Tel Aviv, Israel – February 24, 2021 – 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 that it has engaged Hart Clinical Consultants (HCC), a leading Contract Research Organization (CRO) to conduct the clinical trial for its CGuard Carotid Stent System in the United States.
“HCC is ideally suited to manage this trial having supported clinical trial operations for a variety of products and indications, including with multiple carotid intervention procedures,” stated Marvin Slosman, InspireMD’s CEO. “This is an important step in our goal to achieve commercial registration of the CGuard System in the United States, one of the largest and most important markets for the sale and distribution of our device. This will be the first U.S.-based study of CGuard and our opportunity to demonstrate its potential for the prevention of stroke caused by carotid artery disease in patients in the United States. Now that we have also identified our stellar lead investigator in Dr. Chris Metzger and closed a $20.7 million public offering, which provides the company the financial resources needed to complete the trial, we believe that we are well positioned to continue to execute on our global expansion strategy.”
“We look forward to working with InspireMD on this pivotal trial of the CGuard System to help establish a new standard of care for the management of carotid artery disease and stroke prevention. We differentiate our organization from other CRO’s in that our staff has either direct interventional cath lab or cardio-thoracic operating room experience. This allows us to function extremely well in technical areas when carrying out clinical trial operations or conducting device training,” said Jim Hart, CEO of HCC.
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.
About Hart Clinical Consultants
Hart Clinical Consultants (HCC) is a specialized Functional Service Provider (FSP) that partners innovators of technical, novel medical devices with highly skilled clinical research professionals. HCC specializes in clinical trial operations, study execution, physician training and case proctoring.
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