As
Filed with the Securities and Exchange Commission on September 12, 2023
Registration
No. 333-
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Form
S-3
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
NanoVibronix,
Inc.
(Exact
Name of Registrant as Specified in its Charter)
Delaware |
|
01-0801232 |
(State
or other jurisdiction of
incorporation
or organization) |
|
(I.R.S.
Employer
Identification
No.) |
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
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
to:
Rick
A. Werner, Esq.
Jayun
Koo, Esq.
Haynes
and Boone, LLP
30
Rockefeller Plaza, 26th Floor
New
York, New York 10112
(212)
659-7300
Approximate
date of commencement of proposed sale to the public: From time to time after the effective date of this registration statement.
If
the only securities being registered on this form are being offered pursuant to dividend or interest reinvestment plans, please check
the following 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. ☒
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 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 registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b–2 of the Exchange Act.
Large
accelerated filer |
☐ |
|
Accelerated
filer |
☐ |
Non-accelerated
filer |
☒ |
|
Smaller
reporting company |
☒ |
|
|
|
Emerging
growth company |
☐ |
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.
The
information in this prospectus is not complete and may be changed. The 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, dated September 12, 2023
PROSPECTUS
![](https://www.sec.gov/Archives/edgar/data/1326706/000149315223032353/forms-3_001.jpg)
NanoVibronix,
Inc.
8,956,955
Shares of Common Stock
This
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 reliance upon the exemption from the registration requirements in Section 4(a)(2) of the Securities Act and/or Regulation
D promulgated thereunder, as applicable. We are registering the resale of the PIPE 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, or 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 prevailing market prices or at privately negotiated prices. For additional information on the possible
methods of sale that may be used by the selling stockholders, you should refer to the section of this prospectus entitled “Plan
of Distribution.”
We
will not 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, 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.
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.
No
underwriter or other person has been engaged to facilitate 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 common stock.
Our
common stock is traded on The Nasdaq Capital Market under the symbol “NAOV.” On September 11, 2023, the closing sale
price of our common stock on The Nasdaq Capital Market was $2.58 per share.
Investment
in our common stock involves risk. See “Risk Factors” contained in this prospectus, in our periodic reports filed from time
to time with the Securities and Exchange Commission, which are incorporated by reference in this prospectus and in any applicable prospectus
supplement. You should carefully read this prospectus and the accompanying prospectus supplement, together with the documents we incorporate
by reference, before you invest in our common stock.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or 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 , 2023.
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS
This
prospectus is part of the registration statement that we filed with the Securities and Exchange Commission (the “SEC”) pursuant
to which the selling stockholders named herein may, from time to time, offer and sell or otherwise dispose of the shares 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.
This
prospectus and the documents incorporated by reference into this prospectus include important information about us, the securities being
offered and other information you should know before investing in our securities. You should not assume that the information contained
in this prospectus is accurate 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 documents to which we have referred you under “Where
You Can Find More Information” and “Incorporation of Certain Information by Reference” in this prospectus.
You
should rely only on this prospectus and the information incorporated or deemed to be incorporated by reference in this prospectus. We
have not, and the selling stockholders have not, authorized anyone to give any information or to make any representation 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 does not constitute an offer to sell or the solicitation of an offer to buy securities in
any jurisdiction to any person to whom it is unlawful to make such offer or solicitation in such jurisdiction.
We
further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any document
that is incorporated by reference in 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 covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly,
such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.
Unless
otherwise indicated, information contained or incorporated by reference in this prospectus concerning 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 third parties. Management estimates are derived
from publicly available information, our knowledge of our industry and assumptions based on such information and knowledge, which we
believe to be reasonable. In addition, assumptions and estimates of our and our industry’s future performance are necessarily
uncertain due to a variety of factors, including those described in “Risk Factors” beginning on page 4 of this
prospectus. These and other factors could cause our future performance to differ materially from our assumptions and
estimates.
PROSPECTUS
SUMMARY
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. In this prospectus,
unless the context indicates otherwise, “NanoVibronix,” the “Company,” the “registrant,” “we,”
“us,” “our,” or “ours” refer to NanoVibronix, Inc. and its subsidiaries.
