Benzinga | Feb 24, 2021 06:09AM EST

InspireMD Says Has Engaged Hart Clinical Consultants To Conduct A Clinical Trial Of CGuard Carotid Stent System In The US

TEL AVIV, Israel, Feb. 24, 2021 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NYSE:NSPR), developer of the CGuard(tm) 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.