NSPR InspireMD Inc New

InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of the stroke caused by carotid artery disease, today announces the formation of its Scientific Advisory Board with its newly appointed chair, acclaimed interventional cardiologist, Kenneth Rosenfield, M.D.

The Company intends for the Scientific Advisory Board to provide guidance and direction on clinical need, technology advancements and planning for the Company’s growth and strategic direction. 

Kenneth Rosenfield, M.D., is the Section Head for Vascular Medicine and Intervention and chairs the Acute Myocardial Infarction (STEMI) Committee for the cardiac cath lab at Massachusetts General Hospital. Dr. Rosenfield specializes in complex cardiac and vascular interventions.  He is past-president and a Master of SCAI, prior ACC Governor for Massachusetts, recipient of the AHA Laennec Master Clinician Award, and the distinguished Mason Sones Award.  Dr. Rosenfield has spearheaded the development of less-invasive therapies for patients with coronary and vascular disease, both at MGH and nationally, including treatment of Carotid, Kidney, and Leg artery narrowing using stents and other novel devices. He designed and served as national principal or co-principal investigator for numerous landmark clinical trials, including the Asymptomatic Carotid Trial (ACT 1), the SUPERB SFA stent trial, the LEVANT 2 and TRANSCEND drug-coated balloon trials, and the NIH BEST CLI trial.  A pioneer in carotid stenting, Dr. Rosenfield placed the first carotid stents in New England and has been deeply involved in virtually every major investigational carotid stent initiative.  He further led the effort to define qualifications, training and standards for carotid stenting, and initiated the effort to create a carotid registry that ultimately folded into the NIH CREST 2 trial as the CREST 2 Registry.

“InspireMD’s DNA is built on research and development and advancing new technologies -- such as our MicroNet® mesh used with our CGuard® EPS device -- into the market.  As our pipeline evolves and expands, we recognize the value that the esteemed physicians on this newly formed scientific advisory board bring toward validating and guiding our efforts toward the highest levels of clinical utility, physician acceptance and patient outcomes,” commented InspireMD’s CEO, Marvin Slosman.  “Dr. Rosenfield has been a pioneer in cardiovascular medicine and true supporter of CGuard EPS.  We are thrilled to have his support as we develop and launch new products into the market, while building the global reach for CGuard EPS in the U.S. and Asian markets.  We welcome him as the Chair of our Scientific Advisory Board and look forward to naming members and establishing this important strategic board to guide our success.”

“I firmly believe that CGuard EPS will establish a new standard of care in the treatment of carotid artery disease, based on a deep clinical body of evidence and its unique and proprietary design.  The opportunity to improve patient outcomes with carotid stenting is exciting and, with the momentum of the upcoming C-Guardian Trial and focus on the U.S. and other global markets, the future for carotid stenting is very bright.  It is a privilege to work with management and thought leaders in the industry to provide feedback, direction, and support of the plans of InspireMD.” added Dr. Rosenfield.

About The CGuard® EPS The CGuard® Embolic Protection System is an advanced platform solution designed to deliver the flexibility of the traditional open-cell stent with advanced protection from peri-procedural and post-procedural embolic events caused by plaque prolapse through the stent strut that can lead to stroke.  CGuard’s unique MicroNet® technology mitigates the prolapse and associated embolization and has shown superior clinical outcomes for patients against alternative carotid stent types, conventional and next-generation double-layer stents, as well as invasive procedures such as endarterectomy, a major surgical procedure.  InspireMD’s CGuard™ has created a new dimension in the protected treatment of carotid artery disease and has the potential to establish a new standard of care for the management of carotid artery disease and stroke prevention.

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.  For more information, visit www.inspiremd.com. InspireMD routinely posts information that may be important to investors in the Investors section of its website.

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) the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) 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 (xiv) 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