Overview
We
are a medical device company focusing on noninvasive biological response-activating devices that target 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. All three of our products have CE Mark approval in the European Union, 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.
The
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 Listing 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 continuing operations of $500,000 in the most 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 able to regain 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 Supplies
In
addition to the need to obtain regulatory approvals, we anticipate that sales volumes and prices of our UroShield and PainShield 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 only had reimbursement
codes in the United States (i.e., CPT codes) for clinical use 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 CMS
did not approve 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 in 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 the first bi-annual 2023
Non-Drug and Non-Biological Items and Services. As part of its determination, CMS concluded that PainShield does not fall within a Durable
Medical Equipment, Prosthetics, Orthotics and Supplies benefit category and therefore is not reimbursable under Medicare and Medicaid
at this time. We plan to resubmit an application for additional review and continue to work with our legal and technical teams to weigh
our options, as we believe it will be difficult to achieve market success if PainShield supplies are not eligible for reimbursement.
PainShield currently is subject to reimbursement under certain workers’ compensation plans and Veterans Administration facilities.
August
2023 PIPE
On
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 180,000 PIPE Shares, Pre-Funded Warrants to purchase up to 2,726,977 shares of common 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-2 Warrants to purchase up to 2,906,977 shares of common stock with an exercise price of $1.47 per share. The
A-1 Warrants are exercisable immediately upon issuance and have a termination date of March 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 accompanying
Warrants was $1.72, and the combined purchase price for one Pre-Funded Warrant and the accompanying Warrants was $1.7199.
A
holder of the Pre-Funded Warrants, the A-1 Warrants, and the A-2 Warrants may not exercise any portion of such holder’s Pre-Funded
Warrants, the A-1 Warrants, or the A-2 Warrants to the extent that the holder, together with its affiliates, would beneficially own more
than 4.99% (or, at the election of the holder, 9.99%) of our 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
connection with the Private 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 file 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 event of a “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 its designees the 2023 Wainwright Warrants to purchase up to 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.
November
2022 Offering
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 common stock. In connection with this offering, on December 1, 2022,
we issued to Wainwright or its designees as partial compensation, the 2022 Wainwright Warrants to purchase up to an 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
and Wainwright. The 2022 Wainwright Warrants expire on November 29, 2027.
Corporate
information
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
OFFERING
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 |
|
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. |
|
|
|
Plan
of Distribution |
|
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. |
|
|
|
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. |
RISK
FACTORS
Investing
in our securities involves a high degree of risk. In addition to the other information contained in this prospectus and in the documents
we incorporate by reference, you should carefully consider the risks discussed below and under the heading “Risk Factors”
in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 as well as any amendment or update to our risk factors
reflected in subsequent filings with the SEC, before making a decision about investing in our securities. The risks and uncertainties
discussed below and in the documents incorporated by reference are not the only ones facing us. Additional risks and uncertainties not
presently known to us, or that we currently see as immaterial, may also harm our business. If any of these risks occur, our business,
financial condition and operating results could be harmed, the trading price of our common stock could decline and you could lose part
or all of your investment.
The
sale of a substantial amount of our shares in the 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 and the information incorporated by reference in this prospectus 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 may 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
history of losses and expectation of continued losses. |
|
|
|
|
●
|
Global
economic and political instability and conflicts, such as the conflict between Russia and Ukraine, could adversely affect our business,
financial condition or results of operations. |
|
|
|
|
● |
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 raise funding for, and the timing of, clinical studies and eventual U.S. Food and Drug Administration (“FDA”)
approval of our product candidates. |
|
|
|
|
● |
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 payers (including
CMS). |
|
|
|
|
● |
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 Nasdaq and the risk that our common stock will be delisted
if we cannot do so. |
|
● |
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 portfolio and our ability to protect our intellectual property rights. |
|
|
|
|
● |
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 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 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.
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, 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.
SELLING
STOCKHOLDERS
The
common stock being offered by the selling stockholders are those previously issued to the selling stockholders, and those issuable to
the selling stockholders, upon exercise of the warrants, as applicable. For additional information regarding the issuances of those shares
of common stock and the warrants, see “August 2023 PIPE” and “November 2022 Offering” above. We are registering
the shares of common stock 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.
