As
filed with the Securities and Exchange Commission on February 21, 2018
Registration
No. 333-
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
S-3
REGISTRATION
STATEMENT UNDER THE SECURITIES ACT OF 1933
InspireMD,
Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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26-2123838
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(State
or other jurisdiction of
incorporation
or organization)
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(I.R.S.
Employer
Identification
Number)
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4
Menorat Hamaor. St.
Tel
Aviv, Israel 6744832
(888)
776-6804
(Address,
including zip code, and telephone number, including area code, of registrant’s principal executive offices)
James
Barry, Ph.D.
President
and Chief Executive Officer
InspireMD,
Inc.
4
Menorat Hamaor. St.
Tel
Aviv, Israel 6744832
(888)
776-6804
(Name,
address, including zip code, and telephone number, including area code, of agent for service)
Copies
of all communications, including communications sent to agent for service, should be sent to:
Rick
A. Werner, Esq.
Jayun
Koo, Esq.
Haynes and Boone, LLP
30 Rockefeller Plaza, 26
th
Floor
New York, New York 10112
Tel. (212) 659-7300
Fax (212) 884-8234
Approximate
date of commencement of proposed sale to the public:
From time to time after this Registration Statement becomes effective.
If
the only securities being registered on this Form are being offered pursuant to dividend or interest reinvestment plans, please
check the following box: [ ]
If
any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under
the Securities Act of 1933, other than securities offered only in connection with dividend or interest reinvestment plans, check
the following box: [X]
If
this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please
check the following box and list the Securities Act registration statement number of the earlier effective registration statement
for the same offering. [ ]
If
this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list
the Securities Act registration statement number of the earlier effective registration statement for the same offering. [ ]
If
this Form is a registration statement filed pursuant to General Instruction I.D. or a post-effective amendment thereto that shall
become effective upon filing with the Commission pursuant to Rule 462(e) under the Securities Act, check the following box. [ ]
If
this Form is a post-effective amendment to a registration statement filed pursuant to General Instruction I.D. filed to register
additional securities or additional classes of securities pursuant to Rule 413(b) under the Securities Act, check the following
box. [ ]
Indicate
by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller
reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
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Large
accelerated filer
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[ ]
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Accelerated
filer
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[ ]
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Non-accelerated
filer
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[ ]
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(Do
not check if a smaller reporting company)
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Smaller
reporting company
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[X]
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Emerging
Growth company
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[ ]
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If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided to Section 7(a)(2)(B) of the Securities Act. [ ]
CALCULATION
OF REGISTRATION FEE
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Title
of each class of securities to be registered(1)
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Proposed
maximum
aggregate
offering
price (2)
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Amount
of registration fee (3)
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Common Stock, $0.0001 par value per share
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$
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—
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$
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—
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Preferred Stock, $0.0001 par value per share
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—
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—
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Warrants
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—
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—
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Units
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—
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—
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Total
Offering
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$
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30,000,000
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$
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3,735
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(1)
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There
are being registered hereunder such indeterminate number of shares of common stock and preferred stock, such indeterminate
number of warrants to purchase common stock or preferred stock, and such indeterminate number of units as shall have an aggregate
initial offering price not to exceed $30,000,000, less the aggregate dollar amount of all securities previously sold hereunder.
Any securities registered hereunder may be sold separately or as units with the other securities registered hereunder. The
proposed maximum offering price per unit will be determined, from time to time, by the registrant in connection with the issuance
by the registrant of the securities registered hereunder. The securities registered hereunder also include such indeterminate
number of shares of common stock and preferred stock as may be issued upon conversion of or exchange for preferred stock that
provide for conversion or exchange, upon exercise of warrants or pursuant to the antidilution provisions of any of such securities.
In addition, pursuant to Rule 416 under the Securities Act, the shares being registered hereunder include such indeterminate
number of shares of common stock and preferred stock as may be issuable with respect to the shares being registered hereunder
as a result of stock splits, stock dividends or similar transactions.
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(2)
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The
proposed maximum offering price per security will be determined from time to time by the registrant in connection with, and
at the time of, the issuance of the securities and is not specified as to each class of security pursuant to General Instruction
II.D. of Form S-3, as amended.
