InspireMD Announces CE Mark Approval for CGuard Prime Embolic Prevention System (EPS) Under European MDR for the Prevention of Stroke

MIAMI, June 13, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Prime carotid stent system for the prevention of stroke, today announced the company has received CE Mark approval under the European Medical Device Regulation (MDR) for the CGuard Prime EPS.

CGuard Prime was developed incorporating extensive user feedback and optimizes deliverability and deployment of the proven CGuard stent. With its proprietary MicroNet mesh, CGuard is designed to reduce both early and late embolic events by trapping debris against the vessel wall, preventing plaque prolapse and embolization that can cause stroke.

“Securing CE Mark certification under the EU MDR is a major milestone that demonstrates InspireMD’s commitment to advancing our next-generation platforms, regulatory rigor, and execution,” said Marvin Slosman, CEO of InspireMD. “This approval clears the path for the commercial launch of CGuard Prime EPS across our current CE marked served markets, taking a pivotal step forward in our growth as a commercial-stage company and further strengthening our leadership in carotid stenting innovation. Additionally, this is the same platform that we intend to launch in the United States later this year, subject to FDA approval, enabling greater scale as we move towards offering a unified platform across our served markets.”

About CGuard
The CGuard Embolic Prevention System (EPS) is a novel mesh-covered carotid stent designed to widen narrowed carotid arteries in patients who are at high risk for complications from surgery and need a less invasive treatment and to improve patient safety through sustained embolic protection. CGuard combines the largest open-cell frame of available carotid stents with the smallest mesh pore size, preventing plaque prolapse and embolization through the stent, for lasting protection demonstrated beyond five years.

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 Nasdaq under the ticker symbol NSPR. We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.