The
table below lists the selling stockholders and other information regarding the beneficial ownership of the shares of common stock by
each of the selling stockholders. The second column lists the number of shares of common stock beneficially 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 held by
the selling stockholders on that date, without regard to any limitations on exercises.
The
third column lists the shares of common stock being offered by this prospectus by the selling stockholders.
In
accordance with the terms of the Registration 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 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 investment manager of the
Master Fund; and (ii) Steven Boyd, as the Managing Member of Armistice Capital. As of the date of this registration statement, the
A-1 Warrants and the A-2 Warrants are subject to a beneficial ownership limitation of 4.99%, and 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 selling stockholder and its
affiliates owning, after exercise, a number of shares of common stock in excess of the beneficial ownership limitation. The address
of Armistice Capital Master Fund Ltd. is c/o Armistice Capital, LLC, 510 Madison Avenue, 7th Floor, New York, NY 10022. |
|
|
(2) |
The shares that may be
sold under this prospectus are comprised of 180,000 PIPE Shares, 2,726,977 Pre-Funded Warrant Shares, 2,906,977 A-1 Warrant Shares,
and 2,906,977 A-2 Warrant Shares. |
|
|
(3) |
As
of the date of this registration statement, the Master Fund may not (i) exercise the Pre-Funded Warrants to the extent such exercise
would cause the Master Fund, together with its affiliates and attribution parties, to beneficially own a number of shares of common
stock which would exceed 9.99% of our then outstanding common stock following such exercise, or (ii) exercise the A-1 Warrants or
the A-2 Warrants to the extent such exercise would cause the Master Fund, together with its affiliates and attribution parties, to
beneficially own a number of shares of common stock which would exceed 4.99%, or, upon notice to us, 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 such securities which have not been so exercised.
|
(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 securities held.
Each selling stockholder may not exercise the 2023 Wainwright Warrants or the 2022 Wainwright Warrants to the extent such exercise
would cause each selling stockholder, together with his affiliates and attribution parties, to beneficially own a number of shares
of common stock which would exceed 4.99% of our then outstanding common stock following such exercise, or, upon notice to us, 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 such securities which have not been so exercised. The selling stockholder acquired the placement agent
warrants in the ordinary course of business and, at the time the placement agent warrants were acquired, the selling stockholder
had no agreement or understanding, directly or indirectly, with any person to distribute such securities. |
|
|
(5) |
Represents (i) 139,807
2023 Wainwright Warrant Shares and (ii) 11,543 2022 Wainwright Warrant Shares. |
|
|
(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 certain warrants issued in 2020.
|
(7) |
Represents (i) 68,678 2023
Wainwright Warrant Shares and (ii) 5,670 2022 Wainwright Warrant Shares. |
|
|
(8) |
Represents (i) 7,358 2023
Wainwright Warrant Shares and (ii) 608 2022 Wainwright Warrant Shares. |
|
|
(9) |
Represents (i) 2,180 2023
Wainwright Warrant Shares and (ii) 180 2022 Wainwright Warrant Shares. |
Relationships
with the Selling Stockholders
Each
of 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 Private Placement and the registered direct offering discussed above, for which
Wainwright received compensation.
Armistice
Capital Master Fund Ltd. purchased securities in the Private Placement.
PLAN
OF DISTRIBUTION
Each
selling stockholder of the securities and any of their pledgees, assignees and successors-in-interest may, from time to time, sell any
or all of their securities covered hereby on the Nasdaq Capital Market or any 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 of the following methods when selling securities:
|
● |
ordinary brokerage transactions and transactions in
which the broker-dealer solicits purchasers; |
|
● |
block trades in which the broker-dealer will attempt
to sell the securities as agent but may position and resell a portion of the block as principal to facilitate the transaction; |
|
● |
purchases by a broker-dealer as principal and resale
by the broker-dealer for its account; |
|
● |
an exchange distribution in accordance with the rules
of the applicable exchange; |
|
● |
privately negotiated transactions; |
|
● |
settlement of short sales; |
|
● |
in transactions through broker-dealers that agree with
the Selling Stockholders to sell a specified number of such securities at a stipulated price per security; |
|
● |
through the writing or settlement of options or other
hedging transactions, whether through an options exchange or otherwise; |
|
● |
a combination of any such methods of sale; or |
|
● |
any other method permitted pursuant to applicable law. |
The
selling stockholders may also sell securities under Rule 144 or any other exemption from registration under the Securities Act, if available,
rather than under this prospectus.
