As filedFiled with the Securities and Exchange Commission on December 31, 2018September 12, 2023
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form S-3
FORM S-3
REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933
NanoVibronix, Inc.
(Exact nameName of registrantRegistrant as specifiedSpecified in its charter)Charter)
Delaware | 01-0801232 | |
(State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification |
525 Executive Blvd.
Elmsford, New York 10523
(914) 233-3004
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Brian MurphyChief Executive OfficerNanoVibronix, Inc.525 Executive Blvd.
Elmsford, New York(914) 233-3004
Brian Murphy
Chief Executive Officer
NanoVibronix, Inc.
525 Executive Blvd.
Elmsford, New York
(914) 233-3004
(Name, address, including zip code, and telephone number, including area code, of agent for service)
Copies of all communications, including communications sent to agent for service, should be sent to:
Rick A. Werner, Esq.
Jayun Koo, Esq.
Haynes and Boone, LLP
30 Rockefeller Plaza, 26th26th Floor
New York, New York 10112Tel.
(212) 659-7300Fax (212) 884-8234
Approximate date of commencement of proposed sale to the public:public: From time to time after the effective date of this Registration Statement becomes effective. registration statement.
If the only securities being registered on this Formform are being offered pursuant to dividend or interest reinvestment plans, please check the following box:box. ☐
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check the following box: ☑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. ☐
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. ☐
If this Form is a registration statement filed pursuant to General Instruction I.D. or a post-effective amendment thereto that shall become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. ☐
If this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following box. ☐
Indicate by check mark whether the Registrantregistrant 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” andfiler,” “smaller reporting company” and “emerging growth company” in Rule 12b-212b–2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ | |
Non-accelerated filer | ☒ | Smaller reporting company | ☒ | |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐
The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as amended, or until the registration statement shall become effective on such date as the Securities and Exchange Commission acting pursuant to said Section 8(a) may determine.
CALCULATION OF REGISTRATION FEE
Title of each class of securities to be registered (1) | Proposed maximum aggregate offering price (2) | Amount of registration fee | (3) | |||||
Common Stock, $0.001 par value per share | $ | — | $ | — | ||||
Preferred Stock, $0.001 par value per share | — | — | ||||||
Warrants | — | — | ||||||
Units (4) | — | — | ||||||
Total Offering | $ | 15,000,000 | $ | 1,818.00 |
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THE REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE SECURITIES ACT OF 1933, AS AMENDED, OR UNTIL THE REGISTRATION 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. WeThe selling stockholders named in this prospectus may not sell these securities 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 or sale is not permitted.
SUBJECT TO COMPLETION, DATEDDECEMBER 31, 2018Subject to Completion, dated September 12, 2023
PROSPECTUS
NanoVibronix, Inc.
$15,000,000
8,956,955 Shares of Common Stock
Preferred Stock
Warrants
Units
We may offer and sellThis prospectus relates to the resale by the selling stockholders named in this prospectus from time to time of up to 8,956,955 shares of our common stock, par value $0.001 per share. These 8,956,955 shares of common stock consist of:
● | 180,000 shares of common stock (the “PIPE Shares”) that were issued pursuant to the securities purchase agreement, dated as of August 30, 2023, by and among us and the purchaser named therein (the “Purchase Agreement”); |
● | 2,726,977 shares of common stock (the “Pre-Funded Warrant Shares”) issuable upon the exercise of pre-funded warrants (the “Pre-Funded Warrants”) that were issued pursuant to the Purchase Agreement; |
● ● | 2,906,977 shares of common stock (the “A-1 Warrant Shares”) issuable upon exercise of the of A-1 Warrants (the “A-1 Warrants”) that were issued pursuant to the Purchase Agreement; 2,906,977 shares of common stock (the “A-2 Warrant Shares”) issuable upon exercise of the A-2 Warrants (the “A-2 Warrants”) that were issued pursuant to the Purchase Agreement; |
● | 218,023 shares of common stock (the “2023 Wainwright Warrant Shares”) issuable upon exercise of warrants (the “2023 Wainwright Warrants”) that were issued to H.C. Wainwright & Co., LLC (“Wainwright”) or its designees as part of Wainwright’s compensation for serving as exclusive placement agent in connection with the Purchase Agreement; and |
● | 18,001 shares of common stock (the “2022 Wainwright Warrant Shares”) issuable upon exercise of warrants (the “2022 Wainwright Warrants”) that were issued to Wainwright or its designees as part of Wainwright’s compensation for serving as exclusive placement agent in connection with a securities purchase agreement, dated as of November 29, 2022, by and among us and the purchasers named therein. |
The PIPE Shares, the Pre-Funded Warrants, the A-1 Warrants, the A-2 Warrants, the 2023 Wainwright Warrants and the 2022 Wainwright Warrants were issued in one or more series or issuances and on terms that we will determine atreliance upon the timeexemption from the registration requirements in Section 4(a)(2) of the offering, any combinationSecurities Act and/or Regulation D promulgated thereunder, as applicable. We are registering the resale of the securities describedPIPE Shares, Pre-Funded Warrant Shares, the A-1 Warrant Shares, the A-2 Warrant Shares, the 2023 Wainwright Warrant Shares and the 2022 Wainwright Warrant Shares.
Our registration of the shares of common stock covered by this prospectus does not mean that the selling stockholders will offer or sell any of such shares of common stock. The selling stockholders named in this prospectus, upor their donees, pledgees, transferees or other successors-in-interest, may resell the shares of common stock covered by this prospectus through public or private transactions at prevailing market prices, at prices related to an aggregate amountprevailing market prices or at privately negotiated prices. For additional information on the possible methods of $15,000,000.sale that may be used by the selling stockholders, you should refer to the section of this prospectus entitled “Plan of Distribution.”
We will provide specific termsnot receive any of the proceeds from the sale of common stock by the selling stockholders. However, we will receive proceeds from the exercise of the Pre-Funded Warrants, the A-1 Warrants, the A-2 Warrants, the 2023 Wainwright Warrants, and the 2022 Wainwright Warrants if such securities are exercised for cash. We intend to use those proceeds, if any, offering in a supplementfor general corporate purposes including funding of our development programs, commercial planning and sales and marketing expenses, potential strategic acquisitions, general and administrative expenses and working capital.
Any shares of common stock subject to resale hereunder will have been issued by us and acquired by the selling stockholders prior to any resale of such shares pursuant to this prospectus. Any prospectus supplement may also add, update, or change information contained in this prospectus. You should carefully read this prospectus and the applicable prospectus supplement as well as the documents incorporated or deemed to be incorporated by reference in this prospectus before you purchase any of the securities offered hereby.
These securities may be offered and sold in the same offeringNo underwriter or in separate offerings;other person has been engaged to or through underwriters, dealers, and agents; or directly to purchasers. The names of any underwriters, dealers, or agents involved infacilitate the sale of the common stock in this offering. We will bear all costs, expenses and fees in connection with the registration of the common stock. The selling stockholders will bear all commissions and discounts, if any, attributable to their respective sales of our securities, their compensation and any over-allotment options held by them will be described in the applicable prospectus supplement. See “Plan of Distribution.”common stock.
Our common stock is listedtraded on theThe Nasdaq Capital Market under the symbol “NAOV.” On December 28, 2018,September 11, 2023, the last reportedclosing sale price of our common stock as reported on theThe Nasdaq Capital Market was $3.19$2.58 per share. We recommend that you obtain current market quotations for
Investment in our common stock priorinvolves risk. See “Risk Factors” contained in this prospectus, in our periodic reports filed from time to making an investment decision. We will provide informationtime with the Securities and Exchange Commission, which are incorporated by reference in this prospectus and in any applicable prospectus supplement regarding any listing of securities other than shares of our common stock on any securities exchange.
As of December 28, 2018, the aggregate market value of our outstanding common stock held by non-affiliates, or the public float, was approximately $9,526,833, which was calculated based on 3,073,172 shares of our outstanding common stock held by non-affiliates and a price of $3.10 per share, the last reported sale price for our common stock on December 27, 2018. We have not offered any securities pursuant to General Instruction I.B.6 of Form S-3 during the 12 calendar months prior to and including the date of this prospectus.
supplement. You should carefully read this prospectus anyand the accompanying prospectus supplement, relating to any specific offering of securities, and all information incorporatedtogether with the documents we incorporate by reference, herein and therein.
Investingbefore you invest in our securities involves a high degree of risk. These risks are discussed in this prospectus under “Risk Factors” beginning on page 8 and in the documents incorporated by reference into this prospectus.common stock.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or passed upon the adequacy or the accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The date of this prospectus is , 20182023.
TABLE OF CONTENTS
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This prospectus is part of athe registration statement on Form S-3 that we filed with the Securities and Exchange Commission using a “shelf” registration process. Under this shelf process, we(the “SEC”) pursuant to which the selling stockholders named herein may, from time to time, offer and sell any combinationor otherwise dispose of the securities describedshares of our common stock covered by this prospectus. As permitted by the rules and regulations of the SEC, the registration statement filed by us includes additional information not contained in this prospectus in one or more offerings up to a total amount of $15,000,000.prospectus.
This prospectus provides you with a general description ofand the documents incorporated by reference into this prospectus include important information about us, the securities we may offer. Each time we sell securities, we will provide a prospectus supplementbeing offered and other information you should know before investing in our securities. You should not assume that will contain specificthe information about the terms of that offering. The prospectus supplement may also add to, update or change information contained in the prospectus and, accordingly, to the extent inconsistent, information in this prospectus is supersededaccurate on any date subsequent to the date set forth on the front cover of this prospectus or that any information we have incorporated by reference is correct on any date subsequent to the date of the document incorporated by reference, even though this prospectus is delivered or shares of common stock are sold or otherwise disposed of on a later date. It is important for you to read and consider all information contained in this prospectus, including the documents incorporated by reference therein, in making your investment decision. You should also read and consider the information in the prospectus supplement.
