Filed Pursuant to Rule 424(b)(5)
Registration No. 333-223130
PROSPECTUS
SUPPLEMENT
(to
Prospectus dated February 23, 2018)
InspireMD,
Inc.
Up
to $9,300,000
Shares
of Common Stock
This
prospectus supplement and accompanying prospectus relates to the issuance and sale of up to approximately $9,300,000 of
shares of our common stock, par value $0.0001 per share, from time to time through our sales agent, A.G.P. / Alliance Global Partners,
or A.G.P. These sales, if any, will be made pursuant to a sales agreement, dated July 28, 2020, between us and A.G.P.,
which we refer to as the sales agreement.
Sales
of our common stock, if any, under this prospectus supplement and the accompanying prospectus may be made by any method permitted
by law deemed to be an “at-the-market” offering as defined in Rule 415 under the Securities Act of 1933, as amended,
which we refer to as the Securities Act, including sales made directly on the NYSE American market, on any other existing trading
market for our common stock or to or through a market maker or through an electronic communications network. If expressly authorized
by us, A.G.P. may also sell our common stock in privately negotiated transactions. A.G.P. will act as sales agent on a commercially
reasonable efforts basis, consistent with its normal trading and sales practices and applicable state and federal laws, rules
and regulations and the rules of the NYSE American market. There is no specific date on which the offering will end, there are
no minimum sale requirements and there are no arrangements to place any of the proceeds of this offering in an escrow, trust or
similar account.
A.G.P.
will be entitled to compensation at a fixed commission rate of 3.0% of the gross proceeds from the sale of our common stock pursuant
to the sales agreement. In connection with the sale of the common stock on our behalf, A.G.P. may, and will with respect to sales
effected in an “at-the-market” offering, be deemed to be an “underwriter” within the meaning of the Securities
Act, and the compensation of A.G.P. may be deemed to be underwriting commissions or discounts. We have also agreed to provide
indemnification and contribution to A.G.P. against certain civil liabilities, including liabilities under the Securities Act.
Our
common stock is quoted on the NYSE American market under the symbol “NSPR.” The last reported sale price of our common
stock on the NYSE American market on July 24, 2020 was $0.5099 per share.
Investing
in these securities involves a high degree of risk. Before buying shares of our common stock, you should carefully consider the
risk factors described in “Risk Factors” beginning on page S-7 of this prospectus supplement and in the documents
incorporated by reference into this prospectus supplement and any free writing prospectus that we have authorized for use in connection
with this offering.
Neither
the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities, or
determined if this prospectus supplement and the accompanying prospectus is accurate or complete. Any representation to the contrary
is a criminal offense.
As
of the date of this prospectus supplement, the aggregate market value of our outstanding common stock is $28,020,435, of
which $27,916,254 is held by non-affiliates. That value is based on (i) 33,357,661 shares of our common stock outstanding currently,
of which 33,233,636 shares are held by non-affiliates, and (ii) a price of $0.84 per share, the closing price of our common stock
on May 29, 2020. We have not offered any securities pursuant to General Instruction I.B.6 of Form S-3 during the 12 calendar months
prior to and including the date of this prospectus supplement.
A.G.P.
The
date of this prospectus supplement is July 28, 2020
TABLE
OF CONTENTS
ABOUT
THIS PROSPECTUS SUPPLEMENT
This
prospectus supplement and the accompanying prospectus relate to the offering of our common stock. You should rely only on the
information contained in or incorporated by reference in this prospectus supplement and the accompanying prospectus. We have not,
and A.G.P. has not, authorized anyone to provide you with different information. If anyone provides you with different or inconsistent
information, you should not rely on it. We are not, and A.G.P. is not, making an offer to sell these securities in any jurisdiction
where the offer or sale is not permitted or in which the person making that offer or solicitation is not qualified to do so or
to anyone to whom it is unlawful to make an offer or solicitation. You should assume that the information appearing in this prospectus
supplement, the accompanying prospectus, the documents incorporated by reference in this prospectus supplement and the accompanying
prospectus is accurate only as of the date of those respective documents. Our business, financial condition, results of operations
and prospects may have changed since those dates. You should read this prospectus supplement, the accompanying prospectus, the
documents incorporated by reference in this prospectus supplement and the accompanying prospectus in their entirety before making
an investment decision. You should also read and consider the information in the documents to which we have referred you in the
sections of this prospectus supplement entitled “Where You Can Find Additional Information About Us” and “Incorporation
of Certain Documents by Reference.”
This
document is in two parts. The first part is this prospectus supplement, which describes the terms of this offering and also adds
to and updates information contained in the accompanying prospectus and the documents incorporated by reference in this prospectus
supplement and the accompanying prospectus. The second part, the accompanying prospectus dated February 23, 2018, including the
documents incorporated by reference therein, provides more general information, some of which may not apply to this offering.
Generally, when we refer to this prospectus, we are referring to both parts of this document combined. To the extent there is
a conflict between the information contained in this prospectus supplement, on the one hand, and the information contained in
the accompanying prospectus or in any document incorporated by reference that was filed with the Securities and Exchange Commission,
or SEC, before the date of this prospectus supplement, on the other hand, you should rely on the information in this prospectus
supplement. If any statement in one of these documents is inconsistent with a statement in another document having a later date—for
example, a document incorporated by reference in the accompanying prospectus—the statement in the document having the later
date modifies or supersedes the earlier statement.
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 into the accompanying 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 agreement, 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 in this prospectus or the context otherwise requires, all references to “we,” “us,”
“our,” “the Company,” and “InspireMD” refer to InspireMD, Inc., a Delaware corporation.
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus supplement, the accompanying prospectus and the documents that we incorporate by reference herein, may contain forward-looking
statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking
statements, which are often characterized by the terms “may,” “believes,” “projects,” “expects,”
“plans”, “anticipates,” “plans,” “intends,” “could,” “might,”
“will,” “should,” “approximately” or, in each case, their negative or other variations or
comparable terminology, do not reflect historical facts but instead are based on our current assumptions and predictions regarding
future events, such as business and financial performance. Specific forward-looking statements contained in this prospectus supplement
(including such documents incorporated by reference herein) include, but are not limited to, projections of earnings, revenue
or other financial items, any statements regarding the plans and objectives of management for future operations, any statements
concerning proposed new products or services, any statements regarding future economic conditions or performance, any statements
regarding expected benefits from any transactions and any statements of assumptions underlying any of the foregoing.
You
should read this prospectus supplement, the accompanying prospectus and the documents that we incorporate by reference herein
and therein and have filed as exhibits to the registration statement, of which this prospectus supplement and the accompanying
prospectus is part, completely and with the understanding that our actual future results may be materially different from what
we concurrently expect. You should assume that the information appearing in this prospectus supplement, the accompanying prospectus
and any document incorporated herein and therein by reference is accurate as of its date only. Because the risk factors referred
to in this prospectus supplement and the accompanying prospectus could cause actual results or outcomes to differ materially from
those expressed in any forward-looking statements made by us or on our behalf, you should not place undue reliance on any forward-looking
statements. These risk factors are discussed in “Risk Factors” beginning on page S-7 of this prospectus supplement,
in our Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 10, 2020, in our Quarterly
Report on Form 10-Q for the quarter ended March 31, 2020, filed with the SEC on May 11, 2020, and in subsequent periodic filings
we make with the SEC.
Further,
any forward-looking statement speaks only as of the date on which it is made, and we undertake no obligation to update any forward-looking
statement to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated
events. New factors emerge from time to time, and it is not possible for us to predict which factors will arise. In addition,
we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause
actual results to differ materially from those contained in any forward-looking statements. We qualify all of the information
presented in this prospectus supplement, the accompanying prospectus and any document incorporated herein and therein by reference,
and particularly our forward-looking statements, by these cautionary statements.
PROSPECTUS
SUPPLEMENT SUMMARY
This
summary highlights information contained elsewhere or incorporated by reference in this prospectus supplement and the accompanying
prospectus. This summary does not contain all of the information that you should consider before deciding to invest in our common
stock. You should read this entire prospectus supplement and the accompanying prospectus carefully, including the “Risk
Factors” section contained in this prospectus supplement and the accompanying prospectus, our consolidated financial statements
and the related notes thereto and the other documents incorporated by reference in this prospectus supplement and in the accompanying
prospectus.
Company
Overview
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, or 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
we launched its release on a limited basis in October 2014. In January 2015, a new version of CGuard, with a rapid exchange delivery
system, received CE mark approval in Europe and in September 2015, we announced the full market launch of CGuard EPS in Europe.
Subsequently, we launched CGuard EPS in Russia and certain countries in Latin America and Asia, including India. We have
received approval to launch CGuard EPS in Brazil, and we are seeking strategic partners for the potential launch of CGuard
EPS in Japan and China.
In
April 2017, we had a pre-investigational device exemption, or IDE, submission meeting with the U.S. Food and Drug Administration,
or FDA, regarding CGuard EPS where we presented materials, including our draft synopsis for a clinical trial design, which we
believed supported a formal IDE submission for the approval of a human clinical trial in the United States. The FDA agreed to
our pre-clinical test plan and clinical trial design. On July 26, 2019, we submitted an IDE application for CGuard EPS. In connection
with such application, on August 23, 2019, we received a request for additional information from the FDA in support of our application.
We continue to work closely with the FDA to address the FDA’s information and testing requests in support of our pending
IDE application, as the initiation of clinical testing in the U.S. is our current highest priority. Following the resolution of
all comments from the FDA, we re-submitted the IDE application in May 2020, as IDE approval by the FDA would be a critical step
toward the commencement of a human clinical trial using CGuard EPS in the United States.
Additionally,
we intend to continue to evaluate 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 a procedural protection device to our portfolio.
We cannot give any assurance that we will receive sufficient (or any) proceeds from future financings or the timing of such financings,
if ever, for potential product enhancements and manufacturing enhancements. In addition, such additional financings may be costly
or difficult to complete. Even if we receive sufficient proceeds from future financings, there is no assurance that we will be
able to timely apply for CE mark approval following our receipt of such proceeds. We believe these improvements may allow us to
reduce our cost of goods and increase penetration in our existing geographies and better position us for entry into new markets.
Our
Products and Market
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 an 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, or 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.
Our
Growth Strategy
Our
primary business objective is to utilize our proprietary MicroNet technology and products to become the industry standard for
treatment of stroke, complex vascular and coronary disease and to provide a superior solution to the common acute problems caused
by current stenting procedures, such as restenosis, embolic showers and late thrombosis. We are pursuing the following business
strategies to achieve this objective.
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Widen
the adoption of CGuard EPS. We are seeking to expand the population of CGuard EPS patients in those countries in which
CGuard EPS is commercially available. In particular, our focus is on establishing CGuard EPS as a viable alternative (in appropriate
cases) to conventional carotid stents and vascular surgery within the applicable medical communities. We intend to accomplish
this goal by continuing to publish and present our clinical data and support investigator-initiated clinical registries. We
have partnered and will continue to seek out partnerships with organizations focused on the treatment of stroke. We will also
continue to engage advisory boards and to develop a network of key opinion leaders to assist us in our efforts to widen the
adoption of CGuard EPS.
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Grow
our presence in existing and new markets for CGuard EPS. We have launched CGuard EPS in most European and Latin American
countries through a comprehensive distributor sales organizations network. We are continuing to focus on larger growing markets
through this network by supporting our distributors with comprehensive marketing and clinical education programs. In November
2018, we obtained approval for reimbursement and commercial sale for CGuard EPS in Australia and immediately launched the
product there, and in July 2020, we obtained registration for CGuard EPS in Brazil, clearing it for sale and distribution
there. We are also pursuing additional product registrations and distribution contracts with local distributors in other countries
in Europe, Asia and Latin America.
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Continue
to leverage our MicroNet technology to develop additional applications for interventional cardiologists and vascular surgeons.
In addition to the applications described above, we believe that we will eventually be able to utilize our proprietary
MicroNet technology to address imminent market needs for new product innovations to significantly improve patients’
care. We continue to broadly develop and protect intellectual property related to our mesh technology. Examples of some areas
include peripheral vascular disease, neurovascular disease, renal artery disease and bifurcation disease.
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Establish
relationships with collaborative and development partners to fully develop and market our existing and future products. We
are seeking strategic partners for collaborative research, development, marketing, distribution, or other agreements, which
could assist with our development and commercialization efforts for CGuard EPS and MGuard DES, and other potential products
that are based on our MicroNet technology.
