InspireMD Announces Successful First-in-Human Procedure Utilizing CGuard Prime, its Next Generation Carotid Artery Stent (CAS) Platform

Procedure performed as part of the company’s ongoing CGuardians U.S. Investigational Device Exemption (IDE) trial designed to support potential U.S. marketing approval of the CGuard stent system.

CGuardians enrollment on track to be completed by the end of Q2 2023

Tel Aviv, Israel — May 1, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the first carotid artery disease patient has been treated utilizing CGuard Prime, the company’s next generation CAS stent platform. The procedure was performed by Dr. Anish Thomas of Mercy Hospital South in St. Louis, MO, as part of InspireMD’s ongoing CGuardians U.S. IDE trial.

Marvin Slosman, chief executive officer of InspireMD, stated, “We are very pleased to have achieved this remarkable milestone – the successful first-in-human stenting procedure using CGuard Prime – as the final step in a lengthy development process as we work to advance new technology to build on our well established CGuard stent performance. I am very proud of the entire InspireMD organization for their tireless work building this platform and I would like to thank Dr. Anish Thomas and his staff for their leadership in performing these procedures. Our next generation feature set incorporated into CGuard Prime provides physicians with greater capabilities and confidence in the deployment of CGuard, our third generation MicroNet mesh protected stent. I am excited for our future as we continue to innovate and provide advanced technologies.”

Dr. Anish Thomas, cardiologist at Mercy Hospital South, St. Louis, added, “The favorable post-procedural short- and long-term patient outcomes for carotid artery disease patients treated with CGuard EPS have been well documented across a number of rigorously designed clinical studies. With the advanced features of the CGuard Prime CAS delivery system, including its innovative handle design, and catheter and tip construction, the ease of stent trackability and deployment have been taken to the next level, which should only accelerate its uptake among interventionalists and surgeons alike. I am delighted to have successfully performed the first case with CGuard Prime, and I am pleased to play a continuing role in advancing this novel stent technology toward potential FDA approval.”

InspireMD anticipates completing enrollment in the CGuardians U.S. IDE trial by the end of the second quarter 2023. The company will provide an additional update on this and other recent developments during its regularly scheduled Q1 2023 earnings conference call.

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.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. 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 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; 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; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; 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; 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; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; 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; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. 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