The prospectus supplementdocuments to be attached to the frontwhich we have referred you under “Where You Can Find More Information” and “Incorporation of Certain Information by Reference” in this prospectus may describe, as applicable: the terms of the securities offered; the public offering price; the price paid for the securities; net proceeds; and the other specific terms related to the offering of the securities.prospectus.
You should rely only rely on this prospectus and the information containedincorporated or deemed to be incorporated by reference in this prospectusprospectus. We have not, and any prospectus supplement or issuer free writing prospectus relating to a particular offering. No person has beenthe selling stockholders have not, authorized anyone to give any information or to make any representations in connection with this offeringrepresentation to you other than those contained or incorporated by reference in this prospectus. If anyone provides you with different or inconsistent information, you should not rely on it. This prospectus any accompanying prospectus supplement and any related issuer free writing prospectus in connection with the offering described herein and therein, and, if given or made, such information or representations mustdoes not be relied upon as having been authorized by us. Neither this prospectus nor any prospectus supplement nor any related issuer free writing prospectus shall constitute an offer to sell or athe solicitation of an offer to buy offered securities in any jurisdiction in whichto any person to whom it is unlawful for such person to make such an offeringoffer or solicitation. This prospectus does not contain all of the information includedsolicitation in the registration statement. For a more complete understanding of the offering of the securities, you should refer to the registration statement, including its exhibits.such jurisdiction.
You should readWe further note that the entire prospectusrepresentations, warranties and covenants made by us in any prospectus supplement andagreement that is filed as an exhibit to any related issuer free writing prospectus, as well as the documentsdocument that is incorporated by reference intoin this prospectus were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty or any prospectus supplementcovenant to you. Moreover, such representations, warranties or any related issuer free writing prospectus, before making an investment decision. Neithercovenants were accurate only as of the deliverydate when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of this prospectus or any prospectus supplement or any issuer free writing prospectus nor any sale made hereunder shall under any circumstances imply that theour affairs.
Unless otherwise indicated, information contained or incorporated by reference herein or in any prospectus supplement or issuer free writing prospectus is correct as of any date subsequent to the date hereof or of such prospectus supplement or issuer free writing prospectus, as applicable. You should assume that the information appearing in this prospectus any prospectus supplement or any document incorporatedconcerning our industry, including our general expectations and market opportunity, is based on information from our own management estimates and research, as well as from industry and general publications and research, surveys and studies conducted by reference is accurate only asthird parties. Management estimates are derived from publicly available information, our knowledge of the dateour industry and assumptions based on such information and knowledge, which we believe to be reasonable. In addition, assumptions and estimates of the applicable documents, regardlessour and our industry’s future performance are necessarily uncertain due to a variety of the time of deliveryfactors, including those described in “Risk Factors” beginning on page 4 of this prospectus or any sale of securities. Our business, financial condition, results of operationsprospectus. These and prospects may have changed since that date.other factors could cause our future performance to differ materially from our assumptions and estimates.
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This summary provides an overview of selected information contained elsewhere or incorporated by reference in this prospectus and does not contain all of the information you should consider before investing in our securities. You should carefully read the prospectus, the information incorporated by reference and the registration statement of which this prospectus is a part in their entirety before investing in our securities, including the information discussed under “Risk Factors” in this prospectus and the documents incorporated by reference and our financial statements and related notes that are incorporated by reference in this prospectus. As used inIn this prospectus, unless the context indicates otherwise, indicates,“NanoVibronix,” the terms“Company,” the “registrant,” “we,” “us,” “our,” “us,” or “the Company”“ours” refer to NanoVibronix, Inc., a Delaware corporation, and its subsidiaries taken as a whole.subsidiaries.
Overview
We were organized asare a Delaware corporation in October 2003. Through our wholly-owned subsidiary, NanoVibronix Ltd., a privatemedical device company incorporated under the laws of the State of Israel, we focusfocusing on noninvasive biological response-activating devices that target biofilm prevention, wound healing and pain therapy and can be administered at home, without the assistance of medical professionals. Our primary products, which are in various stages of clinical and market development, currently consist of:
● | UroShield™, an ultrasound-based product that is designed to prevent bacterial colonization and biofilm in urinary catheters, increase antibiotic efficacy and decrease pain and discomfort associated with urinary catheter use. |
● | PainShield™, a patch-based therapeutic ultrasound technology to treat pain, muscle spasm and joint contractures by delivering a localized ultrasound effect to treat pain and induce soft tissue healing in a targeted area; and | |
● | WoundShield™, a patch-based therapeutic ultrasound device intended to facilitate tissue regeneration and wound healing by using ultrasound to increase local capillary perfusion and tissue oxygenation. |
Each of our PainShield, UroShield, and WoundShield products employs a small, disposable transducer that transmits low frequency, low intensity ultrasound acoustic waves that seek to repair and regenerate tissue, musculoskeletal and vascular structures, and decrease biofilm formation on urinary catheters and associated urinary tract infections. Through their size, effectiveness and ease of use, these products are intended to eliminate the need for technicians and medical personnel to manually administer ultrasound treatment through large transducers, thereby promoting patient independence and enabling more cost-effective home-based care.
PainShield is currently cleared for marketing in the United States by the U.S. Food and Drug Administration although to date there has not been a significant sales and marketing effort to date.effort. All three of our products have CE Mark approval in the European Union, a Canadian medical device license and a certificate allowing us to sell PainShield, UroShield and WoundShield in Israel. We are able to sell PainShield, UroShield and WoundShield in India and Ecuador based on our CE Mark. We have consummated sales of PainShield and UroShield in the relevant markets, although to date sales have been minimal; WoundShield has not generated significant revenue to date. Outside of the United States we generally apply, through our distributor, for approval in a particular country for a particular product only when we have a distributor in place with respect to such product.
InThe global wound care device market totaled approximately $20.8 billion in 2022 and it is expected to grow to $27.2 billion by 2027 at a CAGR of 5.4% during 2022-2027 (as reported by Markets and Markets in June 2022).
Nasdaq Minimum Stockholders’ Equity Requirement
On May 23, 2023, we received a letter from the United States, PainShield requires a prescriptionListing Qualifications Department of Nasdaq indicating that we no longer comply with the minimum stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1) for continued listing on Nasdaq because our stockholders’ equity of approximately $2.2 million as reported in our Quarterly Report on Form 10-Q for the period ended March 31, 2023, is below the required minimum of $2.5 million, and as of May 22, 2023, we did not meet the alternative compliance standards relating to the market value of listed securities of $35 million or net income from a licensed healthcare practitioner. If U.S. Food and Drug Administration clearance is obtained, we anticipate that WoundShield and UroShield will require a prescription from a licensed healthcare practitionercontinuing operations of $500,000 in the United States. We anticipate that UroShieldmost recently completed fiscal year or in two of the last three most recently completed fiscal years.
In accordance with Nasdaq Listing Rules, we had 45 calendar days, or until July 7, 2023, to submit a plan to regain compliance. On July 7, 2023 we submitted our plan to regain compliance with the Nasdaq minimum stockholders’ equity standard. On July 19, 2023, the staff of the Listing Qualifications Department of Nasdaq granted our request for continued listing pursuant to an extension through November 20, 2023, to evidence compliance with the minimum stockholders’ equity requirement, conditioned upon achievement of certain milestones included in the plan of compliance previously submitted to Nasdaq. However, there can be no assurance we will be sold directlyable to health care facilitiesregain compliance. If we do not regain compliance by the end of the extension granted by Nasdaq, or we fail to satisfy another Nasdaq requirement for continued listing, Nasdaq staff could provide notice that our common stock will become subject to delisting. In such event, Nasdaq rules permit us to appeal the decision to reject its proposed compliance plan or any delisting determination to a Nasdaq Hearings Panel. Accordingly, there can be no guarantee that we will be able to maintain our Nasdaq listing.
CMS Reimbursement for PainShield Transducer and therefore will not require a prescription for these venues. However, in other countries in which we sell PainShield, UroShield, and WoundShield, such products are eligible for sale without a prescription.Supplies
In addition to the need to obtain regulatory approvals, we anticipate that sales volumes and prices of our UroShield PainShield, and WoundShieldPainShield products will depend in large part on the availability of insurance coverage and reimbursement from third party payers. Third party payers include governmental programs such as Medicare and Medicaid in the United States, private insurance plans and workers’ compensation plans. We do not currently have reimbursement codes for use of WoundShield in any of the markets in which we have regulatory authority to sell WoundShield. Of the markets in which we have regulatory authority to sell PainShield, prior to January 2020, we haveonly had reimbursement codes in the United States (i.e., CPT codes) for clinical use only,only. Effective as of January 2020, the U.S. Centers for Medicare and Medicaid Services (“CMS”) approved our PainShield product for reimbursement for Medicare beneficiaries on a national basis, but doCMS did not have suchapprove PainShield supplies for reimbursement. We conducted additional longevity testing by an independent laboratory and launching a direct-to-consumer rental program for PainShield™, as we were denied reimbursement codesin September 2022 due to a lack of “life-cycle” testing. In 2023, we provided CMS with additional data. In August 2023, CMS announced the publication of its Healthcare Common Procedure Coding System Application Summaries, Coding Decisions and Benefit Category & Payment Determinations for at-home usethe first bi-annual 2023 Non-Drug and Non-Biological Items and Services. As part of the product, although the productits determination, CMS concluded that PainShield does not fall within a Durable Medical Equipment, Prosthetics, Orthotics and Supplies benefit category and therefore is marketednot reimbursable under Medicare and soldMedicaid at this time. We plan to resubmit an application for such use. With respectadditional review and continue to UroShield, which may be used in a clinicalwork with our legal and home setting,technical teams to weigh our options, as we do not currently have reimbursement codes in any of the markets in which we have regulatory authority to sell UroShield. We anticipate that we will begin to seek reimbursement codes for use of our products in the markets in which we have regulatory authority to sell such products; however, additional clinical databelieve it will be required in orderdifficult to obtain suchachieve market success if PainShield supplies are not eligible for reimbursement. PainShield currently is subject to reimbursement codes. Our current ongoing researchunder certain workers’ compensation plans and planned research may facilitate our ability to obtain reimbursement codes and there is no guarantee that we will be successful in obtaining such codes quickly, or at all.
