  -   160,821   251,686 
Bad debt expense  2,600   -   6,400 
Interest expense - related party            4,168         3,690   10,156 
Depreciation and amortization  10,531   8,952   24,192 
Derivative liabilities  3,050,391   -   3,050,391 
             
Changes in operating assets and liabilities:            
Receivables  (35,294)  -   (73,289)
Inventories  4,177   (22,340)   (66,545)
Prepaid expenses and other
  current assets
  70,035   (15,486)   (23,100)
Accounts payable  423,332     112,705     649,922 
Accrued salaries  407,355   -   407,355 
Other accrued expense  (464,738)   32,123   88,626 
Net cash used in operating activities  (673,311)  (375,057)  (1,855,982)
             
Cash flows from investing activities:            
Purchase of equipment                  -      (23,801)  (42,858)
Purchase of intangible assets  -      (20,384)  (77,742)
Net cash used in investing activities  -   (44,185)  (120,600)
             
Cash flows from financing activities:            
Proceeds from demand note payable                  -   779   50,000 
Proceeds from convertible loan  545,000   -   545,000 
Proceeds from loan payable- insurance                  -                     -   70,587 
Proceeds from loan payable- related party  88,000   2,916   190,889 
Repayment of loan payable- related party                (26,000)      -   (32,427)
Proceeds from issuance of common stock                 -    442,000   1,101,938 
Proceeds from subscription receivable  245,000     -   245,000 
Net cash provided by financing activities  852,000   445,695   2,170,987 
             
Net increase in cash and cash equivalents  $178,689   $26,453   $194,405 
             
Cash and cash equivalents at beginning of period  $15,716   $-   $- 
             
Cash and cash equivalents at end of period  $194,405   $26,453   $194,405 
             
Supplemental disclosure of non-cash financing activity:            
Cash paid for interest  $18,538   $5,933   $25,945 
Cash paid for taxes  $456   $             -   $456 
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
F-5
 INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 September 30, 2009
(unaudited)
NOTE 1.  SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ORGANIZATION
(A)              Description of Business
INVO Bioscience, Inc. (“the Company”) offers novel solutions in assisted reproductive technologies while expanding geographic and affordable access to the global reproductive health care community.  Our primary focus is the manufacture and sale of the INVOcell device and the INVO technology to assist infertile couples in having a baby.    We designed our INVOcell device and our INVO procedure to provide an alternative infertility treatment for the patient and the clinician.  The INVO procedure is less expensive and simpler to perform than most comparable infertility treatments currently.  The simplicity of the INVO procedure relates to the ability to potentially perform the INVO procedure in a physician’s practice rather than in a specialized facility at a much lower cost overall than current infertility treatments.  
We believe that the INVO procedure will make infertility treatment more readily available throughout the world.  The INVO procedure is significantly less costly than conventional IVF.  The INVOcell device and INVO procedure facilitates conception and embryo development inside the woman's body, rather than in a dish in a laboratory, which is an attractive feature for most couples.
We are a development stage company, as defined by Accounting Standards Codification (“ASC”) Topic 915, “Accounting and Reporting by Development Stage Enterprise” formerly (“SFAS”) No. 7.  The Company’s activities during our development stage to date has included developing the business plan, seeking regulatory clearance in the European Union and the United States, raising capital, conducting beta tests, sales and marketing of the INVOcell device and offering instructions in the INVO technique to doctors in numerous foreign countries.
Through September 30, 2009, we have generated minimal sales revenues, have incurred significant expenses and have sustained losses.  Consequently, our operations are subject to all of the risks inherent in the establishment of a new business enterprise.
In May 2008, the Company received notice that the INVOcell product meets all the essential requirements of the relevant European Directive(s), and 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 “Conformité Européenne”) certifies that a product has met EU health, safety and environmental requirements, which ensure consumer safety.  With CE marking, the Company possesses the regulatory authority to distribute its product in the European Economic Area, provided we comply with local registration requirements as discussed herein (i.e., the European Union, Canada, Australia, New Zealand and most parts of the Middle East).  The Company has sold approximately 900 INVOcell units through September 30, 2009.
(B)              Basis of Presentation
On December 5, 2008, the Company completed a share exchange with Emy’s Salsa Aji Distribution Company, Inc. (“Emy’s”), a publicly registered shell corporation with no significant assets or operations.  Emy’s was incorporated on July 11, 2005, under the laws of the State of Nevada under the name Certiorari Corp.  In connection with the share exchange, INVO Bioscience became Emy’s wholly-owned subsidiary and the INVO Bioscience Shareholders acquired control of Emy’s.  
The Company accounted for the transaction as a recapitalization and the Company is the surviving entity.  In connection with the share exchange, Emy’s shareholders retained 14,937,500 shares.  Effective with the Agreement, all previously outstanding shares of common stock owned by the Company's shareholders were exchanged for an aggregate of 38,307,500 shares of Emy’s common stock.  Effective with the Agreement, Emy’s changed its name to INVO Bioscience, Inc.
All references to “common stock,” “share” and “per share” amounts have been retroactively restated to reflect the exchange ratio of 357.0197 shares of INVO Bioscience common stock for one share of Emy’s common stock outstanding immediately prior to the merger as if the exchange had taken place as of the beginning of the earliest period presented.
The accompanying unaudited condensed consolidated financial statements present the historical financial condition, results of operations and cash flows of the Company prior to the merger with Emys.  The accompanying unaudited condensed consolidated financial statements present on a consolidated basis the accounts of the Company and its wholly owned subsidiaries.  All significant intercompany accounts and transactions have been eliminated in consolidation.
F-6
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 September 30, 2009
(unaudited)
(C)              Significant Accounting Policies
The financial statements included herein have been prepared, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission.  Certain information and disclosures included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted pursuant to such rules and regulations.  These unaudited condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto included in our 2008 Annual Report filed on Form 10-K on April 15, 2009.  The condensed consolidated balance sheet as of December 31, 2008 was derived from the audited financial statements for the year then ended.
In the opinion of the Company, all adjustments necessary to present fairly our financial position and the results of our operations and cash flows have been included in the accompanying unaudited condensed consolidated financial statements.  The results of operations for interim periods are not necessarily indicative of the expected results for the year ended December 31, 2009.
Use of Estimates
The preparation of interim Consolidated Financial Statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the amounts reported and disclosed in the financial statements and the accompanying notes.  Actual results could differ materially from these estimates.  On an ongoing basis, we evaluate our estimates, including those related to accounts receivable, fair values of financial instruments, fair values of intangible assets and goodwill, useful lives of intangible assets, property, and equipment, fair values of stock-based awards, and income taxes, among others.  We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets and liabilities.
Cash and Cash Equivalents
The Company considers all highly liquid temporary cash investments with an original maturity of three months or less to be cash equivalents.  As of September 30, 2009, and December 31, 2008, the Company had $194,400 and $15,700 in cash equivalents, respectively.
(D)             Effect of Recent Accounting Pronouncements
 With the exception of those discussed below, there have been no recent accounting pronouncements or changes in accounting pronouncements during the three and nine months ended September 30, 2009, as compared to the recent accounting pronouncements described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2008, that are of significance, or potential significance to the Company.
On July 1, 2009, the Financial Accounting Standards Board (“FASB”) launched the FASB Accounting Standards Codification (“ASC”) 105, Generally Accepted Accounting Principles (“ASC 105” and formerly referred to as FAS 168). ASC 105, establishes the FASB Accounting Standards Codification as the source of authoritative accounting principles recognized by the FASB to be applied by nongovernmental entities in the preparation of financial statements in conformity with GAAP. Rules and interpretive releases of the Securities and Exchange Commission (SEC) under authority of federal securities laws are also sources of authoritative GAAP for SEC registrants. ASC 105 is effective for financial statements issued for interim and annual periods ending after September 15, 2009.
GAAP is not intended to be changed as a result of the FASB’s Codification project, but it will change the way the guidance is organized and presented. As a result, these changes will have a significant impact on how companies reference GAAP in their financial statements and in their accounting policies for financial statements issued for interim and annual periods ending after September 15, 2009.
 In June 2008, the FASB ratified EITF Issue No. 07-5, “Determining Whether an Instrument (or Embedded Feature) Is Indexed to an Entity’s Own Stock” (EITF 07-5, included in ASC 815-40). EITF 07-5 mandates a two-step process for evaluating whether an equity-linked financial instrument or embedded feature is indexed to the entity’s own stock. It is effective for fiscal years beginning on or after December 15, 2008. The adoption of EITF 07-5 had a significant effect on our consolidated condensed financial statements (see Note 10).
F-7
 INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 September 30, 2009
(unaudited)
In June 2009, the FASB issued SFAS No. 167, Amendments to FASB Interpretation No. 46(R) (“SFAS 167”).  SFAS 167, which amends ASC 810-10,  Consolidation  (“ASC 810-10”), prescribes a qualitative model for identifying whether a company has a controlling financial interest in a variable interest entity (“VIE”) and eliminates the quantitative model prescribed by ASC 810-10.  The new model identifies two primary characteristics of a controlling financial interest: (1) provides a company with the power to direct significant activities of the VIE, and (2) obligates a company to absorb losses of and/or provides rights to receive benefits from the VIE.  SFAS 167 requires a company to reassess on an ongoing basis whether it holds a controlling financial interest in a VIE.  A company that holds a controlling financial interest is deemed to be the primary beneficiary of the VIE and is required to consolidate the VIE.  SFAS 167, which is referenced in ASC 105-10-65, has not yet been adopted into the Codification and remains authoritative.  This statement is effective for fiscal years beginning after November 15, 2009.  The Company plans to adopt SFAS 167 effective January 1, 2010.  The adoption of SFAS 167 is not expected to have a material impact on the Company’s financial position and results of operations.
In June 2009, the FASB issued SFAS No. 166, Accounting for Transfers of Financial Assets (“SFAS 166”).  SFAS 166 removes the concept of a qualifying special-purpose entity from ASC 860-10,  Transfers and Servicing (“ASC 860-10”), and removes the exception from applying ASC 810-10.  This statement also clarifies the requirements for isolation and limitations on portions of financial assets that are eligible for sale accounting.  SFAS 166, which is referenced in ASC 105-10-65, has not yet been adopted into the Codification and remains authoritative.  This statement is effective for fiscal years beginning after November 15, 2009.  The Company plans to adopt SFAS 166 effective January 1, 2010.  The adoption of SFAS 166 is not expected to have a material impact on the Company’s financial position and results of operations.    
NOTE 2.  GOING CONCERN
As reflected in the accompanying unaudited condensed consolidated financial statements, the Company is in the development stage and commenced operations December 2008.  The Company had a net operating loss for the quarter of $294,000  and a net loss of $3,409,000 and has a cumulative net operating loss of $3,446,000 and a net loss of $6,586,000, a working capital deficiency of $4,677,000, a stockholder deficiency of $4,577,000 and cash used in operations of $673,000 for the nine months ended September 30, 2009.  This raises substantial doubt about its ability to continue as a going concern.  The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.  The ability of the Company to continue as a going concern is dependent on the Company’s ability to raise additional capital and implement its business plan.
The Company’s development activities since inception have been financially sustained through stockholder loans and contributions to the Company and issuance of our common stock and convertible notes in private placements. The Company expects to raise additional funding to continue its operations through additional loans and issuances of additional shares of common stock and other securities.
NOTE 3.  INVENTORY
As of September 30, 2009 and December 31, 2008, the Company recorded the following inventory balances:
  
September 30,
2009
  
December 31,
2008
 
Raw Materials $-  $- 
Work in Process  49,507   55,465 
Finished Goods  17,038   15,257 
Total Inventory $66,545  $70,722 
F-8
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 September 30, 2009
(unaudited)
NOTE 4.  PROPERTY AND EQUIPMENT
The estimated useful lives and accumulated depreciation for furniture, equipment and software are as follows:
Estimated Useful Life
Molds3 to 7 years
Computers and Software3 to 5 years

  
September 30,
2009
  
December 31,
2008
 
Manufacturing Equipment- Molds $35,263  $35,263 
    Accumulated Depreciation  (5,387)   (980) 
Network/IT Equipment  7,595   7,595 
    Accumulated Depreciation  (2,532)   (633) 
  $34,939  $41,245 
During the nine months ended September 30, 2009 and 2008, the Company recorded $6,307 and $0 in depreciation expense respectively.
NOTE 5.  PATENTS
As of September 30, 2009 and December 31, 2008, the Company recorded the following patent balances:
  