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Continue
to protect and expand our portfolio of patents. Our MicroNet technology and the use of patents to protect it are critical
to our success. We own numerous patents for our MicroNet technology. Nineteen patent applications and patents are pending
or in force (fifteen of which are issued patents) in the United States, some of which have corresponding patent applications
and/or issued patents in Canada, China, Europe, Israel, India, and South Africa. We believe these patents and patent applications
collectively cover all of our existing products and may be useful for protecting our future technological developments. We
intend to aggressively continue patenting new technology, and to actively pursue any infringement covered by any of our patents.
We believe that our patents, and patent applications once allowed, are important for maintaining the competitive differentiation
of our products and maximizing our return on research and development investments.
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Resume
development and successfully commercialize MGuard DES. While we have limited the focus of product development to our carotid
products, if we resume development of our coronary products, we plan to evaluate opportunities to further develop MGuard DES.
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Recent
Developments
Public
Offering
On
June 5, 2020, we closed an underwritten public offering of (i) 7,635,800 units, which we refer to as the Units, with each Unit
being comprised of one share of the Company’s common stock, par value $0.0001 per share, and one Series F Warrant to purchase
one share of common stock, and (ii) 14,586,400 pre-funded units, which we refer to the Pre-Funded Units, with each Pre-Funded
Unit being comprised of one pre-funded warrant, or a Pre-Funded Warrant, to purchase one share of common stock and one Series
F Warrant. In connection with this public offering, A.G.P., as the underwriter, exercised the option practically in full, for
3,333,300 shares of common stock and 3,333,300 Series F Warrants. The offering price to the public was $0.45 per Unit and $0.449
per Pre-Funded Unit. The net proceeds to the Company from the offering and the exercise of the underwriter’s over-allotment
option were approximately $10.7 million, after deducting underwriting discounts and commissions and payment of other estimated
expenses associated with the offering, but excluding the proceeds, if any, from the exercise of Series F Warrants and the Pre-Funded
Warrants sold in the offering.
Registration
Clearance for CGuard™ MicroNet® in Brazil
On
July 23, 2020, we announced that we obtained registration from the Brazilian registration authority, Agéncia Nacional de
Vigiláncia Sanitária (ANVISA), for our CGuard MicroNet covered stent, clearing it for sale and distribution in Brazil.
New
Trial Results for CGuard EPS
On
June 10, 2020, we reported the publication of the results of our PARADIGM trial in the EuroIntervention journal. In that
trial, 101 unselected consecutive real-life patients were treated with our CGuard MicroNET covered stent for carotid stenosis
and were monitored for postprocedural neurologic events for a period of 12 months. The results displayed sustained protection
against any such neurologic events. At 30 days, only one adverse event occurred (a minor transient stroke with no other strokes,
myocardial infarctions, or deaths). Furthermore, those study results showed that no strokes occurred between 30 days and twelve
months.
On
June 25, 2020, we reported the results from an investigator-initiated SIBERIA randomized clinical trial of our CGuard EPS, which
evaluated 30-day silent brain infarcts associated with the use of the Acculink™ conventional open-cell nitinol stent vs.
our CGuard Micronet-covered stent. Those results displayed that CGuard had a statistically significant (greater than three-fold)
reduction in the procedure-generated mean cerebral lesion volume relative to Acculink. At 30 days, there were zero new cerebral
lessons in the CGuard arm, compared to six in the Acculink arm, also statistically significant.
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. We did not experience a significant COVID-19 related impact on our financial condition and results of operations in
the first quarter 2020. However, procedures utilizing CGuard EPS, which are generally scheduled or non-emergency procedures,
have mostly been postponed as hospitals shift 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. We anticipate that the continuation of the pandemic and related restrictions and safety measures
may result in a significant decline in sales of our products for the upcoming periods.
In
response to significant market volatility and uncertainties relating to COVID-19 and in order to alleviate corporate operating
expenses, our board of directors, or Board, and management took voluntary reductions of compensation, and the salaries of most
of our employees were also reduced.
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.
On
April 21, 2020, Marvin Slosman, our President, Chief Executive Officer and director, signed a waiver reducing his monthly base
salary from $33,333 to $16,666 for the period beginning April 1, 2020 and ending on such date as Mr. Slosman was to determine.
Craig Shore, our Chief Financial Officer, Chief Administrative Officer, Secretary and Treasurer, also signed a waiver reducing
his monthly base salary from New Israeli Shekels, or NIS, 80,125 to NIS 40,063 for the period beginning April 1, 2020 and
ending on such date as Mr. Shore was to determine.
Effective
April 1, 2020, we reduced the annual salaries of most of our employees by 20% to 30% until further notice.
Based
on a determination made by each of Mr. Slosman and Mr. Shore on June 10, 2020, following the closing of our underwritten public
offering in June 2020, as described above, Mr. Slosman’s and Mr. Shore’s monthly base salaries were restored, to $33,333
and NIS 80,125, respectively, effective as of June 1, 2020.
Each
of the salaries for the remaining officers, directors and employees was similarly reinstated by no later than June 30, 2020.
Release
from Former Underwriter
The
terms of our engagement of the underwriter for our September 2019 financing contained a purported 12 month right of first refusal
in favor of such underwriter with respect to future financings. Due to, among other things, difficulties in the relationship
with that prior underwriter and our need to raise additional funds to finance our ongoing operations, we engaged A.G.P. in May
2020 as underwriter for our June 2020 public offering, and again in July 2020 for the current offering.
On
July 28, 2020, we entered into a settlement agreement and release with that prior underwriter, under which it provided us a final,
unconditional release from any further obligations arising out of or related to the engagement agreements, underwriting agreements
and placement agency agreements which we had been party to with it and with respect to any services which it had provided to us.
We, in turn, provided the prior underwriter a final, unconditional release from any further obligations arising out of or related
to the prior agreements and services.
As
consideration for the final release provided to us, we will pay to the prior underwriter $400,000 in cash and reduce, to $0.495,
the exercise price per share of warrants to purchase 274,029 shares of our common stock that had been issued by us to the prior
underwriter in various offerings that took place between March 2018 and September 2019. That reduced exercise price represents
the exercise price for the Series F Warrants that we issued in our June 2020 public offering. The warrants that will be repriced
had existing exercise prices per share ranging from $187.50 to $2.25 and a weighted average exercise price per share of $7.32.
All other terms of those warrants will remain unchanged.
NYSE
American Deficiency
On
August 7, 2019, we received a notification from the NYSE American that we do not meet the continued listing standards of the NYSE
American as set forth in Part 10 of the NYSE American Company Guide, or the Company Guide. Specifically, we are not in compliance
with Section 1003(a)(iii) of the Company Guide because we reported stockholders’ equity of less than $6 million as of June
30, 2019, and net losses in our five most recent fiscal years ended December 31, 2018. As a result, we became subject to the procedures
and requirements of Section 1009 of the Company Guide.
On
October 11, 2019, the NYSE American accepted our plan to regain compliance with Section 1003(a)(iii) of the Company Guide by August
7, 2020. We are subject to periodic review during the period covered by the compliance plan. Failure to make progress consistent
with the plan or to regain compliance with the continued listing standards by the end of the plan period could result in our common
stock being delisted from the NYSE American.
As a result of our receipt of approximately
$10.7 million of net proceeds from our capital raise in our June 2020 public offering, as well as approximately $1.5 million of
additional funds from subsequent exercises of warrants and pre-funded warrants sold in that offering, and purchase options issued
previously, we believe that we have sufficient stockholders’ equity to regain compliance with Section 1003(a)(iii) of the
Company Guide by August 7, 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.inspire-md.com. Information
accessed through our website is not incorporated into this prospectus supplement or the accompanying prospectus and is not a part
of this prospectus supplement or the accompanying prospectus.
The
Offering
Common
stock offered by us pursuant to this prospectus supplement
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Shares
of common stock, par value $0.0001 per share, for an aggregate offering of up to approximately $9,300,000.
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Common stock to be outstanding
following the offering
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Up to 51,264,093
shares, assuming the sale of the maximum aggregate amount of approximately $9,300,000
of shares of our common stock at an assumed offering price of $0.5099 per share, which is the last reported sale price for
our common stock as reported on the NYSE American on July 24, 2020. The actual number
of shares to be sold in the offering is not known currently and will furthermore vary depending on the sales prices in the
offering.
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Manner
of offering
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“At-the-market
offering” that may be made from time to time on the NYSE American or other market for our common stock in the United
States through our agent, A.G.P. A.G.P. will make all sales using commercially reasonable efforts consistent with its
normal trading and sales practices, on mutually agreeable terms between the sales agent and us. See “Plan of Distribution.”
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Use
of proceeds
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We
plan to use the net proceeds of this offering for research and development, sales and marketing, working capital and other
general corporate purposes, and any other purposes that may be stated in any future prospectus supplement. See “Use
of Proceeds.”
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Risk
factors
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See
“Risk Factors” beginning on page S-7 and the other information included in, or incorporated by reference into,
this prospectus supplement for a discussion of certain factors you should carefully consider before deciding to invest
in shares of our common stock.
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NYSE
American symbol for common stock
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Our
common stock is traded on the NYSE American market under the symbol “NSPR”.
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The
number of shares of common stock to be outstanding immediately after this offering is based on 33,358,994 shares of common stock
outstanding as of June 30, 2020. The number of shares outstanding as of June 30, 2020 excludes:
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26,705,502
shares of common stock issuable upon exercise of outstanding warrants, with an exercise price ranging from $0.495 to $8,750
per share and having a weighted average exercise price of $1.89 per share;
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2,220,552
shares of common stock issuable upon conversion of the outstanding Series B Convertible Preferred Stock, or Series B Preferred
Stock (including the payment of the cumulative dividends accrued on the Series B Preferred Stock in an aggregate of 951,665
shares of common stock but excluding additional shares of common stock that we will be required to issue to the holders of
our Series B Preferred Stock upon conversion of shares of our Series B Preferred Stock as a result of the full ratchet anti-dilution
price protection in the certificate of designation for the Series B Preferred Stock because the effective assumed public offering
price of common stock in this offering is lower than $0.45 per share), at the conversion price of $0.45 per share and the
stated value per share of $33.00;
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33,322
shares of common stock issuable upon conversion of the outstanding Series C Convertible Preferred Stock, or Series C Preferred
Stock (excluding additional shares of common stock that we will be required to issue to the holders of our Series C Preferred
Stock as a result of the full ratchet anti-dilution price protection in the certificate of designation for the Series C Preferred
Stock because the effective assumed public offering price of common stock in this offering is lower than $0.45 per share)
at the conversion price of $0.45 per share and the stated value per share of $6.40;
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60,928
shares of common stock issuable upon the exercise of outstanding options, with exercise prices ranging from $0.001 to $3,675,000
and having a weighted average exercise price of $67,686 per share;
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182,381
shares of common stock issuable upon the exercise of Restricted Stock Units outside our 2013 Long-Term Incentive Plan;
and
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|
|
|
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●
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483,491 shares
of common stock available for future issuance under our 2013 Long-Term Incentive Plan.
|
RISK
FACTORS
An
investment in our common stock involves certain risks, which should be carefully considered by prospective investors before investing.
You should consider carefully the risk factors discussed below and those contained in the section entitled “Risk Factors”
in the prospectus, in our Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on March 10, 2020,
and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the SEC on May 11, 2020, which are each
incorporated herein by reference in their entirety, as well as any amendment or update to our risk factors reflected in subsequent
filings with the SEC. If any of the risks or uncertainties described in our SEC filings actually occurs, our business, financial
condition, results of operations or cash flow could be materially and adversely affected. This could cause the trading price of
our common stock to decline, resulting in a loss of all or part of your investment. The risks and uncertainties we have described
are not the only ones facing our company. Additional risks and uncertainties not presently known to us or that we currently deem
immaterial may also affect our business operations.
Risks
Relate to Our Common Stock, Preferred Stock and Warrants, and this Offering
The
common stock offered under this prospectus supplement and the accompanying prospectus may be sold in “at-the-market”
offerings, and investors who buy shares at different times will likely pay different prices.
Investors
who purchase shares under this prospectus supplement and the accompanying prospectus at different times will likely pay different
prices, and so may experience different outcomes in their investment results. We will have discretion, subject to market demand,
to vary the timing, prices, and numbers of shares sold, and there is no minimum or maximum sales price. Investors may experience
declines in the value of their shares as a result of share sales made at prices lower than the prices they paid.