We have completed 6 separate clinical studies with UroShield that together evaluated approximately 194 patients with urinary catheters. In patients where the UroShield product was used there were no serious adverse events reported, while a variety of clinical beneficial observations were seen including: catheter biofilm reduction, reduction in catheter associated pain, reduction in urinary tract infections, and a significant decrease in bacteriuria rates. We recently completed a double blind clinical trial for UroShield in the United States in order to obtain 510(k) clearance from the U.S. Food and Drug Administration. The results of the study, entitled “The Effect of Surface Acoustic Waves on Bacterial Load and Preventing Catheter-Associated Urinary Tract Infections (CAUTI) in Long Term Indwelling Catheters,” were published in the December 2018 issue of Medical & Surgical Urology, a peer-reviewed journal in the field of urology. In the study, 55 patients in a skilled nursing facility chain treated with long term indwelling catheters were evaluated. There was a significant difference between the treated group and the placebo group in the number of colony forming units (“CFU”) present upon evaluation, as well as on the number of treated urinary tract infections (“UTI”), and the effect lasted beyond the time of active treatment. The study concluded that the UroShield™ device was shown to be effective in significantly reducing the number of CFUs in patients with indwelling catheters. The study also concluded that the UroShield™ device was shown to be effective in reducing the number of treated UTIs in this patient population, and surface acoustic waves in the form of the UroShield™ device is an effective tool in the prevention of catheter-associated UTI and while further evaluation is encouraged, can be safely utilized with a high likelihood of success. In July 2017, we engaged Idonea Solutions, Inc., an FDA consultant, to assist in our efforts. If we are able to successfully obtain 510(k) clearance, we intend to pursue obtaining reimbursement codes and to target completion of partnerships with leading catheter product companies for sales and marketing efforts in the United States.
In addition, we are currently ramping up our clinical development and marketing efforts in North America with respect to PainShield. In February 2018, we completed a clinical trial to evaluate the effect of PainShield in patients with trigeminal neuralgia. The double blinded, crossover trial was conducted across the United States and included 59 patients with a diagnosis of unilateral trigeminal neuralgia. Among the 59 patients, 30 were in the active treatment group and 29 were in the control group. The values which were assessed include Visual Analog Scale (“VAS”) pain score, both baseline prior to trial and VAS pain score at the end of the study. The study also assessed breakthrough medications per week at the start of the trial and breakthrough medications per week at the end of the trial, with a particular focus on the use of opioids. Breakthrough medications are used for chronic pain directly related to the pre-existing trigeminal neuralgia condition.
There was a significant difference in the outcomes of the two groups relative to pain, quality of life, and breakthrough medications taken, which was directly correlated to pain experienced during treatment. Specifically, the control group saw an improvement in baseline scores of 2.3% versus the treatment group, which saw a 55.2% improvement in baseline scores. Additionally, the control group saw a reduction in breakthrough pain medication of 1.5% versus the treatment group, which saw a 46.4% reduction in breakthrough pain medication.
We have also identified a market for PainShield in the professional sports industry, where in some cases reimbursement may be available from sports alumni organizations or, more likely, self-pay. In order to pursue this market, we are exhibiting at sports trainers meetings, pursuing alumni associations, advertising in their media, and, on January 18, 2018, signed an agreement with a leading medical device distributor, which has a sports trainer focused sales organization. The PainShield device is offered for sale to practitioners with a provider rental program which was implemented in January 2017. We are also contemplating establishment of a direct rental program with a rent-to-own option. The PainShield product was also modified and enhanced through various accessories for use within the equine community. We are contemplating pursuing this market through prominent equine clinicians and independent sales representatives and distributors. We believe there is an attractive opportunity in this segment due to the lack of an expectation for reimbursement and the opportunity to sell at a premium price point. We are pursuing appropriate distributors in the U.S. market with resources and qualifications to sell PainShield in the different segments of the pain treatment market.
WoundShield has been evaluated in two published clinical studies done to-date that suggest improved localized blood flow and oxygenation, and improved topical oxygen saturation (Morykwas M, “Oxygen Therapy with Surface Acoustic Waveform Sonication,” European Wound Management Association 2011; Covington S, “Ultrasound-Mediated Oxygen Delivery to Lower Extremity Wounds,” Wounds 2012; 24(8))). We supplied devices for these studies but had no further involvement with them. We are pursuing licensing opportunities to develop commercial markets for the WoundShield product.Veterans Administration facilities.
Business ModelAugust 2023 PIPE
AllOn August 30, 2023, we entered into the Purchase Agreement with an institutional investor for the issuance and sale in a private placement (the “Private Placement”) of our products consist180,000 PIPE Shares, Pre-Funded Warrants to purchase up to 2,726,977 shares of a reusable controller devicecommon stock, with an exercise price of $0.0001 per share, A-1 Warrants to purchase up to 2,906,977 shares of common stock, with an exercise price of $1.47 per share, and a disposable component, or transducer.A-2 Warrants to purchase up to 2,906,977 shares of common stock with an exercise price of $1.47 per share. The controllersA-1 Warrants are exercisable immediately upon issuance and have a life expectancytermination date of up to three years, whileMarch 1, 2029. The A-2 Warrants are exercisable immediately upon issuance and have a termination date of October 1, 2024. The combined purchase price for one PIPE Share and the disposable transducer, has a life expectancy of up to a monthaccompanying Warrants was $1.72, and must be replaced to provide the intended therapy. The components are purchased by eithercombined purchase price for one Pre-Funded Warrant and the distributor or end user for use in anyaccompanying Warrants was $1.7199.
A holder of the intended applications. OncePre-Funded Warrants, the controller is purchased byA-1 Warrants, and the end user, recurring revenue will be realized by purchasesA-2 Warrants may not exercise any portion of replacement transducerssuch holder’s Pre-Funded Warrants, the A-1 Warrants, or the A-2 Warrants to the extent that the end user continues treatmentholder, together with its affiliates, would beneficially own more than 4.99% (or, at the election of the holder, 9.99%) of our product.outstanding shares of common stock immediately after exercise, except that upon at least 61 days’ prior notice from the holder to the us, the holder may increase the beneficial ownership limitation to up to 9.99% of the number of shares of common stock outstanding immediately after giving effect to the exercise.
In all product categories, our products are intended to be distributed both by independent distributors as well as by potential licensees. Distributor cost is discounted to account for their intended margins, based upon purchase volumes and/or periodic purchase commitments,connection with the disposable transducer soldPrivate Placement, we entered into a registration rights agreement (the “Registration Rights Agreement”), dated as of August 30, 2023, with the investor, pursuant to which we agreed to prepare and distributedfile a registration statement with the SEC registering the resale of the PIPE Shares and the shares of common stock underlying the Pre-Funded Warrants, the A-1 Warrants and the A-2 Warrants no later than 15 days after the date of the Registration Rights Agreement, and to use best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no 45 days following the date of the Registration Rights Agreement (or 75 days following the date of the Registration Rights Agreement in the same fashion. We currently have an established distributor network and are implementing certain criteria within such network to ensure the appropriate assignmentevent of a distributor“full review” by the SEC).
Wainwright served as the exclusive placement agent in connection with the Private Placement, pursuant to that certain engagement letter, dated as of July 5, 2023, as amended, between us and Wainwright (the “Engagement Letter”). Pursuant to the Engagement Letter, we issued to Wainwright or licensee. We also intendits designees the 2023 Wainwright Warrants to add additional distributorspurchase up to our network.an aggregate of 218,023 shares of common stock at an exercise price equal to $2.15 per share. The Wainwright Warrants are exercisable immediately upon issuance and have a termination date of March 1, 2029.
Ultrasound Technology and Our ProductsNovember 2022 Offering
As noted above,On November 29, 2022, we entered into a securities purchase agreement with certain institutional investors, pursuant to which we sold to the purchasers in a registered direct offering 240,000 shares of our primary products are basedcommon stock. In connection with this offering, on December 1, 2022, we issued to Wainwright or its designees as partial compensation, the use of low frequency ultrasound, which delivers energy through mechanical vibrations in the form of sound waves. Ultrasound has long been used in physical therapy, physical medicine, rehabilitation and sports medicine.
Our proprietary technology consists of a small, thin (1 millimeter) transducer that is capable of transmitting ultrasonic acoustic waves onto treatment surfaces with a radius of2022 Wainwright Warrants to purchase up to 10 centimeters beyond the transducer. This technology allowsan aggregate of 18,001 shares of common stock at an exercise price of $12.50 per share, pursuant to an engagement letter, dated October 6, 2022, between us to treat wounds by implanting our transducers into a small, portable self-adhering acoustic patch, thereby eliminating the need for technicians and medical personnel to manually administer ultrasound therapy, which should reduce the cost of therapy. Moreover, we believe that, based upon the body of evidence, the delivery of ultrasound through our portable devices is equal to or more effective than existing competitive products, as our technology is better positioned to target the affected areas of the body.
