FDA Approves InspireMD’s CGuard Prime Carotid Stent

InspireMD has received U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its CGuard Prime carotid stent system for stroke protection.

CGuard Prime is a mesh-covered carotid stent designed for sustained embolic protection. It combines the largest open-cell frame of available carotid stents with the smallest mesh size, according to the company. This prevents plaque protrusion through the stent, for embolic protection demonstrated beyond five years.

The FDA approval was backed by evidence from InspireMD’s C-GUARDIANS pivotal trial. The study enrolled 316 patients at 24 U.S. and European sites and evaluated CGuard prime’s safety and efficacy for treating carotid artery stenosis—data showed 0.95% 30-day and 1.93% one-year major adverse rates, the lowest of and pivotal study of carotid intervention.

“The C-GUARDIANS clinical trial provides strong scientific evidence to support the neuro-protective benefits of the next generation MicroNet mesh technology of the CGuard Prime Carotid Stent System and results are consistent with the large body of evidence from outside of the United States with this device,” said Dr. D. Chris Metzger, System Vascular Chief at OhioHealth. “As U.S. Primary Investigator for this pivotal IDE trial, I am proud of the scientific rigor and integrity of the data, which demonstrates the lowest event rates (stroke, death and MI to 30 days and ipsilateral stroke at 1 year) ever reported in any trial of carotid revascularization. These excellent results were in patients who were at high risk for carotid endarterectomy, a quarter of whom were symptomatic. CGuard Prime now offers an important frontline, proven technology for treatment of United States patients with obstructive carotid artery disease, and continued benefits to patients worldwide.”

Inspire MD’s FDA approval triggers the second of four milestone-driven warrant tranches pursuant to May 2023’s private placement financing of $113.6 million. Proceeds from this warrant are expected to be $17.9 million if exercised in full.

Potential proceeds will support CGuard Prime’s U.S. launch, starting new regulatory pathways for advanced applications, developing new products, and developing business outside the U.S.

“I am proud to announce the PMA approval of CGuard Prime, our best-in-class carotid stent system. This is a pivotal milestone for the Company after many years of commitment to bringing this innovative stent platform to patients in the United States,” said Marvin Slosman, CEO of InspireMD. “The significance of CGuard Prime to the shift toward less invasive carotid artery revascularization is tremendous. Our approval marks a true breakthrough in the treatment of carotid disease. Our innovation is built around the protective MicroNet mesh barrier providing durable protection and preventing post procedural events, a unique and next generation advancement in the carotid field. With over 65,000 implants sold to date and studies in over 2,000 patients, CGuard Prime offers an established and tested advancement to patient care. We are grateful to the many who have contributed to this approval, including all of our trial investigators and investors. We look forward to making this technology available to all who can benefit with an immediate and aggressive U.S. launch.”