We
have broad discretion in the use of the net proceeds of this offering and may not use them effectively.
We
intend to use the net proceeds from this offering for research and development, sales and marketing, working capital and other
general corporate purposes, and any other purposes that may be stated in any prospectus supplement. However, our management will
have broad discretion in the application of the net proceeds from this offering and could spend the proceeds in ways that do not
improve our results of operations or enhance the value of our common stock. The failure by management to apply these funds effectively
could result in financial losses that could have a material adverse effect on our business, cause the price of our common stock
to decline and delay the further development and commercialization of our products.
The
actual number of shares we will issue under the sales agreement with A.G.P., at any one time or in total, and the aggregate
proceeds that we receive as a result of those issuances, are uncertain.
Subject
to certain limitations in the sales agreement with A.G.P. and in compliance with applicable law, we have the discretion to deliver
placement notices to A.G.P. at any time throughout the term of the sales agreement. The number of shares that are sold to A.G.P.
after delivering a placement notice, and the aggregate proceeds that we realize therefrom, will fluctuate based on the
market price of our common stock during the sales period and limits we set with A.G.P.
The
market prices of our common stock and our publicly traded warrants are subject to fluctuation and have been and may continue to
be volatile, which could result in substantial losses for investors.
The
market prices of our common stock and our Series A Warrants and Series B Warrants have been and are likely to continue to be highly
volatile and could fluctuate widely in response to various factors, many of which are beyond our control, including the following:
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technological
innovations or new products and services by us or our competitors;
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additions
or departures of key personnel;
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our
ability to execute our business plan;
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operating
results that fall below expectations;
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loss
of any strategic relationship;
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●
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industry
developments;
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●
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economic,
political and other external factors; and
|
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●
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period-to-period
fluctuations in our financial results.
|
In
addition, the securities markets have from time to time experienced significant price and volume fluctuations that are unrelated
to the operating performance of particular companies. Moreover, on March 12, 2020, the WHO declared COVID-19 to be a pandemic,
and the COVID-19 pandemic has resulted in significant financial market volatility and uncertainty, which has persisted up through
the current date. A continuation or worsening of the levels of market disruption and volatility seen in the recent past could
have an adverse effect on our ability to access capital, on our business, results of operations and financial condition, and on
the market price of our common stock.
Our
common stock could be delisted from the NYSE American if we fail to regain compliance with the NYSE American’s stockholders’
equity continued listing standards. Our ability to publicly or privately sell equity securities and the liquidity of our common
stock could be adversely affected if we are delisted from the NYSE American.
On
August 7, 2019, we received a notice indicating that we do not meet certain of the NYSE American’s continued listing standards
as set forth in Part 10 of the Company Guide. Specifically, we were not in compliance with Section 1003(a)(iii) of the Company
Guide because we reported stockholders’ equity of less than $6 million as of June 30, 2019, and had net losses in our five
most recent fiscal years ended December 31, 2018. As a result, we had become subject to the procedures and requirements of Section
1009 of the Company Guide. On August 25, 2019, we submitted a plan of compliance to NYSE Regulation, addressing how we intend
to regain compliance with Section 1003(a)(iii) of the Company Guide by August 7, 2020, and on October 11, 2019, NYSE American
accepted our plan. We are subject to periodic review during the period covered by the compliance plan.
If
we do not regain compliance by August 7, 2020, or fail to maintain our compliance with Section 1003(a)(iii) of the Company Guide
following August 7, 2020, or if we do not maintain our progress consistent with the plan during the applicable plan period, the
NYSE American will initiate delisting proceedings. As a result of our receipt of approximately $10.7 million of net proceeds from
our capital raise in our June 2020 public offering, as well as approximately $1.5 million of additional funds from subsequent
exercises of warrants and pre-funded warrants sold in that offering, and purchase options issued previously, we believe
that we have sufficient stockholders’ equity to regain compliance with Section 1003(a)(iii) of the Company Guide by August
7, 2020. Nevertheless, we will be subject to ongoing review for compliance with NYSE American requirements, and there can be no
assurance that we will continue to remain in compliance with this standard.
Delisting
from NYSE American would adversely affect our ability to raise additional financing through the public or private sale of equity
securities, would significantly affect the ability of investors to trade our securities and would negatively affect the value
and liquidity of our common stock. Delisting could also have additional negative ramifications, including the potential loss of
confidence by employees, the loss of institutional investor interest and fewer business development opportunities.
A
low trading price could lead the NYSE American to take actions toward delisting our common stock, including immediately suspending
trading in our common stock.
On
January 7, 2019, we received notification from the NYSE American that our shares of common stock have been selling for a low price
per share for a substantial period of time. Pursuant to Section 1003(f)(v) of the Company Guide, the NYSE American could take
action to delist our common stock in the event that our common stock trades at levels viewed as abnormally low for a substantial
period of time. NYSE American advised us that if our common stock trades below $0.20 on a 30 trading day average, then it will
be considered non-compliant with NYSE American’s low selling price requirement. On March 29, 2019, we effected a 1-for-50
reverse stock split of our common stock.
Although
on July 8, 2019, we received notice from NYSE American that we have resolved the continued listing deficiency with respect to
low selling price pursuant to Section 1003(f)(v) of the Company Guide, in accordance with Section 1009(h) of the Company Guide,
if we are again determined to be below any of the continued listing standards within 12 months of July 8, 2019, NYSE American
will examine the relationship between the two incidents of noncompliance and re-evaluate our method of financial recovery from
the first incident. NYSE Regulation will then take the appropriate action, which depending on the circumstances, may include truncating
the compliance procedures described in Section 1009 of the Company Guide or immediately initiating delisting proceedings. If in
the future we fall below the continued listing criterion of a minimum average share price of $0.20 over a 30-day trading period,
our common stock will be subject to immediate review by NYSE American. There can be no assurance that the market price of our
common stock will remain above the levels viewed as abnormally low for a substantial period of time. In any event, other factors
unrelated to the number of shares of our common stock outstanding, such as negative financial or operational results, could adversely
affect the market price of our common stock, causing it to fall below the level viewed as a low selling price for a substantial
period of time, and lead the NYSE American to immediately suspend trading in our common stock.
In
addition, the NYSE American has advised us that its policy is to immediately suspend trading in shares of, and commence delisting
procedures with respect to, a listed company if the market price of its shares falls below $0.06 per share at any time during
the trading day.
If
you purchase our securities sold in this offering you may experience immediate dilution in your investment as a result of this
offering.
Because
the price per share of common stock being offered in this offering may be substantially higher than the net tangible book value
per share of our common stock, you may experience substantial dilution to the extent of the difference between the effective offering
price per share of common stock you pay in this offering and the net tangible book value per share of our common stock immediately
after this offering. Our net tangible book value as of March 31, 2020, was approximately $3.5 million, or $0.81 per share of common
stock. Net tangible book value per share is equal to our total tangible assets minus total liabilities, all divided by the number
of shares of common stock outstanding. See “Dilution” beginning on page S-13 below for a more detailed discussion
of the dilution you may incur if you participate in this offering.
Furthermore,
the anti-dilution provisions of our Series B and C Preferred Stock may result in further dilution of your investment (see “Risk
Factors — Risks Related Our Common Stock, Preferred Stock and Warrants, and this Offering —If the effective
price per share of common stock being offered…”).
If
the effective price per share of common stock being offered in this offering is less than the respective current conversion price
of our Series B or Series C Preferred Stock, we will be required to issue additional shares of common stock, as applicable, to
the holders of the preferred stock, which will be dilutive to all of our other stockholders, including new investors in this offering.
The
respective certificate of designation for our Series B Preferred Stock and Series C Preferred Stock contains anti-dilution provisions,
which provisions require the lowering of the applicable conversion price, as then in effect, to the purchase price of equity or
equity-linked securities issued in subsequent offerings. In accordance with this anti-dilution price protection, because the effective
common stock purchase price in each of our March 2018 public offering, April 2018 public offering, July 2018 public offering,
April 2019 public offering, September 2019 public offering and June 2020 public offering, was below the then current Series B
Preferred Stock and the Series C Preferred Stock conversion price, we reduced the Series B Preferred Stock and the Series C Preferred
Stock conversion price upon pricing of each such public offering. As a result of these provisions, if the effective price per
share of common stock being offered in this offering is less than the respective current conversion price of our Series B or Series
C Preferred Stock, each of these conversion prices shall be reduced to the effective price per share of common stock being offered
in this offering. This reduction in the conversion prices will result in a greater number of shares of common stock being issuable
upon conversion of the Series B Preferred Stock or Series C Preferred Stock for no additional consideration, causing greater dilution
to our stockholders and investors in this offering. In addition, should we issue any securities following this offering at an
effective common stock purchase price that is less than the then effective conversion price of our Series B Preferred Stock or
Series C Preferred Stock, we will be required to further reduce the conversion prices of our Series B Preferred Stock and Series
C Preferred Stock, which will result in a greater dilutive effect on our stockholders. Furthermore, as there is no floor price
on the conversion price, we cannot determine the total number of shares issuable upon conversion. As such, it is possible that
we may not have a sufficient number of authorized and available shares to satisfy the conversion of the Series B Preferred Stock
or the Series C Preferred Stock if we enter into a future transaction that reduces the applicable conversion price. The foregoing
features will increase the number of shares of common stock issuable upon conversion of the Series B Preferred Stock or Series
C Preferred Stock for no additional consideration, assuming that the effective offering price of our common stock in a subsequent
financing is lower than the conversion price of these securities then in effect, and will result in a greater dilutive effect
on our stockholders.
Purchasers
in this offering may experience additional dilution of their investment in the future.
We
will need additional capital to fund our future operational plans but cannot assure you that we will be able to obtain sufficient
capital from this offering or from other potential sources of financing. As part of any future financing, we
are generally not restricted from issuing additional securities, including shares of common stock, securities that are convertible
into or exchangeable for, or that represent the right to receive, common stock or substantially similar securities. In particular,
we may conduct one or more additional offerings simultaneously with, or following, this offering, subject to our seeking a waiver
of the lock-up provisions imposed as part of our prior June 2020 offering. The issuance of securities in these or any other offerings
may cause further dilution to our stockholders, including investors in this offering. In order to raise additional capital, such
securities may be at prices that are not the same as the price per share in this offering. We cannot assure you that we will be
able to sell shares or other securities in any other offering at a price per share that is equal to or greater than the price
per share paid by investors in this offering, and investors purchasing shares or other securities in the future could have rights
superior to existing stockholders, including investors who purchase securities in this offering. The price per share at which
we sell additional shares of our common stock or securities convertible into common stock in future transactions may be higher
or lower than the price per share in this offering. The exercise of outstanding stock options and the vesting of outstanding restricted
stock units may also result in further dilution of your investment.
Offers
or availability for sale of a substantial number of shares of our common stock may cause the price of our publicly traded securities
to decline.
Sales
of a significant number of shares of our common stock or our warrants in the public market could harm the market prices of our
common stock or warrants and make it more difficult for us to raise funds through future offerings of common stock or warrants.
Our stockholders and the holders of our options and warrants may sell substantial amounts of our common stock or our publicly
traded warrants in the public market. In addition, we will be required to issue additional shares of common stock to the holders
of our Series B Preferred Stock upon conversion of shares of our Series B Preferred Stock and the payment of the dividends thereunder
in common stock and to the holders of our Series C Preferred Stock upon conversion of such shares of our Series C Preferred Stock,
as a result of the full ratchet anti-dilution price protection in the respective certificate of designation for the Series B Preferred
Stock and the Series C Preferred Stock, if the effective common stock purchase price in a subsequent offering is less than the
respective then-current conversion price of the Series B Preferred Stock or the Series C Preferred Stock, which in turn will increase
the number of shares of common stock available for sale. See “Risk Factors — Risks Related to Our Common Stock,
Preferred Stock and Warrants and this Offering — If the effective price per share of common stock being offered…”
In
addition, the fact that our stockholders, option holders and warrant holders can sell substantial amounts of our common stock
or our publicly traded warrants in the public market, whether or not sales have occurred or are occurring, could make it more
difficult for us to raise additional financing through the sale of equity or equity-related securities in the future at a time
and price that we deem reasonable or appropriate, or at all.
We
do not expect to pay dividends in the future. As a result, any return on investment may be limited to the value of our common
stock.