September 30,
2009
  
December 31,
2008
 
Total Patents  $77,743   $77,743 
    Accumulated Amortization  (13,576)  (9,351)
Patent costs, net $64,167  $68,392 
During the nine months ended September 30, 2009 and 2008, the Company recorded $4,225 and $2,591, respectively in amortization expenses
NOTE 6.  WORKING LINE OF CREDIT
At September 30, 2009, the Company had a $50,000 working capital line of credit with Century Bank with interest payable monthly at 0.24% above the bank’s prime lending rate.  On September 30, 2009, the interest rate was 3.74%.  The line of credit is set to mature on May 31, 2010.  At September 30, 2009 and December 31, 2008, the balance outstanding on the line of credit was $50,000.
NOTE 7.  CONVERTIBLE NOTES
During the three months ended September 30, 2009, the Company issued convertible notes payable (“Bridge Notes”) to investors in the aggregate amount of $545,000.  The Bridge Notes carry interest rates ranging from 10-12% and are due in full in one year from the date of issuance.  The Bridge Notes and accrued interest are convertible into common stock of the Company at a conversion price of $0.10 per share, subject to adjustments. In addition to the Bridge Notes, the Company issued warrants to purchase 5,750,000 shares of the Company’s common stock at a price of $0.20 per share (see Note 9).  Pursuant to the guidance of ASC 470-20-30 (formerly referred to as EITF 00-27), the Company valued the conversion  feature of the Bridge Notes and the warrants issued as consideration for the notes payable via the Black-Scholes valuation method.  The total fair value calculated for the conversion feature was $1,493,710, which is recorded as a derivative liability on the Company’s balance sheet (see note 10). Of this amount, $152,370 was allocated to the discount on the Bridge Notes and $1,341,340 was charged to operations.  The total fair value calculated for the warrants was $1,614,948, which is recorded as a derivative liability on the Company’s balance sheet (see note 10).  Of this amount, $392,630 was allocated to the discount on the Bridge Notes, and $1,222,318 was charged to operations.  The aggregate discount on the Bridge Notes was $545,000, and the aggregate amount charged to operations was $2,563,658.
The discount of $545,000 will be amortized to interest expense over the one year term of the Bridge Notes using the effective interest method. During the three and nine months ended September 30, 2009, the Company recorded $1,977 amortization expense of the discount on the Bridge Notes.  Interest in the aggregate amount of $6,117 was accrued on the Bridge Notes during the three and nine months ended September 30, 2009.
F-9
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 September 30, 2009
(unaudited)
NOTE 8.  NOTE PAYABLE AND OTHER RELATED PARTY TRANSACTIONS
On September 18, 2008, the Company entered into a related party transaction with Dr. Claude Ranoux, the President, Director and Chief Scientific Officer of the Company.  Dr. Ranoux had loaned funds to the Company to sustain its operations since January 5, 2007 (inception).  Dr. Ranoux’s total cumulative loans at September 30, 2009 were $70,462.  On March 26, 2009, the Company and Dr. Ranoux agreed to amend the agreement to a non-convertible note payable bearing interest at 5% per annum and extended the repayment date to March 31, 2010.  The Company and Dr. Ranoux can jointly decide to repay the loan earlier without prepayment penalties.  During the three months and nine months ended September 30, 2009, $26,000 was repaid on the principal of the loan.
On March 5, 2009, the Company entered into a related party transaction with Kathleen Karloff, the Chief Executive Officer and a Director of the Company.  Ms. Karloff provided a short-term loan in the amount of $75,000 bearing interest at 5% per annum to the Company to fund operations.  In May 2009, Ms. Karloff loaned to the Company an additional $13,000, making her total cumulative loan $88,000 as of September 30, 2009.  This note was due on September 15, 2009, which has since been extended to March 4, 2010. 
For the three months ended September 30, 2009 and 2008, the Company recorded $14,224 and $1,907 in interest expense respectively.  Additionally, for the nine months ended September 30, 2009 and 2008, the Company recorded $24,655 and $5,933 in interest expense respectively, with $3,690 of the 2008 expense being charged as an in-kind contribution.
NOTE 9.  STOCKHOLDERS’ EQUITY
Common Stock
For the period from January 5, 2007 (inception) through December 31, 2007, Bio X Cell, Inc., formerly a Commonwealth of Massachusetts corporation doing business as INVO Bioscience before the merger with Emy’s, issued 70,000 shares of common stock for $20,000, at $.2857/share.  The 70,000 shares were retroactively restated to 24,991,379 shares following the stock split on November 12, 2008 and the subsequent share exchange on December 5, 2008.
 On December 29, 2008, the Company filed amended and restated articles of incorporation with the Secretary of State of Nevada.  The Company’s authorized capital stock was changed from 75,000,000 shares, all of which were shares of common stock, par value $.0001 per share, to authorized common stock of 200,000,000 shares, par value $.0001, and 100,000,000 newly created shares of undesignated preferred stock, par value $.0001.
 On November 7, 2008, Emy’s Board of Directors approved a 5-1 forward stock split (the “Forward Split”) of common stock with a record date of November 10, 2008 for the Company’s issued and outstanding shares.  The Forward Split was effective on November 12, 2008.  Emy’s had 12,387,500 shares of common stock outstanding before the Forward Split and 61,937,500 shares outstanding thereafter.
 The Company had 61,937,500 shares issued and outstanding immediately before the Share Exchange.  Pursuant to the Share Exchange Agreement, certain shareholders of Emy’s agreed to cancel 47,000,000 shares of Emy’s common stock and Emys agreed to issue 38,307,500 newly-issued shares of common stock to INVO Bioscience shareholders.  As of December 5, 2008, and immediately after Closing, an aggregate of 53,245,000 shares of common stock were outstanding, including shares issued pursuant to the Closing.
Directly following the consummation of the Share Exchange Agreement transaction, on the day of the Closing, we entered into the Securities Purchase Agreement with investors pursuant to which, the investors contributed $375,000 in exchange for 375,000 shares of our common stock at a price of $1.00 per share.  The investors have piggyback registration rights that permit them to register their common stock on any registration statement filed by the Company, as well as anti-dilution protection per section 7.5.
As of the Closing, Lionshare Ventures, Inc.(LSV), a shareholder in INVO Bioscience  and  the Company executed a pledge agreement between the two parties reaffirming LSV‘s original agreement dated May 18, 2008, the outstanding balance as of the original agreement was $450,000 for shares of common stock previously issued but not paid for noted in the Company’s financial statements as a subscription receivable in its equity section of the balance sheet.  On June 10, 2009, the two parties executed an extension of the time in which the balance outstanding of $205,000 was to be paid, the date is now December 5, 2009, 775,000 shares of common stock are being held in escrow until the balance is paid.
In the same pledge agreement between the Company and LSV dated December 5, 2008, LSV committed to forfeiting a maximum of 562,500 common stock shares if the Company is required to issue additional shares of common stock per the anti-dilution clause (section 7.5) of the Securities Purchase Agreement mentioned previously.
F-10
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 September 30, 2009
(unaudited)
During the period from January 1, 2008 through November 30, 2008, the Company issued an aggregate of 4,561,641 shares of common stock for cash totaling $706,938 for share prices ranging from $0.15 to $1.50.
In March 2008, the Company issued an aggregate of 8,488,857 shares of common stock (net of forfeitures) for services rendered totaling $11,259.  In November 2008, the Company issued an aggregate of 265,623 shares of common stock for services rendered totaling $40,056.
In March 2009, the Company issued an aggregate of 83,333 shares of common stock for services rendered totaling $37,500.
During the 3 months ended March 30, 2009, the Company received $200,000 against the outstanding stock subscription receivable.
In April 2009, the Company received $45,000 against the outstanding stock subscription receivable.  As of September 30, 2009, $205,000 remains outstanding.
In May 2009, the Company issued an aggregate of 125,000 shares of common stock for services rendered totaling $15,500.
In September 2009, the Company issued an aggregate of 1,125,000 shares of common stock in connection with the execution by the Company of a $100,000 convertible note as part of a bridge offering, as discussed on the Company’s  Current Reports on Form 8-K filed July 17, 2009 and September 17, 2009.  The convertible notes have a conversion price of $0.10.  This transaction triggered the anti-dilution clause of the Securities Purchase Agreement executed on December 5, 2008 with the certain investors.  In addition, the Company took possession of the 562,500 shares pledged by Lionshare Ventures to meet this obligation, resulting in a net issuance of 562,500 shares of common stock.
In September 2009, the Company issued an aggregate of 857,000 shares of common stock for services rendered totaling $299,950.
Since January 1, 2008, the Company has signed agreements to compensate certain of its officers, employees and service providers with common stock or options to acquire common stock.  As of December 31, 2008, a total of 857,000 shares of common stock and options to purchase an additional 440,000 shares of common stock were agreed to be issued.  As of September 30, 2009, the Company has issued the 857,000 shares of common stock against its previously recorded accrued liability.  However, as of September 30, 2009, the Company has terminated 70,000 of the options and promised an additional 300,000 to  two employees hired during 2009 bringing the total  to 670,000 as of this date.   The Company has not yet adopted a formal stock option plan and, consequently, the options to purchase 670,000 shares of common stock are deemed not yet issued. 
Non-Statutory Stock Options
The following table summarizes the changes in stock options outstanding and the related prices for the shares of the Company’s common stock issued.  These options were agreed to be issued in lieu of cash compensation for services performed.
   Options Outstanding Options Exercisable 
Exercise Price  
Number
Outstanding
  
Weighted Average
Remaining Contractual
Life (Years)
 
Number
Exercisable
 
Weighted
Average
Exercise Price
 
$1.00   70,000   2.9   $-  $- 
Transactions involving options are summarized as follows:
  
Number of
Shares
  
Weighted
Average Price
Per Share
 
Outstanding at December 31, 2007  -  $- 
Granted  140,000   1.00 
Exercised  -   - 
Canceled or expired  -   - 
Outstanding at December 31, 2008  140,000  $1.00 
Granted  -   - 
Exercised  -   - 
Canceled or expired  70,000   1.00 
Outstanding at September 30, 2009  70,000  $1.00 
F-11
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 September 30, 2009
(unaudited)
 Aggregate intrinsic value of options outstanding and exercisable at September 30, 2009 was $23,800.  Aggregate intrinsic value represents the difference between the Company's closing stock price on the last trading day of the fiscal period, which was $0.34 as of September 30, 2009, and the exercise price multiplied by the number of options outstanding.  As of September 30, 2009, total unrecognized stock-based compensation expense related to stock options was $105,000.  During the quarters ended September 30, 2009 and 2008, the Company did not charge to operations the related expense to recognized stock-based compensation for the above stock options.
 Warrants
During the three months ended September 30, 2009, the Company issued warrants to purchase 5,750,000 shares of common stock pursuant to the Bridge Notes (see note 7) agreement. The warrants have an exercise price, of $0.20 per share.  The warrants are exercisable any time after the issue date, and have a term ranging from 3 to 5 years from the date of issuance.  These warrants were valued using the guidance of ASC 470-20-30 (formerly referred to as EITF 00-27), via the Black-Scholes valuation method resulting in a value of $1,614,948 and were recorded as a derivative liability on the Company’s balance sheet (see note 10).
The following table summarizes the changes in warrants outstanding and the related prices for the shares of the Company's common stock issued to non-employees of the Company. These warrants were granted in lieu of cash compensation for services performed or financing expenses and in connection with placement of convertible debentures.
Warrants Outstanding  Warrants Exercisable
      Weighted        Weighted
      Average  Weighted     Average
      Remaining  Average     Remaining
Exercise  Number  Contractual  Exercise  Number  Contractual
Prices  Outstanding  Life (years)  Price  Exercisable  Life (years)
$0.20   5,750,000   4.09  $0.20   5,750,000  4.09
     5,750,000   4.09       5.750,000  4.09
Transactions involving warrants are summarized as follows:
   Number of Shares  
Weighted Average
Price Per Share
 
Outstanding at December 31, 2008  -  $- 
Granted  5,750,000   0.20 
Exercised  -   - 
Cancelled or expired  -   - 
Outstanding at September 30, 2009  5,750,000  $0.20 
F-12
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 September 30, 2009
(unaudited)
The estimated value of the compensatory warrants granted to non-employees in exchange for financing expenses was determined using the Black-Scholes pricing model and the following assumptions:
  September 30, 
  2009 
Expected volatility

*

Director

July 3, 2023
Barbara Ryan  309-275%
Expected life (years)3-5
Risk free interest rate0.18-0.26%
Forfeiture rate-
Dividend rate-
NOTE 10.  DERIVATIVE LIABILITY
In June 2008, the Financial Accounting Standards Board (“FASB”) ratified Emerging Issues Task Force (“EITF”) Issue No. 07-5, “Determining Whether an Instrument (or Embedded Feature) Is Indexed to Entity’s Own Stock (“EITF 07-5, included in ASC 815-40”).  ASC 815-40 mandates a two-step process for evaluating whether an equity-linked financial instrument or embedded feature is indexed to the entity’s own stock.  As disclosed in Note 7, during the nine months ended September 30, 2009, the Company entered into short term convertible loans with attached warrants which contain a strike price adjustment feature.  Upon the Company’s adoption of ASC 815-40, this resulted in the instruments no longer being considered indexed to the Company’s own stock.  Accordingly, adoption of ASC 815-40 changed the current classification (from equity to liability) and the related accounting for these warrants outstanding as of September 30, 2009.   During the third quarter of 2009, the liability was adjusted for warrants exercised and the change in fair value of the warrants.  In accordance with ASC 815-40, a derivative liability of $3,593,414 related to the loan conversion feature and warrants is included in our unaudited condensed consolidated balance sheet as of September 30, 2009.  During the three and nine months ended September 30, 2009, we recorded an expense of $380,000 related to the change in fair value of the loan conversion feature and warrants.  During the three and nine months ended September 30, 2009, we recorded an expense of  $2,563,658 related to the expense in excess of the discount on loan conversion feature and warrants.  
As a result of the adoption of ASC 815-40, the Company is required to disclose the fair value measurements required by ASC 820 (formerly SFAS No. 157), “Fair Value Measurements and Disclosures.” The other liabilities recorded at fair value in the balance sheet as of September 30, 2009 are categorized based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels, defined by ASC 820 are directly related to the amount of subjectivity associated with the inputs to fair valuations of these liabilities are as follows:
Level 1 —Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date;
Level 2 — Inputs other than Level 1 inputs that are either directly or indirectly observable; and
Level 3 — Unobservable inputs, for which little or no market data exist, therefore requiring an entity to develop its own assumptions.
The following table summarizes the financial liabilities measured at fair value on a recurring basis as of September 30, 2009, segregated by the level of the valuation inputs within the fair value hierarchy utilized to measure fair value:
            Liabilities 
  Level 1  Level 2  Level 3  at fair value 
Line of credit and Notes payable – related party Convertible notes $208,500  $-  $545,000  $753,500 
Derivative liability  -   -   3,593,400   3,593,400 
Total $208,500  $-  $4,138,400  $4,346,900 
F-13
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 September 30, 2009
(unaudited)
 In accordance with EITF 07-5, we calculated the fair value of the loan conversion features and warrants using the Black–Scholes–Merton valuation model.  The assumptions used in the Black-Scholes-Merton valuation model were as follows:
September 30, 
  2009 
Expected volatility*