While there are currently a number of productsWainwright. The 2022 Wainwright Warrants expire on the market that treat pain through ultrasound therapy, we believe that our products differentiate themselves because they are portable, without the requirement to be plugged into an outlet and they have a frequency of 100kHz (in contrast to other devices, which have a frequency of 1MHz), which means our products do not produce heat that can damage tissue. Our products can therefore (i) be self-administered by the patient without the need to be moved about the treated area by the patient or a clinician, (ii) be applied for a significantly longer period without the risk of tissue damage and (iii) do not require the use of gel. We are aware of one competitive product with similar ultrasound technology, the SAM® Sport4 by a company called Zetroz Systems LLC, aka ZetrOz, Inc. However, it is our belief that this product does not generate surface acoustic waves as our products do, the treatment area is generally limited to that of the transducer’s diameter, the use of transmission gel is still required and the transducer thickness is significantly greater than ours (approximately 1.5cm). To our knowledge, the device only provides a battery life of 4 hours and is continuous therapy versus intermittent therapy. We are also aware of a small clinical study, for which results were reported in August 2013, in which the SAM® Sport4 showed positive results in the treatment of venous ulcers, a type of chronic wound.November 29, 2027.
Micro Vibrations Technology and Our Products
It is well established that increasing blood flow to the wound and peri-wound area helps accelerate the healing of ischemic wounds. Micro-vibrations applied on the skin tissue increase local blood flow and oxygen delivery to the wound area and stimulate angiogenesis and growth factors that are helpful for the wound healing process. Vibration therapy has been found to stimulate blood flow due to mechanical stresses of endothelial cells resulting in increased production of nitric oxide and vasodilation, as well as increase soft tissue and skin circulation. In addition, micro vibrations induce skin surface nerve axon reflex and type IIa muscle fibers contraction rates, resulting in vasodilation.
Urinary catheter usage is associated with pain and discomfort caused by the friction between the catheter surface and the urethral tissue. Generally, this friction is treated by applying lubricating gels and low friction catheter coatings. These methods are effective for a short term during the catheter insertion as the lubricating gel is quickly absorbed into the surrounding tissue and loses its effect and the catheter coatings lose their lubricity within a few days, as the coating is covered by a thin film of mucous.
Our UroShield product provides vibrations along the surface of the urinary catheter that is in contact with urethral tissue. We believe that these vibrations create a continuous acoustic lubrication effect along the surface of the indwelling catheter that is in contact with the surrounding tissue, thus reducing catheter-tissue contact time, which may lessen trauma from urethra abrasion and adhesion. We have also shown in animals and in humans that the micro-vibration technology can reduce the level of biofilm formation on urinary catheters.
Markets for Our Products
We believe our products compete and/or will compete in the markets described below:
Corporate Informationinformation
We were organized in the State of Delaware on October 20, 2003. Our principal executive offices are located at 525 Executive Boulevard, Elmsford, New York 10523. Our telephone number is (914) 233-3004. Our website address is www.nanovibronix.com. Information accessed through our website is not incorporated into this prospectus and is not a part of this prospectus.
The Securities We May OfferTHE OFFERING
We may offer up to $15,000,000 of common stock, preferred stock, warrants and/or units in one or more offerings and in any combination. This prospectus provides you with a general description of the securities we may offer. A prospectus supplement, which we will provide each time we offer securities, will describe the specific amounts, prices and terms of these securities.
Under the terms of the Registration Rights Agreement, we agreed to file this registration statement with respect to the registration of the resale by the selling stockholders of the PIPE Shares, the Pre-Funded Warrant Shares, the A-1 Warrant Shares and the A-2 Warrant Shares, as applicable, by the 15th calendar day following the date of the Registration Rights Agreement, and to use best efforts to have the registration statement declared effective as promptly as practical, and in any event, no later than the 45th calendar day following the date of the Registration Rights Agreement or in the event of a full review by the SEC, 75 days. In addition, we agreed that, upon the registration statement being declared effective under the Securities Act of 1933, as amended (the “Securities Act”), we will use our best efforts to maintain the effectiveness of the registration statement until the date that (i) the selling stockholders have sold all of the shares of common stock issuable under the Registration Rights Agreement or (ii) such shares may be resold by the selling stockholders pursuant to Rule 144 of the Securities Act, without the requirement for us to be in compliance with the current public information required under such rule and without volume or manner-of-sale restriction. See “Selling Stockholders” on page 6 of this prospectus for additional information. The selling stockholders named in this prospectus, or their pledgees, donees, transferees, distributees, beneficiaries or other successors-in-interest, may offer or sell the shares of common stock from time to time 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 also resell the shares of common stock to or through underwriters, broker-dealers or agents, who may receive compensation in the form of discounts, concessions or commissions. See “Plan of Distribution” beginning on page 8 of this prospectus for additional information on the methods of sale that may be used by the selling stockholders. Common Stock to be Offered by the Selling Stockholders Up to 8,956,955 shares of our common stock, which are comprised of (i) 180,000 PIPE Shares, (ii) 2,726,977 Pre-Funded Warrant Shares (iii) 2,906,977 A-1 Warrant Shares, (iv) 2,906,977 A-2 Warrant Shares (v) 218,023 2023 Wainwright Warrant Shares and (iv) 18,001 2022 Wainwright Warrant Shares. Use of Proceeds All shares of our common stock offered by this prospectus are being registered for the accounts of the selling stockholders and we will not receive any proceeds from the sale of these shares. However, we will receive proceeds from the exercise of the Pre-Funded Warrants, the A-1 Warrants, the A-2 Warrants, the 2023 Wainwright Warrants and the 2022 Wainwright Warrants if such warrants are exercised for cash. We intend to use those proceeds, if any, for general corporate purposes, including funding of our development programs, commercial planning and sales and marketing expenses, potential strategic acquisitions, general and administrative expenses and working capital. See “Use of Proceeds” beginning on page 6 of this prospectus for additional information. Registration Rights We may issue shares of our common stock from time to time. The holders of common stock are entitled to one vote per share. Our certificate of incorporation does not provide for cumulative voting. All of our directors hold office for one-year terms until the election and qualification of their successors. The holders of our common stock are entitled to receive ratably such dividends, if any, as may be declared by the board of directors out of legally available funds. Upon liquidation, dissolution or winding-up, the holders of our common stock are entitled to share ratably in all assets that are legally available for distribution. The holders of our common stock have no preemptive, subscription, redemption or conversion rights. The rights, preferences and privileges of holders of our common stock are subject to, and may be adversely affected by, the rights of the holders of any series of preferred stock, which may be designated solely by action of the board of directors and issued in the future.Preferred StockWe may issue shares of our preferred stock from time to time, in one or more series. Our board of directors will determine the rights, preferences, privileges and restrictions of the preferred stock, including dividend rights, conversion rights, voting rights, terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation of such series, without any further vote or action by stockholders. Convertible preferred stock will be convertible into our common stock or exchangeable for our other securities. Conversion may be mandatory or at your option or both and would be at prescribed conversion rates.If we sell any series of preferred stock under this prospectus and applicable prospectus supplements, we will fix the rights, preferences, privileges and restrictions of the preferred stock of such series in the certificate of designation relating to that series. We will file as an exhibit to the registration statement of which this prospectus is a part, or will incorporate by reference from reports that we file with the Securities and Exchange Commission, the form of any certificate of designation that describes the terms of the series of preferred stock we are offering before the issuance of the related series of preferred stock. We urge you to read the applicable prospectus supplement related to the series of preferred stock being offered, as well as the complete certificate of designation that contains the terms of the applicable series of preferred stock.WarrantsWe may issue warrants for the purchase of common stock or preferred stock in one or more series. We may issue warrants independently or together with common stock or preferred stock, and the warrants may be attached to or separate from these securities. We will evidence each series of warrants by warrant certificates that we will issue under a separate agreement. We may enter into warrant agreements with a bank or trust company that we select to be our warrant agent. We will indicate the name and address of the warrant agent in the applicable prospectus supplement relating to a particular series of warrants.In this prospectus, we have summarized certain general features of the warrants. We urge you, however, to read the applicable prospectus supplement related to the particular series of warrants being offered, as well as the warrant agreements and warrant certificates that contain the terms of the warrants. We will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference from reports that we file with the Securities and Exchange Commission, the form of warrant agreement or warrant certificate containing the terms of the warrants we are offering before the issuance of the warrants.UnitsWe may issue units consisting of common stock, preferred stock and/or warrants for the purchase of common stock or preferred stock in one or more series. In this prospectus, we have summarized certain general features of the units. We urge you, however, to read the applicable prospectus supplement related to the series of units being offered, as well as the unit agreements that contain the terms of the units. We will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate by reference reports that we file with the Securities and Exchange Commission, the form of unit agreement and any supplemental agreements that describe the terms of the series of units we are offering before the issuance of the related series of units.Plan of Distribution Nasdaq Capital Market Symbol Our common stock is listed on The Nasdaq Capital Market under the symbol “NAOV.” Risk Factors Investing in our common stock involves significant risks. See “Risk Factors” beginning on page 4 of this prospectus and the documents incorporated by reference in this prospectus.