We
do not anticipate paying cash dividends on our common stock in the foreseeable future. The payment of dividends on our common
stock will depend on our earnings, financial condition and other business and economic factors as our board of directors may consider
relevant. If we do not pay dividends, our common stock may be less valuable because a return on an investment in our common stock
will only occur if our stock price appreciates.
The
Series B Preferred Stock provides for the payment of dividends in cash or in shares of our common stock, and we may not be permitted
to pay such dividends in cash, which will require us to have shares of common stock available to pay the dividends.
Each
share of the Series B Preferred Stock is entitled to receive cumulative dividends at the rate per share of 15% per annum of the
stated value per share, until the fifth anniversary of the date of issuance of the Series B Preferred Stock, which is July 7,
2021. The dividends are payable, at our discretion, in cash, out of any funds legally available for such purpose, or in pay-in-kind
shares of common stock calculated based on the conversion price, subject to adjustment as provided in the certificate of designation
for the Series B Preferred Stock. The conversion price is subject to reduction if in the future we issue securities for less than
the conversion price of our Series B Preferred Stock, as then in effect. As there is no floor price on the conversion price, we
cannot determine the total number of shares issuable upon conversion or in connection with the dividend. It is possible that we
will not have a sufficient number of available shares to pay the dividend in common stock, which would require the payment of
the dividend in cash. We will not be permitted to pay the dividend in cash unless we are legally permitted to do so under Delaware
law, which requires cash to be available from surplus or net profits, which may not be available at the time payment is due. In
light of our recurring losses and negative cash flows from operating activities, we do not expect to have cash available to pay
the dividends on our Series B Preferred Stock or to be permitted to make such payments under Delaware law, and will be relying
on having available shares of common stock to pay such dividends, which will result in dilution to our stockholders. If we do
not have such available shares, we may not be able to satisfy our dividend obligations.
CAPITALIZATION
The
following table summarizes our cash and cash equivalents, certain other items from our historical consolidated balance sheet,
and capitalization as of March 31, 2020:
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on
an actual basis;
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on
a pro forma basis, giving effect to: (i) the underwritten public offering of an aggregate of 25,555,500 shares of our common
stock or common stock equivalents (pre-funded warrants to purchase common stock), including shares of common stock issued
upon exercise of the underwriter’s over-allotment option, at $0.45 per share, which offering closed on June 4, 2020;
(ii) the exercise of 14,586,400 pre-funded warrants following that June 2020 offering; (iii) the exercise of 2,866,600 Series
F Warrants following the closing of that June 2020 offering; (iv) the reduction of the conversion price of the Series B and
Series C Preferred Stock to $0.45 per share, effective as of June 2, 2020, pursuant to the full ratchet anti-dilution price
protection in the respective certificates of designation for those series of preferred stock, resulting in 1,948,699 additional
shares of common stock becoming issuable upon conversion of those series of preferred stock, which was also triggered by that
June 2020 offering; and (v) the exercise of 1,976 of the purchase options that we issued to Dawson James Securities, Inc.,
or Dawson James, the placement agent for our July 2016 public offering, which exercise occurred following our June 2020 offering;
and
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●
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on
a pro forma as adjusted basis, giving effect to the sale
by us of 18,249,496 shares of common stock in this offering at an assumed public offering price of $0.5099 per share,
the last reported sale price for our common stock as reported on the NYSE American on July 24, 2020, after deducting the estimated
commissions at the fixed commission rate of 3.0%, as well as estimated offering expenses.
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The
as adjusted information below is illustrative only and our capitalization following the completion of this offering is subject
to various adjustments. You should read this table together with “Management’s Discussion and Analysis of Financial
Condition and Results of Operations” and our financial statements and the related notes for the quarter ended March 31,
2020, which were filed with the SEC as part of our Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, which are
incorporated by reference into this prospectus supplement.
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March 31, 2020
(in thousands) (unaudited)
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|
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Actual
|
|
|
Pro Forma
|
|
|
Pro Forma
As Adjusted
|
|
Cash and cash equivalents
|
|
$
|
3,141
|
|
|
$
|
15,307
|
|
|
|
24,226
|
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Equity:
|
|
|
|
|
|
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|
|
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|
Common stock, par value $0.0001 per share – 150,000,000 shares authorized; 4,338,910 shares issued and outstanding
actual, 34,963,296 shares outstanding pro forma and 53,212,792 shares outstanding pro forma as adjusted
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$
|
-
|
|
|
|
3
|
|
|
|
5
|
|
Preferred stock, par value $0.0001 per share - 5,000,000 shares authorized:
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A Preferred Stock, par value $0.0001 per share; none issued and outstanding actual and as adjusted
|
|
|
-
|
|
|
|
|
|
|
|
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|
Series B Convertible Preferred Stock, par value $0.0001 per share; 17,303 shares issued and outstanding actual and as adjusted
|
|
|
-
|
|
|
|
|
|
|
|
|
|
Series C Convertible Preferred Stock, par value $0.0001 per share; 26,558 shares issued and outstanding actual and as adjusted
|
|
|
-
|
|
|
|
|
|
|
|
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Additional paid-in capital
|
|
|
163,087
|
|
|
|
175,250
|
|
|
|
184,167
|
|
Accumulated deficit
|
|
|
(159,610
|
)
|
|
|
(159,610
|
)
|
|
|
(159,610
|
)
|
Total equity
|
|
$
|
3,477
|
|
|
|
15,643
|
|
|
|
24,562
|
|
Our
capitalization will increase by the net proceeds that we receive from sales of our common stock, which will depend on the number
of shares actually sold and the offering price for such shares. We are limited to the sale of not more than approximately $9,300,000
of shares of our common stock pursuant to the sales agreement.
The
above discussion and table are based on 4,338,910 shares of common stock outstanding (34,963,296 shares outstanding, on a pro
forma basis) as of March 31, 2020, and exclude as of that date, on a pro forma basis, after taking into account our June 2020
public offering and all related changes described in the second bullet point above under “Capitalization”:
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4,016,597
shares of common stock issuable upon exercise of outstanding warrants, with an exercise price ranging from $1.80 to $32,266
per share and having a weighted average exercise price of $9.77 per share;
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●
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555,138
shares of common stock issuable upon conversion of the outstanding
Series B Convertible Preferred Stock, or Series B Preferred Stock (including the payment of the cumulative dividends accrued
on the Series B Preferred Stock in an aggregate of 237,916 shares of common stock but excluding any additional shares
of common stock that we would be required to issue to the holders of our Series B Preferred Stock upon conversion of shares
of our Series B Preferred Stock as a result of the full ratchet anti-dilution price protection in the certificate of designation
for the Series B Preferred Stock, to the extent that the effective public offering price of common stock in this offering
would be lower than $1.80 per share), at the conversion price of $1.80 per share and the stated value per share
of $33.00;
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●
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94,428
shares of common stock issuable upon conversion of the outstanding
Series C Convertible Preferred Stock, or Series C Preferred Stock (excluding additional shares of common stock that we would
be required to issue to the holders of our Series C Preferred Stock as a result of the full ratchet anti-dilution price protection
in the certificate of designation for the Series C Preferred Stock, to the extent that the effective public offering price
of common stock in this offering would be lower than $1.80 per share) at the conversion price of $1.80 per share
and the stated value per share of $6.40;
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●
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60,929
shares of common stock issuable upon the exercise of outstanding options, with exercise prices ranging from $0.001 to $3,675,000
and having a weighted average exercise price of $67,720 per share;
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●
|
182,381
shares of common stock issuable upon the exercise of Restricted Stock Units outside our 2013 Long-Term Incentive Plan; and
|
|
|
|
|
●
|
483,491
shares of common stock available for future issuance under our 2013 Long-Term Incentive Plan.
|
DILUTION
If
you invest in our common stock, your interest will be diluted to the extent of the difference between the price per share you
pay in this offering and the net tangible book value per share of our common stock immediately after this offering. Our net tangible
book value of our common stock as of March 31, 2020, was approximately $3.5 million, or approximately $0.81 per share of common
stock, based upon 4,338,910 shares outstanding.
Our
net tangible book value of our common stock as of March 31, 2020 on a pro forma basis (after giving effect to our June 2020 offering
and all related changes, as described in the second bullet point under “Capitalization” above), was approximately
$15.7 million, or approximately $0.45 per share of common stock, based upon 34,963,296 shares outstanding on a pro forma basis.
Net
tangible book value per share (on an actual or pro forma basis) is equal to our total tangible assets, less our total liabilities,
divided by the total number of shares outstanding (on an actual or pro forma basis) as of March 31, 2020.
After
giving effect to the sale of up to a maximum aggregate amount of approximately $9,300,000 of shares of our common stock
at an assumed offering price of $0.5099 per share, which is the last reported sale price for our common stock as reported on the
NYSE American on July 24, 2020, and after deducting estimated offering commissions payable by us, our net tangible book value
as of March 31, 2020 on a pro forma as adjusted basis (after giving effect to our June 2020 offering and all related changes,
as described in the second bullet point under “Capitalization” above), would have been approximately $24.6 million,
or $0.46 per share of common stock. This represents an immediate increase in the net tangible book value of $0.01 per share to
our existing stockholders and an immediate and substantial dilution in net tangible book value of $0.05 per share to new investors
who purchase our common stock in the offering.
The
following table illustrates this calculation on a per share basis:
Assumed offering price per share
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|
$
|
0.5099
|
|
Net tangible book value per share
|
|
$
|
0.81
|
|
Pro forma decrease in net tangible book value per share
|
|
|
0.36
|
|
Pro forma net tangible book value per share as of March 31, 2020
|
|
|
0.45
|
|
Increase in net tangible book value per share attributable to the offering
|
|
$
|
0.01
|
|
Pro forma as adjusted net tangible book value per share after giving effect to the offering
|
|
$
|
0.46
|
|
Dilution in net tangible book value per share to new investors
|
|
$
|
0.05
|
|
The
number of shares of our common stock to be outstanding immediately after this offering is based on 4,338,910 shares of our common
stock outstanding (actual) or 34,963,296 shares outstanding (on a pro forma basis) as of March 31, 2020, before the offering.
The
foregoing table does not give effect to the exercise of any outstanding options or warrants. To the extent options and warrants
are exercised, there may be further dilution to new investors.
The
above discussion and table are based on 4,338,910 shares of common stock outstanding (actual) or 34,963,296 shares outstanding
(on a pro forma basis) as of March 31, 2020 and exclude as of that date, on a pro forma basis, after taking into account our June
2020 public offering and all related changes described in the second bullet point above under “Capitalization”:
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●
|
4,016,597
shares of common stock issuable upon exercise of outstanding warrants, with an exercise price ranging from $1.80 to $32,266
per share and having a weighted average exercise price of $9.77 per share;
|
|
|
|
|
●
|
555,138
shares of common stock issuable upon conversion of the outstanding
Series B Preferred Stock (including the payment of the cumulative dividends accrued on the Series B Preferred Stock in an
aggregate of 237,916 shares of common stock but excluding any additional shares of common stock that we would be required
to issue to the holders of our Series B Preferred Stock upon conversion of shares of our Series B Preferred Stock as a result
of the full ratchet anti-dilution price protection in the certificate of designation for the Series B Preferred Stock, to
the extent that the effective public offering price of common stock in this offering would be lower than $1.80 per
share), at the conversion price of $1.80 per share and the stated value per share of $33.00;
|
|
|
|
|
●
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94,428
shares of common stock issuable upon conversion of the outstanding
Series C Preferred Stock (excluding additional shares of common stock that we would be required to issue to the holders of
our Series C Preferred Stock as a result of the full ratchet anti-dilution price protection in the certificate of designation
for the Series C Preferred Stock, to the extent that the effective public offering price of common stock in this offering
would be lower than $1.80 per share) at the conversion price of $1.80 per share and the stated value per share
of $6.40;
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60,929
shares of common stock issuable upon the exercise of outstanding options, with exercise prices ranging from $0.001 to $3,675,000
and having a weighted average exercise price of $67,720 per share;
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182,381
shares of common stock issuable upon the exercise of Restricted Stock Units outside our 2013 Long-Term Incentive Plan; and
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483,491
shares of common stock available for future issuance under our 2013 Long-Term Incentive Plan.
