As
filed with the Securities and Exchange Commission on April 5, 2021
Registration
No. 333-
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-3
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
InspireMD,
Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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26-2123838
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(State
or other jurisdiction of
incorporation or organization)
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(I.R.S.
Employer
Identification Number)
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4
Menorat Hamaor. St.
Tel
Aviv, Israel 6744832
(888)
776-6804
(Address,
including zip code, and telephone number, including area code, of registrant’s principal executive offices)
Marvin
Slosman
Chief
Executive Officer
InspireMD,
Inc.
4
Menorat Hamaor. St.
Tel
Aviv, Israel 6744832
(888)
776-6804
(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:
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David
S. Glatt, Adv.
Jonathan
M. Nathan, Adv.
Meitar
| Law Offices
16 Abba Hillel Road
Ramat Gan 5250608, Israel
Tel: +972 (3) 610-3100
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Gary
Emmanuel, Esq.
Mark
Selinger, Esq.
Ze’-ev
D. Eiger, Esq.
McDermott
Will & Emery LLP
340
Madison Ave.
New
York, NY 10173
Tel:
(212) 547-5400
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Approximate
date of commencement of proposed sale to the public: From time to time after this Registration Statement becomes effective.
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: [X]
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 Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller
reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
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Large
accelerated filer
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[ ]
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Accelerated
filer
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[ ]
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Non-accelerated
filer
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[X]
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Smaller
reporting company
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[X]
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Emerging
growth company
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[ ]
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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 to Section 7(a)(2)(B) of the Securities Act. [ ]
CALCULATION
OF REGISTRATION FEE
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Title of each class of securities
to be registered
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Amount to be
Registered(1)
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Proposed Maximum Offering Price Per
Share(2)
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Proposed maximum
aggregate
offering price
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Amount of
registration fee (3)
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Common Stock, $0.0001 par value per share
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1,341,682
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$
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0.676
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$
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906,978
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$
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98.96
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(1)
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Pursuant
to Rule 416 under the Securities Act of 1933, as amended, or the Securities Act, the Registrant is also registering hereunder
an indeterminate number of additional shares of common stock that shall be issuable pursuant to Rule 416 to prevent dilution
resulting from stock splits, stock dividends or similar transactions.
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(2)
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Estimated
solely for the purpose of calculating the registration fee pursuant to Rule 457(c) under the Securities Act and based upon
the average of the high and low sale prices of the Registrant’s shares of common stock on the NYSE American on April
1, 2021.
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(3)
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Calculated
in accordance with Rule 457(c) under the Securities Act.
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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. The selling stockholder 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 the selling stockholder named in this prospectus is not soliciting an offer to buy
these securities in any state where the offer or sale is not permitted.
SUBJECT
TO COMPLETION, DATED APRIL 5, 2021
PROSPECTUS
1,341,682
Shares
InspireMD,
Inc.
Common
Stock
The
selling stockholder named in this prospectus, or the selling stockholder, may use this prospectus to offer and resell from time
to time up to 1,341,682 shares of our common stock, which are the shares of our common stock held by the selling stockholder.
The
selling stockholder received these shares of our common stock from us pursuant to a private placement transaction, which was consummated
on February 5, 2021. We are registering the offer and resale of these shares of our common stock to satisfy a covenant set forth
in the investor rights agreement executed concurrently with securities purchase agreement under which the private placement was
effected, pursuant to which we agreed to register the resale of these shares of our common stock within a limited period of time
following the date of the agreement.
We
will not receive any of the proceeds from the sale of our common stock by the selling stockholder.
Any
shares of our common stock subject to resale hereunder will have been issued by us and received by the selling stockholder prior
to any resale of such shares pursuant to this prospectus.
The
selling stockholder, or its donees, pledgees, transferees or other successors-in-interest, may offer or resell the shares 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 stockholder will bear all commissions and discounts, if any, attributable to the
sale of shares. We will bear all costs, expenses and fees in connection with the registration of the shares. For additional information
on the methods of sale that may be used by the selling stockholder, see “Plan of Distribution” beginning on page 9
of this prospectus.
Our
common stock is listed on the NYSE American under the symbol “NSPR.” On April 1, 2021, the last reported sale price
of our common stock as reported on the NYSE American was $0.67 per share.
Investing
in our securities involves a high degree of risk. These risks are discussed in this prospectus under “Risk Factors”
beginning on page 5 and in our most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are incorporated
by reference in this prospectus and in any applicable prospectus supplement.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or
passed upon the adequacy or accuracy of this prospectus. Any representation to the contrary is a criminal offense.
The
date of this prospectus is , 2021
TABLE OF CONTENTS
ABOUT
THIS PROSPECTUS
This
prospectus is part of a registration statement on Form S-3 that we filed with the Securities and Exchange Commission, or the SEC,
using a “shelf” registration process. The selling stockholder may resell, from time to time, in one or more offerings,
the shares of our common stock offered by this prospectus. Information about the selling stockholder may change over time. When
the selling stockholder sells shares of our common stock under this prospectus, we will, if necessary and required by law, provide
a prospectus supplement that will contain specific information about the terms of that offering. Any prospectus supplement may
also add to, update, modify or replace information contained in this prospectus. If a prospectus supplement is provided and the
description of the offering in the prospectus supplement varies from the information in this prospectus, you should rely on the
information in the prospectus supplement. You should carefully read this prospectus and the accompanying prospectus supplement,
if any, along with all of the information incorporated by reference herein and therein, before making an investment decision.