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An investmentInvesting in our securities involves a high degree of risk. TheIn addition to the other information contained in this prospectus supplement applicable to each offering of our securities will contain a discussion ofand in the risks applicable to an investment in our securities. Before deciding whether to invest in our securities,documents we incorporate by reference, you should carefully consider the specific factorsrisks discussed below and under the heading “Risk Factors” in the applicable prospectus supplement, together with all of the other information contained or incorporated by reference in the prospectus supplement or appearing or incorporated by reference in this prospectus. You should also consider the risks, uncertainties and assumptions discussed under Item 1A, “Risk Factors,” in our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2022 as well as any amendment or any updatesupdate to our risk factors reflected in subsequent filings with the SEC, before making a decision about investing in our Quarterly Reports on Form 10-Q, together with all other information appearingsecurities. The risks and uncertainties discussed below and in orthe documents incorporated by reference into this prospectusare not the only ones facing us. Additional risks and uncertainties not presently known to us, or the applicable prospectus supplement, before deciding whether to purchase any securities being offered.that we currently see as immaterial, may also harm our business. If any of these risks actually occurs,occur, our business, business prospects, financial condition orand operating results of operations could be seriously harmed. This could causeharmed, the trading price of our common stock tocould decline resulting in a loss ofand you could lose part or all or part of your investment. Please also read carefully
The sale of a substantial amount of our shares in the section below entitled “Special Note Regarding Forward-Looking Statements.”public market could adversely affect the prevailing market price of our securities.
We are registering for resale up to 8,956,955 shares of our common stock held by the selling stockholders, which is a significant number of shares compared to the current number of total shares of common stock issued and outstanding. Sales of substantial amounts of shares of our common stock in the public market, or the perception that such sales might occur, could adversely affect the market price of our common stock. We cannot predict if and when selling stockholders may sell such shares of our common stock in the public markets. Furthermore, in the future, we may issue additional shares of our common stock or other equity or debt securities convertible into shares of our common stock. Any such issuance could result in substantial dilution to our existing stockholders and could cause the market price of our securities to decline.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus each prospectus supplement and the information incorporated by reference in this prospectus and each prospectus supplement contain “forward-looking statements,” which include information relating to future events, future financial performance, strategies, expectations, competitive environment and regulation. Words such as “may,” “should,” “could,” “would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, are intended to identify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and will probablymay not be accurate indications of when such performance or results will actually be achieved. Forward-looking statements are based on information we have when those statements are made or our management’s good faith belief as of that time with respect to future events, and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to:
● | Our | |
● | Global economic and political instability and conflicts, such as | |
● | Increasing inflation could adversely affect our business, financial condition, results of operations or cash flows. | |
● | The geographic, social and economic impact of COVID-19 on the Company’s business operations. | |
● | Our ability to | |
● | Regulatory actions that could adversely affect the price of or demand for our approved products. | |
● | Market acceptance of existing and new products. | |
● | Favorable or unfavorable decisions about our products from government regulators, insurance companies or other third-party | |
● | Risks of product liability acclaims and the availability of insurance. | |
● | Our ability to generate internal growth. | |
● | Risks related to computer system failures and cyber-attacks. | |
● | Our ability to obtain regulatory approval in foreign jurisdictions. | |
● | Uncertainty regarding the success of our clinical trials for our products in development. | |
● | Risks related to our operations in Israel, including political, economic and military instability. | |
● | The price of our securities is volatile with limited trading volume. | |
● | Our ability to regain compliance with the continued listing requirements of |
● | Our ability to maintain effective internal control over financial reporting and to remedy identified material weaknesses. | |
● | We are a “smaller reporting company” and have reduced disclosure obligations that may make our stock less attractive to investors. | |
● | Our intellectual property | |
● | Our ability to recruit and retain qualified regulatory and research and development personnel. | |
● | Unforeseen changes in healthcare reimbursement for any of our approved products. | |
● | The adoption of health policy changes and health care reform. |
● | Lack of financial resources to adequately support our operations. |
● | Difficulties in maintaining commercial scale manufacturing capacity and capability. | |
● | Changes in our relationship with key collaborators. | |
● | Changes in the market valuation or earnings of our competitors or companies viewed as similar to us. | |
● | Our failure to comply with regulatory guidelines. | |
● | Uncertainty in industry demand and patient wellness behavior. |
● | General economic conditions and market conditions in the medical device industry. | |
● | Future sales of large blocks of our common stock, which may adversely impact our stock price. | |
● | Depth of the trading market in our common stock. |
You should read this prospectus the applicable prospectus supplement and any related free-writing prospectus and the documents incorporated by reference in this prospectus with the understanding that our actual future results, levels of activity, performance and events and circumstances may be materially different from what we expect. The forward-looking statements contained or incorporated by reference in this prospectus or any prospectus supplement are expressly qualified in their entirety by this cautionary statement. We do not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.
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Unless we specify another use inAll shares of our common stock offered by this prospectus are being registered for the applicable prospectus supplement,accounts of the selling stockholders and we will use the netnot receive any proceeds from the sale of these shares. However, will receive proceeds from the securities offered by usexercise of the Pre-Funded Warrants, the A-1 Warrants, the A-2 Warrants, the 2023 Wainwright Warrants and the 2022 Wainwright Warrants if such warrants are exercised for cash. We intend to use those proceeds, if any, for general corporate purposes, including funding of our development programs, commercial planning and sales and marketing expenses, potential strategic acquisitions, general and administrative expenses and working capital.
Investors are cautioned, however, that expenditures may vary substantially from these uses. Investors will be relying on the judgment of our management, who will have broad discretion regarding the application of the proceeds of this offering. The amounts and timing of our actual expenditures will depend upon numerous factors, including the amount of cash generated by our operations, the amount of competition and other operational factors. We may find it necessary or advisable to use portions of the proceeds from this offering for other purposes.
From time to time, we evaluate these and other factors and we anticipate continuing to make such evaluations to determine if the existing allocation of resources, including the proceeds of this offering, is being optimized. Circumstances that may give rise to a change in the use of proceeds include:
Pending other uses, we intend to invest the proceeds to us in investment-grade, interest-bearing securities such as money market funds, certificates of deposit, or direct or guaranteed obligations of the U.S. government, or hold as cash. We cannot predict whether the proceeds invested will yield a favorable, or any, return.
DESCRIPTION OF CAPITAL STOCKSELLING STOCKHOLDERS
The following description of common stock being offered by the selling stockholders are those previously issued to the selling stockholders, and preferred stock summarizesthose issuable to the material terms and provisionsselling stockholders, upon exercise of the common stock and preferred stock that we may offer under this prospectus, but is not complete.warrants, as applicable. For additional information regarding the complete termsissuances of our common stock and preferred stock, please refer to our amended and restated certificate of incorporation, as amended, any certificates of designation for our preferred stock, and our amended and restated bylaws, as may be amended from time to time. While the terms we have summarized below will apply generally to any future common stock or preferred stock that we may offer, we will describe the specific terms of any series of preferred stock in more detail in the applicable prospectus supplement. If we so indicate in a prospectus supplement, the terms of any preferred stock we offer under that prospectus supplement may differ from the terms we describe below.
We have authorized 25,000,000 shares of capital stock, par value $0.001 per share, of which 20,000,000 are shares of common stock and 5,000,000 are shares of “blank check” preferred stock. On December 28, 2018, there were 3,781,484 shares of common stock, 2,733,192 shares of our Series C Convertible Preferred Stock (“Series C Preferred Stock”) issued and outstanding, and 304 shares of our Series D Convertible Preferred Stock (“Series D Preferred Stock”) issued and outstanding. We currently have 3,000,000 shares of preferred stock designated as Series C Preferred Stock and 506 shares of preferred stock designated as Series D Preferred Stock. The authorized and unissuedthose shares of common stock and the authorizedwarrants, see “August 2023 PIPE” and undesignated shares of preferred stock are available for issuance without further action by our stockholders, unless such action is required by applicable law or the rules of any stock exchange on which our securities may be listed. Unless approval of our stockholders is so required, our board of directors does not intend to seek stockholder approval for the issuance and sale of our common stock or preferred stock.
Common Stock
The holders of common stock are entitled to one vote per share. Our certificate of incorporation does not provide for cumulative voting. All of our directors hold office for one-year terms until the election and qualification of their successors. The holders of our common stock are entitled to receive ratably such dividends, if any, as may be declared by the board of directors out of legally available funds. Upon liquidation, dissolution or winding-up, the holders of our common stock are entitled to share ratably in all assets that are legally available for distribution. The holders of our common stock have no preemptive, subscription, redemption or conversion rights. The rights, preferences and privileges of holders of our common stock are subject to, and may be adversely affected by, the rights of the holders of any series of preferred stock, which may be designated solely by action of the board of directors and issued in the future.
The transfer agent and registrar for our common stock is VStock Transfer, LLC. The transfer agent’s address is 18 Lafayette Place, Woodmere, New York 11598. Our common stock is listed on the Nasdaq Capital Market under the symbol “NAOV.”
Preferred Stock
The board of directors is authorized, subject to any limitations prescribed by law, without further vote or action by the stockholders, to issue from time to time shares of preferred stock in one or more series. Each such series of preferred stock shall have such number of shares, designations, preferences, voting powers, qualifications, and special or relative rights or privileges as shall be determined by the board of directors, which may include, among others, dividend rights, voting rights, liquidation preferences, conversion rights and preemptive rights. Issuance of preferred stock by our board of directors may result in such shares having dividend and/or liquidation preferences senior to the rights of the holders of our common stock and could dilute the voting rights of the holders of our common stock.
Prior to the issuance of shares of each series of preferred stock, the board of directors is required by the Delaware General Corporation Law and our certificate of incorporation to adopt resolutions and file a certificate of designation with the Secretary of State of the State of Delaware. The certificate of designation fixes for each class or series the designations, powers, preferences, rights, qualifications, limitations and restrictions, including, but not limited to, some or all of the following:
Once designated by our board of directors, each series of preferred stock may have specific financial and other terms that will be described in a prospectus supplement. The description of the preferred stock that is set forth in any prospectus supplement is not complete without reference to the documents that govern the preferred stock. These include our certificate of incorporation and any certificates of designation that our board of directors may adopt.
All shares of preferred stock offered hereby will, when issued, be fully paid and nonassessable, including shares of preferred stock issued upon the exercise of preferred stock warrants or subscription rights, if any.