Broker-dealers
engaged by the selling stockholders may arrange for other brokers-dealers to participate in sales. Broker-dealers may receive commissions
or discounts from the selling stockholders (or, if any broker-dealer acts as agent for the purchaser of securities, from the purchaser)
in amounts to be negotiated, but, except as set forth in a supplement to this prospectus, in the case of an agency transaction not in
excess of a customary brokerage commission in compliance with FINRA Rule 2121; and in the case of a principal transaction a markup or
markdown in compliance with FINRA 2121.
In
connection with the sale of the securities or interests therein, the selling stockholders may enter into hedging transactions with broker-dealers
or other financial institutions, which may in turn engage in short sales of the securities in the course of hedging the positions they
assume. The selling stockholders may also sell securities short and deliver these securities to close out their short positions, or loan
or pledge the securities to broker-dealers that in turn may sell these securities. The selling stockholders may also enter into option
or other transactions with broker-dealers or other financial institutions or create one or more derivative securities which require the
delivery to such broker-dealer or other financial institution of securities offered by this prospectus, which securities such broker-dealer
or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such transaction).
The
selling stockholders and any broker-dealers or agents that are involved in selling the securities may be deemed to be “underwriters”
within the meaning of the Securities Act in connection with such sales. In such event, any commissions received by such broker-dealers
or agents and any profit on the resale of the securities purchased by them may be deemed to be underwriting commissions or discounts
under the Securities Act. 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
are required to pay certain fees and expenses incurred by us incident to the registration of the securities. We have agreed to indemnify
the selling stockholders against certain losses, claims, damages and liabilities, including liabilities under the Securities Act.
We
agreed to keep this prospectus effective until the earlier of (i) the date on which the securities may be resold by the selling stockholders
without registration and without regard to any volume or manner-of-sale limitations by reason of Rule 144, without the requirement for
us to be in compliance with the current public information under Rule 144 under the Securities Act or any other rule of similar effect
or (ii) all of the securities have been sold pursuant to this prospectus or Rule 144 under the Securities Act or any other rule of similar
effect. The resale securities will be sold only through registered or licensed brokers or dealers if required under applicable state
securities laws. In addition, in certain states, the resale securities covered hereby may not be sold unless they have been registered
or qualified for sale in the applicable state or an exemption from the registration or qualification requirement is available and is
complied with.
Under
applicable rules and regulations under the Exchange Act, any person engaged in the distribution of the resale securities may not simultaneously
engage in market making activities with respect to the common stock for the applicable restricted period, as defined in Regulation M,
prior to the commencement of the distribution. In addition, the selling stockholders will be subject to applicable provisions of the
Exchange Act and the rules and regulations thereunder, including Regulation M, which may limit the timing of purchases and sales of the
common stock by the selling stockholders or any other person. We will make copies of this prospectus available to the selling stockholders
and 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).
LEGAL
MATTERS
The
validity of the securities offered by this prospectus will be passed upon for us by Haynes and Boone, LLP, New York, New York.
EXPERTS
The
consolidated financial statements of NanoVibronix, Inc. and its subsidiary as of December 31, 2022, and December 31, 2021, and for each
of the two years in the period ended December 31, 2022, included in the Annual Report on Form 10-K for the year ended December 31, 2022,
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 2 to the financial statements)
of Marcum LLP, an independent registered public accounting firm, given on the authority of said firm as experts in auditing and accounting.
WHERE
YOU CAN FIND MORE INFORMATION
We
have filed with the SEC a registration statement on Form S-3 under the Securities Act with respect to the securities offered by this
prospectus. This prospectus, filed as part of the registration statement, does not contain all the information set forth in the registration
statement and its exhibits and schedules, portions of which have been omitted as permitted by the rules and regulations 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 and other information with the SEC. The SEC maintains an internet website at www.sec.gov
that contains periodic and current reports, proxy and information statements, and other information regarding registrants that are
filed electronically with the SEC.