You
should rely only on the information contained or incorporated by reference in this prospectus or any applicable prospectus supplement.
We have not, and the selling stockholder has not, authorized any other person to provide you with different or additional information.
If anyone provides you with different or additional information, you should not rely on it. This prospectus is not an offer to
sell, nor is the selling stockholder seeking an offer to buy, the shares offered by this prospectus in any jurisdiction where
the offer or sale is not permitted. No offers or sales of any of the shares of our common stock are to be made in any jurisdiction
in which such an offer or sale is not permitted. You should assume that the information contained in this prospectus or in any
applicable prospectus supplement is accurate only as of the date on the front cover thereof or the date of the document incorporated
by reference, regardless of the time of delivery of this prospectus or any applicable prospectus supplement or any sales of the
shares of our common stock offered hereby or thereby.
You
should read the entire prospectus and any prospectus supplement and any related issuer free writing prospectus, as well as the
documents incorporated by reference into this prospectus or any prospectus supplement or any related issuer free writing prospectus,
before making an investment decision. Neither the delivery of this prospectus or any prospectus supplement or any issuer free
writing prospectus nor any sale made hereunder shall under any circumstances imply that the 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 incorporated by reference herein or therein
is accurate only as of the date of the applicable documents, regardless of the time of delivery of this prospectus or any sale
of securities. Our business, financial condition, results of operations and prospects may have changed since that date.
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. As used in this prospectus, unless the context otherwise indicates, the terms “we,” “our,”
“us,” or “the Company” refer to InspireMD, Inc., a Delaware corporation, and its subsidiaries taken as
a whole.
Our
Business
We
are a medical device company focusing on the development and commercialization of our proprietary MicroNet™ stent platform
technology for the treatment of complex vascular and coronary disease. A stent is an expandable “scaffold-like” device,
usually constructed of a metallic material, that is inserted into an artery to expand the inside passage and improve blood flow.
Our MicroNet, a micron mesh sleeve, is wrapped over a stent to provide embolic protection in stenting procedures.
Our
CGuard™ carotid embolic prevention system (“CGuard EPS”) combines MicroNet and a self-expandable nitinol stent
in a single device for use in carotid artery applications. Our CGuard EPS received CE mark approval in the European Union in March
2013 and was fully launched in Europe in September 2015. Subsequently, we launched CGuard EPS in Russia and certain countries
in Latin America and Asia, including India. In September 2020, we launched CGuard EPS in Brazil after receiving regulatory approval
in July 2020 and, as discussed below, on February 3, 2021 we executed a distribution agreement with Chinese partners for the purpose
of expanding our presence in China. Currently, we are seeking strategic partners for a potential launch of CGuard EPS in Japan.
On
September 8, 2020, we received approval from the U.S. Food and Drug Administration (“FDA”) of our Investigation Device
Exemption (“IDE”), thereby allowing us to proceed with a pivotal study of our CGuard™ Carotid Stent System,
CARENET-III, for prevention of stroke in patients in the United States. CARENET-lll is a prospective, multicenter, single-arm,
pivotal study to evaluate the safety and efficacy of the CGuard™ Carotid Stent System when used to treat symptomatic and
asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting. The trial will enroll approximately 315 subjects
in a maximum of 40 study sites located in the United States. Additional sites in Europe may also participate in the study, contributing
a maximum of ~50% of the total enrollees. The primary endpoint of the study will be the composite of the following: incidence
of the following major adverse events: death (all- cause mortality), all stroke, and myocardial infarction (DSMI) through 30-days
post-index procedure, based on the clinical events committee (CEC) adjudication or ipsilateral stroke from 31-365 day follow-up,
based on Clinical Events Committee (CEC) adjudication.
Additionally,
we intend to continue to invest in current and future potential product and manufacturing enhancements for CGuard EPS that are
expected to reduce cost of goods and/or provide the best-in-class performing delivery system. In furtherance of our strategy that
focuses on establishing CGuard EPS as a viable alternative to vascular surgery, we are exploring adding new delivery systems and
accessory solutions for procedural protection to our portfolio.
We
consider the addressable market for our CGuard EPS to be individuals with diagnosed, symptomatic high-grade carotid artery stenosis
(HGCS, ≥70% occlusion) for whom intervention is preferable to medical (drug) therapy. This group includes not only carotid
artery stenting patients but also individuals undergoing carotid endarterectomy, as the two approaches compete for the same patient
population. Assuming full penetration of the intervention caseload by CGuard EPS, we estimate that the addressable market for
CGuard EPS was approximately $1.0 billion in 2017 (source: Health Research International 2017 Results of Update Report on Global
Carotid Stenting Procedures and Markets by Major Geography and Addressable Markets).
