InspireMD Announces Successful First-in-Human Procedure Utilizing CGuard Prime, its Next Generation Carotid Artery Stent (CAS) Platform

Procedure performed as part of the company’s ongoing CGuardians U.S. Investigational Device Exemption (IDE) trial designed to support potential U.S. marketing approval of the CGuard stent system

May 1, 2023 — InspireMD, Inc., developer of the CGuard Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the first carotid artery disease patient has been treated utilizing CGuard Prime, the company’s next generation CAS stent platform. The procedure was performed by Dr. Anish Thomas of Mercy Hospital South in St. Louis, MO, as part of InspireMD’s ongoing CGuardians U.S. IDE trial.

Marvin Slosman, chief executive officer of InspireMD, stated, “We are very pleased to have achieved this remarkable milestone – the successful first-in-human stenting procedure using CGuard Prime - as the final step in a lengthy development process as we work to advance new technology to build on our well established CGuard stent performance. I am very proud of the entire InspireMD organization for their tireless work building this platform and I would like to thank Dr. Anish Thomas and his staff for their leadership in performing these procedures. Our next generation feature set incorporated into CGuard Prime provides physicians with greater capabilities and confidence in the deployment of CGuard, our third generation MicroNet mesh protected stent. I am excited for our future as we continue to innovate and provide advanced technologies.”

Dr. Anish Thomas, cardiologist at Mercy Hospital South, St. Louis, added, “The favorable post-procedural short- and long-term patient outcomes for carotid artery disease patients treated with CGuard EPS have been well documented across a number of rigorously designed clinical studies. With the advanced features of the CGuard Prime CAS delivery system, including its innovative handle design, and catheter and tip construction, the ease of stent trackability and deployment have been taken to the next level, which should only accelerate its uptake among interventionalists and surgeons alike. I am delighted to have successfully performed the first case with CGuard Prime, and I am pleased to play a continuing role in advancing this novel stent technology toward potential FDA approval.”

InspireMD anticipates completing enrollment in the CGuardians U.S. IDE trial by the end of the second quarter 2023. The company will provide an additional update on this and other recent developments during its regularly scheduled Q1 2023 earnings conference call.

For more information: www.inspiremd.com