Director

July 3, 2023
Rebecca Messina  309-275%
Expected life (years) 

*By:3-5/s/ Steven Shum 
Risk free interest rate 0.18-0.26%
Forfeiture rate-Steven Shum, Attorney-in-Fact 
Dividend rateDate:-July 3, 2023 
Expected volatility is based primarily on historical volatility. Historical volatility was computed using daily pricing observations for the recent two years.  The Company believes this method produces an estimate that is representative of the Company’s expectations of future volatility over the expected term of the notes and warrants. The Company currently has no reason to believe future volatility over the expected remaining life of the notes and warrants is likely to differ materially from historical volatility. The expected life is based on the remaining term of the notes and warrants. The risk-free interest rate is based on U.S. Treasury securities according to the remaining term of the notes and warrants. The Company has not, and does not intend to, issue dividends; therefore, the dividend yield assumption is 0.
NOTE 11.  INCOME TAXES
The Company has adopted Accounting Standard Codification (“ASC”) Topic 740, formerly Financial Accounting Standard (“FAS”) 109 that requires the recognition of deferred tax liabilities and assets for the expected future tax consequences of events that have been included in the financial statement or tax returns.  Topic 740 determines deferred tax liabilities and assets based on the difference between financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse.  Temporary differences between taxable income reported for financial reporting purposes and income tax purposes are insignificant.
For income tax reporting purposes, the Company's aggregate unused net operating losses (“NOL”) of approximately $3,400,000, expire at various times through 2029, subject to limitations of Section 382 of the Internal Revenue Code of 1986, as amended.  The deferred tax asset related to the NOL carryforward is approximately $540,000.  The Company has provided a valuation reserve against the full amount of the net operating loss benefit, since in the opinion of management based upon the earning history of the Company, it is more likely than not that the benefits will not be realized.
NOTE 12.  COMMITMENTS

A)Operating LeasesII-5
On January 1, 2007, the Company entered into an operating lease (the “lease”) with Cummings Properties, LLC, to lease 3,294 square feet of general office space.  The lease commenced on January 1, 2007 and was automatically extended in October 2008 until December 31, 2010.  The Company agreed to pay a security deposit of $3,000 on January 1, 2007, which was repaid to the Company in equal $500 installments over the first six months of the lease.  The Company received no rent incentives or improvement allowances under this agreement.  The lease requires the Company to pay minimum lease payments of $2,000 per month for the duration of the lease.  The lease is subject to a cost of living increase equal to the Boston, MA Consumer Price Index at the beginning of each calendar year.  As of January 1, 2009, the Company’s lease payments under this agreement increased 3.53% to $2,070.60.

EXHIBIT INDEX

Exhibit No. B)Consulting agreementsExhibit
On December 5, 2008 in conjunction with the closing of the Share Exchange Agreement, the Company signed a letter agreement with Lionshare Ventures LLC (“LSV”).  As part of the letter agreement, LSV agreed to invest the balance of its original commitment to the Company effective as of May 19, 2008 for $450,000.  Thereafter, 2,000,000 shares of common stock were escrowed pending LSV’s tendering of this amount to the Company.  As of September 30, 2009, LSV has delivered $245,000 to the Company and the Company has released 1,225,000 of the 2,000,000 common shares it held in escrow.  On June 10, 2009, the Company and LSV agreed to extend the time period until December 5, 2009 in which LSV has to deliver the outstanding balance of $205,000.
F-14
 INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 September 30, 2009
(unaudited)
On March 10, 2009, the Company entered into an agreement with Wakabayashi Fund, LLC of Tokyo, Japan for investor relation services focused on the Asian financial markets. This agreement has expired as of September 30, 2009.
On April 17, 2009, the Company entered into an agreement with Red Chip Securities, Inc. of Alpharetta, Georgia to act as the Company’s investment banker and placement agent in assisting the Company in securing a private placement equity financing.  In May 2009, Red Chip Securities ceased operations and its members joined Moody Capital, Inc.  This agreement has expired as of September 30, 2009.
 On June 5, 2009, the Company engaged Hallmark Investments, Inc. for 90 days to act as its placement agent on an exclusive basis in connection a private placement bridge offering of convertible promissory notes for an aggregate principal amount of up to $500,000.  On July 15, 2009, the Company consummated the initial closing in the total principal amount of $100,000 to one accredited investor.  The Company continued to consummate additional closings for the bridge offering over the next 60 days as reported in its Current Report 8-K filed September 17, 2009.  This agreement has expired as of September 30, 2009.
 On September 1, 2009, the Company entered into a written agreement with CollegeStock, Inc. (“CollegeStock”) for certain investor relations services.    The Company’s one-year agreement with CollegeStock entitles the Company, in part, to: a detailed profile of the Company on the CollegeStock website, a minimum of one 60 second placement featuring client on the Wide World of Stocks television show, a detailed “Stock Wiki” featured on www.Wikinvest.com for the duration of the agreement, management of the Company’s twitter feed and other social networking outlets, and branding and advertising of the Company on the homepage of CollegeStock.com, for the duration of the agreement.  As compensation for the services, the Company has agreed to pay a retainer of 1,000,000 shares of common stock, 50% of which was due upon the signing of the agreement and the remainder is due by March 1, 2010.
On September 24, 2009, the Company engaged Gilford Securities, Inc. for a period of 60 days to act as its placement agent on a non-exclusive basis in connection with a proposed Reserve Equity Financing of securities by AGS Capital Group, LLC of up to $10,000,000.  The Company reported this agreement in its Current Report on Form 8-K filed November 2, 2009.
3.1 C)Anti-DilutionAmended and Piggyback Registration Rights
The Securities Purchase Agreement we entered into on December 5, 2008, granted certain investors piggyback registration rights that permit themRestated Articles of Incorporation. Incorporated by reference to Exhibit 3.1 to register their common stock on certain registration statements filed by the Company.  In addition, pursuant to certain anti-dilution rights granted under the Securities Purchase Agreement to the investors, the Company may be obligated to issue additional shares of its common stock to the investors in the event it issues common stock to future investors at a per share purchase price less than $1.00.  The number of additional shares to be issued in such event is equal to that number of shares that the investors would have acquired at such price had that price been offered at the time of their original investment, minus the number of shares acquired in their original investment.  Further, pursuant to the letter agreement, LSV and its managing member, Christopher Esposito, have agreed to forfeit to us, one share of our common stock for every two shares we would be required to issue up to the maximum of 562,500 shares, which are being held in escrow by the Company until December 5, 2010.
As discussed above, in July 2009, the Company executed a $100,000 convertible note in connection with the initial closing of its bridge offering (discussed in Note 7), which has a conversion price of $0.10.  The conversion price triggered the anti-dilution clause contained in the Securities Purchase Agreement entered into with previous investors.  In September 2009, the Company issued 1,125,000  shares of common stock to the  investors that were parties to the Securities Purchase Agreement.  In addition, the Company took possession and cancelled the 562,500 shares pledged by LSV.
D)Employee Agreements
Since January 1, 2008, the Company has signed nine employee agreements for officers, executives and employees of the Company.  Three of these agreements were with the founders of the Company.  The remaining six of the agreements were executed with executives and staff of the Company.  The Company agreed to issue options and shares of common stock of the Company.  Under the terms of these agreements, the shares and options are only issued the completion of the share exchange and the implementation of the Company’s employee stock plan.  The share exchange closed on December 5, 2008, however, the Company has not yet implemented an employee stock plan.  The Company intends to implement an employee stock plan within the next 9 months.  As of September 30, 2009, options to purchase an additional 670,000 shares of the Company’s common stock have been promised but not issued.  In addition, in view of the fact that the Company has not yet adopted a formal stock option plan, these options to purchase shares of common stock are deemed not yet issued. 
F-15
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 September 30, 2009
(unaudited)
NOTE 13.  SUBSEQUENT EVENT
 Management has reviewed and evaluated material subsequent events from the balance sheet date of September 30, 2009 through the financial statements issue date of November 16, 2009. All appropriate subsequent event disclosures, if any, have been made in notes to our Unaudited Condensed Consolidated Financial Statements.
 On October 28, 2009, the Company entered into a Reserve Equity Financing Agreement (“REF”) with AGS Capital Group, LLC (“AGS”), pursuant to which AGS committed to purchase, from time-to-time over a period of two years, shares of our common stock for cash consideration up to $10,000,000, subject to certain conditions and limitations.  In connection with the REF, we also entered into a registration rights agreement with AGS, dated October 28, 2009.
The following is a summary of the REF and the registration rights agreement, is not complete, and is qualified in its entirety by reference to the full text of those agreements, each of which are incorporated by reference into this Quarterly Report on Form 10-Q from the Current Report on Form 8-K filed on November 2, 2009. Readers should review those agreements for a complete understanding of the terms and conditions associated with this financing. 
Reserve Equity Financing Agreement
For a period of 24 months from the effectiveness of a registration statement filed pursuant to the registration rights agreement (the “Registration Statement”), we may, from time to time, at our discretion, and subject to certain conditions that we must satisfy, draw down funds under the REF by selling shares of our common stock to AGS. The purchase price of these shares will be 92% of the “VWAP” of the common stock during the five consecutive trading days after we give AGS a notice of an advance of funds (an “Advance”) under the REF (the “Pricing Period”). “VWAP” generally means, as of any date, the daily dollar volume weighted average price of our common stock as reported by Bloomberg, L.P. or comparable financial news service.  The amount of an Advance will automatically be reduced by 50% if on any day during the Pricing Period, the VWAP for that day does not meet or exceed 85% of the VWAP for the five trading days prior to the notice of Advance (the “Floor Price”). The REF does not prohibit the Company from raising additional debt or equity financings, other than financings similar to the REF.
Our ability to require AGS to purchase our common stock is subject to various limitations. The maximum amount of each Advance is 100% of the average daily trading volume for the five days immediately preceding the notice of Advance, as reported by Bloomberg or comparable financial news service (the “Maximum Advance Amount”).  In addition, unless AGS agrees otherwise, a minimum of five calendar days must elapse between each notice of Advance.
In addition, before AGS is obligated to buy any shares of our common stock pursuant to a notice of Advance, the following conditions, none of which is in AGS’s control, must be met:
 ·  
The Company shall have filed with the SEC a Registration Statement with respectSecurities and Exchange Commission on January 5, 2009.
3.2Certificate of Change. Incorporated by reference to Exhibit 3.1 to the resale ofCurrent Report on Form 8-K filed with the shares of common stock issued to AGS in accordance withSecurities and subject to the terms of the registration rights agreement.Exchange Commission on May 22, 2020.
 ·  
3.3		The Company shall have obtained all permits and qualifications requiredBy-Laws of INVO Bioscience. Incorporated by any applicable state in accordance with the registration rights agreement for the offer and sale of the shares of common stock, or shall have the availability of exemptions therefrom. The sale and issuance of the shares of common stock shall be legally permitted by all laws and regulationsreference to which the Company is subject.
 ·  
There shall not be any fundamental changesExhibit 3.1 to the information set forth in the Registration Statement which are not already reflected in a post-effective amendment toon Form SB-2 filed with the Registration Statement.Securities and Exchange Commission on November 13, 2007.
 ·  
The Company shall have performed, satisfied and complied in all material respects with all covenants, agreements and conditions required by the REF agreement and the registration rights agreement to be performed, satisfied or complied with by the Company.
 ·  
No statute, rule, regulation, executive order, decree, ruling or injunction shall have been enacted, entered, promulgated or endorsed by any court or governmental authority of competent jurisdiction that prohibits the consummation of or which would materially modify or delay any of the transactions contemplated by the REF agreement, and no proceeding shall have been commenced that may have the effect of prohibiting the consummation of or materially modify or delay any of the transactions contemplated by the REF Agreement.
F-16
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 September 30, 2009
(unaudited)
  ·  
The common stock is trading on a principal market (as defined in the REF, and including the OTC Bulletin Board). The trading of the common stock is not suspended by the SEC or the principal market. The issuance of shares of common stock with respect to the applicable closing will not violate the shareholder approval requirements of the principal market. The Company shall not have received any notice threatening the continued quotation of the common stock on the principal market and the Company shall have no knowledge of any event which would be more likely than not to have the effect of causing the common stock to not be trading or quoted on a principal market.
 ·  
The amount of an Advance shall not exceed the Maximum Advance Amount. In no event shall the number of shares issuable to AGS pursuant to an Advance cause the aggregate number of shares of common stock beneficially owned by AGS and its affiliates to exceed 4.99% of the then outstanding shares of common stock of the Company (“Ownership Limitation”). Any portion of an Advance that would cause AGS exceed the Ownership Limitation shall automatically be withdrawn. For the purposes of this provision, beneficial ownership is calculated in accordance with Section 13(d) of the Exchange Act.
 ·  
The Company has no knowledge of any event which would be more likely than not to have the effect of causing such Registration Statement to be suspended or otherwise ineffective at Closing.
 ·  
AGS shall have received an Advance notice executed by an officer of the Company and the representations contained in such Advance notice shall be true and correct.
There is no guarantee that we will be able to meet the foregoing conditions or any other conditions under the REF agreement or that we will be able to draw down any portion of the amounts available under the REF.
There is no contractual limit to the number of shares that we may be required to issue to obtain funds from the REF as it is dependent upon our share price, which varies from day to day. If we draw down amounts under the REF when our share price is decreasing, we will need to issue more shares to raise the same amount than if our stock price was higher. This could cause downward pressure on the price of our common stock.
The Company currently intends to issue and register approximately 8,100,000 shares of common stock under the REF.  The entire share requirement for the full $10,000,000 would be approximately 21,505,000 based on current market prices.  However, the Company has decided to limit itself to 8,100,000 shares available, or $3,756,500, based on current market prices.  If the Company’s share price rises, the Company will be able to draw down in excess of $3,800,000. If the Company decides to issue more than 8,100,000 shares, we will need to file an additional registration statement with the SEC covering those additional shares. 
The REF contains representations and warranties of the Company and AGS which are typical for transactions of this type. AGS agreed that during the term of the REF, neither AGS nor any of its affiliates, nor any entity managed or controlled by it, will, or cause or assist any person to, enter into or execute any short sale of any shares of our common stock as defined in Regulation SHO promulgated under the Exchange Act.  The representations and warranties made by the Company in the REF are qualified by reference to certain exceptions contained in disclosure schedules delivered to AGS. The REF also contains a variety of covenants on the part of the Company which are typical for transactions of this type, as well as the obligation, without the prior written consent of AGS, not to enter into any other equity line of credit agreement with a third party during the term of the REF. 
The REF obligates the Company to indemnify AGS for certain losses resulting from a misrepresentation or breach of any representation or warranty made by the Company or breach of any obligation of the Company. AGS also indemnifies the Company for similar matters.
The Company paid no fees, and is not obligated to pay any fees in the future, in connection with the REF, other than a due diligence fee of $10,000, all of which has been paid as of the date hereof.
The Company may terminate the REF effective upon fifteen trading days’ prior written notice to AGS; provided that (i) there are no Advances outstanding, and (ii) the Company has paid all amounts owed to AGS pursuant to the REF. The obligation of AGS to make an Advance to the Company pursuant to the REF shall terminate permanently if (i) there shall occur any stop order or suspension of the effectiveness of the Registration Statement for an aggregate of fifty (50) trading days or (ii) the Company shall at any time fail materially to comply with certain covenants specified in the REF and such failure is not cured within thirty (30) days after receipt of written notice from AGS, subject to exceptions.
F-17
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
 September 30, 2009
(unaudited)
 Registration Rights Agreement
The shares of common stock that may be issued to AGS under the REF will be issued pursuant to an exemption from registration under the Securities Act of 1933, as amended, or the Securities Act of 1933, as amended (the “Securities Act”). Pursuant to the registration rights agreement, we will file a registration statement, covering the possible resale by AGS of the shares that we may issue to AGS under the REF (the “Registration Statement”). The Registration Statement may cover only a portion of the total shares of our common stock issuable pursuant to the REF with AGS. We may file subsequent Registration Statements covering the resale of additional shares of our common stock issuable pursuant to the REF.  As described above, the effectiveness of this Registration Statement is a condition precedent to our ability to sell common stock to AGS under the REF. We intend to file the Registration Statement within 30-45 days from the date hereof.
 Placement Agent
The Company engaged Gilford Securities, Inc. (“Gilford”) to act as its placement agent on a nonexclusive basis in connection with the REF.  Gilford will receive a cash commission equaling six percent (6%) of the total proceeds received by the Company from the sale of securities sold to AGS.  In addition, the Company is to issue and sell to Gilford and/or its designees, for a total cost of one dollar ($1.00), 600,000 shares of common stock of the Company.  If the Company elects to have a closing under the REF on more than $6,000,000, then the Company shall issue and sell to Gilford and/or its designees, for a total cost of one dollar ($1), an additional 400,000 shares of common stock of the Company.
The Company will pay all reasonable expenses, not to exceed $10,000, incurred by Gilford in connection with the negotiation, preparation and execution of the definitive documents, including but not limited to attorneys’ fees and consulting expenses in two installments.  The first installment of $5,000 was paid upon execution of the definitive documents and the balance will be due upon the first funding under the REF based on actual expenses.   The placement agent agreement also contains customary mutual indemnification provisions.