Our
MGuard™ Prime™ embolic protection system (“MGuard Prime EPS”) is marketed for use in patients with acute
coronary syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions (bypass
surgery). MGuard Prime EPS combines MicroNet with a bare-metal cobalt-chromium based stent. MGuard Prime EPS received CE mark
approval in the European Union in October 2010 for improving luminal diameter and providing embolic protection. However, as a
result of a shift in industry preferences away from bare-metal stents in favor of drug-eluting (drug-coated) stents, in 2014 we
decided to curtail further development of this product in order to focus on the development of a drug-eluting stent product, MGuard
DES™. Due to limited resources, however, our efforts have been limited to testing drug-eluting stents manufactured by potential
partners for compatibility with MicroNet and seeking to incorporate MicroNet onto a drug-eluting stent manufactured by a potential
partner. The FDA has clarified that the primary mode of action for drug-eluting cardiovascular stents, which are regulated as
combination products, is that of the device component and has assigned the FDA Center for Devices and Radiological Health (CDRH)
primary responsibility for premarket review and regulation, providing some clarity about what to expect regarding the regulatory
framework related to the development of MGuard DES™.
We
also intend to develop a pipeline of other products and additional applications by leveraging our MicroNet technology to new applications
to improve peripheral vascular and neurovascular procedures, such as the treatment of the superficial femoral artery disease,
vascular disease below the knee and neurovascular stenting to seal aneurysms in the brain.
Presently,
none of our products may be sold or marketed in the United States.
Recent
Developments
Public
Offering
On
February 8, 2021, we closed an underwritten public offering of 29,032,258 units, with each such unit being comprised of one share
of our common stock, par value $0.0001 per share, and one Series G Warrant to purchase one-half of one share of our common stock.
The offering price to the public was $0.62 per unit. The Series G Warrants were immediately exercisable at a price of $0.682 per
share, subject to adjustment in certain circumstances, and expire five years from the date of issuance. We also granted the underwriter
of the offering an option to purchase an additional 4,354,838 shares of our common stock and Series G Warrants to purchase 2,177,419
shares of our common stock, which the underwriter exercised in full. In connection with the offering we granted to the underwriter
a compensation warrant to purchase up to 1,669,355 shares of our common stock with an exercise price of $0.682 per share and which
are exercisable for five years from February 3, 2021. Our net proceeds from the offering, after giving effect to the exercise
of the underwriter’s over-allotment option, were approximately $18.9 million, after deducting underwriting discounts and
commissions and payment of other expenses associated with the offering, but excluding the proceeds, if any, from the exercise
of Series G Warrants sold in the offering.
Distribution
and Purchase Agreement with Chinese Partners
On
February 3, 2021, we entered into a Distribution Agreement with three China-based partners, pursuant to which the Chinese partners
will be responsible for conducting the necessary registration trials for commercial approval of our products in China, followed
by an eight-year exclusive distribution right to sell our products in China with the term of the agreement continuing on a year-to-year
basis unless terminated. Under the Distribution Agreement, the China-based partners will be subject to minimum purchase obligations.
The Distribution Agreement may be terminated for cause upon failure to meet minimum purchase obligations, failure to obtain regulatory
approvals or for other material breaches.
In
addition, and on the same day, we entered into an investment transaction with QIDI, which included (i) a securities purchase agreement,
or SPA, pursuant to which QIDI Asia Medical Limited, a Hong Kong limited company, or QIDI, agreed to invest $900,000 in exchange
for shares of our common stock at a purchase price of $0.6708 per share, and (ii) an investor rights agreement, or IRA, whereby
QIDI was provided certain customary registration rights, including a commitment by us to file a registration statement with the
SEC on Form S-1 or Form S-3 and have such registration statement become effective not later than 150 days following the closing
of the transactions under the SPA.
The
transactions closed on February 5, 2021.
ATM
Offering
On
July 28, 2020, we entered into a Sales Agreement with A.G.P. pursuant to which we may offer and sell, from time to time, at our
option, through or to A.G.P., up to an aggregate of approximately $9,300,000 of shares of our common stock (the “ATM Facility”).
On January 11, 2021, we increased the aggregate amount of shares of our common stock that may be sold under the Sales Agreement
from $9,300,000 to $10,382,954, and, as a result, utilized and sold the maximum amount allowable under the ATM Facility, which
resulted in an aggregate amount of $10,381,958.
COVID-19
Developments
In
an effort to contain and mitigate the spread of COVID-19, which the World Health Organization, or WHO, declared to be a pandemic
on March 12, 2020, many countries have imposed unprecedented restrictions on travel, quarantines and other public health safety
measures. As of the beginning of the second quarter of 2020, we began to experience a significant COVID-19 related impact on our
financial condition and results of operations, which we primarily attribute to the postponement of CGuard EPS procedures (non-emergency
procedures), as hospitals shifted resources to patients affected by COVID-19. To our knowledge, most European countries in which
we operate are slowly reinstating elective procedures, but we do not know when the hospitals will resume to normal pre-pandemic
levels with such procedures in light of recent increases in COVID-19 cases in the territories we sell into. We anticipate that
the continuation of the pandemic and related restrictions and safety measures would likely result in continued fluctuations in
sales of our products for the upcoming periods. For more discussion on our risks related to COVID-19, please see risk factors
included under “Item 1A. Risk Factors” herein.
In
response to significant market volatility and uncertainties relating to COVID-19, the fees and salaries of our Board, management
and most of our employees were reduced in order to alleviate corporate operating expenses.
Effective
April 1, 2020, the Board approved a 50% decrease in the annual cash compensation for non-employee directors from an aggregate
amount of $154,000 to $77,000. Effective as of the same date, we reduced the annual salaries of most of our employees by 20% to
30% until further notice.