Although our board of directors has no intention at the present time of doing so, it could authorize the issuance of a series of preferred stock that could, depending on the terms of such series, impede the completion of a merger, tender offer or other takeover attempt.
Delaware Anti-Takeover Law, Provisions of our Certificate of Incorporation and Bylaws
Delaware Anti-Takeover Law
“November 2022 Offering” above. We are subject to Section 203 ofregistering the Delaware General Corporation Law. Section 203 generally prohibits a public Delaware corporation from engaging in a “business combination” with an “interested stockholder” for a period of three years after the date of the transaction in which the person became an interested stockholder, unless:
Section 203 defines a business combination to include:
In general, Section 203 defines an “interested stockholder” as any entity or person beneficially owning 15% or more of the outstanding voting stock of the corporation and any entity or person affiliated with, or controlling, or controlled by, the entity or person. The term “owner” is broadly defined to include any person that, individually, with or through that person’s affiliates or associates, among other things, beneficially owns the stock, or has the right to acquire the stock, whether or not the right is immediately exercisable, under any agreement or understanding or upon the exercise of warrants or options or otherwise or has the right to vote the stock under any agreement or understanding, or has an agreement or understanding with the beneficial owner of the stock for the purpose of acquiring, holding, voting or disposing of the stock.
The restrictions in Section 203 do not apply to corporations that have elected, in the manner provided in Section 203, not to be subject to Section 203 of the Delaware General Corporation Law or, with certain exceptions, which do not have a class of voting stock that is listed on a national securities exchange or held of record by more than 2,000 stockholders. Our certificate of incorporation and bylaws do not opt out of Section 203.
Section 203 could delay or prohibit mergers or other takeover or change in control attempts with respect to us and, accordingly, may discourage attempts to acquire us even though such a transaction may offer our stockholders the opportunity to sell their stock at a price above the prevailing market price.
Certificate of Incorporation and Bylaws
Provisions of our certificate of incorporation and bylaws may delay or discourage transactions involving an actual or potential change in our control or change in our management, including transactions in which stockholders might otherwise receive a premium for their shares, or transactions that our stockholders might otherwise deem to be in their best interests. Therefore, these provisions could adversely affect the price of our common stock. Among other things, our certificate of incorporation and bylaws:
As of December 28, 2018, there were 2,535,272 shares of common stock that may be issued upon exercise of outstanding warrants.in order to permit the selling stockholders to offer the shares for resale from time to time. Except as described below under “Relationships with the Selling Stockholders,” the selling stockholders have not had any material relationship with us within the past three years.
We may issue warrants forThe table below lists the purchaseselling stockholders and other information regarding the beneficial ownership of the shares of common stock or preferred stock in one or more series. We may issue warrants independently or together withby each of the selling stockholders. The second column lists the number of shares of common stock or preferredbeneficially owned by each selling stockholders, based on its ownership of the shares of common stock and warrants, as of September 7, 2023, assuming exercise of the warrants may be attachedheld by the selling stockholders on that date, without regard to or separate from these securities.any limitations on exercises.
We will evidence each seriesThe third column lists the shares of warrantscommon stock being offered by warrant certificates that we may issue under a separate agreement. We may enter into a warrant agreement with a warrant agent. Each warrant agent may be a bank that we select which has its principal office inthis prospectus by the United States. We may also choose to act as our own warrant agent. We will indicate the name and address of any such warrant agent in the applicable prospectus supplement relating to a particular series of warrants.selling stockholders.
We will describe in the applicable prospectus supplementIn accordance with the terms of the seriesRegistration Rights Agreement with the selling stockholders, this prospectus generally covers the resale of the sum of (i) the number of shares of common stock issued to the selling stockholders in the “August 2023 PIPE” described above and (ii) the maximum number of shares of common stock issuable upon exercise of the Pre-Funded Warrants, the A-1 Warrants, the A-2 Warrants, the 2023 Wainwright Warrants and the 2022 Wainwright Warrants, determined as if such outstanding warrants including:were exercised in full as of the trading day immediately preceding the date this registration statement was initially filed with the SEC, each as of the trading day immediately preceding the applicable date of determination and all subject to adjustment as provided in the Registration Rights Agreement, without regard to any limitations on the exercise of the warrants. The fourth column assumes the sale of all of the shares offered by the selling stockholders pursuant to this prospectus.
Under the terms of the A-1 Warrants, the A-2 Warrants, the 2023 Wainwright Warrants and the 2022 Wainwright Warrants, a selling stockholder may not exercise applicable warrants to the extent such exercise would cause such selling stockholder, together with its affiliates and attribution parties, to beneficially own a number of shares of common stock which would exceed 4.99% (or, at the election of the holder, 9.99%) of our then outstanding common stock following such exercise, excluding for purposes of such determination shares of common stock issuable upon exercise of the warrants which have not been exercised. The number of shares in the second column does not reflect this limitation. The selling stockholders may sell all, some or none of their shares in this offering. See “Plan of Distribution.”
Name of Selling Stockholder | Number of shares of common stock owned prior to offering | Maximum number of shares of common stock to be sold pursuant to this Prospectus | Number of shares of common stock owned after offering | Percentage of common stock owned after offering | ||||||||||||
Armistice Capital, LLC (1)(3) | 8,720,931 | (3) | 8,720,931 | (2)(3) | 0 | 84 | %(3) | |||||||||
Michael Vasinkevich (4) | 151,350 | 151,350 | (5) | 0 | * | |||||||||||
Noam Rubinstein (4) | 91,946 | (6) | 89,206 | (7) | 17,598 | * | ||||||||||
Craig Schwabe (4) | 7,966 | 7,966 | (8) | 0 | * | |||||||||||
Charles Worthman (4) | 2,360 | 2,360 | (9) | 0 | * |
* Less than 1%
(1) | The shares 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 Capital”), as the |
Pre-Funded Warrants are subject to a beneficial ownership limitation of 9.99%, which such limitation restricts the selling stockholder from exercising that portion of the A-1 Warrants, A-2 Warrants or the Pre-Funded Warrants, as applicable, that would result in the | ||
(2) | The shares that may be |
(3) | As of the |
the |
(4) | The selling stockholder was issued compensation warrants as a designee of Wainwright in connection with the |
Private Placement and a registered direct offering in 2022. Each selling stockholder is affiliated with Wainwright, a registered broker dealer with a registered address of H.C. Wainwright & Co., LLC, 430 Park Ave, 3rd Floor, New York, NY 10022, and has sole voting and dispositive power over the |
(5) | |
(6) | Represents (i) 68,678 2023 Wainwright Warrant Shares, (ii) 5,670 2022 Wainwright Warrant Shares and (iii) 17,598 shares of common stock issuable upon exercise of |
(7) | Represents (i) 68,678 2023 Wainwright Warrant Shares and (ii) 5,670 2022 Wainwright Warrant Shares. |
(8) | |
(9) | Represents (i) 2,180 2023 Wainwright Warrant Shares and (ii) 180 2022 Wainwright Warrant Shares. |
Before exercising their warrants, holders of warrants will not have any ofRelationships with the rights of holders of the securities purchasable upon such exercise, including, in the case of warrants to purchase common stock or preferred stock, the right to receive dividends, if any, or, payments upon our liquidation, dissolution or winding up or to exercise voting rights, if any.
Exercise of WarrantsSelling Stockholders
Each warrant will entitleof Noam Rubinstein, Craig Schwabe, Michael Vasinkevich, and Charles Worthman, are associated persons of Wainwright, which served as our exclusive placement agent in connection with the holder to purchasePrivate Placement and the registered direct offering discussed above, for which Wainwright received compensation.
Armistice Capital Master Fund Ltd. purchased securities that we specify in the applicable prospectus supplement at the exercise price that we describe in the applicable prospectus supplement. Unless we otherwise specify in the applicable prospectus supplement, holders of the warrants may exercise the warrants at any time up to 5:00 P.M. eastern time, the close of business, on the expiration date that we set forth in the applicable prospectus supplement. After the close of business on the expiration date, unexercised warrants will become void.
Holders of the warrants may exercise the warrants by delivering the warrant certificate representing the warrants to be exercised together with specified information, and paying the required exercise price by the methods provided in the applicable prospectus supplement. We will set forth on the reverse side of the warrant certificate, and in the applicable prospectus supplement, the information that the holder of the warrant will be required to deliver to the warrant agent.
Upon receipt of the required payment and the warrant certificate properly completed and duly executed at the corporate trust office of the warrant agent or any other office indicated in the applicable prospectus supplement, we will issue and deliver the securities purchasable upon such exercise. If fewer than all of the warrants represented by the warrant certificate are exercised, then we will issue a new warrant certificate for the remaining amount of warrants.
Enforceability of Rights By Holders of Warrants
Any warrant agent will act solely as our agent under the applicable warrant agreement and will not assume any obligation or relationship of agency or trust with any holder of any warrant. A single bank or trust company may act as warrant agent for more than one issue of warrants. A warrant agent will have no duty or responsibility in case of any default by us under the applicable warrant agreement or warrant, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us. Any holder of a warrant may, without the consent of the related warrant agent or the holder of any other warrant, enforce by appropriate legal action the holder’s right to exercise, and receive the securities purchasable upon exercise of, its warrants in accordance with their terms.
Warrant Agreement Will Not Be Qualified Under Trust Indenture Act
No warrant agreement will be qualified as an indenture, and no warrant agent will be required to qualify as a trustee, under the Trust Indenture Act. Therefore, holders of warrants issued under a warrant agreement will not have the protection of the Trust Indenture Act with respect to their warrants.
Governing Law
Unless we provide otherwise in the applicable prospectus supplement, each warrant agreement and any warrants issued under the warrant agreements will be governed by New York law.Private Placement.