These
documents are also available, free of charge, through the Investors section of our website, which is located at www.nanovibronix.com.
Information contained on our website is not incorporated by reference into this prospectus and you should not consider information on
our website to be part of this prospectus.
INCORPORATION
OF CERTAIN INFORMATION BY REFERENCE
The
SEC 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 SEC 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 SEC pursuant to Sections l3(a), l3(c), 14 or l5(d) of the Exchange Act 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, 2022, filed with the SEC on April 17, 2023; |
|
|
|
|
● |
Our Definitive Proxy Statement
on Schedule 14A, filed with the SEC on May 1, 2023; |
|
|
|
|
● |
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 SEC on February 8, 2023; |
|
|
|
|
● |
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, 2023; |
|
|
|
|
● |
Our
Current Report on Form
8-K, filed with the SEC on May 25, 2023; |
|
|
|
|
● |
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 contained in our
Registration Statement on Form 8-A, filed on October 19, 2017 pursuant to Section 12(b) of the Exchange Act, which incorporates by
reference the description of the shares of our common stock contained in the “Description of Securities” filed as Exhibit
4.15 to our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on April 17, 2023, and any amendment
or report filed with the SEC for purposes of updating such description. |
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.
8,956,955
Shares
![](https://www.sec.gov/Archives/edgar/data/1326706/000149315223032353/forms-3_001.jpg)
COMMON
STOCK
PROSPECTUS
PART
II:
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
14. Other Expenses of Issuance and Distribution
The
following table sets forth the various costs and expenses payable by us in connection with the sale of the securities being registered.
All such costs and expenses shall be borne by us. Except for the Securities and Exchange Commission registration fee, all the amounts
shown are estimates.
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.
Item
16. Exhibits
(b) |
All schedules have been
omitted because they are not required, are not applicable or the information is otherwise set forth in the financial statements and
related notes thereto. |
Exhibit
No. |
|
Description |
4.1 |
|
Form of Common Stock Certificate (incorporated by reference to Exhibit 4.2 to Amendment No. 1 to the Registration Statement on Form S-1 filed with the Securities and Exchange Commission on March 6, 2014) |
4.2 |
|
Form of May 10 and May 15, 2019 Warrants (incorporated by reference to Exhibit 4.1 to the Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 20, 2019) |
4.3 |
|
Form of Warrant (incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on June 26, 2019) |
4.4 |
|
Form of Preferred Warrant (incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on July 31, 2019) |
4.5 |
|
Form of Common Warrant (incorporated by reference to Exhibit 4.3 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on July 31, 2019) |
4.6 |
|
Form of Warrant Amendment (incorporated by reference to Exhibit 4.10 to the Annual Report on Form 10-K filed with the Securities and Exchange Commission on May 20, 2020) |
4.7 |
|
Form of Underwriter Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on August 26, 2020). |
4.8 |
|
Form of Underwriter Common Stock Purchase Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on September 24, 2020). |
4.9 |
|
Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on December 7, 2020). |
4.10 |
|
Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on December 7, 2020). |
4.11 |
|
Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on December 1, 2020). |
4.12 |
|
Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on September 1, 2023). |
4.13 |
|
Form of Warrant (incorporated by reference to Exhibit 4.2 to the Current Report on Form 8-K filed with the Securities and Exchange Commission on September 1, 2023). |
4.14 |
|
Form of Placement Agent Warrant (incorporated by reference to Exhibit 4.3 to the Current Report on Form 8-K filed with the Securities Exchange Commission on September 1, 2023). |
5.1* |
|
Opinion of Haynes and Boone, LLP. |
23.1* |
|
Consent of Marcum LLP, independent registered public accounting firm. |
23.2* |
|
Consent of Haynes and Boone, LLP (included in Exhibit 5.1). |
24.1* |
|
Power of Attorney (contained in the signature page to this registration statement). |
107 * |
|
Calculation of Filing Fee. |
|
|
|
* |
|
Filed herewith |
Item
17. Undertakings
The
undersigned registrant hereby undertakes:
(1)
To file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
(i)
To include any prospectus required by section 10(a)(3) of the Securities Act of 1933;
(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.