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USE
OF PROCEEDS
After
giving effect to the sale of the maximum aggregate approximate $9.3 million amount of shares of our common stock that are
available under this prospectus supplement, we estimate that the maximum potential net proceeds we will receive will be approximately
$8.9 million, after deducting the agent’s fees and estimated offering expenses. However, we cannot guarantee if or when
these net proceeds will be received and the method by which they are offered to the public. The amount of proceeds from this offering
will depend upon the number of shares of our common stock sold and the market price at which they are sold. There can be no assurance
that we will be able to sell any shares under or fully utilize the sales agreement with A.G.P. as a source of financing.
Any portion of the gross approximate $9.3 million amount included in this prospectus supplement that is not sold or included
in an active placement notice pursuant to the sales agreement may be made available later for sale in other offerings pursuant
to the accompanying base prospectus. If no shares are sold under the sales agreement, the full approximate $9.3 million of shares
of common stock may be made available later for sale in other offerings pursuant to the accompanying base prospectus.
We
intend to use the net proceeds of this offering for our operations, including, but not limited to, for research and development,
sales and marketing, and working capital and other general corporate purposes. We do not currently have more specific plans or
commitments with respect to the net proceeds from this offering and, accordingly, are unable to quantify the allocation of such
proceeds among the various potential uses.
The
expected use of net proceeds of this offering represents our current intentions based upon our present plan and business conditions.
Investors are cautioned, however, that expenditures may vary substantially from these uses. Investors will be relying on the judgment
of our management, who will have broad discretion regarding the application of the proceeds of this offering. The amounts and
timing of our actual expenditures will depend upon numerous factors, including the amount of cash generated by our operations,
the amount of competition we face and other operational factors. We may find it necessary or advisable to use portions of the
proceeds from this offering for other purposes.
From
time to time, we evaluate these and other factors and we anticipate continuing to make such evaluations to determine if the existing
allocation of resources, including the proceeds of this offering, is being optimized. Circumstances that may give rise to a change
in the use of proceeds include:
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a
change in development plan or strategy;
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the
addition of new products or applications;
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technical
delays;
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delays
or difficulties with our clinical trials;
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negative
results from our clinical trials;
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difficulty
obtaining regulatory approval;
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failure
to achieve sales as anticipated; and
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the
availability of other sources of cash including cash flow from operations and new bank debt financing arrangements, if any.
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Until
we use the net proceeds of this offering, we intend to hold such funds in cash or invest the funds in short-term, investment grade,
interest-bearing securities.
DIVIDEND
POLICY
In
the past, we have not declared or paid cash dividends on our common stock. We do not intend to pay cash dividends in the future,
rather, we intend to retain future earnings, if any, to fund the operation and expansion of our business and for general corporate
purposes.
PLAN
OF DISTRIBUTION
We
have entered into the sales agreement with A.G.P., under which we may issue and sell our common stock having an aggregate offering
price of up to approximately $9,300,000 from time to time through A.G.P., acting as our sales agent. The sales agreement
has been filed as an exhibit to our Current Report on Form 8-K filed with the SEC on July 28, 2020, which is incorporated by reference
in this prospectus supplement. The actual dollar amount and number of shares of common stock we sell pursuant to this prospectus
supplement will be dependent, among other things, on market conditions and our capital raising requirements. The sales of our
common stock, if any, under the sales agreement may be made by any method permitted by law deemed to be an “at-the-market”
offering as defined in Rule 415 under the Securities Act, including sales made directly on the NYSE American market, on any other
existing trading market for our common stock or to or through a market maker or through an electronic communications network.
If expressly authorized by us, A.G.P. may also sell our common stock in privately negotiated transactions. We expect that a
vast majority of the shares of common stock to be sold pursuant to the sales agreement will be sold to the public and not in privately
negotiated transactions.
Each
time that we wish to issue and sell shares of our common stock under the sales agreement, we will provide A.G.P. with a placement
notice describing the amount of shares to be sold or the gross proceeds to be raised in a given time period, the time period during
which sales are requested to be made, any limitation on the amount of shares of common stock that may be sold in any single day,
any minimum price below which sales may not be made or any minimum price requested for sales in a given time period and any other
instructions relevant to such requested sales. Upon receipt of a placement notice, A.G.P., as our sales agent, will use commercially
reasonable efforts, consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations
and the rules of the NYSE American, to sell shares of our common stock under the terms and subject to the conditions of the placement
notice and the sales agreement. We or A.G.P. may suspend the offering of common stock pursuant to a placement notice upon proper
notice and subject to other conditions. A.G.P., in its sole discretion, may decline to accept any placement notice. During the
term of the sales agreement, A.G.P. will not engage in any market making, bidding, stabilization or other trading activity with
regard to our common stock if such activity would be prohibited under Regulation M or other anti-manipulation rules under the
Securities Act.
A.G.P.
will provide written confirmation to us no later than the opening of the trading day on the NYSE American market following
the trading day on which shares of our common stock are sold through A.G.P. under the sales agreement. Each confirmation will
include the number of shares sold on the preceding day, the net proceeds to us and the commissions payable by us to A.G.P. in
connection with the sales.
We
will pay A.G.P. commissions for its services in acting as agent in the sale of our common stock pursuant to the sales agreement.
A.G.P. will be entitled to compensation at a fixed commission rate of 3.0% of the gross proceeds from the sale of our common stock
pursuant to the sales agreement, less certain concessions, as applicable, which concessions if applicable shall not in any way
reduce the maximum amount of proceeds to be received by us as set forth on the cover of this prospectus supplement. Because there
are no minimum sale requirements as a condition to this offering, the actual total public offering price, commissions and net
proceeds to us, if any, are not determinable at this time. We estimate that the total expenses for this offering, excluding compensation
payable to A.G.P. and certain expenses reimbursable to A.G.P. under the terms of the sales agreement, will be approximately $40,000.
Settlement
for sales of common stock will occur on the third trading day following the date on which any sales are made (or on such other
date as is industry practice for regular-way trading), unless otherwise specified in the applicable placement notice, in return
for payment of the net proceeds to us. There are no arrangements to place any of the proceeds of this offering in an escrow, trust
or similar account. Sales of our common stock as contemplated in this prospectus supplement will be settled through the facilities
of The Depository Trust Company or by such other means as we and A.G.P. may agree upon.
In
connection with the sale of the common stock on our behalf, A.G.P. may, and will with respect to sales effected in an “at-the-market”
offering, be deemed to be an “underwriter” within the meaning of the Securities Act, and the compensation of A.G.P.
may be deemed to be underwriting commissions or discounts. We have agreed to provide indemnification and contribution to A.G.P.
against certain civil liabilities, including liabilities under the Securities Act. We also have agreed to reimburse A.G.P. for
its reasonable out-of-pocket expenses, including the fees and disbursements of counsel to A.G.P., incurred in connection with
the offering, up to a maximum amount of $40,000.
The
offering pursuant to the sales agreement will terminate upon the earlier of (i) the sale of all shares of common stock subject
to the agreement and (ii) termination of the sales agreement as permitted therein. We may terminate the sales agreement in our
sole discretion at any time by giving 10 days’ prior notice to A.G.P. A.G.P. may terminate the sales agreement under the
circumstances specified in the sales agreement and in its sole discretion at any time by giving 10 days’ prior notice to
us.
This
prospectus supplement and the accompanying base prospectus may be made available in electronic format on a website maintained
by A.G.P., and A.G.P. may distribute this prospectus supplement and the accompanying base prospectus electronically.
A.G.P.
has no relationship with us other than its current role as sales agent for our offering of common stock pursuant to the sales
agreement described above. In June 2020, A.G.P. managed our underwritten public offering of units consisting of shares of common
stock, pre-funded warrants to purchase common stock, and warrants. A.G.P. and its affiliates previously have provided,
and may in the future provide, various investment banking and other financial services for us and our affiliates, for
which services it has received, and may in the future receive, customary fees.
LEGAL
MATTERS
The
validity of the securities being offered by this prospectus
and legal matters relating to applicable laws will be passed upon for us by McDermott Will & Emery LLP, New York, New York. A.G.P.
is being represented in connection with this offering by Olshan Frome Wolosky LLP, New York, New York.
EXPERTS
The
consolidated financial statements incorporated in this prospectus supplement by reference to the Annual Report on Form 10-K for
the year ended December 31, 2019 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 1b to the financial statements) 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 ADDITIONAL INFORMATION ABOUT US
We
have filed a registration statement on Form S-3 with the SEC for the securities we are offering by this prospectus supplement.
This prospectus supplement does not include all of the information contained in the registration statement. You should refer to
the registration statement and its exhibits for additional information. We are subject to the informational requirements of the
Securities Exchange Act of 1934, as amended, and in accordance therewith we file annual, quarterly, and other reports, proxy statements
and other information with the SEC. Such reports, proxy statements and other information, including the Registration Statement,
and exhibits and schedules thereto, are available to the public through the SEC’s website at http://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 Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after we electronically file such
material with or otherwise furnish it to the SEC.
We
have filed with the SEC a registration statement under the Securities Act of 1933, as amended, relating to the offering
of these securities. The registration statement, including the attached exhibits, contains additional relevant information about
us and the securities. This prospectus does not contain all of the information set forth in the registration statement. You can
obtain a copy of the registration statement for free at www.sec.gov. The registration statement and the documents referred to
below under “Incorporation of 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 DOCUMENTS BY REFERENCE
This
prospectus supplement incorporates by reference the documents set forth below that we have previously filed with the SEC:
The
following documents are incorporated by reference into this document:
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Our
Annual Report on Form 10-K for the fiscal year ended December 31, 2019, filed with the Securities and Exchange Commission
on March 10, 2020.
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Our
Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2020, filed with the Securities and Exchange Commission
on May 11, 2020.
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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 Securities and Exchange Commission on January 6, 2020, January 28,
2020, January 30, 2020, April 27, 2020, May 12, 2020, June 8, 2020, June 10, 2020, June 25, 2020, July 23, 2020 and July 28, 2020.
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We
also incorporate by reference into this prospectus supplement and accompanying prospectus all documents we file or furnish under
Sections 13(a), 13(c), 14 or 15(d) of the Exchange Act: (i) after the initial filing date of the registration statement of which
this prospectus supplement is a part and before the effectiveness of the registration statement; and (ii) until all of the common
stock to which this prospectus supplement and the accompanying prospectus relates has been sold or the offering is otherwise terminated.
Any statement contained herein or in a document incorporated or deemed to be incorporated by reference herein shall be deemed
to be modified or superseded for purposes hereof to the extent that a statement in any other subsequently filed document which
is also incorporated or deemed to be incorporated herein modifies or supersedes such statement. Any such statement so modified
or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus supplement.
PROSPECTUS
InspireMD,
Inc.
$30,000,000
Common
Stock
Preferred
Stock
Warrants
Units
We
may offer and sell from time to time, in one or more series or issuances and on terms that we will determine at the time of the
offering, any combination of the securities described in this prospectus, up to an aggregate amount of $30,000,000.
We
will provide specific terms of any offering in a supplement to this prospectus. Any prospectus supplement may also add, update,
or change information contained in this prospectus. You should carefully read this prospectus and the applicable prospectus supplement
as well as the documents incorporated or deemed to be incorporated by reference in this prospectus before you purchase any of
the securities offered hereby.
These
securities may be offered and sold in the same offering or in separate offerings; to or through underwriters, dealers, and agents;
or directly to purchasers. The names of any underwriters, dealers, or agents involved in the sale of our securities, their compensation
and any over-allotment options held by them will be described in the applicable prospectus supplement. See “Plan of Distribution.”
Our
common stock is listed on the NYSE American under the symbol “NSPR.” On February 20, 2018, the last reported sale
price of our common stock as reported on the NYSE American was $4.46 per share. We recommend that you obtain current market quotations
for our common stock prior to making an investment decision. We will provide information in any applicable prospectus supplement
regarding any listing of securities other than shares of our common stock on any securities exchange.
As
of February 14, 2018, the aggregate market value of our outstanding common stock held by non-affiliates, or the public float,
was approximately $9,120,979, which was calculated based on 1,634,584 shares of our outstanding common stock held by non-affiliates
and a price of $5.58 per share, the last reported sale price for our common stock on February 14, 2018. We have not offered any
securities pursuant to General Instruction I.B.6 of Form S-3 during the 12 calendar months prior to and including the date of
this prospectus.
You
should carefully read this prospectus, any prospectus supplement relating to any specific offering of securities, and all information
incorporated by reference herein and therein.