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(3)
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Calculated
pursuant to Rule 457(o) under the Securities Act based on the proposed maximum aggregate offering price of all securities
listed.
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THE
REGISTRANT HEREBY AMENDS THIS REGISTRATION STATEMENT ON SUCH DATE OR DATES AS MAY BE NECESSARY TO DELAY ITS EFFECTIVE DATE UNTIL
THE REGISTRANT SHALL FILE A FURTHER AMENDMENT WHICH SPECIFICALLY STATES THAT THIS REGISTRATION STATEMENT SHALL THEREAFTER BECOME
EFFECTIVE IN ACCORDANCE WITH SECTION 8(a) OF THE SECURITIES ACT OF 1933, AS AMENDED, OR UNTIL THE REGISTRATION STATEMENT SHALL
BECOME EFFECTIVE ON SUCH DATE AS THE SECURITIES AND EXCHANGE COMMISSION, ACTING PURSUANT TO SAID SECTION 8(a), MAY DETERMINE.
The
information in this prospectus is not complete and may be changed. We may not sell these securities until the registration statement
filed with the Securities and Exchange Commission is effective. This prospectus is not an offer to sell these securities and it
is not soliciting an offer to buy these securities in any state where the offer or sale is not permitted.
SUBJECT
TO COMPLETION, DATED
February
21, 2018
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 , 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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|if
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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●
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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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●
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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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●
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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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●
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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.
$30,000,000
COMMON
STOCK
PREFERRED
STOCK
WARRANTS
UNITS
PROSPECTUS
PART
II
INFORMATION
NOT REQUIRED IN PROSPECTUS
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Item
14.
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Other
Expenses of Issuance and Distribution.
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The
fees and expenses payable by us in connection with this registration statement are estimated as follows:
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Securities
and Exchange Commission Registration Fee
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$
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3,735
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Accounting
Fees and Expenses
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15,000
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Legal
Fees and Expenses
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20,000
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Printing
Fees and Expenses
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-
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Transfer
Agent Fees and Expenses
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3,000
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Miscellaneous
Fees and Expenses
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5,000
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Total
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$
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46,735
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Item
15.
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Indemnification
of Directors and Officers.
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Section
145 of the General Corporation Law of the State of Delaware provides, in general, that a corporation incorporated under the laws
of the State of Delaware, as we are, may indemnify any person who was or is a party or is threatened to be made a party to any
threatened, pending or completed action, suit or proceeding (other than a derivative action by or in the right of the corporation)
by reason of the fact that such person is or was a director, officer, employee or agent of the corporation, or is or was serving
at the request of the corporation as a director, officer, employee or agent of another enterprise, against expenses (including
attorneys’ fees), judgments, fines and amounts paid in settlement actually and reasonably incurred by such person in connection
with such action, suit or proceeding if such person acted in good faith and in a manner such person reasonably believed to be
in or not opposed to the best interests of the corporation and, with respect to any criminal action or proceeding, had no reasonable
cause to believe such person’s conduct was unlawful. In the case of a derivative action, a Delaware corporation may indemnify
any such person against expenses (including attorneys’ fees) actually and reasonably incurred by such person in connection
with the defense or settlement of such action or suit if such person acted in good faith and in a manner such person reasonably
believed to be in or not opposed to the best interests of the corporation, except that no indemnification will be made in respect
of any claim, issue or matter as to which such person will have been adjudged to be liable to the corporation unless and only
to the extent that the Court of Chancery of the State of Delaware or any other court in which such action was brought determines
such person is fairly and reasonably entitled to indemnity for such expenses.
Our
certificate of incorporation and bylaws provide that we will indemnify our directors, officers, employees and agents to the extent
and in the manner permitted by the provisions of the General Corporation Law of the State of Delaware, as amended from time to
time, subject to any permissible expansion or limitation of such indemnification, as may be set forth in any stockholders’
or directors’ resolution or by contract. Any repeal or modification of these provisions approved by our stockholders will
be prospective only and will not adversely affect any limitation on the liability of any of our directors or officers existing
as of the time of such repeal or modification.