(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,
however, that:
Paragraphs
(1)(i), (1)(ii) and (1)(iii) of 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.
(4)
That, for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
(i)
If the registrant is 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 Section 13(a) or 15(d) of the Securities Exchange Act of 1934 (and, where applicable, each filing of an employee benefit
plan’s annual report pursuant to Section 15(d) of the Securities Exchange Act of 1934) that is incorporated by reference in the
registration statement shall be deemed to be a new registration statement relating to the securities offered therein, and the offering
of such securities at that time shall be deemed to be the initial bona fide offering thereof.
(7)
Insofar as indemnification for liabilities arising under the Securities Act of 1933 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.
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 September 12, 2023.
|
NanoVibronix, Inc. |
|
|
|
|
By: |
/s/ Brian
Murphy |
|
Name: |
Brian Murphy |
|
Title: |
Chief Executive Officer |
POWER
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 |
|
September
12, 2023 |
Brian
Murphy |
|
(Principal
Executive Officer) |
|
|
|
|
|
|
|
/s/
Stephen Brown |
|
Chief
Financial Officer |
|
September
12, 2023 |
Stephen
Brown |
|
(Principal
Financial and Accounting Officer) |
|
|
|
|
|
|
|
/s/
Christopher Fashek |
|
Chairman
of the Board of Directors |
|
September
12, 2023 |
Christopher
Fashek |
|
|
|
|
|
|
|
|
|
/s/
Martin Goldstein |
|
Director |
|
September
12, 2023 |
Martin
Goldstein |
|
|
|
|
|
|
|
|
|
/s/
Harold Jacob, M.D. |
|
Director |
|
September
12, 2023 |
Harold
Jacob, M.D. |
|
|
|
|
|
|
|
|
|
/s/
Michael Ferguson |
|
Director |
|
September
12, 2023 |
Michael
Ferguson |
|
|
|
|
|
|
|
|
|
/s/
Thomas R. Mika |
|
Director |
|
September
12, 2023 |
Thomas
R. Mika |
|
|
|
|
|
|
|
|
|
/s/
Aurora Cassirer |
|
Director |
|
September
12, 2023 |
Aurora
Cassirer |
|
|
|
|
|
|
|
|
|
/s/
Maria Schroeder |
|
Director |
|
September
12, 2023 |
Maria
Schroeder |
|
|
|
|
Exhibit 5.1
September
12, 2023
NanoVibronix,
Inc.
525
Executive Blvd.
Elmsford,
New York, 10523
Ladies
and Gentlemen:
We
have acted as counsel for NanoVibronix, Inc., a Delaware corporation (the “Company”), in connection with the filing
with the Securities and Exchange Commission (the “Commission”) on the date hereof, under the Securities Act of 1933,
as amended (the “Securities Act”), of a registration statement on Form S-3 (the “Registration Statement”)
by the Company which registers the resale by the holders thereof of 8,956,955 shares of common stock of the Company, par value $0.001
per share (the “Common Stock”), comprised of (i) 180,000 shares of Common Stock (the “PIPE Shares”)
that were issued pursuant to a securities purchase agreement, dated as of August 30, 2023, by and among the Company and the purchaser
named therein (the “Purchase Agreement”), (ii) 2,726,977 shares of Common Stock (the “Pre-Funded Warrant
Shares”) issuable upon exercise of pre-funded warrants (the “Pre-Funded Warrants”) that were issued pursuant
to the Purchase Agreement, (iii) 2,906,977 shares of Common Stock (the “A-1 Warrant Shares”) issuable upon exercise
of the A-1 Warrants (the “A-1 Warrants”) that were issued pursuant to the Purchase Agreement, (iv) 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, (v) 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”) as part of Wainwright’s compensation for serving as exclusive placement agent in connection
with the Purchase Agreement, and (vi) 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 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 the Company and the purchasers named therein. The PIPE Shares, the 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 are referred to herein collectively as
the “Securities.”