Investing
in our securities involves a high degree of risk. These risks are discussed in this prospectus under “Risk Factors”
beginning on page 4 and in the documents incorporated by reference into this prospectus.
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 February 23, 2018
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 using a “shelf”
registration process. Under this shelf process, we may, from time to time, sell any combination of the securities described in
this prospectus in one or more offerings up to a total amount of $30,000,000.
This
prospectus provides you with a general description of the securities we may offer. Each time we sell securities, we will provide
a prospectus supplement that will contain specific information about the terms of that offering. The prospectus supplement may
also add to, update or change information contained in the prospectus and, accordingly, to the extent inconsistent, information
in this prospectus is superseded by the information in the prospectus supplement.
The
prospectus supplement to be attached to the front of this prospectus may describe, as applicable: the terms of the securities
offered; the public offering price; the price paid for the securities; net proceeds; and the other specific terms related to the
offering of the securities.
You
should only rely on the information contained or incorporated by reference in this prospectus and any prospectus supplement or
issuer free writing prospectus relating to a particular offering. No person has been authorized to give any information or make
any representations in connection with this offering other than those contained or incorporated by reference in this prospectus,
any accompanying prospectus supplement and any related issuer free writing prospectus in connection with the offering described
herein and therein, and, if given or made, such information or representations must not be relied upon as having been authorized
by us. Neither this prospectus nor any prospectus supplement nor any related issuer free writing prospectus shall constitute an
offer to sell or a solicitation of an offer to buy offered securities in any jurisdiction in which it is unlawful for such person
to make such an offering or solicitation. This prospectus does not contain all of the information included in the registration
statement. For a more complete understanding of the offering of the securities, you should refer to the registration statement,
including its exhibits.
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 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.
Overview
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 we launched its release on a limited basis in October 2014. In January 2015, a new version of CGuard, with a rapid exchange
delivery system, received CE mark approval in Europe and in September 2015, we announced the full market launch of CGuard EPS
in Europe. Subsequently, we launched CGuard EPS in Russia and certain countries in Latin America and Asia, and, in January 2018,
received regulatory approval to commercialize CGuard EPS in India.
In
April 2017, we had a pre-investigational device exemption (“IDE”) submission meeting with the U.S. Food and Drug Administration
regarding CGuard EPS where we presented materials that we believed would support a formal IDE submission seeking approval to conduct
a human clinical trial in the United States which included our draft synopsis for the clinical trial design. We intend to make
a formal submission once sufficient funds are available.
If
we receive sufficient proceeds from future financings, we plan to develop CGuard EPS with a smaller delivery catheter (5 French
gauge), which we intend to submit for CE mark approval. We cannot give any assurance that we will receive sufficient (or any)
proceeds from any such financings or the timing of such financings, if ever. In addition, such additional financings may be costly
or difficult to complete. Even if we receive sufficient proceeds from future financings, there is no assurance that we will be
able to timely apply for CE mark approval following our receipt of such proceeds.
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, though, 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.
We
are also developing a neurovascular flow diverter, which is an endovascular device that directs blood flow away from cerebral
aneurysms in order to ultimately seal the aneurysms. Our flow diverter would utilize an open cell, highly flexible metal scaffold
to which MicroNet would be attached. We have completed initial pre-clinical testing of this product in both simulated bench models
and standard in vivo pre-clinical models. However, we have currently suspended further development of this product as we plan
to focus our resources primarily on the further expansion of our sales and marketing activities for CGuard EPS.
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.
In
2017, we decided to shift our commercial strategy to focus on sales of our products through local distribution partners and our
own internal sales initiatives to gain greater reach into all the relevant clinical specialties and to expand our geographic coverage.
Pursuant to our new strategy, we completed our transition away from a single distributor covering 18 European countries to a direct
distribution model intended to broaden our sales efforts to key clinical specialties. All territories previously covered by our
former European distributor were transferred to local distributors by June 2017. We also have begun to participate in international
trade shows and industry conferences in an attempt to gain market exposure and brand recognition.
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.inspire-md.com. Information
accessed through our website is not incorporated into this prospectus and is not a part of this prospectus.
The
Securities We May Offer
We
may offer up to $30,000,000 of common stock, preferred stock, warrants and/or units in one or more offerings and in any combination.
This prospectus provides you with a general description of the securities we may offer. A prospectus supplement, which we will
provide each time we offer securities, will describe the specific amounts, prices and terms of these securities.
Common
Stock
We
may issue shares of our common stock from time to time. The holders of our common stock are entitled to one vote per share. Our
certificate of incorporation does not provide for cumulative voting. Our directors are divided into three classes. At each annual
meeting of stockholders, directors elected to succeed those directors whose terms expire are elected for a term of office to expire
at the third succeeding annual meeting of stockholders after their election. The holders of our common stock are entitled to receive
ratably such dividends, if any, as may be declared by our board of directors out of legally available funds; however, the current
policy of our board of directors is to retain earnings, if any, for operations and growth. Upon liquidation, dissolution or winding-up,
the holders of our common stock are entitled to share ratably in all assets that are legally available for distribution. The holders
of our common stock have no preemptive, subscription, redemption or conversion rights. The rights, preferences and privileges
of holders of our common stock are subject to, and may be adversely affected by, the rights of the holders of any series of preferred
stock, which may be designated solely by action of our board of directors and issued in the future.
Preferred
Stock
We
may issue shares of our preferred stock from time to time, in one or more series. Our board of directors will determine the rights,
preferences, privileges and restrictions of the preferred stock, including dividend rights, conversion rights, voting rights,
terms of redemption, liquidation preferences, sinking fund terms and the number of shares constituting any series or the designation
of such series, without any further vote or action by stockholders. Convertible preferred stock will be convertible into our common
stock or exchangeable for our other securities. Conversion may be mandatory or at your option or both and would be at prescribed
conversion rates.
If
we sell any series of preferred stock under this prospectus and applicable prospectus supplements, we will fix the rights, preferences,
privileges and restrictions of the preferred stock of such series in the certificate of designation relating to that series. We
will file as an exhibit to the registration statement of which this prospectus is a part, or will incorporate by reference from
reports that we file with the Securities and Exchange Commission, the form of any certificate of designation that describes the
terms of the series of preferred stock we are offering before the issuance of the related series of preferred stock. We urge you
to read the applicable prospectus supplement related to the series of preferred stock being offered, as well as the complete certificate
of designation that contains the terms of the applicable series of preferred stock.
Warrants
We
may issue warrants for the purchase of common stock or preferred stock in one or more series. We may issue warrants independently
or together with common stock or preferred stock, and the warrants may be attached to or separate from these securities. We will
evidence each series of warrants by warrant certificates that we will issue under a separate agreement. We may enter into warrant
agreements with a bank or trust company that we select to be our warrant agent. We will indicate the name and address of the warrant
agent in the applicable prospectus supplement relating to a particular series of warrants.
In
this prospectus, we have summarized certain general features of the warrants. We urge you, however, to read the applicable prospectus
supplement related to the particular series of warrants being offered, as well as the warrant agreements and warrant certificates
that contain the terms of the warrants. We will file as exhibits to the registration statement of which this prospectus is a part,
or will incorporate by reference from reports that we file with the Securities and Exchange Commission, the form of warrant agreement
or warrant certificate containing the terms of the warrants we are offering before the issuance of the warrants.
Units
We
may issue units consisting of common stock, preferred stock and/or warrants for the purchase of common stock or preferred stock
in one or more series. In this prospectus, we have summarized certain general features of the units. We urge you, however, to
read the applicable prospectus supplement related to the series of units being offered, as well as the unit agreements that contain
the terms of the units. We will file as exhibits to the registration statement of which this prospectus is a part, or will incorporate
by reference reports that we file with the Securities and Exchange Commission, the form of unit agreement and any supplemental
agreements that describe the terms of the series of units we are offering before the issuance of the related series of units.
RISK
FACTORS
An
investment in our securities involves a high degree of risk. The prospectus supplement applicable to each offering of our securities
will contain a discussion of the risks applicable to an investment in our securities. Before deciding whether to invest in our
securities, you should carefully consider the specific factors discussed under the heading “Risk Factors” in the applicable
prospectus supplement, together with all of the other information contained or incorporated by reference in the prospectus supplement
or appearing or incorporated by reference in this prospectus. You should also consider the risks, uncertainties and assumptions
discussed under Item 1A, “Risk Factors,” in our Annual Report on Form 10-K for the fiscal year ended December 31,
2017, all of which are incorporated herein by reference, as updated or superseded by the risks and uncertainties described under
similar headings in the other documents that are filed after the date hereof and incorporated by reference into this prospectus
and any prospectus supplement related to a particular offering. The risks and uncertainties we have described are not the only
ones we face. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also affect
our operations. Past financial performance may not be a reliable indicator of future performance, and historical trends should
not be used to anticipate results or trends in future periods. If any of these risks actually occurs, our business, business prospects,
financial condition or results of operations could be seriously harmed. This could cause the trading price of our common stock
to decline, resulting in a loss of all or part of your investment. Please also read carefully the section below entitled “Special
Note Regarding Forward-Looking Statements.”
SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This
prospectus, each prospectus supplement and the information incorporated by reference in this prospectus and each prospectus supplement
contain “forward-looking statements,” which include information relating to future events, future financial performance,
strategies, expectations, competitive environment and regulation. Words such as “may,” “should,” “could,”
“would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,”
“future,” “intends,” “plans,” “believes,” “estimates,” and similar
expressions, as well as statements in future tense, 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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our
history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty
regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability
to continue as a going concern;
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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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our
ability to regain compliance with 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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negative
clinical trial results or lengthy product delays in key markets;
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an
inability to secure and maintain regulatory approvals for the sale of our products;
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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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price
increases for supplies and components;
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adverse
economic conditions;
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insufficient
or inadequate reimbursement by governmental and other third-party payers for our products;
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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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adverse
federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions;
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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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the
escalation of hostilities in Israel, which could impair our ability to manufacture our products; and
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loss
or retirement of key executives and research scientists.
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You
should review carefully the section entitled “Risk Factors” beginning on page 4 of this prospectus for a discussion
of these and other risks that relate to our business and investing in our securities. The forward-looking statements contained
or incorporated by reference in this prospectus or any prospectus supplement are expressly qualified in their entirety by this
cautionary statement. We do not undertake any obligation to publicly update any forward-looking statement to reflect events or
circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.
USE
OF PROCEEDS
Unless
we specify another use in the applicable prospectus supplement, we will use the net proceeds from the sale of the securities offered
by us for general corporate purposes, including funding of our development programs, commercial planning and sales and marketing
expenses, general and administrative expenses, acquisition or licensing of additional product candidates or businesses and working
capital.
Investors
are cautioned, however, that expenditures may vary substantially from these uses. Investors will be relying on the judgment of
our management, who will have broad discretion regarding the application of the proceeds of this offering. The amounts and timing
of our actual expenditures will depend upon numerous factors, including the amount of cash generated by our operations, the amount
of competition and other operational factors. We may find it necessary or advisable to use portions of the proceeds from this
offering for other purposes.
From
time to time, we evaluate these and other factors and we anticipate continuing to make such evaluations to determine if the existing
allocation of resources, including the proceeds of this offering, is being optimized. Circumstances that may give rise to a change
in the use of proceeds include:
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a
change in development plan or strategy;
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the
addition of new products or applications;
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technical
delays;
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delays
or difficulties with our clinical trials;
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negative
results from our clinical trials;
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difficulty
obtaining U.S. Food and Drug Administration approval;
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failure
to achieve sales as anticipated; and
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the
availability of other sources of cash including cash flow from operations and new bank debt financing arrangements, if any.
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Pending
other uses, we intend to invest the proceeds to us in investment-grade, interest-bearing securities such as money market funds,
certificates of deposit, or direct or guaranteed obligations of the U.S. government, or hold as cash. We cannot predict whether
the proceeds invested will yield a favorable, or any, return.
DESCRIPTION
OF CAPITAL STOCK
The
following description of common stock and preferred stock summarizes the material terms and provisions of the common stock and
preferred stock that we may offer under this prospectus, but is not complete. For the complete terms of our common stock and preferred
stock, please refer to our amended and restated certificate of incorporation, as amended, any certificates of designation for
our preferred stock, and our amended and restated bylaws, as may be amended from time to time. While the terms we have summarized
below will apply generally to any future common stock or preferred stock that we may offer, we will describe the specific terms
of any series of preferred stock in more detail in the applicable prospectus supplement. If we so indicate in a prospectus supplement,
the terms of any preferred stock we offer under that prospectus supplement may differ from the terms we describe below.
