UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date of
Report (Date of earliest event reported): September 24, 2018
InspireMD,
Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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001-35731
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26-2123838
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(State
or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification
No.)
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321 Columbus
Avenue
Boston,
MA
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02116
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(Address of principal executive offices)
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(Zip Code)
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Registrant’s
telephone number, including area code: (857) 305-2410
(Former name or former address, if changed since
last report)
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
[ ]
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ]
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ]
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ]
Pre-commencement communications pursuant to Rule 13e-4 (c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 5.02
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Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
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On September 24, 2018,
InspireMD, Inc. (the “
Company
”) and Agustin Gago, the Company’s executive vice president and chief
commercial officer, entered into a General Release and Severance Agreement (the “
Separation Agreement
”),
pursuant to which the parties mutually agreed that Mr. Gago’s employment shall cease for all positions, offices and authority
with the Company, effective as of September 30, 2018 (the “
Separation Date
”). Mr. Gago fully and irrevocably
released and discharged the Company, including all of its affiliates, parent companies, subsidiary companies, employees, owners,
directors, officers, principals, agents, insurers, and attorneys from any and all claims arising or existing on, or at any time
prior to, the date the Separation Agreement was signed by him, and the Company agreed to pay severance payments, in an amount equal
to Mr. Gago’s base salary Mr. Gago would have earned if he had remained employed from the Separation Date through October
23, 2018, less applicable payroll deductions and tax withholdings, to be paid in equal installments in accordance with the Company’s
standard payroll practices; and (ii) additional severance payments, in an amount equal to $125,000, less applicable payroll deductions
and tax withholdings, to be paid in equal installments in accordance with the Company’s standard payroll practices, commencing
on the first payroll date following October 23, 2018 through March 23, 2019.
The foregoing summary of
the Separation Agreement is not complete and is qualified in its entirety by reference to the full text of the Separation Agreement,
a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
On September 24, 2018,
the Company issued a press release announcing that its CGuard™ Embolic Prevention System has been granted regulatory approval
by COFEPRIS (the Mexican Ministry of Health) for commercial sale in Mexico. A copy of such press release is attached to this Current
Report on Form 8-K as Exhibit 99.1 and is hereby incorporated by reference herein.
On
September 27, 2018, the Company issued a press release announcing that preliminary cumulative three-year follow-up safety, efficacy
and stroke prevention durability data from the PARADIGM-Extend trial of CGuard™ EPS was presented at the Cardiovascular
Research Foundation’s Transcatheter Cardiovascular Therapeutics (TCT) 2018 conference, which was held September 21-25 in
San Diego. A copy of such press release is attached to this Current Report on Form 8-K as Exhibit 99.2 and is hereby incorporated
by reference herein.
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Item 9.01
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Financial Statements and Exhibits.
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(d) Exhibits
SIGNATURES
Pursuant to the requirements
of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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InspireMD,
Inc.
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Date:
September 28, 2018
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By:
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/s/
Craig Shore
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Name:
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Craig
Shore
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Title:
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Chief
Financial Officer
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GENERAL
RELEASE AND SEVERANCE AGREEMENT
This
General Release and Severance Agreement (the “
Agreement
”), dated as of September 16, 2018, is made and
entered into by and between Agustin Gago (“
Executive
”) and InspireMD, Inc. (the “
Company
”).
For
good and valuable consideration, receipt of which is hereby acknowledged, in order to effect a mutually satisfactory and amicable
separation of employment from the Company and to resolve and settle finally, fully and completely all matters and disputes that
now or may exist between them, as set forth below, Executive and the Company agree as follows:
1.
Separation from Employment
. Effective September 30, 2018 (the “
Separation Date
”), Executive’s
employment with the Company shall cease based upon the mutual agreement of the parties hereto and he shall, as of the Separation
Date, relinquish all positions, offices, and authority with the Company. Executive acknowledges and agrees, except for the payments
described hereunder, Executive has no rights to any other wages and other compensation or remuneration of any kind due or owed
from the Company, including, but not limited, to all wages, reimbursements, bonuses (including for 2017 and 2018), advances, vacation
pay, severance pay, vested or unvested equity or stock options, awards, and any other incentive-based compensation or benefits
to which Executive was or may become entitled or eligible. Notwithstanding the foregoing, Executive shall (i) be reimbursed for
any expenses reasonably incurred by Executive at any time prior to the Separation Date in accordance with applicable Company reimbursement
policies and procedures, submitted for reimbursement on or before October 5, 2018; and (ii) receive payment for fifteen (15) accrued
but unused vacation days, less applicable payroll deductions and tax withholdings, to be paid within the time period required
by applicable law.
2.