On
April 21, 2020, Marvin Slosman, our President, Chief Executive Officer and Director, and Craig Shore, our Chief Financial Officer,
Chief Administrative Officer, Secretary and Treasurer, each signed waivers reducing their monthly base salaries for the period
beginning April 1, 2020 and which, pursuant to their independent determinations, ended on June 1, 2020. Each of the salaries for
the remaining officers, directors and employees was similarly reinstated by no later than June 30, 2020.
As
a result of the reduction of those fees and salaries during the second quarter of 2020, our operating expenses were reduced by
approximately $235,000 in the second quarter of 2020.
Corporate
Information
We
were organized in the State of Delaware on February 29, 2008. Our principal executive offices are located at 4 Menorat Hamaor
St., Tel Aviv, Israel 6744832. Our telephone number is (888) 776-6804. Our website address is www.inspiremd.com. Information accessed
through our website is not incorporated into this prospectus and is not a part of this prospectus.
THE
OFFERING
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Securities
offered by the selling stockholder
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Up
to 1,341,682 shares of our common stock, par value $0.0001 per share that have been issued to the selling stockholder pursuant
to the securities purchase agreement by and between the Company and the selling stockholder, dated February 3, 2021.
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Selling
stockholder
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All
of the shares of our common stock are being offered by the selling stockholder. See “Selling Stockholder” on page
7 of this prospectus for more information on the selling stockholder.
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Use
of proceeds
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We
will not receive any proceeds from the sale of the shares in this offering. See “Use of Proceeds” beginning on
page 6 of this prospectus for additional information.
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Registration
Rights
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Under
the terms of the IRA with the selling stockholder, we have agreed to file the registration statement of which this prospectus
forms a part in order to register the resale by the selling stockholder of the shares of our common stock offered hereby.
See “Selling Stockholder” on page 7 of this prospectus for additional information.
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Plan
of Distribution
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The
selling stockholder, or its pledgees, donees, transferees, distributees, beneficiaries or other successors-in-interest, may
offer or sell the shares of our common stock offered under this prospectus from time to time through public or private transactions
at our prevailing market prices, at prices related to prevailing market prices or at privately negotiated prices. The selling
stockholder may also resell the shares of our common stock offered under this prospectus 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 9 of this prospectus for additional information on the methods of sale that may be used by the selling stockholder.
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Risk
factors
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Investing
in our common stock involves a high degree of risk. You should carefully read and consider the information beginning on page
5 of this prospectus set forth under the heading “Risk Factors” and all other information set forth in this prospectus
and the documents incorporated herein and therein by reference before deciding to invest in our common stock.
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NYSE
American symbol for common stock
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“NSPR”
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RISK
FACTORS
An
investment in our securities involves certain risks. Before investing in our securities, you should carefully consider the risk
set forth below, as well as the risks described in our most recent Annual Report on Form 10-K, any updates to those risks in our
Quarterly Reports on Form 10-Q or Current Reports on Form 8-K, together with all of the other information appearing in this prospectus
or incorporated by reference into this prospectus. The risks so described are not the only risks facing our company. Additional
risks not presently known to us or that we currently deem immaterial may also impair our business operations. Any of these risks
could materially and adversely affect our business, financial condition, results of operations and cash flows and could result
in a loss of all or part of your investment. In any case, the value of the securities offered by means of this prospectus could
decline due to any of these risks, and you may lose all or part of your investment.
The
sale of a substantial number of shares of our common stock in the public market, including resale of the shares issued to the
selling stockholder, could adversely affect the prevailing market price for our common stock.
We
are registering for resale 1,341,682 shares of our common stock that we have issued to the selling stockholder pursuant to the
SPA. 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, and the market value of our other securities. We cannot predict
if and when the selling stockholder may sell such shares in the public markets. Furthermore, in the future, we may issue additional
shares of our common stock or other equity or debt securities exercisable for, or convertible into, shares of our common stock.
Any such issuances could result in substantial dilution to our existing stockholders and could cause our stock price 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, identify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance
or results and will probably not be accurate indications of when such performance or results will 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:
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the
impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy;
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negative
clinical trial results or lengthy product delays in key markets;
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our
ability to maintain compliance with the NYSE American listing standards;
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our
ability to generate revenues from our products and obtain and maintain regulatory approvals for our products;
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our
ability to adequately protect our intellectual property;
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our
dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and
to increase production as necessary;
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the
risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology
is an attractive alternative to other procedures and products;
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market
acceptance of our products;
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our
need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or
difficult to obtain and could dilute out stockholders’ ownership interests;
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intense
competition in our industry, with competitors having substantially greater financial, technological, research and development,
regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do;
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entry
of new competitors and products and potential technological obsolescence of our products;
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inability
to carry out research, development and commercialization plans;
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loss
of a key customer or supplier;
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technical
problems with our research and products and potential product liability claims;
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product
malfunctions;
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●
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price
increases for supplies and components;
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●
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adverse
economic conditions;
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●
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insufficient
or inadequate reimbursement by governmental and other third-party payers for our products;
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●
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our
efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful;
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●
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adverse
federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions;
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●
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the
fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations,
logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability
in each jurisdiction;
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●
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the
escalation of hostilities in Israel, which could impair our ability to manufacture our products; and
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●
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loss
or retirement of key executives and research scientists.
|
The
foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein
or risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking
statements. You should review carefully the risks and uncertainties described under the heading “Item 1A. Risk Factors”
in our recently filed Annual Report on Form 10-K for a discussion of these and other risks that relate to our business and investing
in shares of our common stock. 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
We
will not receive any proceeds from the sale of shares of our common stock by the selling stockholder.