We
are also permitted to apply for insurance on behalf of any director, officer, employee or other agent for liability arising out
of his actions, whether or not the General Corporation Law of the State of Delaware would permit indemnification.
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Exhibit
No.
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Description
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1.1*
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Form
of Underwriting Agreement
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3.1
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Amended
and Restated Certificate of Incorporation (incorporated by reference to Exhibit 3.1 to Quarterly Report on Form 10-Q filed
with the Securities and Exchange Commission on November 9, 2015)
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3.2
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Amended
and Restated Bylaws (incorporated by reference to Exhibit 3.2 to Current Report on Form 8-K filed with the Securities and
Exchange Commission on April 1, 2011)
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3.3
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Certificate
of Designation, Preferences and Rights of Series A Preferred Stock (incorporated by reference to Exhibit 3.1 to Current Report
on Form 8-K filed with the Securities and Exchange Commission on October 25, 2013)
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3.4
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Certificate
of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit
3.1 to the Current Report on Form 8-K filed on May 25, 2016)
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3.5
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Certificate
of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (incorporated by reference to
Exhibit 3.5 to the Quarterly Report on Form 10-Q filed on August 9, 2016)
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3.6
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Certificate
of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit
3.1 to the Current Report on Form 8-K filed on September 29, 2016)
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3.7
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Certificate
of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock (incorporated by reference to
Exhibit 3.1 to the Current Report on Form 8-K filed on March 15, 2017)
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3.8
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Certificate
of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series C Convertible Preferred Stock (incorporated
by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on November 29, 2017)
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3.9
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Certificate
of Designation of Preferences, Rights and Limitation of Series D Convertible Preferred Stock (incorporated by reference to
Exhibit 3.1 to the Current Report on Form 8-K filed on December 4, 2017)
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3.10
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Certificate
of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series B Convertible Preferred Stock (incorporated
by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on December 12, 2017)
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3.11
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Certificate
of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series B Convertible Preferred Stock (incorporated
by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on December 22, 2017)
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3.12
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Certificate
of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit
3.1 to the Current Report on Form 8-K filed on February 7, 2018)
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3.13*
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Certificate
of Designation of Preferred Stock
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4.1
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Form
of Common Stock Certificate (incorporated by reference to Exhibit 4.1 to Amendment No. 3 to Registration Statement on Form
S-1 filed with the Securities and Exchange Commission on March 5, 2013)
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*
To be filed as an exhibit to a Current Report of the registrant on Form 8-K or other document to be incorporated herein by reference.
**
Filed herewith.
The
undersigned registrant hereby undertakes:
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(a)
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(1)
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To
file, during any period in which offers or sales are being made, a post-effective amendment to this registration statement:
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(i)
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To
include any prospectus required by Section 10(a)(3) of the Securities Act of 1933;
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(ii)
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To
reflect in the prospectus any facts or events arising after the effective date of the registration statement (or the most
recent post-effective amendment thereof) which, individually or in the aggregate, represent a fundamental change in the information
set forth in the registration statement. Notwithstanding the foregoing, any increase or decrease in volume of securities offered
(if the total dollar value of securities offered would not exceed that which was registered) and any deviation from the low
or high end of the estimated maximum offering range may be reflected in the form of prospectus filed with the Commission pursuant
to Rule 424(b) if, in the aggregate, the changes in volume and price represent no more than a 20% change in the maximum aggregate
offering price set forth in the “Calculation of Registration Fee” table in the effective registration statement;
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(iii)
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To
include any material information with respect to the plan of distribution not previously disclosed in the registration statement
or any material change to such information in the registration statement;
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provided,
however,
that the undertakings set forth in paragraphs (a)(1)(i), (a)(1)(ii) and (a)(1)(iii) above do not apply if the information
required to be included in a post-effective amendment by those paragraphs is contained in reports filed with or furnished to the
Commission by the registrant pursuant to section 13 or section 15(d) of the Securities Exchange Act of 1934 that are incorporated
by reference in the registration statement, or is contained in a form of prospectus filed pursuant to Rule 424(b) that is part
of the registration statement.