We
have authorized 155,000,000 shares of capital stock, par value $0.0001 per share, of which 150,000,000 are shares of common stock
and 5,000,000 are shares of “blank check” preferred stock. On February 13, 2018, there were 1,675,592 shares of common
stock, 17,303 shares of Series B Convertible Preferred Stock, 741,651 shares of Series C Convertible Preferred Stock and 750 shares
of Series D Convertible Preferred Stock issued and outstanding. We currently have 200,000 shares of preferred stock designated
as Series A Preferred Stock, 500,000 shares of preferred stock designated as Series B Convertible Preferred Stock, 1,172,000 shares
of preferred stock designated as Series C Convertible Preferred Stock and 750 shares of preferred stock designated as Series D
Convertible Preferred Stock. The authorized and unissued shares of common stock and the authorized and undesignated shares of
preferred stock are available for issuance without further action by our stockholders, unless such action is required by applicable
law or the rules of any stock exchange on which our securities may be listed. Unless approval of our stockholders is so required,
our board of directors does not intend to seek stockholder approval for the issuance and sale of our common stock or preferred
stock.
The
discussion below gives effect to the one-for-thirty-five reverse stock split of our common stock that occurred on February 7,
2018.
Common
Stock
The
holders of our common stock are entitled to one vote per share. Our certificate of incorporation does not provide for cumulative
voting. Our directors are divided into three classes. At each annual meeting of stockholders, directors elected to succeed those
directors whose terms expire are elected for a term of office to expire at the third succeeding annual meeting of stockholders
after their election. The holders of our common stock are entitled to receive ratably such dividends, if any, as may be declared
by our board of directors out of legally available funds; however, the current policy of our board of directors is to retain earnings,
if any, for operations and growth. Upon liquidation, dissolution or winding-up, the holders of our common stock are entitled to
share ratably in all assets that are legally available for distribution. The holders of our common stock have no preemptive, subscription,
redemption or conversion rights. The rights, preferences and privileges of holders of our common stock are subject to, and may
be adversely affected by, the rights of the holders of any series of preferred stock, which may be designated solely by action
of our board of directors and issued in the future.
The
transfer agent and registrar for our common stock is Action Stock Transfer Corp. The transfer agent’s address is 2469 E.
Fort Union Blvd., Suite 214, Salt Lake City, Utah 84121. Our common stock is listed on the NYSE American under the symbol “NSPR.”
Preferred
Stock
The
board of directors is authorized, subject to any limitations prescribed by law, without further vote or action by the stockholders,
to issue from time to time shares of preferred stock in one or more series. Each such series of preferred stock shall have such
number of shares, designations, preferences, voting powers, qualifications, and special or relative rights or privileges as shall
be determined by the board of directors, which may include, among others, dividend rights, voting rights, liquidation preferences,
conversion rights and preemptive rights. Issuance of preferred stock by our board of directors may result in such shares having
dividend and/or liquidation preferences senior to the rights of the holders of our common stock and could dilute the voting rights
of the holders of our common stock.
Prior
to the issuance of shares of each series of preferred stock, the board of directors is required by the Delaware General Corporation
Law and our certificate of incorporation to adopt resolutions and file a certificate of designation with the Secretary of State
of the State of Delaware. The certificate of designation fixes for each class or series the designations, powers, preferences,
rights, qualifications, limitations and restrictions, including, but not limited to, some or all of the following:
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the
number of shares constituting that series and the distinctive designation of that series, which number may be increased or
decreased (but not below the number of shares then outstanding) from time to time by action of the board of directors;
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the
dividend rate and the manner and frequency of payment of dividends on the shares of that series, whether dividends will be
cumulative, and, if so, from which date;
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whether
that series will have voting rights, in addition to any voting rights provided by law, and, if so, the terms of such voting
rights;
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whether
that series will have conversion privileges, and, if so, the terms and conditions of such conversion, including provision
for adjustment of the conversion rate in such events as the board of directors may determine;
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whether
or not the shares of that series will be redeemable, and, if so, the terms and conditions of such redemption;
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whether
that series will have a sinking fund for the redemption or purchase of shares of that series, and, if so, the terms and amount
of such sinking fund;
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whether
or not the shares of the series will have priority over or be on a parity with or be junior to the shares of any other series
or class in any respect;
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the
rights of the shares of that series in the event of voluntary or involuntary liquidation, dissolution or winding up of the
corporation, and the relative rights or priority, if any, of payment of shares of that series; and
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any
other relative rights, preferences and limitations of that series.
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Once
designated by our board of directors, each series of preferred stock may have specific financial and other terms that will be
described in a prospectus supplement. The description of the preferred stock that is set forth in any prospectus supplement is
not complete without reference to the documents that govern the preferred stock. These include our certificate of incorporation
and any certificates of designation that our board of directors may adopt.
All
shares of preferred stock offered hereby will, when issued, be fully paid and nonassessable, including shares of preferred stock
issued upon the exercise of preferred stock warrants or subscription rights, if any.
Although
our board of directors has no intention at the present time of doing so, it could authorize the issuance of a series of preferred
stock that could, depending on the terms of such series, impede the completion of a merger, tender offer or other takeover attempt.
Delaware
Anti-Takeover Law, Provisions of our Certificate of Incorporation and Bylaws and our Stockholder Rights Agreement
Delaware
Anti-Takeover Law
We
are subject to Section 203 of the Delaware General Corporation Law. Section 203 generally prohibits a public Delaware corporation
from engaging in a “business combination” with an “interested stockholder” for a period of three years
after the date of the transaction in which the person became an interested stockholder, unless:
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prior
to the date of the transaction, the board of directors of the corporation approved either the business combination or the
transaction which resulted in the stockholder becoming an interested stockholder;
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the
interested stockholder owned at least 85% of the voting stock of the corporation outstanding at the time the transaction commenced,
excluding for purposes of determining the number of shares outstanding (i) shares owned by persons who are directors and also
officers and (ii) shares owned by employee stock plans in which employee participants do not have the right to determine confidentially
whether shares held subject to the plan will be tendered in a tender or exchange offer; or
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on
or subsequent to the date of the transaction, the business combination is approved by the board and authorized at an annual
or special meeting of stockholders, and not by written consent, by the affirmative vote of at least 66 2/3% of the outstanding
voting stock which is not owned by the interested stockholder.
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Section
203 defines a business combination to include:
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any
merger or consolidation involving the corporation and the interested stockholder;
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any
sale, transfer, pledge or other disposition involving the interested stockholder of 10% or more of the assets of the corporation;
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subject
to exceptions, any transaction that results in the issuance or transfer by the corporation of any stock of the corporation
to the interested stockholder; or
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the
receipt by the interested stockholder of the benefit of any loans, advances, guarantees, pledges or other financial benefits
provided by or through the corporation.
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In
general, Section 203 defines an interested stockholder as any entity or person beneficially owning 15% or more of the outstanding
voting stock of the corporation and any entity or person affiliated with, or controlling, or controlled by, the entity or person.
The term “owner” is broadly defined to include any person that, individually, with or through that person’s
affiliates or associates, among other things, beneficially owns the stock, or has the right to acquire the stock, whether or not
the right is immediately exercisable, under any agreement or understanding or upon the exercise of warrants or options or otherwise
or has the right to vote the stock under any agreement or understanding, or has an agreement or understanding with the beneficial
owner of the stock for the purpose of acquiring, holding, voting or disposing of the stock.
The
restrictions in Section 203 do not apply to corporations that have elected, in the manner provided in Section 203, not to be subject
to Section 203 of the Delaware General Corporation Law or, with certain exceptions, which do not have a class of voting stock
that is listed on a national securities exchange or held of record by more than 2,000 stockholders. Our certificate of incorporation
and bylaws do not opt out of Section 203.
Section
203 could delay or prohibit mergers or other takeover or change in control attempts with respect to us and, accordingly, may discourage
attempts to acquire us even though such a transaction may offer our stockholders the opportunity to sell their stock at a price
above the prevailing market price.
Certificate
of Incorporation and Bylaws
Provisions
of our certificate of incorporation and bylaws may delay or discourage transactions involving an actual or potential change in
our control or change in our management, including transactions in which stockholders might otherwise receive a premium for their
shares, or transactions that our stockholders might otherwise deem to be in their best interests. Therefore, these provisions
could adversely affect the price of our common stock. Among other things, our certificate of incorporation and bylaws:
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permit
our board of directors to issue up to 5,000,000 shares of preferred stock, without further action by the stockholders, with
any rights, preferences and privileges as they may designate, including the right to approve an acquisition or other change
in control;
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provide
that the authorized number of directors may be changed only by resolution of the board of directors;
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provide
that all vacancies, including newly created directorships, may, except as otherwise required by law, be filled by the affirmative
vote of a majority of directors then in office, even if less than a quorum;
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divide
our board of directors into three classes, with each class serving staggered three-year terms;
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do
not provide for cumulative voting rights (therefore allowing the holders of a majority of the shares of common stock entitled
to vote in any election of directors to elect all of the directors standing for election, if they should so choose);
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provide
that special meetings of our stockholders may be called only by our board of directors; and
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set
forth an advance notice procedure with regard to the nomination, other than by or at the direction of our board of directors,
of candidates for election as directors and with regard to business to be brought before a meeting of stockholders.
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DESCRIPTION
OF WARRANTS
As
of February 13, 2018, there were 181,912 shares of common stock that may be issued upon exercise of outstanding warrants.
We
may issue warrants for the purchase of common stock or preferred stock in one or more series. We may issue warrants independently
or together with common stock or preferred stock, and the warrants may be attached to or separate from these securities.
We
will evidence each series of warrants by warrant certificates that we may issue under a separate agreement. We may enter into
a warrant agreement with a warrant agent. Each warrant agent may be a bank that we select which has its principal office in the
United States. We may also choose to act as our own warrant agent. We will indicate the name and address of any such warrant agent
in the applicable prospectus supplement relating to a particular series of warrants.
We
will describe in the applicable prospectus supplement the terms of the series of warrants, including:
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the
offering price and aggregate number of warrants offered;
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applicable, the designation and terms of the securities with which the warrants are issued and the number of warrants issued
with each such security or each principal amount of such security;
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if
applicable, the date on and after which the warrants and the related securities will be separately transferable;
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in
the case of warrants to purchase common stock or preferred stock, the number or amount of shares of common stock or preferred
stock, as the case may be, purchasable upon the exercise of one warrant and the price at which and currency in which these
shares may be purchased upon such exercise;
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the
manner of exercise of the warrants, including any cashless exercise rights;
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the
warrant agreement under which the warrants will be issued;
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the
effect of any merger, consolidation, sale or other disposition of our business on the warrant agreement and the warrants;
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anti-dilution
provisions of the warrants, if any;
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the
terms of any rights to redeem or call the warrants;
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any
provisions for changes to or adjustments in the exercise price or number of securities issuable upon exercise of the warrants;
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the
dates on which the right to exercise the warrants will commence and expire or, if the warrants are not continuously exercisable
during that period, the specific date or dates on which the warrants will be exercisable;
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the
manner in which the warrant agreement and warrants may be modified;
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the
identities of the warrant agent and any calculation or other agent for the warrants;
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federal
income tax consequences of holding or exercising the warrants;
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the
terms of the securities issuable upon exercise of the warrants;
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any
securities exchange or quotation system on which the warrants or any securities deliverable upon exercise of the warrants
may be listed or quoted; and
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any
other specific terms, preferences, rights or limitations of or restrictions on the warrants.
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Before
exercising their warrants, holders of warrants will not have any of the rights of holders of the securities purchasable upon such
exercise, including, in the case of warrants to purchase common stock or preferred stock, the right to receive dividends, if any,
or, payments upon our liquidation, dissolution or winding up or to exercise voting rights, if any.
Exercise
of Warrants
Each
warrant will entitle the holder to purchase the securities that we specify in the applicable prospectus supplement at the exercise
price that we describe in the applicable prospectus supplement. Unless we otherwise specify in the applicable prospectus supplement,
holders of the warrants may exercise the warrants at any time up to 5:00 P.M. eastern time, the close of business, on the expiration
date that we set forth in the applicable prospectus supplement. After the close of business on the expiration date, unexercised
warrants will become void.