SELLING
STOCKHOLDER
Background
Regarding the Selling Stockholder
On
February 5, 2021, we issued 1,341,682 shares of our common stock to the selling stockholder in a private placement, exempt from
registration under the Securities Act of 1933, as amended, or the Securities Act, pursuant to the SPA.
Under
the terms of the SPA and the IRA, each executed concurrently with the selling stockholder, we agreed, among other things:
|
|
(i)
|
to
issue to the selling stockholder 1,341,682 shares of our common stock; and
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(ii)
|
to
file a registration statement with the SEC under the Securities Act in order to register the resale of the shares of our common
stock issued pursuant to the SPA and to have that registration statement declared effective within one hundred and fifty (150)
days of the signing of the SPA.
|
Information
About Selling Stockholder Offering
The
following table sets forth the number and percentage of shares of our common stock beneficially owned by the selling stockholder
as of March 25, 2021, taking into account number of shares that may be offered under this prospectus and the number and percentage
of our common stock beneficially owned by the selling stockholder assuming all of the shares offered under this prospectus are
sold. Beneficial ownership is determined in accordance with the rules of the SEC and includes voting or investment power with
respect to shares of our common stock. Generally, a person “beneficially owns” shares of our common stock if the person
has or shares with others the right to vote those shares or to dispose of them, or if the person has the right to acquire voting
or disposition rights within 60 days.
All
information contained in the table below and the footnotes thereto is based upon information provided to us by the selling stockholder.
The information in the table below and the footnotes thereto regarding shares of our common stock to be beneficially owned after
the offering under this prospectus assumes the sale of all shares of our common stock being offered by the selling stockholder
under this prospectus. The percentage of shares of our common stock owned prior to and after the offering under this prospectus
is based on 117,791,865 shares of our common stock outstanding as of March 25, 2021. Unless otherwise indicated in the footnotes
to this table, we believe that the selling stockholder has sole voting and investment power with respect to the shares of our
common stock indicated as beneficially owned.
Except
as described above, neither the selling stockholder nor any of its affiliates, officers, directors or principal equity holders
have held any position or office or had any other material relationship with us or our affiliates within the past three years.
As
used in this prospectus, the term “selling stockholder” includes the selling stockholder named below and any donees,
pledgees, transferees or other successors-in-interest selling shares of our common stock received after the date of this prospectus
from the selling stockholder as a gift, pledge, or other non-sale related transfer.
The
number of shares in the column “Maximum Number of Shares Offered” represents all of the shares of our common stock
that the selling stockholder may offer under this prospectus. The fourth column assumes the sale of all the shares of our common
stock offered by the selling stockholder under this prospectus and that the selling stockholder does not acquire any additional
shares of our common stock before the completion of the offering under this prospectus. However, because the selling stockholder
may sell all or some of the shares offered under this prospectus from time to time, or in another permitted manner, we cannot
assure you as to the actual number of shares of our common stock that will be sold by the selling stockholder or that will be
held by the selling stockholder after completion of any sales. The selling stockholder may sell some, all or none of the shares
of our common stock offered under this prospectus. We do not know how long the selling stockholder will hold the shares of our
common stock offered under this prospectus before selling them, and we currently have no agreements, arrangements or understandings
with the selling stockholder regarding the sale of any of the shares of our common stock.
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Ownership Before Offering
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Ownership After Offering
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Selling Stockholder
|
|
Number of shares of common stock
beneficially
owned
|
|
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Percentage of
common stock
beneficially owned
|
|
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Maximum number of
shares of common stock offered
|
|
|
Number of shares
of common stock beneficially owned
|
|
|
Percentage of
common stock beneficially owned
|
|
|
QIDI Medical Asia Limited (1)
|
|
|
1,341,682
|
|
|
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1.14
|
%
|
|
|
1,341,682
|
|
|
|
-
|
|
|
|
-
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%
|
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(1)
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Wenjing
Liu, may be deemed to share voting and investment power with respect to the shares of our common stock held by the selling
stockholder.
|
PLAN
OF DISTRIBUTION
The
selling stockholder, including its pledgees, donees, transferees, distributees, beneficiaries or other successors in interest,
may from time to time offer some or all of the shares of our common stock offered under this prospectus. We will not receive any
of the proceeds from the sale of the shares of our common stock offered under this prospectus by the selling stockholder. We will
bear all fees and expenses incident to our obligation to register the shares of our common stock offered under this prospectus.
The
selling stockholder may sell all or a portion of the shares of our common stock beneficially owned by it and offered hereby from
time to time directly or through one or more underwriters, broker-dealers or agents. If the shares of our common stock are sold
through underwriters or broker-dealers, the selling stockholder will be responsible for underwriting discounts or commissions
or agent’s commissions. The shares of our common stock may be sold on any national securities exchange or quotation service
on which the securities may be listed or quoted at the time of sale, in the over-the-counter market or in transactions otherwise
than on these exchanges or systems or in the over-the-counter market and in one or more transactions at fixed prices, at prevailing
market prices at the time of the sale, at varying prices determined at the time of sale, or at privately negotiated prices. These
sales may be effected in transactions, which may involve crosses or block transactions.