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We may issue units comprised of one or more of the other securities described in this prospectus or any prospectus supplement in any combination. Each unit will be issued so that the holder of the unit is also the holder, with the rights and obligations of a holder, of each security included in the unit. The unit agreement under which a unit is issued may provide that the securities included in the unit may not be held or transferred separately, at any time or at any times before a specified date or upon the occurrence of a specified event or occurrence.
The applicable prospectus supplement will describe:
We may sellEach selling stockholder of the securities being offered pursuantand any of their pledgees, assignees and successors-in-interest may, from time to this prospectus totime, sell any or through underwriters, through dealers, through agents,all of their securities covered hereby on the Nasdaq Capital Market or directly toany other stock exchange, market or trading facility on which the securities are traded or in private transactions. These sales may be at fixed or negotiated prices. A selling stockholder may use any one or more purchasers or through a combination of these methods. The applicable prospectus supplement will describe the terms of the offering of the securities, including:following methods when selling securities:
● | ordinary brokerage transactions and transactions in which the |
● | block trades in which the | |
● | 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 | |
● | through the | |
● | a combination of any such methods of sale; or |
● | any |
WeThe selling stockholders may distributealso sell securities under Rule 144 or any other exemption from registration under the securities from time to time in one or more transactions at:
Only underwriters named in the prospectus supplement are underwriters of the securities offered by the prospectus supplement.Securities Act, if available, rather than under this prospectus.
If underwriters are used in an offering, we will execute an underwriting agreement with such underwriters and will specify the name of each underwriter and the terms of the transaction (including any underwriting discounts and other terms constituting compensation of the underwriters and any dealers) in a prospectus supplement. The securities may be offered to the public either through underwriting syndicates represented by managing underwriters or directly by one or more investment banking firms or others, as designated. If an underwriting syndicate is used, the managing underwriter(s) will be specified on the cover of the prospectus supplement. If underwriters are used in the sale, the offered securities will be acquiredBroker-dealers engaged by the underwritersselling stockholders may arrange for their own accounts andother brokers-dealers to participate in sales. Broker-dealers may be resold from time to time in one or more transactions, including negotiated transactions, at a fixed public offering price or at varying prices determined at the time of sale. Any public offering price and any discounts or concessions allowed or reallowed or paid to dealers may be changed from time to time. Unless otherwise set forth in the prospectus supplement, the obligations of the underwriters to purchase the offered securities will be subject to conditions precedent, and the underwriters will be obligated to purchase all of the offered securities, if any are purchased.
We may grant to the underwriters options to purchase additional securities to cover over-allotments, if any, at the public offering price, with additional underwritingreceive commissions or discounts from the selling stockholders (or, if any broker-dealer acts as mayagent for the purchaser of securities, from the purchaser) in amounts to be negotiated, but, except as set forth in a related prospectus supplement. The terms of any over-allotment option will be set forth in the prospectus supplement for those securities.
If we use a dealer in the sale of the securities being offered pursuant to this prospectus, or any prospectus supplement, we will sell the securities to the dealer, as principal. The dealer may then resell the securities to the public at varying prices to be determined by the dealer at the time of resale. The names of the dealers and the terms of the transaction will be specified in a prospectus supplement.
We may sell the securities directly or through agents we designate from time to time. We will name any agent involved in the offeringcase of an agency transaction not in excess of a customary brokerage commission in compliance with FINRA Rule 2121; and sale of securities and we will describe any commissions we will pay the agent in the prospectus supplement. Unless the prospectus supplement states otherwise, any agent will act oncase of a best-efforts basis for the period of its appointment.
We may authorize agentsprincipal transaction a markup or underwriters to solicit offers by institutional investors to purchase securities from us at the public offering price set forthmarkdown in the prospectus supplement pursuant to delayed delivery contracts providing for payment and delivery on a specified date in the future. We will describe the conditions to these contracts and the commissions we must pay for solicitation of these contracts in the prospectus supplement.compliance with FINRA 2121.
In connection with the sale of the securities underwriters, dealers or agentsinterests therein, the selling stockholders may receive compensation from usenter into hedging transactions with broker-dealers or from purchasersother financial institutions, which may in turn engage in short sales of the securities for whom they act as agents, in the formcourse of discounts, concessionshedging the positions they assume. The selling stockholders may also sell securities short and deliver these securities to close out their short positions, or commissions. Underwriters may sellloan or pledge the securities to broker-dealers that in turn may sell these securities. The selling stockholders may also enter into option or through dealers,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 those dealers may receive compensation in the form of discounts, concessionsany broker-dealers or commissions from the underwriters or commissions from the purchasers for whom they may act as agents. Underwriters, dealers and agents that participateare involved in the distribution ofselling the securities and any institutional investors or others that purchase securities directly for the purpose of resale or distribution, may be deemed to be underwriters, and“underwriters” within the meaning of the Securities Act in connection with such sales. In such event, any discounts or commissions received by them from ussuch broker-dealers or agents and any profit on the resale of the common stocksecurities purchased by them may be deemed to be underwriting commissions or discounts and commissions under the Securities Act of 1933, as amended.Act. Each selling stockholder has informed us that it does not have any written or oral agreement or understanding, directly or indirectly, with any person to distribute the securities.
We may provide agents, underwritersare required to pay certain fees and other purchasers with indemnificationexpenses incurred by us incident to the registration of the securities. We have agreed to indemnify the selling stockholders against particular civilcertain losses, claims, damages and liabilities, including liabilities under the Securities ActAct.
We agreed to keep this prospectus effective until the earlier of 1933, as amended,(i) the date on which the securities may be resold by the selling stockholders without registration and without regard to any volume or contribution with respect to payments thatmanner-of-sale limitations by reason of Rule 144, without the agents, underwriters or other purchasers may make with respect to such liabilities. Agents and underwriters may engage in transactions with, or perform servicesrequirement for us to be in compliance with the ordinary coursecurrent public information under Rule 144 under the Securities Act or any other rule of business.
To facilitate the public offering of a series of securities, persons participating in the offering may engage in transactions that stabilize, maintain,similar effect or otherwise affect the market price of the securities. This may include over-allotments or short sales(ii) all of the securities which involves the sale by persons participating in the offering of more securities than have been sold to them by us. In addition, those persons may stabilize or maintain the price of the securities by bidding for or purchasing securities in the open market or by imposing penalty bids, whereby selling concessions allowed to underwriters or dealers participating in any such offering may be reclaimed if securities sold by them are repurchased in connection with stabilization transactions. The effect of these transactions may be to stabilize or maintain the market price of the securities at a level above that which might otherwise prevail in the open market. Such transactions, if commenced, may be discontinued at any time. We make no representation or prediction as to the direction or magnitude of any effect that the transactions described above, if implemented, may have on the price of our securities.
Unless otherwise specified in the applicable prospectus supplement, any common stock sold pursuant to a prospectus supplement will be eligible for listing on the Nasdaq Capital Market, subject to official notice of issuance. Any underwriters to whom securities are sold by us for public offering and sale may make a market in the securities, but such underwriters will not be obligated to do so and may discontinue any market making at any time without notice.
In order to comply with the securities laws of some states, if applicable, the securities offered pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar effect. The resale securities will be sold in those states only through registered or licensed brokers or dealers.dealers if required under applicable state securities laws. In addition, in somecertain 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 have informed them 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).
The validity of the securities offered by this prospectus will be passed upon for us by Haynes and Boone, LLP, New York, New York.
The consolidated financial statements incorporatedof NanoVibronix, Inc. and its subsidiary as of December 31, 2022, and December 31, 2021, and for each of the two years in this Prospectus by reference tothe period ended December 31, 2022, included in the Annual Report on Form 10-K for the year ended December 31, 20172022, and incorporated in this prospectus by reference, 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 12 to the financial statements) of Kost Forer Gabbay & Kasierer,Marcum LLP, an independent registered public accounting firm, and a member of Ernst & Young Global, given on the authority of said firm as experts in auditing and accounting.
WHERE YOU CAN FIND MORE INFORMATION
We are subjecthave filed with the SEC a registration statement on Form S-3 under the Securities Act with respect to the informational requirementssecurities offered by this prospectus. This prospectus, filed as part of the Securities Exchange Actregistration statement, does not contain all the information set forth in the registration statement and its exhibits and schedules, portions of 1934,which have been omitted as amended,permitted by the rules and in accordance therewithregulations of the SEC. For further information about us, we refer you to the registration statement and to its exhibits and schedules.
We file annual, quarterly and current reports proxy statements and other information with the SecuritiesSEC. The SEC maintains an internet website at www.sec.gov that contains periodic and Exchange Commission. The Securities and Exchange Commission maintains a website that containscurrent reports, proxy and information statements, and other information regarding registrants that fileare filed electronically with the Securities and Exchange Commission. The address of the Securities and Exchange Commission’s website is www.sec.gov.SEC.
We makeThese documents are also available, free of charge, on or through the Investors section of our website, which is located at www.nanovibronix.com, our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after we electronically file such material with or otherwise furnish it to the Securities and Exchange Commission.
We have filed with the Securities and Exchange Commission a registration statement under the Securities Act of 1933, as amended, relating to the offering of these securities. The registration statement, including the attached exhibits, contains additional relevant information about us and the securities. This prospectus does not contain all of the information set forth in the registration statement. You can obtain a copy of the registration statement for free at www.sec.gov. The registration statement and the documents referred to below under “Incorporation of Certainwww.nanovibronix.com. Information By Reference” are also availablecontained on our website www.nanovibronix.com.
We haveis not incorporated by reference into this prospectus the information on our website, and you should not consider itinformation on our website to be a part of this prospectus.