Holders
of the warrants may exercise the warrants by delivering the warrant certificate representing the warrants to be exercised together
with specified information, and paying the required exercise price by the methods provided in the applicable prospectus supplement.
We will set forth on the reverse side of the warrant certificate, and in the applicable prospectus supplement, the information
that the holder of the warrant will be required to deliver to the warrant agent.
Upon
receipt of the required payment and the warrant certificate properly completed and duly executed at the corporate trust office
of the warrant agent or any other office indicated in the applicable prospectus supplement, we will issue and deliver the securities
purchasable upon such exercise. If fewer than all of the warrants represented by the warrant certificate are exercised, then we
will issue a new warrant certificate for the remaining amount of warrants.
Enforceability
of Rights By Holders of Warrants
Any
warrant agent will act solely as our agent under the applicable warrant agreement and will not assume any obligation or relationship
of agency or trust with any holder of any warrant. A single bank or trust company may act as warrant agent for more than one issue
of warrants. A warrant agent will have no duty or responsibility in case of any default by us under the applicable warrant agreement
or warrant, including any duty or responsibility to initiate any proceedings at law or otherwise, or to make any demand upon us.
Any holder of a warrant may, without the consent of the related warrant agent or the holder of any other warrant, enforce by appropriate
legal action the holder’s right to exercise, and receive the securities purchasable upon exercise of, its warrants in accordance
with their terms.
Warrant
Agreement Will Not Be Qualified Under Trust Indenture Act
No
warrant agreement will be qualified as an indenture, and no warrant agent will be required to qualify as a trustee, under the
Trust Indenture Act. Therefore, holders of warrants issued under a warrant agreement will not have the protection of the Trust
Indenture Act with respect to their warrants.
Governing
Law
Each
warrant agreement and any warrants issued under the warrant agreements will be governed by New York law.
DESCRIPTION
OF UNITS
We
may issue units comprised of one or more of the other securities described in this prospectus or any prospectus supplement in
any combination. Each unit will be issued so that the holder of the unit is also the holder, with the rights and obligations of
a holder, of each security included in the unit. The unit agreement under which a unit is issued may provide that the securities
included in the unit may not be held or transferred separately, at any time or at any times before a specified date or upon the
occurrence of a specified event or occurrence.
The
applicable prospectus supplement will describe:
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the
designation and the terms of the units and of the securities comprising the units, including whether and under what circumstances
those securities may be held or transferred separately;
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any
unit agreement under which the units will be issued;
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any
provisions for the issuance, payment, settlement, transfer or exchange of the units or of the securities comprising the units;
and
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whether
the units will be issued in fully registered or global form.
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PLAN
OF DISTRIBUTION
We
may sell the securities being offered pursuant to this prospectus to or through underwriters, through dealers, through agents,
or directly to one or more purchasers or through a combination of these methods. The applicable prospectus supplement will describe
the terms of the offering of the securities, including:
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the
name or names of any underwriters, if any, and if required, any dealers or agents;
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the
purchase price of the securities and the proceeds we will receive from the sale;
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any
underwriting discounts and other items constituting underwriters’ compensation;
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any
discounts or concessions allowed or reallowed or paid to dealers; and
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any
securities exchange or market on which the securities may be listed or traded.
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We
may distribute the securities from time to time in one or more transactions at:
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a
fixed price or prices, which may be changed;
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market
prices prevailing at the time of sale, directly by us or through a designated agent;
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prices
related to such prevailing market prices; or
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negotiated
prices.
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Only
underwriters named in the prospectus supplement are underwriters of the securities offered by the prospectus supplement.
If
underwriters are used in an offering, we will execute an underwriting agreement with such underwriters and will specify the name
of each underwriter and the terms of the transaction (including any underwriting discounts and other terms constituting compensation
of the underwriters and any dealers) in a prospectus supplement. The securities may be offered to the public either through underwriting
syndicates represented by managing underwriters or directly by one or more investment banking firms or others, as designated.
If an underwriting syndicate is used, the managing underwriter(s) will be specified on the cover of the prospectus supplement.
If underwriters are used in the sale, the offered securities will be acquired by the underwriters for their own accounts and may
be resold from time to time in one or more transactions, including negotiated transactions, at a fixed public offering price or
at varying prices determined at the time of sale. Any public offering price and any discounts or concessions allowed or reallowed
or paid to dealers may be changed from time to time. Unless otherwise set forth in the prospectus supplement, the obligations
of the underwriters to purchase the offered securities will be subject to conditions precedent, and the underwriters will be obligated
to purchase all of the offered securities, if any are purchased.
We
may grant to the underwriters options to purchase additional securities to cover over-allotments, if any, at the public offering
price, with additional underwriting commissions or discounts, as may be set forth in a related prospectus supplement. The terms
of any over-allotment option will be set forth in the prospectus supplement for those securities.
If
we use a dealer in the sale of the securities being offered pursuant to this prospectus or any prospectus supplement, we will
sell the securities to the dealer, as principal. The dealer may then resell the securities to the public at varying prices to
be determined by the dealer at the time of resale. The names of the dealers and the terms of the transaction will be specified
in a prospectus supplement.
We
may sell the securities directly or through agents we designate from time to time. We will name any agent involved in the offering
and sale of securities and we will describe any commissions we will pay the agent in the prospectus supplement. Unless the prospectus
supplement states otherwise, any agent will act on a best-efforts basis for the period of its appointment.
We
may authorize agents or underwriters to solicit offers by institutional investors to purchase securities from us at the public
offering price set forth in the prospectus supplement pursuant to delayed delivery contracts providing for payment and delivery
on a specified date in the future. We will describe the conditions to these contracts and the commissions we must pay for solicitation
of these contracts in the prospectus supplement.
In
connection with the sale of the securities, underwriters, dealers or agents may receive compensation from us or from purchasers
of the securities for whom they act as agents, in the form of discounts, concessions or commissions. Underwriters may sell the
securities to or through dealers, and those dealers may receive compensation in the form of discounts, concessions or commissions
from the underwriters or commissions from the purchasers for whom they may act as agents. Underwriters, dealers and agents that
participate in the distribution of the securities, and any institutional investors or others that purchase securities directly
for the purpose of resale or distribution, may be deemed to be underwriters, and any discounts or commissions received by them
from us and any profit on the resale of the common stock by them may be deemed to be underwriting discounts and commissions under
the Securities Act of 1933, as amended.
We
may provide agents, underwriters and other purchasers with indemnification against particular civil liabilities, including liabilities
under the Securities Act of 1933, as amended, or contribution with respect to payments that the agents, underwriters or other
purchasers may make with respect to such liabilities. Agents and underwriters may engage in transactions with, or perform services
for, us in the ordinary course of business.
To
facilitate the public offering of a series of securities, persons participating in the offering may engage in transactions that
stabilize, maintain, or otherwise affect the market price of the securities. This may include over-allotments or short sales of
the securities, which involves the sale by persons participating in the offering of more securities than have been sold to them
by us. In addition, those persons may stabilize or maintain the price of the securities by bidding for or purchasing securities
in the open market or by imposing penalty bids, whereby selling concessions allowed to underwriters or dealers participating in
any such offering may be reclaimed if securities sold by them are repurchased in connection with stabilization transactions. The
effect of these transactions may be to stabilize or maintain the market price of the securities at a level above that which might
otherwise prevail in the open market. Such transactions, if commenced, may be discontinued at any time. We make no representation
or prediction as to the direction or magnitude of any effect that the transactions described above, if implemented, may have on
the price of our securities.
Unless
otherwise specified in the applicable prospectus supplement, any common stock sold pursuant to a prospectus supplement will be
eligible for listing on the NYSE American, subject to official notice of issuance. Any underwriters to whom securities are sold
by us for public offering and sale may make a market in the securities, but such underwriters will not be obligated to do so and
may discontinue any market making at any time without notice.
In
order to comply with the securities laws of some states, if applicable, the securities offered pursuant to this prospectus will
be sold in those states only through registered or licensed brokers or dealers. In addition, in some states securities 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 complied with.
LEGAL
MATTERS
The
validity of the securities offered by this prospectus will be passed upon by Haynes and Boone, 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, 2017 have been so incorporated in reliance on the report (which contains an explanatory paragraph relating to the Company’s
ability to continue as a going concern as described in Note 1 to the financial statements) 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 Securities Exchange Act of 1934, as amended, and in accordance therewith
file annual, quarterly and current reports, proxy statements and other information with the Securities and Exchange Commission.
Such reports, proxy statements and other information can be read and copied at the Securities and Exchange Commission’s
public reference facilities at 100 F Street, N.E., Washington, D.C. 20549, at prescribed rates. Please call the Securities and
Exchange Commission at 1-800-732-0330 for further information on the operation of the public reference facilities. In addition,
the Securities and Exchange Commission maintains a website that contains reports, proxy and information statements and other information
regarding registrants that file electronically with the Securities and Exchange Commission. The address of the Securities and
Exchange Commission’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 Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after we electronically file such material
with or otherwise furnish it to the Securities and Exchange Commission.
We
have filed with the Securities and Exchange Commission a registration statement under the Securities Act of 1933, as amended,
relating to the offering of these securities. The registration statement, including the attached exhibits, contains additional
relevant information about us and the securities. This prospectus does not contain all of the information set forth in the registration
statement. You can obtain a copy of the registration statement, at prescribed rates, from the Securities and Exchange Commission
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
Securities and Exchange Commission allows us to “incorporate by reference” the information we have filed with it,
which means that we can disclose important information to you by referring you to those documents. The information we incorporate
by reference is an important part of this prospectus, and later information that we file with the Securities and Exchange Commission
will automatically update and supersede this information. We incorporate by reference the documents listed below and any future
documents (excluding information furnished pursuant to Items 2.02 and 7.01 of Form 8-K) we file with the Securities and Exchange
Commission pursuant to Sections l3(a), l3(c), 14 or l5(d) of the Securities Exchange Act of 1934, as amended, subsequent to the
date of this prospectus and prior to the termination of the offering:
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Our
Annual Report on Form 10-K for the fiscal year ended December 31, 2017, filed with the Securities and Exchange Commission
on February 13, 2018;
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Our
Current Report on Form 8-K, filed with the Securities and Exchange Commission on January 8, 2018 (two reports);
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Our
Current Report on Form 8-K, filed with the Securities and Exchange Commission on January 19, 2018;
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Our
Current Report on Form 8-K, filed with the Securities and Exchange Commission on January 26, 2018;
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Our
Current Report on Form 8-K, filed with the Securities and Exchange Commission on February 1, 2018;
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Our
Current Report on Form 8-K, filed with the Securities and Exchange Commission on February 7, 2018;
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Our
Current Report on Form 8-K, filed with the Securities and Exchange Commission on February 14, 2018;
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Our
Current Report on Form 8-K, filed with the Securities and Exchange Commission on February
20, 2018;
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Our
Current Report on Form 8-K, filed with the Securities and Exchange Commission on February
21, 2018; and
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The
description of our common stock, which is contained in our registration statement on Form 8-A, filed with the Securities and
Exchange Commission on March 12, 2013, as updated or amended in any amendment or report filed for such purpose.
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All
filings filed by us pursuant to the Securities Exchange Act of 1934, as amended, after the date of the initial filing of this
registration statement and prior to the effectiveness of such registration statement (excluding information furnished pursuant
to Items 2.02 and 7.01 of Form 8-K) shall also be deemed to be incorporated by reference into the prospectus.
You
should rely only on the information incorporated by reference or provided in this prospectus. We have not authorized anyone else
to provide you with different information. Any statement contained in a document incorporated by reference into this prospectus
will be deemed to be modified or superseded for the purposes of this prospectus to the extent that a later statement contained
in this prospectus or in any other document incorporated by reference into this prospectus modifies or supersedes the earlier
statement. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to constitute a part
of this prospectus. You should not assume that the information in this prospectus is accurate as of any date other than the date
of this prospectus or the date of the documents incorporated by reference in this prospectus.
We
will provide without charge to each person to whom a copy of this prospectus is delivered, upon written or oral request, a copy
of any or all of the reports or documents that have been incorporated by reference in this prospectus but not delivered with this
prospectus (other than an exhibit to these filings, unless we have specifically incorporated that exhibit by reference in this
prospectus). Any such request should be addressed to us at: 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.
Up
to $9,300,000
Common
Stock
PROSPECTUS
SUPPLEMENT
A.G.P.
July
28, 2020
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