F-18


REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

Board of Directors
INVO Bioscience, Inc.
Beverly, MA

We have audited the accompanying consolidated balance sheet of INVO Bioscience, Inc. (“the Company”) ,  a development stage company, as of December 31, 2008, and the related consolidated statements of losses,  stockholders' deficiency, and cash flows for the year ended December 31, 2008 and the period January 5, 2007 (date of inception) through December 31, 2008.  These financial statements are the responsibility of the Company's management.  Our responsibility is to express an opinion on the financial statements based upon our audit.

We conducted our audit in accordance with standards of the Public Company Accounting Oversight Board (United States of America).  Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatements.  The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting.  Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, 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.  An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements.  An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation.  We believe our audit provide a reasonable basis for our opinion.

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of Invo Bioscience, Inc. a development stage company, at December 31, 2008 and the results of its operations and its cash flows for the year ended December 31, 2008 and for the period January 5, 2007 (date of inception) through December 31, 2008 in conformity with accounting principles generally accepted in the United States of America.

The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern.  As discussed in Note 2, the Company has a generated negative cash outflows from operating activities, experienced recurring net operating losses, and is dependent on securing additional equity and debt financing to support its business efforts.  These factors raise substantial doubt about the Company's ability to continue as a going concern.  Management's plans in regards to this matter are described in Note 2.  The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.


/s/ RBSM LLP
RBSM LLP                      
New York, New York
April 15, 2009                                                                 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors of:
BioXcell, Inc.

We have audited the accompanying balance sheet of BioXcell, Inc. (A Development Stage Company) as of December 31, 2007, and the related statements of operations, changes in stockholders’ equity and cash flows for the period January 5, 2007 (Inception) to December 31, 2007. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States).  Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation.  We believe that our audit provides a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly in all material respects, the financial position of BioXcell, Inc. (A Development Stage Company) as of December 31, 2007 and the results of its operations and its cash flows for the period January 5, 2007 (Inception) to December 31, 2007 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 is in the development stage with no operations and has a net loss of $214,089, stockholders’ deficiency of $100,926, and cash used in operations of $116,041 for the period from January 5, 2007 (inception) to December 31, 2007.  This raises substantial doubt about its ability to continue as a going concern.  These factors raise substantial doubt about the Company's ability to continue as a going concern.  Management's plans concerning these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

WEBB & COMPANY, P.A.
Certified Public Accountants
Boynton Beach, Florida
November 6, 2008, except for Note 8, to which the date is December 10, 2008

F-20


INVO Bioscience, Inc.
(A DEVELOPMENT STAGE COMPANY)
Consolidated Balance Sheets
 
Assets 
  December 31,  December 31, 
  2008  2007 
       
Current Assets:      
  Cash $15,716  $- 
  Accounts receivable  34,195     
  Other receivable  7,500     
  Inventory  70,722   - 
  Prepaid expenses  73,785   3,349 
   Total current assets  201,918   3,349 
         
  Property and equipment, net  41,245   - 
         
Other Assets:        
  Deferred financing costs, net  -   9,153 
  Capitalized patents, net  68,392   43,270 
   Total other assets  68,392   52,423 
         
  Total assets $311,555  $55,772 
         
Liabilities and Stockholders' Deficiency 
         
Current Liabilities:        
  Accounts payable $226,861  $10,351 
  Accrued expenses  614,799   3,581 
  Line of credit  50,000   49,221 
   Total current liabilities  891,660   63,153 
         
Long Term Liabilities:        
  Note payable- related party  96,462   93,545 
   Total long term liabilities  96,462   93,545 
         
  Total liabilities  988,122   156,698 
         
Commitments and Contingencies        
Stockholders' Deficiency:        
Preferred Stock, $.0001 par value; 100,000,000 shares authorized;
No shares issued and outstanding as of December 31, 2008 and 2007 
  -   - 
Common Stock, $.0001 par value; 200,000,000 shares authorized; 53,620,000 and 24,991,379 issued
and outstanding as of December 31, 2008 and 2007, respectively.
  5,362   2,499 
Additional paid-in capital  1,855,565   110,664 
Stock subscription receivable  (450,000)   - 
  Accumulated deficit during the development stage  (2,087,494)  (214,089)
   Total stockholders' deficiency  (676,567)  (100,926)
         
  Total liabilities and stockholders' deficiency $311,555  $55,772 
The accompanying notes are an integral part of these consolidated financial statements.

F-21
INVO Bioscience, Inc.
 
(A DEVELOPMENT STAGE COMPANY) 
Consolidated Statements of Losses 
  
          
  Year  From January 5, 2007  From January 5, 2007 
  Ended  (Inception)to  (Inception) to 
  December 31, 2008  December 31, 2007  December 31, 2008 
          
Revenue:         
Product Revenue $37,995  $-  $37,995 
Cost of Goods Sold:            
Product Costs  10,088       10,088 
             
Gross Margin:  27,907       27,907 
             
Operating Expenses:            
  Research and development  51,761   33,350   85,111 
  Selling, general and administrative  1,837,606   177,170   2,014,776 
   Total Operating Expenses  1,889,367   210,520   2,099,887 
             
Loss from operations  (1,861,460)  (210,520)  (2,071,980)
             
Other Expenses:            
  Interest expense  11,945   3,569   15,514 
   Total other expenses  11,945   3,569   15,514 
             
Loss before income taxes  (1,873,405)  (214,089)  (2,087,494)
             
Provisions for income taxes  -   -   - 
             
Net Loss $(1,873,405) $(214,089) $(2,087,494)
             
Basic and diluted net loss per weighted average shares of common stock $(0.05) $(0.01) $  
Basic and diluted Weighted average number of shares of common stock  36,691,176   24,649031     
The accompanying notes are an integral part of these consolidated financial statements.
F-22
INVO Bioscience, Inc.
 
Consolidated Statement of Stockholders' Deficiency 
For the Period January 5, 2007 (Date of Inception) to December 31, 2008 
  
  Common Stock            
  Shares  Amount  Additional Paid in Capital  
 
Subscription
Receivable
 
Accumulated
Deficit during Development Stage
  Total 
                  
Stock issuance to founder in January 2007  24,991,379  $2,499  $17,501     -  $20,000 
                       
In Kind contribution of services in December 2007  -   -   90,865     -   90,865 
                       
In Kind contribution of interest in December 2007  -   -   2,298     -   2,298 
                       
Net Loss for the period January 5, 2007  (Inception)to December 31, 2007  -   -   -    $(214,089)  (214,089)
                            
Balance, December 31, 2007  24,991,379  $2,499  $110,664    $(214,089) $(100,926)
                       
Common stock issued for services in
March 2008
  10,728,442   1,073   11,978     -   13,051 
                       
Common stock issued for cash in April 2008  312,392   31   31,969     -   32,000 
                       
Common stock issued for cash in May 2008  365,588   37   54,963     -   55,000 
                       
Common stock issued for cash in June 2008  431,994   43   64,957     -   65,000 
                       
Common stock issued for cash in July 2008  399,148   40   59,960     -   60,000 
                       
Common stock issued for cash in
August 2008
  365,588   37   54,963     -   55,000 
                       
Common stock issued for cash in September 2008  1,136,751   114   174,886     -   175,000 
                       
In Kind Contribution of services in September 2008  -   -   160,821     -   160,821 
                       
In Kind Contribution of interest in September 2008  -   -   3,690     -   3,690 
                       
Common stock issued for cash in
October 2008
  1,118,186   112   199,826     -   199,938 
                       
Common stock issued for services in November 2008  265,623   27   40,029     -   40,056 
                       
Forfeited common stock for services not fully rendered during 2008  (2,239,585)  (224)  (1,568)    -   (1,792)
                       
Common stock issued for cash in November 2008  431,994   43   64,957     -   65,000 
                       
Common stock issued to Registrant’s shareholders in December 2008  14,937,500   1,494   448,506  (450,000) -   - 
                       
Common stock issued for Cash in December 2008  375,000   38   374,962     -   375,000 
                       
Net Loss, for the year ended
December 31, 2008
  -   -   -  - $(1,873,405)  (1,873,405)
                       
Balance, December 31, 2008  53,620,000  $5,362  $1,855,565  $(450,000) $(2,087,494) $(676,567)
The accompanying notes are an integral part of these consolidated financial statements.
F-23
INVO Bioscience, Inc
 
(A DEVELOPMENT STAGE COMPANY) 
Consolidated Statements of Cash Flows 
  
  For the Year  From January 5, 2007  From January 5, 2007 
  
Ended
December 31, 2008
  
(Inception) to December 31,
2007
  (Inception) to December 31, 2008 
          
Net Loss $(1,873,405) $(214,089) $(2,087,494)
Adjustments to reconcile net loss to net cash used in operating activities:            
  Non-cash stock compensation issued for services  51,585   -   51,585 
  In kind contribution to employees  160,821   90,865   251,686 
  In kind interest on loan payable- related party  3,690   2,298   5,988 
  Depreciation and amortization  7,509   6,152   13,661 
Changes in operating assets and liabilities:            
 Receivables
  (41,695)  -   (41,695)
  Inventories  (70,721)  -   (70,721)
  Prepaid expenses and other current assets  (70,436)  (15,199)  (85,635)
  Accounts payable  216,240   10,351   226,591 
  Other accrued expenses  549,784   3,581   553,365 
Net cash used in operating activities  (1,066,629)  (116,041)  (1,182,670)
             