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(2)
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That,
for the purpose of determining any liability under the Securities Act of 1933, each such post-effective amendment shall be
deemed to be a new registration statement relating to the securities offered therein, and the offering of such securities
at that time shall be deemed to be the initial bona fide offering thereof.
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(3)
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To
remove from registration by means of a post-effective amendment any of the securities being registered which remain unsold
at the termination of the offering.
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(4)
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That,
for the purpose of determining liability under the Securities Act of 1933 to any purchaser:
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(i)
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If
the registrant is relying on Rule 430B (§230.430B of this chapter):
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(A)
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Each
prospectus filed by the registrant pursuant to Rule 424(b)(3) shall be deemed to be part of the registration statement as
of the date the filed prospectus was deemed part of and included in the registration statement; and
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(B)
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Each
prospectus required to be filed pursuant to Rule 424(b)(2), (b)(5), or (b)(7) as part of a registration statement in reliance
on Rule 430B relating to an offering made pursuant to Rule 415(a)(1)(i), (vii), or (x) for the purpose of providing the information
required by section 10(a) of the Securities Act of 1933 shall be deemed to be part of and included in the registration statement
as of the earlier of the date such form of prospectus is first used after effectiveness or the date of the first contract
of sale of securities in the offering described in the prospectus. As provided in Rule 430B, for liability purposes of the
issuer and any person that is at that date an underwriter, such date shall be deemed to be a new effective date of the registration
statement relating to the securities in the registration statement to which that prospectus relates, and the offering of such
securities at that time shall be deemed to be the initial bona fide offering thereof.
Provided, however
, that no statement
made in a registration statement or prospectus that is part of the registration statement or made in a document incorporated
or deemed incorporated by reference into the registration statement or prospectus that is part of the registration statement
will, as to a purchaser with a time of contract of sale prior to such effective date, supersede or modify any statement that
was made in the registration statement or prospectus that was part of the registration statement or made in any such document
immediately prior to such effective date.
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(ii)
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If
the registrant is subject to Rule 430C, each prospectus filed pursuant to Rule 424(b) as part of a registration statement
relating to an offering, other than registration statements relying on Rule 430B or other than prospectuses filed in reliance
on Rule 430A, shall be deemed to be part of and included in the registration statement as of the date it is first used after
effectiveness. Provided, however, that no statement made in a registration statement or prospectus that is part of the registration
statement or made in a document incorporated or deemed incorporated by reference into the registration statement or prospectus
that is part of the registration statement will, as to a purchaser with a time of contract of sale prior to such first use,
supersede or modify any statement that was made in the registration statement or prospectus that was part of the registration
statement or made in any such document immediately prior to such date of first use.
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(5)
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That,
for the purpose of determining liability of the registrant under the Securities Act of 1933 to any purchaser in the initial
distribution of the securities: The undersigned registrant undertakes that in a primary offering of securities of the undersigned
registrant pursuant to this registration statement, regardless of the underwriting method used to sell the securities to the
purchaser, if the securities are offered or sold to such purchaser by means of any of the following communications, the undersigned
registrant will be a seller to the purchaser and will be considered to offer or sell such securities to such purchaser:
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(i)
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Any
preliminary prospectus or prospectus of the undersigned registrant relating to the offering required to be filed pursuant
to Rule 424;
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(ii)
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Any
free writing prospectus relating to the offering prepared by or on behalf of the undersigned registrant or used or referred
to by the undersigned registrant;
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(iii)
|
The
portion of any other free writing prospectus relating to the offering containing material information about the undersigned
registrant or its securities provided by or on behalf of the undersigned registrant; and
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(iv)
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Any
other communication that is an offer in the offering made by the undersigned registrant to the purchaser.
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(b)
The undersigned registrant hereby undertakes that, for purposes of determining any liability under the Securities Act of 1933,
each filing of the registrant’s annual report pursuant to section 13(a) or section 15(d) of the Securities Exchange Act
of 1934 (and, where applicable, each filing of an employee benefit plan’s annual report pursuant to section 15(d) of the
Securities Exchange Act of 1934) that is incorporated by reference in the registration statement shall be deemed to be a new registration
statement relating to the securities offered therein, and the offering of such securities at that time shall be deemed to be the
initial bona fide offering thereof.
