Advancing the CARENET-III study of CGuard System for Stroke Prevention
in the United States
Tel Aviv, Israel — September 10, 2020 – InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announced the addition of Dr. Christina Brennan as a strategic advisor to the company to assist with planning and execution of a pivotal study of the CGuard™ Carotid Stent System, CARENET-III, for prevention of stroke in patients in the United States. The company recently announced that it had received approval from the FDA for the company to proceed with this pivotal study.
“We are pleased to have Dr. Brennan join the team as we advance our efforts of planning and execution of the CARENET -III pivotal trial. Dr. Brennan brings a wealth of experience to InspireMD with specific expertise in vascular and stent related research and clinical trial development and execution,” said Marvin Slosman, InspireMD’s CEO. “Our expectations are to accelerate the planning and preparation efforts for our pivotal study with Dr. Brennan’s help.”
Christina Brennan, M.D. has devoted her career to clinical research and currently serves as Northwell Health’s vice president of clinical research. Committed to the advancement of science and medicine, Dr. Brennan has more than 20 years of extensive clinical research experience, including over 15 years in management roles. She is on the board of trustees for the Association of Clinical Research Professionals. She is the immediate past president of the NY Metropolitan Chapter of the Association of Clinical Research Professionals and she is an active member of the Clinical Trial Transformation Initiative (CCTI), with Duke University and the FDA, where she actively sits on some of their committees. She is on the leadership council for Society for Clinical Research Sites (SCRS), where she also sits on the oncology advisory board and technology site advocacy group. She is an adjunct professor for a Masters of Science program with Yeshiva University teaching a clinical trial & research management class. She is also an active member of the Women in Bio and the American College of Healthcare Executives.
Her clinical research interest is in carotid artery disease. She began her clinical research career 20 years ago working at Lenox Hill Hospital in NY alongside the internationally renowned interventional cardiologist and the pioneer of carotid artery stenting – Dr. Gary Roubin. For over 10 years she had the opportunity to have him as her mentor and work with him, Dr. Sriram Iyer and the late Dr. Jiri Vitek. Together they worked on many important carotid artery trials, including the global NIH CREST trial where over 2,500 subjects were recruited. They enrolled the first ACT I trial patient in which Abbott Vascular later went on to receive FDA approval of their X.ACT stent and embolic protection device.
Dr. Brennan also has authored chapters in textbooks, coauthored many manuscripts and abstracts, and has presented at numerous scientific and research meetings.
“We have an opportunity for CGuard EPS to create a paradigm shift in the field of carotid artery stenting, bringing it to the next level, and I look forward to bringing my years of expertise in the management and operations of carotid stent trials to the CARENET-III trial with InspireMD,” added Dr. Brennan.
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 or 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 with the potential to truly 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.
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 and NSPR.WSB.
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.
Chief Financial Officer