Employment Agreement
. As of the Separation Date, the employment agreement between the parties dated October 18, 2016 (the
“
Employment Agreement
”) shall terminate forever and no party shall have any further obligation or liability
thereunder, except that Executive acknowledges and agrees that
ARTICLE IV RESTRICTIVE COVENANTS
of the Employment Agreement,
and all sections and provisions thereunder, shall remain in full force and effect in accordance with their terms. With respect
to the “Non-Disparagement” provisions set forth therein, the Company agrees to modify such provisions to also provide
that following the Separation Date, the members of the Company’s Board of Directors and Executive Committee shall not in
any way, directly or indirectly, disparage, libel or defame Executive.
3.
Consideration
. In consideration of this Agreement and the release herein becoming effective, and his compliance with his obligations
hereunder, the Company shall provide Executive with (i) severance payments, in an amount equal to his base salary he would have
earned if he had remained employed from the Separation Date through October 23, 2018, less applicable payroll deductions and tax
withholdings, to be paid in equal installments in accordance with the Company’s standard payroll practices; and (ii) additional
severance payments, in an amount equal to $125,000, less applicable payroll deductions and tax withholdings, to be paid in equal
installments in accordance with the Company’s standard payroll practices, commencing on the first payroll date following
October 23, 2018 through March 23, 2019.
4.
Transition Services
. Through the Separation Date, Executive shall only perform such services as the Chief Executive Officer
may reasonably request, including, without limitation, those relating to the transition of his positions, offices, authority,
duties, or responsibilities with the Company. Employee also agrees to assist with the execution of all documents and all other
instruments which the Chief Executive Officer shall deem necessary to accomplish any such transition.
5.
Release of Claims
. For and in consideration of the right to receive the consideration described in Section 3 of this Agreement,
Executive fully and irrevocably releases and discharges the Company, including all of its affiliates, parent companies, subsidiary
companies, employees, owners, directors, officers, principals, agents, insurers, and attorneys from any and all claims arising
or existing on, or at any time prior to, the date this Agreement is signed by Executive. Such released claims include, without
limitation, claims relating to or arising out of: (i) Executive’s hiring, compensation, benefits and employment with the
Company, (ii) Executive’s separation from employment with the Company, and (iii) all claims known or unknown or which could
or have been asserted by Executive against the Company, at law or in equity, or sounding in contract (express or implied) or tort,
including claims arising under any federal, state, or local laws of any jurisdiction that prohibit age, sex, race, national origin,
color, disability, religion, veteran, military status, pregnancy, sexual orientation, or any other form of discrimination, harassment,
or retaliation, including, without limitation, age discrimination claims under the Age Discrimination in Employment Act; the Americans
with Disabilities Act; claims under Title VII of the Civil Rights Act of 1964; the Rehabilitation Act; the Equal Pay Act; the
Family and Medical Leave Act, 42 U.S.C. §1981; the Civil Rights Act of 1991; the Civil Rights Act of 1866 and/or 1871; the
Sarbanes Oxley Act; the Executive Polygraph Protection Act; the Uniform Services and Employment and Re-Employment Rights Act;
the Worker Adjustment Retraining Notification Act; the National Labor Relations Act and the Labor Management Relations Act; the
New York State and City Human Rights Laws and any other similar or equivalent state laws; and any other federal, state, local,
municipal or common law whistleblower protection claim, discrimination or anti-retaliation statute or ordinance; claims arising
under the Executive Retirement Income Security Act; claims arising under the Fair Labor Standards Act; or any other statutory,
contractual or common law claims. Executive does not release Executive’s right to enforce the terms of this Agreement or
release his rights to defense and indemnity or to liability insurance coverage.
6.
Review and Consultation.
Executive acknowledges that: (a) this Agreement is written in terms and sets forth conditions in
a manner which he understands; (b) he has carefully read and understands all of the terms and conditions of this Agreement; (c)
he agrees with the terms and conditions of this Agreement; and (d) he enters into this Agreement knowingly and voluntarily. Executive
acknowledges that he does not waive rights or claims that may arise after the date this Agreement is executed, that he has been
given twenty-one (21) days from receipt of this Agreement in which to consider whether he wanted to sign it, that any modifications,
material or otherwise made to this Agreement do not restart or affect in any manner the original twenty-one (21) day consideration
period, and that the Company advises Executive to consult with an attorney before he signs this Agreement. The Company agrees,
and Executive represents that he understands, that he may revoke his acceptance of this Agreement at any time for seven (7) days
following his execution of the Agreement and must provide notice of such revocation by giving written notice to the Company. If
not revoked by written notice received on or before the eighth (8
th
) day following the date of his execution of the
Agreement, this Agreement shall be deemed to have become enforceable and on such eighth (8
th
) day.