In
rendering the opinions expressed herein, we have examined and relied upon the originals, or copies certified to our satisfaction, of
(i) the Amended and Restated Certificate of Incorporation, as amended, and Amended and Restated Bylaws of the Company, as amended, as
of the date hereof (“Company Charter Documents”); (ii) the Registration Statement and all exhibits thereto; (iii)
the Pre-Funded Warrants; (iv) the A-1 Warrants; (v) the A-2 Warrants; (vi) the 2023 Wainwright Warrants; (vii) the 2022 Wainwright Warrants;
(viii) a specimen of the Company’s Common Stock certificate; (ix) a certificate executed by an officer of the Company, dated as
of the date hereof, and (x) such other corporate records of the Company as we have deemed necessary or appropriate for purposes of the
opinions hereafter expressed.
As
to questions of fact material to the opinions expressed below, we have, without independent verification of their accuracy, relied to
the extent we deemed reasonably appropriate upon the representations and warranties of the Company contained in such documents, records,
certificates, instruments or representations furnished or made available to us by the Company.
In
making the foregoing examinations, we have assumed (i) the genuineness of all signatures, (ii) the authenticity of all documents submitted
to us as originals, (iii) the conformity to original documents of all documents submitted to us as certified or photostatic copies, (iv)
that all agreements or instruments we have examined are the valid, binding and enforceable obligations of the parties thereto, and (v)
that all factual information on which we have relied was accurate and complete.
We
have also assumed that (i) the Company will continue to be incorporated and in existence and good standing in its jurisdiction of organization;
(ii) the Registration Statement, and any amendments thereto (including post-effective amendments), will have become effective; (iii)
no stop order of the Commission preventing or suspending the use of the prospectus contained in the Registration Statement or any prospectus
supplement will have been issued; (iv) a prospectus properly describing the Securities offered thereby will have been delivered to the
purchaser(s) of the Securities as required in accordance with applicable law; (v) all Securities will be offered, issued and sold in
compliance with applicable federal and state securities laws and in the manner stated in the Registration Statement and the prospectus
and any prospectus supplement; (vi) any definitive purchase, underwriting or similar agreement with respect to any Securities offered
will have been duly authorized and validly executed and delivered by the Company and the other parties thereto and will be an enforceable
obligation of the parties thereto; (vii) upon effectiveness of the Registration Statement, there will be sufficient shares of Common
Stock authorized under the Company Charter Documents and not otherwise reserved for issuance; and (viii) there will not have occurred
any change in law or in the Company Charter Documents of the Company adversely affecting the Securities or the rights of the holders
thereof.
Based
upon the foregoing and subject to the assumptions and qualifications stated herein, we are of the opinion that (i) the PIPE Shares are
validly issued, fully paid and non-assessable; (ii) the Pre-Funded Warrant Shares, when issued in accordance with the terms of the Pre-Funded
Warrants, will be validly issued, fully paid and non-assessable; (iii) the A-1 Warrant Shares, when issued in accordance with the terms
of the A-1 Warrants, will be validly issued, fully paid and non-assessable; (iv) the A-2 Warrant Shares, when issued, in accordance with
the terms of the A-2 Warrants, will be validly issued, fully paid and non-assessable; (v) the 2023 Wainwright Warrant Shares, when issued
in accordance with the terms of the 2023 Wainwright Warrants, will be validly issued, fully paid and non-assessable, and (vi) the 2022
Wainwright Warrant Shares, when issued in accordance with the terms of the 2022 Wainwright Warrants, will be validly issued, fully paid
and non-assessable.
The
opinions expressed herein are limited exclusively to the General Corporation Law of the State of Delaware (the “DGCL”)
and applicable provisions of the Delaware Constitution and reported judicial decisions interpreting the DGCL and such provisions of the
Delaware Constitution and we have not considered, and express no opinion on, any other laws or the laws of any other jurisdiction.
