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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): March 15, 2023

 

InspireMD, Inc.

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware

(State or Other Jurisdiction of Incorporation)

 

001-35731   26-2123838

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

4 Menorat Hamaor St.

Tel Aviv, Israel

  6744832
(Address of Principal Executive Offices)   (Zip Code)

 

(888) 776-6804

(Registrant’s Telephone Number, Including Area Code)

 

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))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of each exchange on which registered
Common Stock, par value $0.0001 per share   NSPR   The Nasdaq Capital Market LLC

 

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

   
 

 

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

 

On March 19, 2023, InspireMD, Inc. (the “Company”), announced that its Board of Directors (the “Board”) promoted Andrea Tommasoli to Chief Operating Officer of the Company, effective as of March 19, 2023.

 

Prior to Mr. Tommasoli’s appointment, he served as Senior Vice President of Global Sales and Marketing since November 2020 and brings over two decades of life sciences industry experience to the Company. Prior to joining the Company, Mr. Tommasoli held commercial leadership positions at Integra LifeSciences, a medical device manufacturing company that manufactures products for skin regeneration, neurosurgery, reconstructive and general surgery, from 2011 to 2020, serving as the Senior Director of Indirect Markets from January 2017 to October 2020, as Director of Sales for Specialty Surgical Solutions Europe from June 2014 to December 2016 and as Director of Sales for Neurosurgery EMEA from July 2011 to June 2014. Prior to joining Integra, Mr. Tommasoli was a Managing Partner at Alticare, an independent company focusing on start-ups and growth companies in the medtech business from 2009 to 2011 and was the Director of St. Jude Medical Neuromodulation division in France from 2007 to 2009. Mr. Tommasoli has vast experience in commercializing innovative medical technology solutions that improve and advance standard of care. Mr. Tommasoli received his B.A. in nuclear engineering from Bologna University, Italy and his M.B.A. from HEC Paris, France.

 

There are no arrangements or understandings between Mr. Tommasoli and any other person pursuant to which Mr. Tommasoli was appointed to serve as the Chief Operating Officer of the Company. There are no family relationships between Mr. Tommasoli and any of the Company’s directors or executive officers. Mr. Tommasoli has no direct or indirect material interest in any existing or currently proposed transaction that would require disclosure under Item 404(a) of Regulation S-K.

 

Mr. Tommasoli is party to an Employment Contract with the Company (the “Agreement”), which took effect on November 2, 2020. Following his promotion, Mr. Tommasoli will receive an annual base salary of 240,000 Euros (approximately $258,000) and is entitled to a yearly gross bonus of 35% of his base salary, which will be based on the Board’s assessment of Mr. Tommasoli’s individual performance and the overall performance of the Company. Mr. Tommasoli’s remuneration is subject to deduction of the employee’s share of social contributions, and CSG and CRDS. The Agreement was entered into for an indefinite period, and it may be terminated at any time by either the Company or Mr. Tommasoli with a six months’ notice period; however, no notice period applies in case of serious or gross misconduct. The Agreement further provides for standard benefits, such as reimbursement of business expenses, professional vehicle expenses and participation in the Company’s employee benefit plans and programs. The Agreement also contains certain standard confidentiality requirements.

 

The foregoing description of the Agreement is only a summary and is qualified in its entirety by reference to the complete terms and conditions of the Agreement, a copy of which will be filed as an exhibit to the Company’s Annual Report on Form 10-K for the year ending December 31, 2022.

 

Item 7.01. Regulation FD Disclosures

 

On March 20, 2023, the Company issued a press release announcing the appointment of Mr. Tommasoli as the Company’s Chief Operating Officer and providing related information, a copy of which is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number   Description
99.1   Press release, dated March 20, 2023
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

   
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  INSPIREMD, INC.
     
Date: March 20, 2023 By: /s/ Craig Shore
  Name: Craig Shore
  Title: Chief Financial Officer

 

   

 

 

 

 

Exhibit 99.1

 

 

 

InspireMD Announces Promotion of Andrea Tommasoli to Chief Operating Officer

 

Mr. Tommasoli formerly served as the Company’s Senior Vice President of Global Sales & Marketing since 2020 and has significant prior commercial leadership experience at Integra LifeSciences and St. Jude Medical

 

Tel Aviv, Israel — March 20, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has promoted Andrea Tommasoli to Chief Operating Officer. Mr. Tommasoli formerly served as the Company’s Senior Vice President of Global Sales & Marketing since joining InspireMD in November 2020.

 

“Andrea has been instrumental in expanding the footprint of CGuard EPS across our approved markets in the EU and, as we advance toward potential U.S. approval with our ongoing U.S. Investigational Device Exemption (IDE) clinical trial, and as our business requirements shift toward operational capacity to support our commercial growth, we believe his background and skill set make him an ideal candidate to assume the role of Chief Operating Officer of the Company at this important time.” Stated Marvin Slosman, Chief Executive Officer of InspireMD. “On behalf of the entire InspireMD team, I would like to congratulate Andrea on this promotion and look forward to his continued contributions.”

 

“I joined InspireMD because of the tremendous potential of the CGuard EPS stent platform in changing the standard of care for Carotid revascularization through our proprietary MicroNet™ technology,” stated Mr. Tommasoli. “As the needs of the business grow beyond European commercialization, I am pleased to be able to play a more significant leadership role with broader responsibilities to drive scalability and operational efficiency to meet our anticipated growth needs. I am highly confident in the Company’s ability to meet these ever-expanding drivers of growth and look forward to serving in this important role.”

 

Mr. Tommasoli joined InspireMD from Integra LifeSciences (Nasdaq: IART), where he served in several senior commercial leadership roles, most recently as Senior Sales Director – Indirect Markets, where he led the commercial expansion and integration of Codman’s acquired portfolio in all OUS indirect countries. Before that, Mr. Tommasoli ran Integra’s Neurosurgery and Instruments business in direct sales countries in Europe. Prior to Integra, Mr. Tommasoli was the Director of St. Jude Medical’s (part of Abbott, NYSE: ABT) Neuromodulation division in France. Mr. Tommasoli received his B.A. in nuclear engineering from Bologna University, Italy and his M.B.A. from HEC Paris, France.

 

About InspireMD, Inc.

 

InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.

 

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

 

   
 

 

 

 

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”, “scheduled” 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

 

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com