InspireMD Appoints Leading Interventional Cardiologist Chris Metzger, M.D. as Principal Investigator for CGuard Registration Trial in the United States
InspireMD (NYSE American: NSPR) has appointed Dr. Chris Metzger as the principal investigator for its upcoming FDA registration trial for the CGuard™ Embolic Prevention System (EPS). Dr. Metzger brings extensive clinical trial experience and is expected to provide significant leadership for the study. The CGuard EPS aims to address stroke prevention related to carotid artery disease, leveraging its unique MicroNet technology. InspireMD's CEO, Marvin Slosman, emphasized the importance of Dr. Metzger's role in ensuring the trial's success, which could potentially establish CGuard as a new standard in carotid artery management.
- Appointment of Dr. Chris Metzger as principal investigator enhances credibility and leadership for the FDA trial.
- CGuard's MicroNet technology shows promise in improving patient outcomes in stroke prevention.
- Dependence on successful FDA trial outcomes poses significant risk to future market acceptance and revenue.
- Existing uncertainties regarding regulatory approvals could delay product launch and financial performance.
TEL AVIV, Israel, Feb. 09, 2021 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, announced today the appointment of Chris Metzger, M.D., system chair of clinical research at Ballad Health System in Eastern Tennessee as the principal investigator for its planned FDA registration trial for CGuard EPS.
“InspireMD is extremely fortunate to have Chris Metzger enthusiastically agree to shepherd the CGuard clinical trial. Chris is an extremely skilled, high volume cardiovascular and carotid stent operator. He is also a highly regarded mentor and educator. His vast clinical trial experience will bring strong leadership to this landmark FDA study," stated Gary Roubin, M.D., Ph.D., InspireMD Director and internationally renowned interventional cardiologist recognized for his pioneering work in carotid stenting and embolic and protection devices.
Dr. Metzger currently serves as medical director of the Interventional and Diagnostic Catheterization Labs at Holston Valley Medical Center and medical director of clinical research at Ballard Health Systems, both located in Eastern Tennessee and Southwestern Virginia. Dr. Metzger is widely published and has participated in more than 100 clinical studies, in most of which he served as principal investigator.
“Following a close review of the extensive European experience and clinical outcomes, I’m looking forward to participating in the upcoming U.S. pivotal trial for CGuard. There remains a significant need to address stroke prevention in the United States and based on CGuard’s protective MicroNet technology, I’m intrigued with the potential for success here,” commented Dr. Metzger.
“The appointment of Chris Metzger as our principal investigator is an important step toward the initiation of our pivotal clinical trial for CGuard in the United States. We are confident that connecting the study to such a well-respected and experienced practitioner will help guide the continued development and execution of the study to a successful conclusion, reflective of the results we have seen internationally. We are grateful to Dr. Metzger for his collaboration and look forward to providing updates on the trial’s development,” added Marvin Slosman, CEO of InspireMD.
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
FAQ
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