Cash flows from investing activities:            
Purchase of property and equipment  (42,858)  -   (42,858)
Purchase of intangible assets  (31,017)  (46,725)  (77,742)
Net cash used in investing activities  (73,875)  (46,725)  (120,600)
             
Cash flows from financing activities:            
Proceeds from demand note payable  779   49,221   50,000 
Proceeds from loan payable- insurance  70,587   -   70,587 
Proceeds from loan payable- related party  9,344   93,545   102,889 
Repayment of loan payable- related party  (6,428)  -   (6,248)
Proceeds from the issuance of common stock  1,081,938   20,000   1,101,938 
Net cash provided by financing activities  1,156,221   162,766   1,318,986 
             
Net increase in cash and cash equivalents  15,716   -   15,716 
             
Cash and cash equivalents at beginning of period  -   -   - 
             
Cash and cash equivalents at end of period  15,716   -   15,716 
             
Supplemental disclosure of non-cash financing activity:            
  Cash paid for interest  8,255   1,243   9,498 
  Cash paid for taxes  -   -   - 
The accompanying notes are an integral part of these consolidated financial statements.
F-24
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
as of DECEMBER 31, 2008 and DECEMBER 31, 2007
NOTE 1SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND ORGANIZATION
(A) General
INVO Bioscience, Inc. (“the Company”) intends to commercialize its proven and patented technology that will revolutionize the treatment of infertility.  The Company’s device, the INVOcell and the INVO procedure are designed to be simple for the patient and the clinician, less expensive and simpler to perform than conventional in vitro fertilization.  The simplicity of INVO means that it may be performed in a physician’s practice and therefore it will be available in many more locations than conventional IVF.  INVO also allows conception and embryo development to take place inside the woman's body; an attractive feature for most women.
We are a development stage company, as defined by Statement of Financial Accounting Standards (“SFAS”) No. 7.  The Company’s Activities during the development stage include developing the business plan, seeking regulatory clearance in the European Union and the United States and raising capital.
Through December 31, 2008, we have generated minimal sales revenues, have incurred significant expenses and have sustained losses.  Consequently, our operations are subject to all the risks inherent in the establishment of a new business enterprise.
In May 2008, the Company received notice that the INVOcell product meets all the essential requirements of the relevant European Directive(s), and 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 “Conformité Européenne”) certifies that a product has met EU health, safety and environmental requirements, which ensure consumer safety.
With CE Marking, the Company now has the ability and necessary regulatory authority to distribute its product in the European Economic Area (Includes: The European Union, Canada, Australia, New Zealand, and most parts of the Middle East).  The Company has sold 785 units of INVOcell to date.
(B) Basis of Presentation (Reverse Merger and Corporate Structure)
On December 5, 2008, the Company completed a merger transaction with Emy’s Salsa Aji Distribution Company, Inc. (“Emy’s”) an inactive publicly registered shell corporation with no significant assets or operations.  Emy’s was incorporated on July 11, 2005, under the laws of the State of Nevada under the name Certiorari Corp.  In connection with the reverse merger, INVO Bioscience became our wholly-owned subsidiary and the INVO Bioscience Shareholders acquired control of Emy’s.  
For accounting purposes, the Company accounted for the transaction as a recapitalization and the Company is the surviving entity.  In connection with the reverse merger, 14,937,500 shares were retained by Emy’s shareholders.
Effective with the Agreement, all previously outstanding shares of common owned by the Company's shareholders were exchanged for an aggregate of 38,307,500 shares of Emy’s common stock.
Effective with the Agreement, Emys changed its name to INVO Bioscience Inc.
All references to common stock, share and per share amounts have been retroactively restated to reflect the exchange ratio of 357.0197 shares of INVO Bioscience common stock for 1 shares of the acquirer's common stock outstanding immediately prior to the merger as if the exchange had taken place as of the beginning of the earliest period presented.
The accompanying financial statements present the historical financial condition, results of operations and cash flows of the Company prior to the merger with Emys.
The accompanying consolidated financial statements present on a consolidated basis the accounts of the Company and its wholly owned subsidiaries.  All significant intercompany accounts and transactions have been eliminated in consolidation.
F-25
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
as of DECEMBER 31, 2008 and DECEMBER 31, 2007
(C) Use of Estimates
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 financial statements and revenues and expenses during the reported period.  Actual results could differ from those estimates.
(D) Cash and Cash Equivalents
The Company considers all highly liquid temporary cash investments with an original maturity of three months or less to be cash equivalents.  As of December 31, 2008 and 2007, the Company had $15,716 and $0 cash equivalents respectively.
(E) Inventory
Inventories consist of finished products and are stated at the lower of cost or market; using the first-in, first-out (FIFO) method as a cost flow convention. 
(F) Property and Equipment
The Company records property and equipment at cost.  Depreciation and amortization are provided using the straight-line method over the estimated economic lives of the assets, which are from 3 to 7 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.
(G) Stock Based Compensation
The Company accounts for stock-based compensation under the provisions of SFAS 123R, Share-Based Payment (“SFAS 123R”).  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 in exchange for the award, which is usually the vesting period.
(H) Loss Per Share
We use SFAS No. 128, “Earnings Per Share” for calculating the basic and diluted loss per share.  We compute basic loss per share by dividing net loss and net loss attributable to common shareholders by the weighted average number of common shares outstanding.  Common equivalent shares are excluded from the computation of net loss per share if their effect is anti-dilutive.  There were 120,000 common share equivalents at December 31, 2008 and none at December 31, 2007.  For the year ended December 31, 2008, these potential shares were excluded from the shares used to calculate diluted earnings per share as their inclusion would reduce net loss per share.
F-26
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
as of DECEMBER 31, 2008 and DECEMBER 31, 2007
(I) Identifiable Intangible Assets
Intangible assets are stated at cost net of accumulated amortization and impairment.  During the period December 31, 2008, the Company purchased $31,000 of additional patents that establish and protect its proprietary technology and product in several countries.  The Company intends to amortize these costs over the useful life of the patents.  
(J) Fair Value of Financial Instruments
SFAS No. 107, “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 Statement of Financial Accounting Standards No. 157, Fair Value Measurements (SFAS 157), which provides a framework for measuring fair value under GAAP.  SFAS 157 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.  SFAS 157 requires that valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs.
(K) Income Taxes
The Company accounts for income taxes under the Statement of Financial Accounting Standards No. 109, “Accounting for Income Taxes” (“SFAS 109”).  Under SFAS 109, deferred 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.  Under SFAS 109, the effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date.
In July 2006, the FASB issued FIN 48, “Accounting for Uncertainty in Income Taxes-an interpretation of FASB Statement No. 109” (“FIN 48”).  FIN 48 clarifies the recognition threshold and measurement of a tax position taken on a tax return.  FIN 48 is effective for fiscal years beginning after December 15, 2006.  FIN 48 also requires expanded disclosure with respect to the uncertainty in income taxes.
(L) Business Segments
The Company operates in one segment and therefore segment information is not presented.
(M) Concentration of Credit Risk
The Company at times has cash in banks in excess of FDIC insurance limits.  The Company had no amounts in excess of FDIC insurance limits as of December 31, 2008 and December 31, 2007.
(N) Revenue Recognition
The Company will recognize revenue on arrangements in accordance with Securities and Exchange Commission Staff Accounting Bulletin No. 101, “Revenue Recognition in Financial Statements” and No. 104, “Revenue Recognition”.  In all cases, revenue is recognized only when the price is fixed and determinable, persuasive evidence of an arrangement exists, the service is performed and collectability of the resulting receivable is reasonably assured.
F-27
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
as of DECEMBER 31, 2008 and DECEMBER 31, 2007
(O) Long- Lived Assets
Long-lived assets and certain identifiable assets related to those assets are periodically reviewed for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recoverable.  If the non-discounted future cash flows of the enterprise are less than their carrying amount, their carrying amounts are reduced to the fair value and an impairment loss recognized.  There was no impairment recorded from January 5, 2007 (inception) to December 31, 2008.
(P) Research and Development
The Company accounts for research and development costs in accordance with the Financial Accounting Standards Board's Statement of Financial Accounting Standards No. 2 (“SFAS 2”), “Accounting for Research and Development Costs.”  Research and development costs include expenses incurred by the Company for research, design and development of our proprietary technology and are charged to operations as incurred.  Accordingly, internal research and development costs are expensed as incurred.  Total expenditures on research and product development for 2008 and 2007 were approximately $52,000 and $33,000 respectively.
 (Q) Recent Accounting Pronouncements
In December 2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 160, “Noncontrolling Interests in Consolidated Financial Statements – an amendment of ARB No. 51.”  This statement improves the relevance, comparability, and transparency of the financial information that a reporting entity provides in its consolidated financial statements by establishing accounting and reporting standards that require; the ownership interests in subsidiaries held by parties other than the parent and the amount of consolidated net income attributable to the parent and to the noncontrolling interest be clearly identified and presented on the face of the consolidated statement of income, changes in a parent’s ownership interest while the parent retains its controlling financial interest in its subsidiary be accounted for consistently, when a subsidiary is deconsolidated, any retained noncontrolling equity investment in the former subsidiary be initially measured at fair value, entities provide sufficient disclosures that clearly identify and distinguish between the interests of the parent and the interests of the noncontrolling owners.   SFAS No. 160 affects those entities that have an outstanding noncontrolling interest in one or more subsidiaries or that deconsolidate a subsidiary.  SFAS No. 160 is effective for fiscal years, and interim periods within those fiscal years, beginning on or after December 15, 2008.  Early adoption is prohibited.  The adoption of this statement is not expected to have a material effect on the Company's financial statements. 
In March 2008, the FASB issued SFAS No. 161, “Disclosures about Derivative Instruments and Hedging Activities, an amendment of FASB Statement No. 133” (SFAS 161).  This statement is intended to improve transparency in financial reporting by requiring enhanced disclosures of an entity’s derivative instruments and hedging activities and their effects on the entity’s financial position, financial performance and cash flows.  SFAS 161 applies to all derivative instruments within the scope of SFAS 133, “Accounting for Derivative Instruments and Hedging Activities” (SFAS 133) as well as related hedged items, bifurcated derivatives, and nonderivative instruments that are designated and qualify as hedging instruments.  Entities with instruments subject to SFAS 161 must provide more robust qualitative disclosures and expanded quantitative disclosures.  SFAS 161 is effective prospectively for financial statements issued for fiscal years and interim periods beginning after November 15, 2008, with early application permitted.  We are currently evaluating the disclosure implications of this statement.
In May 2008, the FASB issued SFAS No. 162, “The Hierarchy of Generally Accepted Accounting Principles.”  SFAS No. 162 identifies the sources of accounting principles and provides entities with a framework for selecting the principles used in preparation of financial statements that are presented in conformity with GAAP.  The current GAAP hierarchy has been criticized because it is directed to the auditor rather than the entity, it is complex, and it ranks FASB Statements of Financial Accounting Concepts, which are subject to the same level of due process as FASB Statements of Financial Accounting Standards, below industry practices that are widely recognized as generally accepted but that are not subject to due process.  The Board believes the GAAP hierarchy should be directed to entities because it is the entity (not its auditors) that is responsible for selecting accounting principles for financial statements that are presented in conformity with GAAP.  SFAS 162 is effective 60 days following the SEC’s approval of PCAOB Auditing Standard No. 6, Evaluating Consistency of Financial Statements (AS/6).  The adoption of FASB 162 is not expected to have a material impact on the Company’s financial position.
In May 2008, the FASB issued SFAS No. 163, “Accounting for Financial Guarantee Insurance Contracts-an interpretation of FASB Statement No. 60.”  Diversity exists in practice in accounting for financial guarantee insurance contracts by insurance enterprises under FASB Statement No. 60, Accounting and Reporting by Insurance Enterprises.  This results in inconsistencies in the recognition and measurement of claim liabilities.  This Statement requires that an insurance enterprise recognize a claim liability prior to an event of default (insured event) when there is evidence that credit deterioration has occurred in an insured financial obligation.  This Statement requires expanded disclosures about financial guarantee insurance contracts.  SFAS 163 is effective for financial statements issued for fiscal years beginning after December 15, 2008, and interim periods for those fiscal years.  The accounting and disclosure requirements of the Statement will improve the quality of information provided to users of financial statements.  The adoption of FASB 163 is not expected to have a material impact on the Company’s financial position.
F-28
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
as of DECEMBER 31, 2008 and DECEMBER 31, 2007
In April 2008, the FASB issued FSP No. FAS 142-3, “Determination of the Useful Life of Intangible Assets.” This FSP amends the factors that should be considered in developing renewal or extension assumptions used to determine the useful life of a recognized intangible asset under SFAS No. 142, “Goodwill and Other Intangible Assets.”  The Company is required to adopt FSP 142-3 on January 1, 2009.  The guidance in FSP 142-3 for determining the useful life of a recognized intangible asset shall be applied prospectively to intangible assets acquired after adoption, and the disclosure requirements shall be applied prospectively to all intangible assets recognized as of, and subsequent to, adoption.  The Company is currently evaluating the impact of FSP 142-3 on its consolidated financial position, results of operations or cash flows.
In May 2008, the FASB issued FSP Accounting Principles Board (“APB”) 14-1 “Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement)” (“FSP APB 14-1”).  FSP APB 14-1 requires the issuer of certain convertible debt instruments that may be settled in cash (or other assets) on conversion to separately account for the liability (debt) and equity (conversion option) components of the instrument in a manner that reflects the issuer's non-convertible debt borrowing rate.  FSP APB 14-1 is effective for fiscal years beginning after December 15, 2008 on a retroactive basis.  The Company is currently evaluating the potential impact, if any, of the adoption of FSP APB 14-1 on its consolidated financial position, results of operations or cash flows.
In June 2008, the FASB issued Emerging Issues Task Force No. 07-5 (EITF 07-5), Determining Whether an Instrument (or Embedded Feature) is Indexed to an Entity’s Own Stock.  EITF 07-5 requires entities to evaluate whether an equity-linked financial instrument (or embedded feature) is indexed to its own stock by assessing the instrument’s contingent exercise provisions and settlement provisions.  Instruments not indexed to their own stock fail to meet the scope exception of Statement of Financial Accounting Standards No. 133, Accounting for Derivative Instruments and Hedging Activities, paragraph 11(a), and should be classified as a liability and marked-to-market.  The statement is effective for fiscal years beginning after December 15, 2008 and is to be applied to outstanding instruments upon adoption with the cumulative effect of the change in accounting principle recognized as an adjustment to the opening balance of retained earnings.  The Company is assessing the impact of this EITF for the year ended December 31, 2009.
Other recent accounting pronouncements issued by the FASB (including its Emerging Issues Task Force), the AICPA, and the SEC did not, or are not believed by management to, have a material impact on the Company's present or future consolidated financial statements.
NOTE 2GOING CONCERN
As reflected in the accompanying consolidated financial statements, the Company is in the development stage and has just commenced operations in December 2008, has a net loss of $1,873,000 a working capital deficiency of $690,000, a stockholder deficiency of $677,000 and cash used in operations of $1,067,000 for the year ended December 31, 2008.  This raises substantial doubt about its ability to continue as a going concern.  The financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.  The ability of the Company to continue as a going concern is dependent on the Company’s ability to raise additional capital and implement its business plan.
NOTE 3INVENTORY
As of December 31, 2008 and 2007, the Company recorded the following inventory balances:
  
