InspireMD's CGuard Prime Carotid Stent System Receives FDA Approval for Stroke Prevention.

InspireMD has received FDA approval for its CGuard Prime Carotid Stent System to prevent stroke. The approval is based on data from the C-GUARDIANS pivotal trial, which demonstrated the system's safety and efficacy in treating carotid artery stenosis. The system is designed to reduce the risk of stroke and is now available in the US.

In a significant milestone for medical technology, InspireMD, Inc. (Nasdaq: NSPR) has received U.S. Food and Drug Administration (FDA) approval for its CGuard Prime Carotid Stent System. The approval is based on compelling data from the C-GUARDIANS pivotal trial, which demonstrated the system's safety and efficacy in treating carotid artery stenosis. The CGuard Prime stent system is designed to reduce the risk of stroke and is now available in the United States.

The FDA approval of the CGuard Prime Carotid Stent System marks a substantial advancement in the field of carotid artery revascularization. The system combines the largest open-cell frame of available carotid stents with the smallest mesh pore size, providing sustained embolic protection. This unique design helps prevent plaque protrusion through the stent, ensuring lasting protection beyond five years.

The C-GUARDIANS pivotal trial enrolled 316 patients across 24 sites in the United States and Europe. The study evaluated the safety and efficacy of the CGuard Prime Carotid Stent System, with a primary endpoint including the composite of death, all-stroke, or myocardial infarction through 30 days post-index procedure, and ipsilateral stroke from 31 to 365 days follow-up. The trial demonstrated the lowest 30-day (0.95%) and 1-year (1.93%) primary endpoint major adverse event rates of any pivotal study of carotid intervention [1].

The FDA approval of the CGuard Prime Carotid Stent System triggers the second of four milestone-driven warrant tranches, pursuant to a private placement financing of up to $113.6 million announced in May 2023. Gross proceeds from this warrant tranche are expected to be $17.9 million if exercised in full. The proceeds will support the imminent commercial launch of the CGuard Prime Carotid Stent System in the United States, initiating new regulatory pathways for advanced applications of the CGuard stent platform, and developing new products [1].

InspireMD's Chief Executive Officer, Marvin Slosman, expressed pride in the achievement, stating, "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" [1].

The CGuard Prime Carotid Stent System is designed to offer an important frontline, proven technology for treating United States patients with obstructive carotid artery disease, and continued benefits to patients worldwide. 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 [1].

References:
[1] https://www.globenewswire.com/news-release/2025/06/24/3104650/0/en/InspireMD-Announces-FDA-Approval-for-CGuard-Prime-Carotid-Stent-System-for-the-Prevention-of-Stroke.html