INCORPORATION OF CERTAIN INFORMATION BY REFERENCE
The Securities and Exchange CommissionSEC allows us to “incorporate by reference” the information we have filed with it, which means that we can disclose important information to you by referring you to those documents. The information we incorporate by reference is an important part of this prospectus, and later information that we file with the Securities and Exchange CommissionSEC will automatically update and supersede this information. We incorporate by reference the documents listed below and any future documents (excluding information furnished pursuant to Items 2.02 and 7.01 of Form 8-K) we file with the Securities and Exchange CommissionSEC pursuant to Sections l3(a), l3(c), 14 or l5(d) of the Securities Exchange Act of 1934, as amended, subsequent to the date of this prospectus and prior to the termination of the offering:
● | Our Annual Report on Form 10-K for the fiscal year ended December 31, |
● | Our |
| ||
● | Our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 15, 2023; | |
● | Our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, filed with the SEC on August 11, 2023; | |
● | Our Current Report on Form 8-K, filed with the | |
● | Our Current Report on Form 8-K, filed with the SEC on March 3, 2023; | |
● | Our Current Report on Form 8-K, filed with the SEC on April 19, | |
● | Our Current Report on Form 8-K, filed with the | |
● | Our Current Report on Form 8-K, filed with the SEC on June 21, 2023; | |
● | Our Current Report on Form 8-K, filed with the SEC on July 20, 2023; | |
● | Our Current Report on Form 8-K, filed with the SEC on August 23, 2023; | |
● | Our Current Report on Form 8-K, filed with the SEC on September 1, 2023; and | |
● | The description of our common stock |
All filings filed by us pursuant to the Securities Exchange Act of 1934, as amended, after the date of the initial filing of this registration statement and prior to the effectiveness of such registration statement (excluding information furnished pursuant to Items 2.02 and 7.01 of Form 8-K) shall also be deemed to be incorporated by reference into the prospectus.
You should rely only on the information incorporated by reference or provided in this prospectus. We have not authorized anyone else to provide you with different information. Any statement contained in a document incorporated by reference into this prospectus will be deemed to be modified or superseded for the purposes of this prospectus to the extent that a later statement contained in this prospectus or in any other document incorporated by reference into this prospectus modifies or supersedes the earlier statement. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to constitute a part of this prospectus. You should not assume that the information in this prospectus is accurate as of any date other than the date of this prospectus or the date of the documents incorporated by reference in this prospectus.
We will provide without charge to each person to whom a copy of this prospectus is delivered, upon written or oral request, a copy of any or all of the reports or documents that have been incorporated by reference in this prospectus but not delivered with this prospectus (other than an exhibit to these filings, unless we have specifically incorporated that exhibit by reference in this prospectus). Any such request should be addressed to us at: 525 Executive Boulevard, Elmsford, New York 10523, Attention: Stephen Brown, Chief Financial Officer, or made by phone at (914) 233-3004. You may also access the documents incorporated by reference in this prospectus through our website at www.nanovibronix.com. Except for the specific incorporated documents listed above, no information available on or through our website shall be deemed to be incorporated in this prospectus or the registration statement of which it forms a part.
$15,000,0008,956,955 Shares
COMMON STOCK
PREFERRED STOCK
WARRANTS
UNITS
PROSPECTUS
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PART II
II:
INFORMATION NOT REQUIRED IN PROSPECTUS
Item 14. Other Expenses of Issuance and Distribution
The feesfollowing table sets forth the various costs and expenses payable by us in connection with thisthe sale of the securities being registered. All such costs and expenses shall be borne by us. Except for the Securities and Exchange Commission registration statementfee, all the amounts shown are estimated as follows:estimates.
Securities and Exchange Commission Registration Fee | $ | 1,818.00 | ||
Accounting Fees and Expenses | 15,000 | |||
Legal Fees and Expenses | 20,000 | |||
Printing Fees and Expenses | — | |||
Transfer Agent Fees and Expenses | 3,000 | |||
Miscellaneous Fees and Expenses | 5,000 | |||
Total | $ | 44,818 |
Securities and Exchange Commission Registration Fee | $ | 2,280.10 | ||
Printing and engraving costs | $ | 3,000 | ||
Legal fees and expenses | $ | 25,000 | ||
Accounting fees and expenses | $ | 15,000 | ||
Miscellaneous Fees and Expenses | $ | 2,000 | ||
Total | $ | 47,280.10 |
Item 15. Indemnification of Directors and Officers
Section 145 of the General Corporation Law of the State of Delaware provides, in general, that a corporation incorporated under the laws of the State of Delaware, as we are, may indemnify any person who was or is a party or is threatened to be made a party to any threatened, pending or completed action, suit or proceeding (other than a derivative action by or in the right of the corporation) by reason of the fact that such person is or was a director, officer, employee or agent of the corporation, or is or was serving at the request of the corporation as a director, officer, employee or agent of another enterprise, against expenses (including attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection with such action, suit or proceeding if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the corporation and, with respect to any criminal action or proceeding, had no reasonable cause to believe such person’s conduct was unlawful. In the case of a derivative action, a Delaware corporation may indemnify any such person against expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection with the defense or settlement of such action or suit if such person acted in good faith and in a manner such person reasonably believed to be in or not opposed to the best interests of the corporation, except that no indemnification will be made in respect of any claim, issue or matter as to which such person will have been adjudged to be liable to the corporation unless and only to the extent that the Court of Chancery of the State of Delaware or any other court in which such action was brought determines such person is fairly and reasonably entitled to indemnity for such expenses.
Our certificate of incorporation and bylaws provide that we will indemnify our directors, officers, employees and agents to the extent and in the manner permitted by the provisions of the General Corporation Law of the State of Delaware, as amended from time to time, subject to any permissible expansion or limitation of such indemnification, as may be set forth in any stockholders’ or directors’ resolution or by contract. Any repeal or modification of these provisions approved by our stockholders will be prospective only and will not adversely affect any limitation on the liability of any of our directors or officers existing as of the time of such repeal or modification.
We are also permitted to apply for insurance on behalf of any director, officer, employee or other agent for liability arising out of his actions, whether or not the General Corporation Law of the State of Delaware would permit indemnification.
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Item 16. Exhibits
(b) |
* To be filed as an exhibit to a Current Report of the registrant on Form 8-K or other document to be incorporated herein by reference.Item 17. Undertakings
** Filed herewith.
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 the 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 a 20 percent change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement.
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(iii) To include any material information with respect to the plan of distribution not previously disclosed in the registration statement or any material change to such information in the registration statement;
provided,Provided, however, that:that the undertakings set forth in paragraphs (a)
Paragraphs (1)(i), (a)(1)(ii) and (a)(1)(iii) aboveof this section 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 Commission by the registrant pursuant to section 13 or section 15(d) of the Securities Exchange Act of 1934 that are incorporated by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part of the 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.
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(b) The undersigned(4) That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
(i) If the registrant hereby undertakesis relying on Rule 430B (§230.430B of this chapter):
(A) Each prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as of the date the filed prospectus was deemed part of and included in the registration statement; and
(B) 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)(1)(i), (vii), or (x) for the purpose of providing the information required by section 10 (a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement as of the earlier of the date such form of 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.
(6) That, for purposes of determining any liability under the Securities Act of 1933, each filing of the registrant’s annual report pursuant to sectionSection 13(a) or section 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to sectionSection 15(d) of the Securities Exchange Act of 1934) 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.
(c)(7) 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 Securities Act of 1933 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 and will be governed by the final adjudication of such issue.
(d) The undersigned registrant hereby undertakes that:
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SIGNATURES
Pursuant to the requirements of the Securities Act of 1933, as amended, the registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf by the undersigned, thereunto duly authorized, in the City of Elmsford, State of New York, on December 31, 2018.September 12, 2023.
By: | /s/ Brian Murphy | |
Name: | Brian Murphy | |
Title: | Chief Executive Officer |
Power of AttorneyPOWER OF ATTORNEY
Each person whose signature appears below hereby appoints each of Brian Murphy and Stephen Brown, severally, acting alone and without the other, his or her true and lawful attorney-in-fact, with full power of substitution, and with the authority to execute in the name of each such person, any and all amendments (including without limitation, post-effective amendments) to this registration statement on Form S-3, to sign any and all additional registration statements relating to the same offering of securities as this registration statement that are filed pursuant to Rule 462(b) of the Securities Act of 1933, and to file such registration statements with the Securities and Exchange Commission, together with any exhibits thereto and other documents therewith, necessary or advisable to enable the registrant to comply with the Securities Act of 1933, and any rules, regulations and requirements of the Securities and Exchange Commission in respect thereof, which amendments may make such other changes in the registration statement as the aforesaid attorney-in-fact executing the same deems appropriate.
Pursuant to the requirements of the Securities Act of 1933, as amended, this registration statement has been signed by the following persons in the capacities and on the dates indicated.
Signature | Title | Date | ||
/s/ Brian Murphy | Chief Executive Officer and Director | |||
Brian Murphy | ( | |||
Principal Executive Officer) | ||||
/s/ Stephen Brown | Chief Financial Officer | |||
Stephen Brown | ( | |||
/s/ Christopher Fashek | Chairman of the Board of Directors | |||
Christopher Fashek | ||||
/s/ Martin Goldstein | Director | |||
Martin Goldstein | ||||
/s/ Harold Jacob, M.D. | Director | |||
Harold Jacob, M.D. | ||||
/s/ Michael Ferguson | Director | |||
Michael Ferguson | ||||
/s/ Thomas R. Mika | Director | |||
Thomas R. Mika | ||||
/s/ Aurora Cassirer | Director | September 12, 2023 | ||
Aurora Cassirer | ||||
/s/ Maria Schroeder | Director | September 12, 2023 | ||
Maria Schroeder |
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