7.
Confidentiality
. Executive agrees that he will keep both the fact of this Agreement and the terms of this Agreement confidential,
and will not disclose the fact of this Agreement or the terms of this Agreement to anyone other than the Executive’s spouse/registered
domestic partner, attorney or accountant/tax advisor, unless otherwise required to under applicable law or regulation after providing
reasonable notice in writing to the Company and a reasonable opportunity to challenge any such disclosure.
8.
Governing Law/Venue
. The parties agree that the Agreement shall be governed by and construed under the laws of the State of
New York. In the event of any dispute regarding this Agreement or Executive’s employment, the parties hereby irrevocably
agree to submit to the federal and state courts situated in New York, New York, and Executive agrees that he shall not challenge
personal or subject matter jurisdiction in such courts.
9.
Voluntary.
This Agreement is executed voluntarily and without any duress or undue influence on the part or behalf of the parties
hereto. The parties acknowledge that they have had ample opportunity to have this Agreement reviewed by the counsel of their choice.
10.
Acknowledgment
. Executive acknowledges and agrees that the severance payments and other consideration provided herein are
consideration to which Executive is not otherwise entitled except pursuant to the terms of this Agreement, and are being provided
in exchange for Executive’s compliance with his obligations set forth hereunder.
11.
No Admission of Liability
. This Agreement shall not in any way be construed as an admission by the Company or Executive of
any acts of wrongdoing or violation of any statute, law or legal right.
12.
Successors and Assigns
. This Agreement is binding upon, and shall inure to the benefit of the parties themselves, as well
as their respective representatives, successors, permitted assigns, heirs and estates.
13.
Sole Agreement and Severability
. Except as set forth herein, this Agreement is the sole, entire and complete agreement of
the parties relating in any way to the subject matter hereof. No statements, promises or representations have been made by any
party to any other party, or relied upon, and no consideration has been offered, promised, expected or held out other than as
expressly set forth herein, provided only that the release of claims in any prior agreement or release shall remain in full force
and effect. The covenants contained in this Agreement are intended by the parties hereto as separate and divisible provisions,
and in the event that any or all of the covenants expressed herein shall be determined by a court of competent jurisdiction to
be invalid or unenforceable, the remaining parts, terms or provisions of this Agreement shall not be affected and such provisions
shall remain in full force and effect.
SIGNATURE
PAGE FOLLOWS
PLEASE
READ CAREFULLY. THIS GENERAL RELEASE AND SEVERANCE AGREEMENT INCLUDES A RELEASE OF ANY AND ALL CLAIMS, KNOWN OR UNKNOWN, AGAINST
INSPIREMD, INC.
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INSPIREMD,
INC.
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AGUSTIN
GAGO
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By:
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/s/
James Barry
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/s/
Agustin Gago
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Title:
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President
& CEO
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Date:
9/16/2018
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Date:
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9/24/2018
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InspireMD
Announces Regulatory Approval of CGuard™ Embolic Prevention System in Mexico
Commercial
Launch to Occur Immediately
Tel
Aviv, Israel— September 24, 2018
– InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic
Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced that its
novel CGuard™ Embolic Prevention System (EPS) has been granted regulatory approval by COFEPRIS (the Mexican Ministry of
Health) for commercial sale in Mexico.
“The
expansion of our commercial footprint into new key geographies is a fundamental component of our growth strategy,” said
James Barry, PhD, Chief Executive Officer of InspireMD. “We are pleased to have received regulatory approval for the commercial
sale of CGuard EPS in Mexico, and very grateful for the support provided by our distribution partner, LevBeth Medical, throughout
this rigorous approval process.”
Mr.
Mauro Levinton, Managing Director of LevBeth Medical S.A. de C.V, noted, “We have been eagerly following the clinical data
being generated on CGuard™ as it continues to demonstrate its superiority over conventional stents, and we look forward
to launching this innovative product and technology and making it available to patients in Mexico who suffer from carotid artery
disease.”
About
InspireMD, Inc.
InspireMD
seeks to utilize its proprietary MicroNet
®
technology to make its products the industry standard for treatment
of carotid arter disease by providing outstanding acute results and durable stroke free long-term outcomes.
InspireMD’s
common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American
under the ticker symbol NSPR.WS.
Forward-looking
Statements
This
press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,”
“may,” “will,” “plans,” “expects,” “anticipates,” “projects,”
“predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”
or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are
subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot
be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking
statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance
of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability
to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much
larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities
and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third
party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering
our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and
foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need
to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive
or difficult to obtain and (xiii) 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. More detailed information about the Company and the risk factors
that may affect the realization of forward looking statements is set forth in the Company’s filings with the Securities
and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q.
Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov.
The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information,
future events or otherwise.
Investor
Contacts:
Craig
Shore
Chief
Financial Officer
InspireMD,
Inc.
888-776-6804
craigs@inspiremd.com
Jeremy
Feffer
LifeSci
Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.com
InspireMD
Announces Presentation of Preliminary Cumulative Three-Year CGuard™ EPS Safety and Efficacy Data at the Transcatheter Cardiovascular
Therapeutics 2018 Conference
Preliminary
Three-Year Data Continue to Show Unprecedented Safety, Efficacy and Durability of Stroke Prevention in Treating Carotid Artery
Stenosis
Tel
Aviv, Israel— September 27, 2018
– InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic
Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today announced that preliminary
cumulative three-year follow-up safety, efficacy and stroke prevention durability data from the PARADIGM-Extend trial of CGuard™
EPS was presented at the Cardiovascular Research Foundation’s Transcatheter Cardiovascular Therapeutics (TCT) 2018 conference,
which was held September 21-25 in San Diego.
Overall
cumulative data showed no stroke or stroke-related deaths between 24 and 36 months and the absence of any device related issues
in the first 93 of the 251 patients in the PARADIGM-Extend cohort.
PARADIGM-Extend
is the continuation of PARADIGM, an investigator-led clinical study evaluating the use of CGuard™ EPS in patients with symptomatic
or asymptomatic carotid artery stenosis (CAD) with increased stroke risk.
“These
preliminary three-year follow-up data continue to show very compelling safety, stroke prevention efficacy and long-term durability
of CGuard™ EPS in an all-comer symptomatic and asymptomatic carotid artery stenosis patient population with various stages
of disease progression,” said Prof. Piotr Musiałek, MD, Department of Cardiac and Vascular Diseases, John Paul II Hospital,
Kraków, Poland, and lead investigator in the PARADIGM-Extend trial. “The risk of stroke and other serious complications
post-procedure remains a significant consideration in the treatment of CAS, and these results reflect the sustained, long term
potential of CGuard™ EPS to significantly improve patient outcomes and evolve into the new standard of care.”
“We
are grateful to Prof. Musiałek for his continued interest in CGuard™ EPS for treating all his patients with carotid
artery disease, and we are pleased that the data from this investigator-led study continues to demonstrate strong safety and efficacy
up to 36 months post-procedure,” said James Barry, PhD, Chief Executive Officer of InspireMD. “With this latest presentation,
we are compiling a significant body of evidence suggesting that treatment with CGuard™ EPS could result in sustained, long
term normal vessel healing with no device-related issues. We look forward to the presentation of additional three-year data at
the 45th Annual Symposium on Vascular and Endovascular Issues, Techniques, Horizons (VEITHsymposium) in New York in November.”
The
poster, entitled “PARADIGM-Extend Prospective Academic Trial of the CGuard™ MicroNET-Covered Embolic Prevention Stent
in All-comer Symptomatic and Increased-Stroke-Risk Asymptomatic Carotid Stenosis: Cumulative 3-Year Evidence for Safety, Efficacy
and Stroke Prevention Durability,” was recognized by TCT as among the “Best of Moderated Endovascular Intervention
and Structural Heart Disease” poster presentations at this year’s conference.
InspireMD
previously reported two-year PARADIGM-Extend follow up data on 251 patients in May at the EuroPCR 2018.
About
the TCT Conference
Transcatheter
Cardiovascular Therapeutics (TCT) is the world’s largest and most important educational meeting specializing in interventional
cardiovascular medicine. For 30 years, TCT has been the center of cutting-edge educational content, showcasing the latest advances
in current therapies and clinical research.
About
InspireMD, Inc.
InspireMD
seeks to utilize its proprietary MicroNet
®
technology to make its products the industry standard for treatment
of carotid arter disease by providing outstanding acute results and durable stroke free long-term outcomes.
InspireMD’s
common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American
under the ticker symbol NSPR.WS.
Forward-looking
Statements
This
press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,”
“may,” “will,” “plans,” “expects,” “anticipates,” “projects,”
“predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”
or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are
subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot
be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking
statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance
of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability
to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much
larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities
and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third
party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering
our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and
foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need
to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive
or difficult to obtain and (xiii) 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. More detailed information about the Company and the risk factors
that may affect the realization of forward looking statements is set forth in the Company’s filings with the Securities
and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q.
Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov.
The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information,
future events or otherwise.
Investor
Contacts:
Craig
Shore
Chief
Financial Officer
InspireMD,
Inc.
888-776-6804
craigs@inspiremd.com
Jeremy
Feffer
LifeSci
Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.com