December 31,
2008
 
December 31,
2007
Raw Materials $- $-
Work in Process  55,466  -
Finished Goods  15,257  -
Total Inventory $70,722 $-
F-29
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
as of DECEMBER 31, 2008 and 2007
NOTE 4PROPERTY AND EQUIPMENT
The estimated useful lives and accumulated depreciation for furniture, equipment and software are as follows:
Estimated Useful Life
Molds3 to 7 years
Computers and Software3 to 5 years
  
December 31,
2008
 
December 31,
2007
Manufacturing Equipment- Molds $35,263 $-
  Less: Accumulated Depreciation  980   
Network/IT Equipment  7,595  -
  Less: Accumulated Depreciation  633   
  $41,245 $-
During the periods December 31, 2008 and 2007, the Company recorded $1,613 and $0 in depreciation expense, respectively.
NOTE 5PATENTS
As of December 31, 2008 and 2007, the Company recorded the following patent costs:
  December 31, 2008  
December 31,
2007
 
Total Patents  $77,743   $46,725 
         
ACCUMULATED AMORTIZATION  (9,351)  (3,455)
         
Patent costs, net $68,392  $43,270 
During the periods December 31, 2008 and 2007, the Company recorded $ 5,896 and $3,455, respectively in amortization expenses.
NOTE 6WORKING LINE OF CREDIT
At December 31, 2008, the Company had a $50,000 working capital line of credit with Century Bank, interest payable monthly 0.24% above the bank’s prime lending rate on 12/31/08 the rate was 3.79%, maturing May 31, 2010.  At December 31, 2008 and 2007, the balance outstanding on the line of credit was $50,000 and $49,221, respectively.
NOTE PAYABLE AND OTHER RELATED PARTY TRANSACTIONS
On September 18, 2008, the Company entered into a related party transaction with Dr. Claude Ranoux.  Dr. Ranoux is the President, Director and Chief Scientific Officer of the Company.  Dr. Ranoux had loaned funds to the Company to sustain its operations since January 5, 2007 (inception).  Ranoux’s total cumulative investment at December 31, 2008 is $96,462 (“the Principal Amount”) in INVO Bioscience.  On December 1, 2008, Dr. Ranoux executed a letter agreement with the Company to amend the Promissory Note to allow conversion into shares of Emy’s common stock following the Closing.  On March 26, 2009, the Company and Dr Ranoux agreed to re-write the agreement to a non-convertible note payable bearing interest at 5% per annum and extended the repayment date to March 31, 2010. The Company and Dr. Ranoux can jointly decide to repay the loan earlier without prepayment penalties. 
For the years ended December 31, 2008 and 2007, the Company charged an in-kind contribution related to interest expense totaling $3,690 and $2,298, respectively.
F-30
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
as of DECEMBER 31, 2008 and 2007
NOTE  8STOCKHOLDERS’ EQUITY
For the period from January 5, 2007 (inception) through December 31, 2007, BioXcell (INVO Bioscience) issued 70,000 shares of common stock for $20,000, at $.2857/share. This was retroactively restated to 24,991,379 shares due to the reverse merger on December 29, 2008.
On December 29, 2008, the Company filed an amended and restated articles of incorporation with the Secretary of State of Nevada.  The Company’s authorized capital stock was changed from 75,000,000 shares, all of which were shares of common stock, par value $.0001 per share, to authorized common stock of 200,000,000 shares, par value $.0001, and 100,000,000 newly created shares of undesignated preferred stock, par value $.0001.
On November 7, 2008, Emy’s Board of Directors approved a 5-1 forward stock split (the “Forward Split”) of our common stock with a record date of November 10, 2008 for the Company’s issued and outstanding shares and not its authorized shares.  The Forward Split was payable on November 12, 2008.  Emys had 12,387,500 shares outstanding prior to the Forward Split and 61,937,500 shares outstanding thereafter.
The Company had 61,937,500 shares issued and outstanding immediately prior to the Share Exchange.  Our charter does not authorize any shares of preferred stock.  Pursuant to the Share Exchange Agreement, certain shareholders of Emy’s agreed to cancel 47,000,000 shares of Emy’s common stock and Emys agreed to issue 38,307,500 newly-issued shares of common stock to INVO Bioscience shareholders.  As of December 5, 2008 and immediately after Closing, an aggregate of 53,245,000 shares of common stock were outstanding, including shares issued pursuant to the Closing.
After the consummation of the transaction contemplated by the Share Exchange Agreement, on the day of the Closing, we entered into the Securities Purchase Agreement with the investors pursuant to which, the investors contributed $375,000 in exchange for 375,000 shares of our common stock at a price of $1.00 per share.  The investors have piggyback registration rights that permit them to register their common stock on any registration statement filed by the Company. 
During the period from January 1, 2008 through November 30, 2008, the Company issued an aggregate of 4,561,641 shares of common stock for cash totaling $706,938 for share prices ranging from $0.15 to $1.50.
In March 2008, the Company issued an aggregate of 8,488,857 shares of common stock (net of forfeitures) for services rendered totaling $11,259.  In November 2008, the Company issued an aggregate of 265,623 shares of common stock for services rendered totaling $40,056.
Since January 1, 2008, the Company has signed agreements for officers, executives and service providers of the Company.   As of December 31, 2008, a total of 303,500 shares of common stock and options to purchase an additional 500,000 (including 461,000 of employee incentive stock options) of the Company’s common stock were agreed to be issued.  As of December 31, 2008, the Company has not issued the committed shares and has recorded an accrued liability of $313,500.  As of December 31, 2008, the Company has not obtained shareholder approval for the employee incentive stock option plan and has not deemed the 500,000 options as granted until the plan is approved. 
During the years ended December 31, 2008 and 2007, the Company recorded related party contributed services and interest of $164,511 and $93,163, respectively.
Non-Statutory Options
The following table summarizes the changes in options outstanding and the related prices for the shares of the Company’s common stock issued.  These options were granted in lieu of cash compensation for services performed.
   Options Outstanding Options Exercisable 
Exercise Prices  
Number
Outstanding
  
Weighted Average
Remaining Contractual
Life (Years)
 
Number
Exercisable
 
Weighted
Average
Exercise Price
 
$1.00   140,000   2.9   $-  $- 
F-31
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
as of DECEMBER 31, 2008 and 2007
Transactions involving warrants are summarized as follows:
  
Number of
Shares
 
Weighted
Average Price
Per Share
Outstanding at January 5, 2007  - $-
Granted  -  -
Exercised  -  -
Canceled or expired  -  -
Outstanding at December 31, 2007  - $-
Granted  140,000  1.00
Exercised  -  -
Canceled or expired  -  -
Outstanding at December 31, 2008  140,000 $1.00
Aggregate intrinsic value of options outstanding and exercisable at December 31, 2008 was $630,000.  Aggregate intrinsic value represents the difference between the Company's closing stock price on the last trading day of the fiscal period, which was $5.50 as of December 31, 2008, and the exercise price multiplied by the number of options outstanding.  As of December 31, 2008, total unrecognized stock-based compensation expense related to stock options was $210,000.  During the year ended December 31, 2008, the Company did not charge to operations the related expense to recognized stock-based compensation for the above stock options.
NOTE  9INCOME TAXES
The Company has adopted Financial Accounting Standard number 109, which requires the recognition of deferred tax liabilities and assets for the expected future tax consequences of events that have been included in the financial statement or tax returns.  Under this method, deferred tax liabilities and assets are determined based on the difference between financial statements and tax basis of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse.  Temporary differences between taxable income reported for financial reporting purposes and income tax purposes are insignificant.
For income tax reporting purposes, the Company's aggregate unused net operating losses approximate $1,800,000, expire at various times through 2028, subject to limitations of Section 382 of the Internal Revenue Code, as amended.  The deferred tax asset related to the carry forward is approximately $540,000.  The Company has provided a valuation reserve against the full amount of the net operating loss benefit, since in the opinion of management based upon the earning history of the Company, it is more likely than not that the benefits will not be realized.
NOTE 10COMMITMENTS
A)Operating Leases
On January 1, 2007, the Company entered into an operating lease (the “lease”) with Cummings Properties, LLC, to lease 3,294 square feet of general office space.  The lease commenced on January 1, 2007 and was automatically extended in October 2008 until December 31, 2010.  The Company agreed to pay a security deposit of $3,000 on January 1, 2007, which was repaid to the Company in equal $500 installments over the first six months of the lease.  The Company received no rent incentives or improvement allowances under this agreement.  The lease requires the Company to pay minimum lease payments of $2,000 per month for the duration of the lease.  The lease is subject to a cost of living increase equal to the Boston, MA Consumer Price Index at the beginning of each calendar year.  As of January 1, 2009, the Company’s lease payments under this agreement increased 3.53% to $2,070.60.
Fiscal Year Minimum Future Lease Payments 
    2009 $24,847 
    2010 $24,847 
F-32
INVO BIOSCIENCE, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
as of DECEMBER 31, 2008 and 2007
B)Consulting agreements
On October 22, 2007, the Company entered into a fee agreement with Business Growth Resources, LLC (“BGR”), 28 Aspenwood St., Suite 215, Simsbury, CT to assist the Company with raising operating capital.  The Company agreed to pay Business Growth Resources a retainer of $7,500 payable as follows: $2,500 upon execution of the agreement, and $2,500 every thirty days thereafter.  The Company also agreed to pay Business Growth Resources, LLC 5% of any investment proceeds that were introduced to the Company by BGR.  Because of BGR’s inability to introduce viable investment opportunities to the Company, the two parties separated the agreement on August 9, 2008.  The Company paid $5,000 for BGR’s efforts.
On December 5, 2008 in conjunction with the closing of the Securities Exchange Agreement the Company signed a term sheet with Lionshare Ventures LLC (“LSV”).  The terms of the agreement were such that LSV agreed to invest the balance of its original commitment to the Company dated May 19, 2008 in the amount of $450,000.  2,000,000 shares of common stock were escrowed until the money was funded to the Company.  As of today, LSV has delivered $200,000 and the Company released 1,000,000 of common shares from escrow.
C)Anti-Dilution and Piggyback Registration Rights
On December 5, 2008, we entered into the Securities Purchase Agreement with the certain investors who have piggyback registration rights that permit them to register their common stock on any registration statement filed by the Company.  In addition, pursuant to certain anti-dilution rights granted under the Securities Purchase Agreement to the investors, the Company may be obligated to issue additional shares of its common stock to the investors in the event it issues common stock to future investors at a per share purchase price less than $1.00.  The number of additional shares to be issued in such event is equal to that number of shares that the investors would have acquired at such price had that price been offered at the time of their original investment, minus the number of shares acquired in their original investment.  Further, pursuant to the letter agreement, LSV and its managing member, Christopher Esposito, have agreed to forfeit to us, one share of our common stock for every two shares we would be required to issue up to the maximum of 562,5000 shares, which number of shares are being held in escrow by us until December 5, 2010.
D)Employee Agreements
Since January 1, 2008, the Company has signed nine employee agreements for officers, executives and employees of the Company.  Three of these agreements were with the founders of the Company.  
The remaining six of the agreements were executed with executives and staff of the Company.  These employees were issued common shares and options to purchase common shares of the Company.  Under the terms of these employee agreements, these shares only vest upon the completion of the Exchange Agreement and the implementation of the Company’s Employee Stock Plan.  The Exchange Agreement closed on December 5, 2008, the Company has yet to implement an Employee Stock Plan, it is planning to do so in the second quarter of 2009.  As of today, a total of 303,500 shares of common stock and options to purchase an additional 700,000 shares of the Company’s common stock have been promised but not issued.  
F-33


8,790,000 Shares of
Common Stock
________________________
PROSPECTUS
_______________________
December 21, 2009
PART II - INFORMATION NOT REQUIRED IN PROSPECTUS
ITEM 13. OTHER EXPENSES OF ISSUANCE AND DISTRIBUTION
The following table sets forth an itemization of various expenses, all of which we will pay, in connection with the sale and distribution of the securities being registered. All of the amounts shown are estimates, except the Securities and Exchange Commission registration fee.