(c)
Insofar as indemnification for liabilities arising under the Securities Act of 1933 may be permitted to directors, officers and
controlling persons of the registrant pursuant to the foregoing provisions, or otherwise, the registrant has been advised that
in the opinion of the Securities and Exchange Commission such indemnification is against public policy as expressed in the Act
and is, therefore, unenforceable. In the event that a claim for indemnification against such liabilities (other than the payment
by the registrant of expenses incurred or paid by a director, officer or controlling person of the registrant in the successful
defense of any action, suit or proceeding) is asserted by such director, officer or controlling person in connection with the
securities being registered, the registrant will, unless in the opinion of its counsel the matter has been settled by controlling
precedent, submit to a court of appropriate jurisdiction the question whether such indemnification by it is against public policy
as expressed in the Act and will be governed by the final adjudication of such issue.
(d)
The undersigned registrant hereby undertakes that:
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|
(1)
|
For
purposes of determining any liability under the Securities Act of 1933, the information omitted from the form of prospectus
filed as part of this registration statement in reliance upon Rule 430A and contained in a form of prospectus filed by the
registrant pursuant to Rule 424(b)(1) or (4) or 497(h) under the Securities Act shall be deemed to be part of this registration
statement as of the time it was declared effective.
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(2)
|
For
the purpose of determining any liability under the Securities Act of 1933, each post-effective amendment that contains a form
of prospectus shall be deemed to be a new registration statement relating to the securities offered therein, and the offering
of such securities at that time shall be deemed to be the initial bona fide offering thereof.
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SIGNATURES
Pursuant
to the requirements of the Securities Act of 1933, the registrant certifies that it has reasonable grounds to believe that it
meets all of the requirements for filing on Form S-3 and has duly caused this registration statement to be signed on its behalf
by the undersigned, thereunto duly authorized, in the City of Boston, Commonwealth of Massachusetts, on February 21, 2018.
|
|
INSPIREMD,
INC.
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By:
|
/s/
James Barry
|
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Name:
|
James
Barry, Ph.D.
|
|
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Title:
|
Chief
Executive Officer
|
Power
of Attorney
Each
person whose signature appears below hereby appoints each of James Barry Ph.D. and Craig Shore, severally, acting alone and without
the other, his or her true and lawful attorney-in-fact, with full power of substitution, and with the authority to execute in
the name of each such person, any and all amendments (including without limitation, post-effective amendments) to this registration
statement on Form S-3, to sign any and all additional registration statements relating to the same offering of securities as this
registration statement that are filed pursuant to Rule 462(b) of the Securities Act of 1933, and to file such registration statements
with the Securities and Exchange Commission, together with any exhibits thereto and other documents therewith, necessary or advisable
to enable the registrant to comply with the Securities Act of 1933, and any rules, regulations and requirements of the Securities
and Exchange Commission in respect thereof, which amendments may make such other changes in the registration statement as the
aforesaid attorney-in-fact executing the same deems appropriate.
Pursuant
to the requirements of the Securities Act of 1933, this registration statement has been signed by the following persons in the
capacities and on the dates indicated.
|
Signature
|
|
Title
|
|
Date
|
|
/s/
James Barry
|
|
President,
Chief Executive Officer and Director
|
|
February
21, 2018
|
|
James
Barry, Ph.D.
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|
(principal
executive officer)
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/s/
Craig Shore
|
|
Chief
Financial Officer, Chief Administrative Officer, Secretary and Treasurer
|
|
February
21, 2018
|
|
Craig
Shore
|
|
(principal
financial and accounting officer)
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/s/
Paul Stuka
|
|
Chairman
of the Board of Directors
|
|
February
21, 2018
|
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Paul
Stuka
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/s/
Michael Berman
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|
Director
|
|
February
21, 2018
|
|
Michael
Berman
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/s/
Thomas J. Kester
|
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Director
|
|
February
21, 2018
|
|
Thomas
J. Kester
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/s/
Campbell Rogers, M.D.
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Director
|
|
February
21, 2018
|
|
Campbell
Rogers, M.D.
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