InspireMD announced that the FDA granted premarket approval (PMA) for its CGuard Prime carotid stent system.
The CGuard embolic prevention stent (EPS) system — designed to prevent stroke — received CE mark earlier this month. It utilizes the company’s MicroNet technology for strong acute results and durable, stroke-free, long-term outcomes.
Miami-based InspireMD developed the next-generation carotid stent system based on physician feedback. It features improved deliverability and deployment. It builds on the original CGuard design, which uses the proprietary MicroNet mesh to reduce the risk of stroke by trapping embolic debris and preventing plaque prolapse.
Data from the company’s C-GUARDIANS pivotal trial of 316 patients across 24 U.S. and European sites backed the CGuard Prime. It evaluated the safety and efficacy of the stent in treating carotid artery stenosis. InspireMD said it 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.
FDA approval for CGuard also adds significant funding for the company. It triggers the second of four milestone-driven warrant tranches pursuant to a $113.6 million financing announced in May 2023. The company expects proceeds of $17.9 million if exercised in full.
InspireMD plans to use proceeds to support CGuard Prime’s U.S. launch as it looks to initiate new regulatory pathways for more applications. The company also noted the development of new products and continued business development outside the U.S.
“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.
“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.”