Securities and Exchange Commission Registration Fee $200.57 
Accounting Fees and Expenses  10,000.00 
Legal Fees and Expenses  30,000.00 
State securities fees  2,000.00 
Transfer agent fees  10,000.00 
Miscellaneous  5,000.00 
Total $57,200.57 

ITEM 14. INDEMNIFICATION OF DIRECTORS AND OFFICERS
Our Articles of Incorporation and By-laws provide for indemnification of our officers and directors to the fullest extent permissible under Nevada law. Additionally, we have entered into indemnification agreements with each of our officers and Directors, and therefore purchasers of these securities may have a more limited right of action than they would have except for this limitation in the Articles of Incorporation and By-laws. These agreements provide, in general, that we shall indemnify and hold harmless such directors and officers to the fullest extent permitted by law against any judgments, fines, amounts paid in settlement, and expenses, including attorneys' fees and disbursements, incurred in connection with, or in any way arising out of, any claim, action or proceeding against, or affecting, such directors and officers resulting from, relating to or in any way arising out of, the service of such persons as our directors and officers.
ITEM 15. RECENT SALES OF UNREGISTERED SECURITIES

We have sold certain shares of common stock for cash and have issued shares of common stock in exchange for services.  For the following issuances of our securities, we claimed the exemption from registration set forth in Section 4(2) of the Securities Act and the rules thereunder, as private transactions not involving a public distribution.  The facts we relied upon to claim the exemption include: (i) the purchasers represented that they purchased shares from the Company for investment and not with a view to distribution to the public; (ii) each certificate issued for unregistered securities contains a legend stating that the securities have not been registered under the Securities Act and setting forth the restrictions on the transferability and the sale of the securities; (iii) the purchasers as well as most of those who received shares for services represented that they were accredited investors and sophisticated and all were familiar with our business activities; and (iv) the purchasers and service providers were given full and complete access to any corporate information requested by them.

On December 5, 2008, Bio X Cell, Inc., a Commonwealth of Massachusetts corporation doing business as INVO Bioscience (hereinafter “INVO Bioscience”), and each of the  8 shareholders of INVO Bioscience (the “INVO Bioscience Shareholders”). entered into a share exchange agreement (the “Share Exchange Agreement”) and consummated a share exchange (the “Share Exchange”) with the Company, which was then known as Emy’s Salsa Aji Distribution Company, Inc. (“Emy’s”). Upon the closing of the Share Exchange on December 5, 2008 (the “Closing”), the INVO Bioscience Shareholders transferred all of their shares of common stock in INVO Bioscience to Emy’s.  In exchange, we issued to the INVO Bioscience Shareholders an aggregate of 38,307,500 shares of Emy’s common stock (the “common stock”), $0.0001 par value per share, representing 71.9% of the shares issued and outstanding immediately after the Closing.  As a result of the Share Exchange, INVO Bioscience became a wholly-owned subsidiary of Emy’s.

Immediately following the Closing of the Share Exchange, we entered into a securities purchase agreement (the “Securities Purchase Agreement”) with GRQ Consulting, LLC and Whalehaven Capital Fund Limited.  Pursuant to the Securities Purchase Agreement, the investors invested $375,000 in exchange for 375,000 shares of our common stock at a price of $1.00 per share.  
In March 2009, we issued an aggregate of 83,333 shares of common stock Wakabayashi Fund, LLC for investor relations services in the Asian markets totaling $37,500.
In May 2009, we issued an aggregate of 125,000 shares of common stock for U.S. based investor relations and fund raising services rendered to Investor Awareness, Inc and Red Chip Securities for a combined value totaling $15,500.
II-1
During the period July 15, 2009 to September 15, 2009, we issued convertible notes payable (“Bridge Notes”) to accredited investors in the aggregate amount of $545,000.  The Bridge Notes carry interest rates ranging from 10-12% and are due in full in one year from the date of issuance.  The Bridge Notes and accrued interest are convertible into our common stock at a conversion price of $0.10 per share, subject to adjustments. In addition to the Bridge Notes, we issued warrants to purchase 5,750,000 shares of the Company’s common stock at a price of $0.20 per share.

In September 2009, we issued an aggregate of 1,125,000 shares of common stock to GRQ Consulting and Whalehaven (described above) in connection with the execution of a $100,000 convertible note as part of a bridge offering.  The Bridge Notes transaction triggered the anti-dilution clause of the Securities Purchase Agreement executed on December 5, 2008 with the investors.  

In September 2009, the Company issued an aggregate of 857,000 shares of common stock for a number of different services which rendered a total of $299,950. The services included investor relations from College Stock LLC which received the majority of these shares (500,000), 140,000 shares were issued to two former employees per their employment agreement, the balance of the shares were distributed to 7 other individuals for engineering and manufacturing support (25,000 shares), sales consulting (102,000 shares), legal guidance (50,000 shares) and technical assistance (40,000 shares),

In October, 2009, we entered into the REF with AGS Capital Group, LLC pursuant to which AGS committed to purchase, from time to time over a period of two years, shares of our common stock for cash consideration up to $10,000,000, subject to certain conditions and limitations.  In connection with the REF, we also entered into a registration rights agreement with AGS, dated October 28, 2009.  The terms of the REF are described elsewhere in this Registration Statement.

In November 2009, we issued an aggregate of 612,000 shares of common stock of which 600,000 were issued to Gilford Securities for the REF and 12,000 for accounting & reporting services rendered for a value totaling $312,120.

In November 2009, we issued an aggregate of 2,100,000 shares of common stock for the conversion of $210,000 of the Bridge Notes described above.

In November 2009, we issued an aggregate of 42,930 shares of common stock for the interest related to conversion of $210,000 of Convertible Notes Payable into common stock at a price of $0.10 per common share.
II-2
ITEM 16. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a) (1)  Our un-audited and audited financial statements are included in the prospectus.
(a) (2)  The following exhibits are being filed herewith.
EXHIBIT  NUMBER4.1 DESCRIPTIONDescription of Capital Stock, filed as an Exhibit to our Annual Report on Form 10-K for the year ended December 31, 2022 and incorporated herein by reference.
  2.  14.2 Share Exchange Agreement, dated December 5, 2008, by and among Registrant, INVO Bioscience and INVO Bioscience Shareholders(3)
  2.  2
Securities Purchase Agreement dated December 5, 2008, between Registrant and the investors named   therein(3)
  3.  1Articles of Incorporation of Registrant(1)
  3.  2     Certificate of Amendment to Articles of Incorporation of Registrant(1)
  3.  3        By-Laws of Registrant(2)
  3.  4Certificate of Amendment to Articles of Incorporation of Registrant dated December 22, 2008(4)
  4.  1Form of Senior Secured Convertible Promissory Note(9)Note, dated July 2009. Incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on July 17, 2009.
  4.  24.3 Form of Convertible Promissory Note Purchase Agreement(9)Agreement, dated July 2009. Incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on July 17, 2009.
  4.  34.4 Form of Convertible Promissory Note, dated January 2018. Incorporated by reference to Exhibit 4.3 to the Annual Report on Form 10-K filed on April 16, 2019.
4.5Form of Convertible Note Purchase Agreement, dated January 2018. Incorporated by reference to Exhibit 4.4 to the Annual Report on Form 10-K filed on April 16, 2019.
4.6Form of Secured Convertible Note, dated May 2020. Incorporated by reference to Exhibit 4.1 to the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2020.
4.7Form of Unit Purchase Option, dated May 2020. Incorporated by reference to Exhibit 4.2 to the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2020.
4.8Form of Warrant, Purchase Agreement(9)dated May 2020. Incorporated by reference to Exhibit 4.3 to the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2020.
  4.  44.9 Reserve Equity FinancingForm of Placement Agent Warrant to Purchase Common Stock, filed as Exhibit 4.1 to our Current Report dated October 1, 2021 and filed with the Securities and Exchange Commission on October 5, 2021 and incorporated herein by reference.
4.10Demand Promissory Note between the registrant and JAG Multi Investments LLC, filed as Exhibit 4.1 to our Quarterly Report on Form 10-Q filed with the Securities Exchange Commission on November 14, 2022 and incorporated herein by reference.
4.11Form of Warrant, filed as Exhibit 4.5 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on January 5, 2023 and incorporated herein by reference.
4.12Form of Debenture, filed as Exhibit 4.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on February 9, 2023 and incorporated herein by reference.
4.13Form of Warrant, filed as Exhibit 4.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on February 9, 2023 and incorporated herein by reference.
4.14Form of Debenture, filed as Exhibit 4.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on February 9, 2023 and incorporated herein by reference.
4.15Form of Warrant, filed as Exhibit 4.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on February 9, 2023 and incorporated herein by reference.
4.17Form of Convertible Promissory Note, filed as Exhibit 4.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 23, 2023 and incorporated herein by reference.
4.18Form of Warrant, filed as Exhibit 4.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 23, 2023 and incorporated herein by reference.
4.20Form of Pre-funded Warrant, filed as Exhibit 4.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 28, 2023 and incorporated herein by reference.
4.21Form of Private Placement Warrant, filed as Exhibit 4.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 28, 2023 and incorporated herein by reference.
4.22Form of Placement Agent Warrant, filed as Exhibit 4.3 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 28, 2023 and incorporated herein by reference.
5.1***Opinion of Sheppard Mullin Richter & Hampton LLP
10.1Short Term Note, dated March 5, 2009 between the registrant and Kathleen Karloff. Incorporated by reference to Exhibit 10.5 to the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2009.
10.2Short Term Note, dated May 19, 2019 between the registrant and Kathleen Karloff. Incorporated by reference to Exhibit 10.5 to the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 14, 2009.
10.3Promissory Note, dated August 9, 2016, between the registrant and Kavanaugh Rosenthal Peisch & Ford, LLP. Incorporated by reference to Exhibit 10.3 the Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 16, 2019.

II-6

10.4Distribution Agreement, dated November 12, 2018, between the Registrant and Ferring International Center S.A,. Incorporated by reference to Exhibit 10.4 to the Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 16, 2019.
10.5Supply Agreement, dated November 12, 2018, between the registrant and Ferring International Center S.A. Incorporated by reference to Exhibit 10.5 to the Annual Report on Form 10-K filed with the Securities and Exchange Commission on April 16, 2019.
10.6Joint Venture Agreement, dated January 13, 2020, between the registrant and Medesole Healthcare and Trading Private Limited, India. Incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on January 16, 2020.
10.7Employment Agreement, dated October 28, 2009,16, 2019, between the registrant and Steven Shum. Incorporated by reference to the Current Report on Form 8-K filed with the Securities and between AGS Capital Group, LLC and Invo Bioscience, Inc(11)Exchange Commission on October 15, 2019.
  4.  510.8 Registration RightsEmployment Agreement, dated October 28, 2009,January 15, 2020, between the registrant and Michael Campbell. Incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the Securities and between AGS Capital Group, LLC and Invo Bioscience, Inc.(11)Exchange Commission on January 21, 2020.
  5.  110.9 
Opinion of Shulman, Rogers, Gandal, Pordy & Ecker P.A.
10.Commercial Lease Agreement, dated May 1, Distribution Agreement2019 between the companyregistrant and Orbital Group,PJ LLC.(2)
10.  2Employment Agreement for Incorporated by reference to Exhibit 10.9 to the Registrant’s President(7)
10.  3Employment Agreement forAnnual Report on Form 10-K filed with the Registrant’s Chief Executive Officer(7)
10.  4Employment Agreement for the Registrant’s Chief Financial Officer(7)
10.  5Customer Distribution Agreement – Canada – MediTech First(7)
10.  6Customer Distribution Agreement – Turkey – Gonagen(7)
10.  7Customer Distribution Agreement – Peru – CRHL(7)
10.  8Claude Ranoux Loan Agreement(8)
10.  9Claude Ranoux Loan Amendment(8)Securities and Exchange Commission on March 30, 2020.
10.10 Wakabayashi Fund, LLC Agreement(8)2019 Stock Incentive Plan, incorporated by reference to the Registration Statement on Form S-8 with the Securities and Exchange Commission on October 16, 2019.
10.11 Red ChipPre-Incorporation and Shareholders Agreement between INVO Centers, LLC, Francisco Arredondo, M.D. PLLC and Ramiro Ramirez Guiterrez. Incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the Securities Inc. Agreement(8)and Exchange Commission on September 30, 2020.
10.12 Kathleen Karloff Loan Agreement(8)Distribution Agreement, dated November 23, 2020, between the registrant and IDS Medical Systems (M) Sdn Bhda. Incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on November 25, 2020.
10.13 Hallmark Investments, Inc.  Agreement(9)Joint Venture Agreement, dated November 23, 2020, between the registrant and SNS Nurni SDN BHD. Incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on November 25, 2020.
10.14 Kathleen Karloff Revised Loan Agreement(10)Joint Venture Agreement, dated November 23, 2020, between the registrant and Ginekaliks Dooel. Incorporated by reference to Exhibit 10.3 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on November 25, 2020.
10.15 Lionshare Ventures Revised Agreement(10)Distribution Agreement, dated December 2, 2020, between the registrant and Tasnim Behboud Arman. Incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on December 8, 2020.
10.16 Placement AgentForm of Securities Purchase Agreement, dated September 22, 2009,May 2020. Incorporated by reference to Exhibit 10.1 to the Quarterly Report on Form 10-Q filed with the Securities and between Gilford Securities, Inc. and Invo Bioscience, Inc.(11)Exchange Commission on May 15, 2020.
10.17 College Stock, Inc. Agreement(12)Form of Security Agreement, dated May 2020. Incorporated by reference to Exhibit 10.2 to the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2020.
23.  110.18 Form of Registration Rights Agreement, dated May 2020. Incorporated by reference to Exhibit 10.3 to the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 15, 2020.
10.19Amendment No. 1 to Distribution Agreement, between the registrant and Ferring International Center S.A. Incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on March 8, 2021.
 10.20HRCFG INVO LLC Limited Liability Company Agreement, dated March 10, 2021, between the registrant and HRCFG, LLC. Incorporated by reference to Exhibit 10.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on March 15, 2021.
10.21Note, dated March 10, 2021, between the registrant and HRCFG, LLC. Incorporated by reference to Exhibit 10.2 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on March 15, 2021.
10.22Lease, dated March 2021, with Trustmark National Bank filed as Exhibit 10.22 to our Annual Report on Form 10-K for the year ended December 31, 2020 and incorporated herein by reference.
10.23Partnership Agreement dated April 9, 2021 between the registrant and Lyfe Medical, LLC, filed as Exhibit 10.1 to our Current Report on Form 8-K dated April 9, 2021 and filed with the Securities and Exchange Commission on April 13, 2021 and incorporated by reference herein.
10.24Amended and Restated Employment Agreement with Andrea Goren dated June 14, 2021, filed as Exhibit 10.1 to our Current Report on Form 8-K dated June 14, 2021 and filed with the Securities and Exchange Commission on June 15, 2021 and incorporated herein by reference.
10.25Joint Venture Agreement dated June 28, 2021 between INVO Centers, LLC and Bloom Fertility, LLC, filed as Exhibit 10.1 to our Current Report on Form 8-K dated June 28, 2021 and filed with the Securities and Exchange Commission on June 30, 2021 and incorporated herein by reference.

