Business
InspireMD Announces Submission of Premarket Approval Application to FDA Seeking U.S. Regulatory Approval of the CGuard™ Prime Carotid Stent System
PMA based on overwhelmingly positive results from the pivotal C-GUARDIANS clinical study that were first presented at LINC 2024 in May U.S. commercial launch
About this update from Inspiremd Inc.
[{"type":"text","content":"PMA based on overwhelmingly positive results from the pivotal C-GUARDIANS clinical study that were first presented at LINC 2024 in May U.S. commercial launch anticipated in H1 2025, if approved TEL AVIV, Israel and MIAMI, Sept. 16, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) seeking marketing approval for the CGuard Prime carotid stent system in the U.S. The PMA application is based on the overwhelmingly positive one-year data from the Company’s C-GUARDIANS pivotal clinical trial that were presented at the Leipzig Interventional Course (LINC) 2024 in May. The C-GUARDIANS clinical trial evaluated the safety and efficacy of CGuard for the treatment of carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in the U.S. and Europe. The C-GUARDIANS results showed a primary endpoint1 major adverse event rate of 1.95% through twelve months post-procedure, the lowest such event rate reported for any carotid stent or embolic protection device pivotal trial to date. Marvin Slosman, chief executive officer of InspireMD, stated, “The submission of our PMA application to the FDA represents a significant step forward in our quest for U.S. approval of our next generation CGuard Prime stent to address carotid artery disease and stroke prevention with its best-in-class clinical outcomes. We look forward to the agency’s review of our application, which we have provided in a modular submission to facilitate the most efficient review process. Concurrently, we continue to build what I consider to be world class U.S. commercial and operational infrastructure to enter the U.S. market with as much momentum as possible to offer to this breakthrough technology.” About InspireMD, Inc.InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR. We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com. Forwa...