The
selling stockholder may use any one or more of the following methods when disposing of shares of our common stock or interests
therein:
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●
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ordinary
brokerage transactions and transactions in which the broker-dealer solicits purchasers;
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●
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block
trades in which the broker-dealer will attempt to sell shares of our common stock as agent, but may position and resell a
portion of the block as principal to facilitate the transaction;
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●
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purchases
by a broker-dealer as principal and resale by the broker-dealer for its account;
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●
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an
over-the-counter distribution;
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●
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an
exchange distribution in accordance with the rules of the applicable exchange;
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●
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privately
negotiated transactions;
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●
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short
sales effected after the effective date of the registration statement of which this prospectus forms a part;
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●
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through
the writing or settlement of options or other hedging transactions, whether through an options exchange or otherwise;
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●
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broker-dealers
may agree with the selling stockholder to sell a specified number of such shares at a stipulated price per share;
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●
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a
combination of any such methods of sale; or
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●
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any
other method permitted pursuant to applicable law.
|
The
selling stockholder may, from time to time, pledge or grant a security interest in some or all of the shares of our common stock
owned by it and, if it defaults in the performance of its secured obligations, the pledgees or secured parties may offer and sell
the shares of our common stock, from time to time, under this prospectus, or under an amendment to this prospectus under Rule
424(b)(3) or other applicable provision of the Securities Act amending the list of the selling stockholder to include the pledgee,
transferee, or other successors in interest as selling stockholder under this prospectus. The selling stockholder also may transfer
the shares of our common stock in other circumstances, in which case the transferees, pledgees or other successors in interest
will be the selling beneficial owners for purposes of this prospectus.
In
connection with the sale of shares of our common stock or interests therein, the selling stockholder may enter into hedging transactions
with broker-dealers or other financial institutions, which may in turn engage in short sales of shares of our common stock in
the course of hedging the positions it assumes. The selling stockholder may also sell shares of our common stock short and deliver
these securities to close out its short positions, or loan or pledge the shares of our common stock to broker-dealers that in
turn may sell these securities. The selling stockholder may also enter into option or other transactions with broker-dealers or
other financial institutions or the creation of one or more derivative securities which require the delivery to such broker-dealer
or other financial institution of shares of our common stock offered under this prospectus, which shares of our common stock such
broker-dealer or other financial institution may resell pursuant to this prospectus (as supplemented or amended to reflect such
transaction).
Broker-dealers
engaged by the selling stockholder may arrange for other broker-dealers to participate in sales. If the selling stockholder effects
certain transactions by selling shares of our common stock to or through underwriters, broker-dealers or agents, such underwriters,
broker-dealers or agents may receive commissions in the form of discounts, concessions or commissions from the selling stockholder
or commissions from purchasers of the shares of our common stock for whom they may act as agent or to whom they may sell as principal.
Such commissions will be in amounts to be negotiated, but, except as set forth in a supplement to this prospectus, in the case
of an agency transaction will not be in excess of a customary brokerage commission in compliance with applicable rules of the
Financial Industry Regulatory Authority, Inc., or FINRA; and in the case of a principal transaction a markup or markdown in compliance
with applicable FINRA rules.
The
aggregate proceeds to the selling stockholder from the sale of the shares of our common stock offered under this prospectus will
be the purchase price of the shares of common stock less discounts or commissions, if any. The selling stockholder reserves the
right to accept and, together with its agents from time to time, to reject, in whole or in part, any proposed purchase of shares
of our common stock to be made directly or through agents. We will not receive any of the proceeds from the offering under this
prospectus.
The
selling stockholder also may resell all or a portion of the shares of our common stock offered under this prospectus in open market
transactions in reliance upon Rule 144 under the Securities Act, provided that it meets the criteria and conforms to the requirements
of that rule.
The
selling stockholder and any underwriters, broker-dealers or agents that participate in the sale of the shares of our common stock
or interests therein may be deemed to be “underwriters” within the meaning of Section 2(a)(11) of the Securities Act.
Any discounts, commissions, concessions or profit they earn on any resale of the shares of our common stock may be underwriting
discounts and commissions under the Securities Act. The selling stockholder is subject to the prospectus delivery requirements
of the Securities Act.
To
the extent required pursuant to Rule 424(b) under the Securities Act, the shares of our common stock to be sold, the name of the
selling stockholder, the purchase price and public offering price, the names of any agents, dealer or underwriter, and any applicable
commissions or discounts with respect to a particular offer will be set forth in an accompanying prospectus supplement or, if
appropriate, a post-effective amendment to the registration statement that includes this prospectus.
In
order to comply with the securities laws of some states, if applicable, the shares of our common stock may be sold in these jurisdictions
only through registered or licensed brokers or dealers. In addition, in some states the shares of our common stock may not be
sold unless the shares been registered or qualified for sale or an exemption from registration or qualification requirements is
available and is complied with.
The
selling stockholder and any other person participating in a sale of shares of our common stock registered under this prospectus
will be subject to applicable provisions of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and the rules
and regulations thereunder, including, without limitation, to the extent applicable, Regulation M of the Exchange Act, which may
limit the timing of purchases and sales of any of the shares of our common stock by the selling stockholder and any other participating
person. All of the foregoing may affect the marketability of the shares of our common stock and the ability of any person or entity
to engage in market-making activities with respect to the shares of our common stock. In addition, we will make copies of this
prospectus (as it may be supplemented or amended from time to time) available to the selling stockholder for the purpose of satisfying
the prospectus delivery requirements of the Securities Act. The selling stockholder may indemnify any broker-dealer that participates
in transactions involving the sale of the shares of our common stock against certain liabilities, including liabilities arising
under the Securities Act.
