FDA Approves InspireMD's CGuard Prime Carotid Stent System, Shares Surge 50%

InspireMD shares surged 50% in after-market trading after the FDA granted premarket approval for its CGuard Prime Carotid Stent System. The approval was backed by evidence from a pivotal trial demonstrating the stent's safety and efficacy in treating carotid artery stenosis. This milestone triggers a $17.9 million warrant tranche from a private placement financing, which will support the imminent commercial launch of the CGuard system.

InspireMD, Inc. (Nasdaq: NSPR) experienced a significant after-market surge in its stock price, with shares increasing by 50% following the U.S. Food and Drug Administration (FDA) approval of its CGuard Prime Carotid Stent System. The approval, granted on June 24, 2025, was based on compelling evidence from the company's pivotal C-GUARDIANS clinical trial, which demonstrated the stent's safety and efficacy in treating carotid artery stenosis [1].

The C-GUARDIANS trial, presented at the Leipzig Interventional Course (LINC) in May 2024, 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, showcasing the lowest 30-day and 1-year major adverse event rates of any pivotal study in carotid intervention [1].

The FDA's approval of the CGuard Prime Carotid Stent System marks a significant milestone for InspireMD. The approval triggers the second of four milestone-driven warrant tranches, resulting in an expected $17.9 million in gross proceeds if exercised in full. These proceeds will support the imminent commercial launch of the CGuard Prime Carotid Stent System in the United States, as well as the initiation of new regulatory pathways for advanced applications of the company's CGuard stent platform and the development of new products [1].

InspireMD's CEO, Marvin Slosman, expressed pride in the achievement, stating, "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" [1]. The company's innovation is built around the protective MicroNet mesh barrier, which provides durable protection and prevents post-procedural events, a unique advancement in the carotid field [1].

The CGuard Prime Carotid Stent System combines the largest open-cell frame of available carotid stents with the smallest mesh pore size, offering sustained embolic protection demonstrated beyond five years [1]. The system is designed to improve patient safety through sustained embolic protection, making it an attractive alternative to other procedures and products in the market.

The FDA approval and subsequent stock surge reflect investor confidence in InspireMD's technology and its potential to disrupt the carotid artery revascularization market. The company's ability to successfully launch the CGuard Prime Carotid Stent System in the United States and expand its regulatory pathways could significantly impact its future financial performance and market position.

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