We
hereby consent to the filing of this opinion with the Commission as Exhibit 5.1 to the Registration Statement and to the reference to
our firm under the heading “Legal Matters” in the prospectus constituting part of such Registration Statement. In giving
such consent, we do not hereby admit that we are in the category of persons whose consent is required under Section 7 of the Securities
Act or the rules and regulations of the Commission thereunder.
|
Very
truly yours, |
|
|
|
/s/
Haynes and Boone, LLP |
|
Haynes
and Boone, LLP |
Exhibit
23.1
Independent
Registered Public Accounting Firm’s Consent
We
consent to the incorporation by reference in this Registration Statement of NanoVibronix, Inc. on Form S-3 of our report dated April
17, 2023, which includes an explanatory paragraph as to the Company’s ability to continue as a going concern, with respect to our
audits of the consolidated financial statements of NanoVibronix, Inc. as of December 31, 2022 and 2021 and for each of the two years
in the period ended December 31, 2022 appearing in the Annual Report on Form 10-K of NanoVibronix, Inc. for the year ended December 31,
2022. We also consent to the reference to our firm under the heading “Experts” in the Prospectus, which is part of this Registration
Statement.
/s/
Marcum llp
Marcum
llp
New
York, NY
September
12, 2023
Exhibit
107
Calculation
of Filing Fee Tables
Form
S-3
NanoVibronix,
Inc.
Table
1: Newly Registered and Carry Forward Securities
| |
Security Type | |
Security Class Title | |
Fee Calculation or Carry Forward Rule | |
Amount Registered (1) | | |
Proposed Maximum Offering Price Per Unit | |
|
Maximum Aggregate Offering Price | | |
Fee Rate | | |
Amount of Registration Fee | | |
Carry Forward Form Type | | |
Carry Forward File Number | | |
Carry Forward Initial effective date | | |
Filing Fee Previously Paid In Connection with Unsold Securities to be Carried Forward | |
Newly Registered Securities | |
Fees to Be Paid | |
Equity | |
Common Stock, par value $0.0001 per share | |
Rule 457(c) | |
| 8,956,955 | (2) | |
$ | 2.31 | (3) |
|
$ | 20,690,567 | | |
$ | 0.00011020 | | |
$ | 2,280.10 | | |
| | | |
| | | |
| | | |
| | |
Fees Previously Paid | |
| |
| |
| |
| | | |
| | |
|
| | | |
| | | |
| | | |
| | | |
| | | |
| | | |
| | |
Carry Forward Securities | |
Carry Forward Securities | |
- | |
- | |
- | |
| - | | |
| | |
|
| - | | |
| | | |
| | | |
| - | | |
| - | | |
| - | | |
| - | |
| |
Total Offering Amounts | | |
| | |
|
$ | 20,690,567 | | |
| | | |
$ | 2,280.10 | | |
| | | |
| | | |
| | | |
| | |
| |
Total Fees Previously Paid | | |
| | |
|
| | | |
| | | |
| - | | |
| | | |
| | | |
| | | |
| | |
| |
Total Fee Offsets | | |
| | |
|
| | | |
| | | |
| - | | |
| | | |
| | | |
| | | |
| | |
| |
Net Fee Due | | |
| | |
|
| | | |
| | | |
$ | 2,280.10 | | |
| | | |
| | | |
| | | |
| | |
(1) |
Pursuant
to Rule 416 under the Securities Act of 1933 (the “Securities Act”), the shares being registered hereunder include such
indeterminate number of shares of common stock as may be issuable with respect to the shares being registered hereunder as a result
of stock splits, stock dividends or similar transactions. |
|
|
(2) |
Represents
(i) 180,000 PIPE shares (as defined in the registration statement), (ii) 2,726,977 Pre-Funded Warrant Shares (as defined in the registration
statement), (iii) 2,906,977 A-1 Warrant Shares (as defined in the registration statement), (iv) 2,906,977 A-2 Warrant Shares (as
defined in the registration statement), (v) 218,023 2023 Wainwright Warrant Shares (as defined in the registration statement) and
(vi) 18,001 2022 Wainwright Warrant Shares (as defined in the registration statement). |
|
|
(3) |
Estimated
solely for the purpose of calculating the amount of the registration fee pursuant to Rule 457(c) under the Securities Act, based
on the average of the high and low prices of the common stock as reported on The Nasdaq Capital Market on September 8, 2023, which
such date is within five business days of the filing of this registration statement, of $2.31 per share. |
Grafico Azioni NanoVibronix (NASDAQ:NAOV)
Storico
Da Gen 2025 a Feb 2025
Grafico Azioni NanoVibronix (NASDAQ:NAOV)
Storico
Da Feb 2024 a Feb 2025