LEGAL
MATTERS
The
validity of the securities offered by this prospectus will be passed upon by McDermott Will & Emery LLP, New York, New York.
EXPERTS
The
financial statements incorporated in this prospectus by reference to the Annual Report on Form 10-K for the year ended December
31, 2020 have been so incorporated in reliance on the report of Kesselman & Kesselman, an independent registered public accounting
firm and a member firm of PricewaterhouseCoopers International Limited, given on the authority of said firm as experts in auditing
and accounting.
WHERE
YOU CAN FIND MORE INFORMATION
We
are subject to the informational requirements of the Exchange Act and in accordance therewith file annual, quarterly and current
reports, proxy statements and other information with the SEC. Such reports, proxy statements and other information can be read
and copied at the SEC’s public reference facilities at 100 F Street, N.E., Washington, D.C. 20549, at prescribed rates.
Please call the SEC at 1-800-732-0330 for further information on the operation of the public reference facilities. In addition,
the SEC maintains a website that contains reports, proxy and information statements and other information regarding registrants
that file electronically with the SEC. The address of the SEC’s website is www.sec.gov.
We
make available free of charge on or through our website at www.inspire-md.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 Exchange Act as soon as reasonably practicable after we electronically file such material with or otherwise furnish it
to the SEC.
We
have filed with the SEC a registration statement under the Securities Act, relating to the securities offered under this prospectus.
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, at prescribed rates, from the SEC at the address listed above, or for free at www.sec.gov. The registration
statement and the documents referred to below under “Incorporation of Certain Information by Reference” are also available
on our website, www.inspire-md.com.
We
have not incorporated by reference into this prospectus the information on our website, and you should not consider it to be a
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 13(a), 13(c), 14 or 15(d) of the Exchange Act subsequent
to the date of this prospectus and prior to the termination of the offering:
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|
●
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Our
Annual Report on Form 10-K for the fiscal year ended December 31, 2020, filed with the SEC on March 8, 2021;
|
|
|
|
|
|
|
●
|
Our
Current Reports on Form 8-K (other than portions thereof furnished under Item 2.02 or Item 7.01 of Form 8-K and exhibits accompanying
such reports that relate to such items), filed with the SEC on the following dates: January 11, 2021, January 19, 2021, February
3, 2021, February 9, 2021, March 10, 2021 and March 17, 2021; and
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|
|
|
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|
|
●
|
The
description of our common stock, which is contained in our registration statement on Form 8-A, filed with the SEC on March
12, 2013, as supplemented by Exhibit 4.4 to our Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed
with the SEC on March 10, 2020, and as may be further updated or amended in any amendment or report filed for such purpose.
|
All
filings filed by us pursuant to the Exchange Act of 1934 after the date of the initial filing of the registration statement of
which this prospectus forms a part 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 this 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: 4 Menorat Hamaor St., Tel Aviv, Israel 6744832, Attention: Craig Shore,
Chief Financial Officer, or made by phone at (888) 776-6804. You may also access the documents incorporated by reference in this
prospectus through our website at www.inspire-md.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.
1,341,682
Shares
COMMON
STOCK
PROSPECTUS
,
2021
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
Item
14. Other Expenses of Issuance and Distribution.
The
fees and expenses payable by us in connection with this registration statement are estimated as follows:
|
SEC Registration Fee
|
|
$
|
100
|
|
|
Accounting Fees and Expenses
|
|
$
|
7,000
|
|
|
Legal Fees and Expenses
|
|
$
|
15,000
|
|
|
Printing Fees and Expenses
|
|
$
|
-
|
|
|
Transfer Agent Fees and Expenses
|
|
$
|
-
|
|
|
Miscellaneous Fees and Expenses
|
|
$
|
-
|
|
|
Total
|
|
$
|
22,100
|
|
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
amended and restated certificate of incorporation and amended and restated 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 or her actions, whether or not the General Corporation Law of the State of Delaware would permit indemnification.
Item
16. Exhibits.
|
Exhibit
No.