II-7

10.26Limited Liability Company Agreement of Bloom INVO, LLC dated June 28, 2021, filed as Exhibit 10.2 to our Current Report on Form 8-K dated June 28, 2021 and filed with the Securities and Exchange Commission on June 30, 2021 and incorporated herein by reference.
10.27Management Services Agreement dated June 28, 2021 between Bloom INVO LLC, Bloom Fertility LLC and Sue Ellen Carpenter, filed as Exhibit 10.3 to our Current Report on Form 8-K dated June 28, 2021 and filed with the Securities and Exchange Commission on June 30, 2021 and incorporated herein by reference.
10.28INVOcell Supply Agreement dated June 28, 2021 between the registrant and Bloom INVO LLC, filed as Exhibit 10.4 to our Current Report on Form 8-K dated June 28, 2021 and filed with the Securities and Exchange Commission on June 30, 2021 and incorporated herein by reference.
10.29Intellectual Property License Agreement dated June 28, 2021 between Bloom INVO LLC and the registrant, filed as Exhibit 10.5 to our Current Report on Form 8-K dated June 28, 2021 and filed with the Securities and Exchange Commission on June 30, 2021 and incorporated herein by reference.
10.30Intellectual Property License Agreement dated June 28, 2021 between Bloom INVO LLC, Bio X Cell Inc. and the registrant, filed as Exhibit 10.6 to our Current Report on Form 8-K dated June 28, 2021 and filed with the Securities and Exchange Commission on June 30, 2021 and incorporated herein by reference.
10.31Sublease Agreement dated June 29, 201 between Assure Fertility Partners of Atlanta II, LLC and Bloom INVO LLC, filed as Exhibit 10.7 to our Current Report on Form 8-K dated June 28, 2021 and filed with the Securities and Exchange Commission on June 30, 2021 and incorporated herein by reference.
10.32Guarantee of Sublease made by the registrant in favor of Assure Fertility Partners of Atlanta II, LLC and Bloom INVO, LLC, filed as Exhibit 10.8 to our Current Report on Form 8-K dated June 28, 2021 and filed with the Securities and Exchange Commission on June 30, 2021 and incorporated herein by reference.
10.33Share Purchase Agreement dated September 1, 2021 among Ernest Broome, Lyle Oberg, Richard Ross, Dr. Seang Lin Tan, the registrant and Effortless IVF Canada Inc., filed as Exhibit 10.1 to our Current Report dated September 1, 2021 and filed with the Securities and Exchange Commission on September 7, 2021 and incorporated herein by reference.
10.34Stock Purchase Agreement dated September 30, 2021 between the registrant and Paradigm Opportunities Fund, LP, filed as Exhibit 10.1 to our Current Report dated October 1, 2021 and filed with the Securities and Exchange Commission on October 4, 2021 and incorporated herein by reference.
10.35Placement Agent Agreement dated October 1, 2021 between the registrant and Paulson Investment Company, LLC, filed as Exhibit 10.1 to our Current Report dated October 1, 2021 and filed with the Securities and Exchange Commission on October 5, 2021 and incorporated herein by reference.
10.36Form of Stock Purchase Agreement dated October 1, 2021 between the registrant and the purchasers set forth therein, filed as Exhibit 10.2 to our Current Report dated October 1, 2021 and filed with the Securities and Exchange Commission on October 5, 2021 and incorporated herein by reference.
10.37Termination Notice from Ferring International Center S.A. dated November 2, 2021, filed as Exhibit 10.1 to our Current Report on Form 8-K dated November 2, 2021 and filed with the Securities and Exchange Commission on November 8, 2021 and incorporated herein by reference.
10.38Amendment No. 1 to Stock Purchase Agreement dated November 29, 2021 between the registrant and Paradigm Opportunities Fund LP, filed as Exhibit 10.1 to our Current Report on Form 8-K dated November 29, 2021 and filed with the Securities and Exchange Commission on December 2, 2021 and incorporated herein by reference.
10.39Amendment No. 2 to Stock Purchase Agreement dated November 29, 2021 between the registrant and Paradigm Opportunities Fund LP, filed as Exhibit 10.1 to our Current Report on Form 8-K dated December 31, 2021 and filed with the Securities and Exchange Commission on January 6, 2022 and incorporated herein by reference.
10.41Exclusive Distribution Agreement between the registrant and Onesky Holding Limited dated May 13, 2022, filed as Exhibit 10.1 to our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 16, 2022 and incorporated herein by reference.
10.42Lease Agreement with INVO Centers, LLC dated May 23, 2022, filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on May 26, 2022 and incorporated herein by reference.
10.43Second Amended and Restated 2019 Stock Option Plan, filed as Appendix A to our Definitive Proxy Statement on Schedule 14A filed with the Securities and Exchange Commission on August 25, 2022 and incorporated herein by reference.
10.44Distribution Agreement by and between the registrant and Ming Mei Technology Co. Ltd. dated January 3, 2023, filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on January 5, 2023 and incorporated herein by reference.
10.45Form of Convertible Promissory Note, filed as Exhibit 4.4 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on January 5, 2023 and incorporated herein by reference.
10.46Securities Purchase Agreement dated January 4, 2023, filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on January 5, 2023 and incorporated herein by reference.
10.47Registration Rights Agreement dated January 4, 2023, filed as Exhibit 10.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on January 5, 2023 and incorporated herein by reference.

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10.48Securities Purchase Agreement dated February 3, 2023, filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on February 9, 2023 and incorporated herein by reference.
10.49Registration Rights Agreement to Debenture and Warrant dated February 3, 2023, filed as Exhibit 10.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on February 9, 2023 and incorporated herein by reference.
10.50Equity Purchase Agreement dated February 3, 2023, filed as Exhibit 10.4 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on February 9, 2023 and incorporated herein by reference.
10.51Registration Rights Agreement to Equity Purchase Agreement dated February 3, 2023, filed as Exhibit 10.5 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on February 9, 2023 and incorporated herein by reference.
10.52Asset Purchase Agreement between the registrant, WFRSA and The Elizabeth Pritts Revocable Living Trust dated March 16, 2023, filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 20, 2023 and incorporated herein by reference.
10.53Membership Interest Purchase Agreement by and between the registrant and FLOW, IVF Science, LLC dated March 16, 2023, filed as Exhibit 10.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 20, 2023 and incorporated herein by reference.
10.54Securities Purchase Agreement dated March 17, 2023, filed as Exhibit 10.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 23, 2023 and incorporated herein by reference.
10.55Registration Rights Agreement dated March 17, 2023, filed as Exhibit 10.2 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 23, 2023 and incorporated herein by reference.
10.56Placement Agency Agreement by and between the registrant and Maxim Group, LLC dated March 23, 2023, filed as Exhibit 1.1 to our Current Report on Form 8-K filed with the Securities and Exchange Commission on March 28, 2023 and incorporated herein by reference.
21.1Subsidiaries filed as an Exhibit to our Annual Report on Form 10-K for the year ended December 31, 2022 and incorporated herein by reference.
23.1*Consents of M&K CPAs, PLLC
23.2***Consent of RBSM,Sheppard Mullin Richter & Hampton LLP (included as Exhibit 5.1).
23.  224.1*** 
ConsentPower of Webb & Company P.A.Attorney (included on signature page)
23.  3107* Consent of Shulman, Rogers, Gandal, Pordy & Ecker P.A (included in Exhibit 5.1)Filing Fee Table
101.INS* Inline XBRL Instance Document
101.SCH*Inline XBRL Taxonomy Extension Schema Document
101.CAL*Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF*Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB*Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE *Inline XBRL Taxonomy Extension Presentation Linkbase Document
104*Cover Page Interactive Data File – the cover page of the registrant’s Annual Report on Form 10-K for the year ended December 31, 2022 is formatted in Inline XBRL

* Filed herewith

** Furnished herewith

***Previously filed

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(1)   Incorporated by reference to the Registrant’s Registration Statement on Form SB-2/A filed with the Securities and Exchange Commission on January 25, 2008
(2)   Incorporated by reference to the Registrant’s Registration Statement on Form SB-2 filed with the Securities and Exchange Commission on November 13, 2007
(3)   Incorporated by reference to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on December 12, 2008
(4)   Incorporated by reference to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on January 5, 2009
(5)   Incorporated by reference to the Registrant’s Current Report on Form 8-K/A filed with the Securities and Exchange Commission on February 17, 2009
(6)   Incorporated by reference to the Registrant’s Current Report on Form 8-K/A filed with the Securities and Exchange Commission on March 19, 2009
(7)   Incorporated by reference to the Registrant’s Annual Report on Form 10-K for the fiscal year ended December 31, 2008 and filed with the Securities and Exchange Commission on April 15, 2009
(8)   Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q for the three months ended March 31, 2009 filed with the Securities and Exchange Commission on May 15, 2009
(9)   Incorporated by reference to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on July 17, 2009
(10) Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q for the three months ended June 30, 2009 filed with the Securities and Exchange Commission on August 15, 2009
(11)  Incorporated by reference to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on November 3, 2009
(12)  Incorporated by reference to the Registrant’s Quarterly Report on Form 10-Q for the three months ended September 30, 2009 filed with the Securities and Exchange Commission on November 16, 2009
ITEM 17. UNDERTAKINGS
(a) The undersigned registrant hereby undertakes:
(1) To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i) to include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
(ii) to reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information set forth in this registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered (if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant to Rule 424(b) if, in the aggregate the changes in volume and price represent no more than 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement; and
(iii) to include any material information with respect to the plan of distribution not previously disclosed in this registration statement or any material change to such information in this registration statement.
(2) That, for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(3) To remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold at the termination of the offering.
 (h) Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy as expressed in the Act and will be governed by the final adjudication of such issue.
(i) The undersigned registrant hereby further undertakes that:
(1) For purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus filed as part of this registration statement in reliance under Rule 430A and contained in a form of prospectus filed by the registrant pursuant to Rule 424(b)(1) or (4), or 497(h) under the Securities Act of 1933 shall be deemed to be part of this registration statement as of the time it was declared effective.
(2) For the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the initial bona fide offering thereof.
SIGNATURES
In accordance with the requirements of the Securities Act of 1933, the Registrant has duly caused this Registration Statement to be signed on its behalf by the undersigned, in the City Beverly in the Commonwealth of Massachusetts, on December 28, 2009 .
INVO BIOSCIENCE, INC.
By: /s/ Kathleen T. Karloff
            Kathleen T. Karloff
            Chief Executive Officer
We the undersigned officers and directors of INVO Bioscience, hereby severally constitute and appoint Kathleen T. Karloff and Robert Bowdring, our true and lawful attorney-in-fact and agent, with full power of substitution and re-substitution in her, for her, and in her name, place and stead, and in any and all capacities, to sign any and all amendments (including post-effective amendments) to this Registration Statement (or any other Registration Statement for the same offering that is to be effective upon filing pursuant to Rule 462(b)  under  the Securities  Act  of 1933),  and  to file the same, with all exhibits  thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorney-in- fact and agents full power and authority to do and perform each and every act and thing requisite or necessary to be done in and about the premises, as full to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorney-in-fact and agent or his substitute may lawfully do or cause to be done by virtue hereof.
In accordance with the requirements of the Securities Act of 1933, this Registration Statement was signed by the following persons in the capacities and on the dates indicated
INVO BIOSCIENCE, INC.
Date: December 28, 2009
By: /s/ Kathleen T. Karloff
Name: Kathleen T. Karloff
Title: Chief Executive Officer and Director
By: /s/ Claude Ranoux
Name: Claude Ranoux, MD
Title: President and Director
By: /s/ Robert J. Bowdring
Name: Robert J. Bowdring
Title: Chief Financial and Accounting Officer