|
|
Description
|
|
|
|
|
|
3.1
|
|
Amended and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2015)
|
|
|
|
|
|
3.2
|
|
Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to Current Report on Form 8-K filed with the Securities and Exchange Commission on April 1, 2011)
|
|
|
|
|
|
3.3
|
|
Certificate of Designation, Preferences and Rights of Series A Preferred Stock (incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed with the Securities and Exchange Commission on October 25, 2013)
|
|
|
|
|
|
3.4
|
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on May 25, 2016)
|
|
|
|
|
|
3.5
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.5 to the Quarterly Report on Form 10-Q filed on August 9, 2016)
|
|
|
|
|
|
3.6
|
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on September 29, 2016)
|
|
|
|
|
|
3.7
|
|
Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on March 15, 2017)
|
|
|
|
|
|
3.8
|
|
Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series C Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on November 29, 2017)
|
|
|
|
|
|
3.9
|
|
Certificate of Designation of Preferences, Rights and Limitation of Series D Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on December 4, 2017)
|
|
|
|
|
|
3.10
|
|
Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on December 22, 2017)
|
|
|
|
|
|
3.11
|
|
Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on December 12, 2017)
|
|
|
|
|
|
3.12
|
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on February 7, 2018)
|
|
|
|
|
|
3.13
|
|
Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series D Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on March 1, 2018)
|
|
|
|
|
|
3.14
|
|
Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series D Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on April 3, 2018)
|
|
|
|
|
|
3.15
|
|
Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on July 5, 2018)
|
|
|
|
|
|
3.16
|
|
Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on March 28, 2019)
|
|
|
|
|
|
4.1
|
|
Form of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to Amendment No. 3 to Registration Statement on Form S-1 filed with the Securities and Exchange Commission on March 5, 2013)
|
|
|
|
|
|
4.2
|
|
Rights Agreement dated as of October 22, 2013 between InspireMD, Inc. and Action Stock Transfer Corporation, as Rights Agent, including exhibits thereto (incorporated by reference to an exhibit to the Registration Statement on Form 8-A filed with Securities and Exchange Commission on October 25, 2013)
|
|
|
|
|
|
4.3
|
|
Form of Series B Warrant Agent Agreement and Form of Series B Warrant (incorporated by reference to Exhibit 4.3 to Amendment No.3 to Registration Statement on Form S-1 filed with the Securities and Exchange Commission on March 6, 2017)
|
|
|
|
|
|
4.4
|
|
Form of Series D Warrant (incorporated by reference to Exhibit A to Exhibit 4.3 to the Company’s Registration Statement on Form S-1, Amendment No. 2, filed with the SEC on June 26, 2018 (File No. 333-225680))
|
|
|
|
|
|
4.5
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Form of Pre-Funded Warrant (incorporated by reference to Exhibit 4.4 to Amendment No. 2 to Registration Statement on Form S-1 filed with the Securities and Exchange Commission on June 1, 2020)
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4.6
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Form of Series F Warrant (incorporated by reference to Exhibit 4.5 to Amendment No. 2 to Registration Statement on Form S-1 filed with the Securities and Exchange Commission on June 1, 2020)
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4.7
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Form of Series G Warrant (incorporated by reference to Exhibit 4.5 to the Company’s Registration Statement on Form S-1, Amendment No. 1, filed with the SEC on February 3, 2021 (File No. 333-238247))
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*
Filed herewith.
Item
17. Undertakings.
The
undersigned registrant hereby undertakes:
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(a) (1)
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To
file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
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(i)
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To
include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
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(ii)
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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 Securities and
Exchange Commission pursuant to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a
20% change in the maximum aggregate offering price set forth in the “Calculation of Registration Fee” table in
the effective registration statement;
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(iii)
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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;
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provided,
however, that the undertakings set forth in paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) above do not apply if the information
required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the
Securities and Exchange 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.
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(2)
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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.
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(3)
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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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(4)
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That,
for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
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(i)
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If
the registrant is relying on Rule 430B:
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(A)
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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
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(B)
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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.
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(ii)
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If
the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance
on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after
effectiveness. 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 first use,
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 date of first use.
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(5)
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That,
for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial
distribution of the securities: The undersigned registrant undertakes that in a primary offering of securities of the undersigned
registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the
purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned
registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
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(i)
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Any
preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant
to Rule 424;
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(ii)
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Any
free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred
to by the undersigned registrant;
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(iii)
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The
portion of any other free writing prospectus relating to the offering containing material information about the undersigned
registrant or its securities provided by or on behalf of the undersigned registrant; and
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(iv)
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Any
other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
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(b)
The undersigned registrant hereby undertakes 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 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 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.
(c)
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, 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 Tel Aviv, Israel, on April 5, 2021.
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INSPIREMD,
INC.
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By:
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/s/
Marvin Slosman
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Name:
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Marvin
Slosman
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Title:
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Chief
Executive Officer
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Power
of Attorney
KNOW
ALL PERSONS BY THESE PRESENTS, that each individual whose signature appears below hereby constitutes and appoints Marvin Slosman
and Craig Shore, jointly and severally, his or her true and lawful attorneys-in-fact and agents with full powers of substitution,
for him and in his name, place and stead, in any and all capacities, to sign any and all supplements amendments (including post-effective
amendments) to this Registration Statement, and to file the same, with all exhibits thereto, and all documents in connection therewith,
with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents, and each of them, full power and
authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully
to all intents and purposes as he might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact
and agents, or their substitute or substitutes, may lawfully do or cause to be done by virtue thereof.
Pursuant
to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the
capacities and on the dates indicated.
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Signature
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Title
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Date
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/s/
Marvin Slosman
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Chief
Executive Officer and Director
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April 5, 2021
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Marvin
Slosman
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(principal
executive officer)
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/s/
Craig Shore
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Chief
Financial Officer, Chief Administrative Officer, Secretary and Treasurer
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April 5, 2021
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Craig
Shore
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(principal
financial and accounting officer)
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/s/
Paul Stuka
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Chairman
of the Board of Directors
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April 5, 2021
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Paul
Stuka
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/s/
Michael Berman
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Director
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April 5, 2021
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Michael
Berman
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/s/
Thomas J. Kester
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Director
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April 5, 2021
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Thomas
J. Kester
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/s/
Campbell Rogers, M.D.
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Director
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April 5, 2021
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Campbell
Rogers, M.D.
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/s/
Gary Roubin, M.D.
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Director
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|
April 5, 2021
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|
Gary
Roubin, M.D.
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