Core Viewpoint - InspireMD, Inc. has received FDA premarket application approval for its CGuard Prime Carotid Stent System, marking a significant milestone in the treatment of carotid artery disease [1][3]. Group 1: FDA Approval and Clinical Evidence - The FDA approval is supported by data from the C-GUARDIANS pivotal trial, which included 316 patients across 24 sites in the U.S. and Europe, demonstrating the lowest 30-day (0.95%) and 1-year (1.93%) major adverse event rates in carotid intervention studies [2][5]. - The C-GUARDIANS trial showed strong evidence of the neuro-protective benefits of the MicroNet™ mesh technology used in the CGuard Prime system, with the lowest event rates for stroke, death, and myocardial infarction reported in any carotid revascularization trial [3][6]. Group 2: Product Features and Market Impact - The CGuard Prime Carotid Stent System features a novel mesh-covered design aimed at improving patient safety through sustained embolic protection, combining a large open-cell frame with a small mesh pore size to prevent plaque protrusion [4]. - With over 65,000 implants sold and studies involving over 2,000 patients, the CGuard Prime is positioned as a proven technology for treating obstructive carotid artery disease, with plans for an immediate U.S. launch following FDA approval [3][4]. Group 3: Financial Implications - The FDA approval triggers the second of four milestone-driven warrant tranches from a private placement financing of up to $113.6 million, with gross proceeds expected to be $17.9 million if fully exercised [3]. - Proceeds from the warrant tranche will support the commercial launch of the CGuard Prime system in the U.S., regulatory pathways for advanced applications, and the development of new products [3].

思宇年度活动回顾： 首届全球眼科大会 | 首届全球骨科大会 | 首届全球心血管大会 | 首届全球医美科技大会 即将召开： 2025年7月17日，第二届全球医疗科技大会 2025年9月3-5日，第三届全球手术机器人大会 心未来 CGuard 支架的全名为 CGuard Embolic Prevention System (EPS) ，EPS直译过来就是"颈动脉栓塞预 防支架"。"架"如其名，这款支架能够将潜在的栓塞物拦截在动脉壁上的同时保持颈外动脉的灌注，以此 来预防围手术期和远期远端血管的栓塞。 2024年年初，Ins pire MD 就宣布了其主要收入来源 CGuard 颈动脉支架获得CE认证。如今的 CGuard Prime 颈动脉支架系统是在此基础上的升级产品。 CGuard Prime是 在广泛采纳临床用户反馈的基础上研发而成，进一步优化了CGuard 支架在递送和释放 方面的性能 。 近日， 专注于脑卒中预防领域 的 InspireMD 公司 （纳斯达克股票代码：NSPR）宣布其 新一代颈动脉 支架 CGuard Prime 获CE批准上市，该产品主要用于治疗颈动脉狭窄。 该产品采用独有的 Micr ...

InspireMD Inc (NSPR) Q1 2025 Earnings Call May 09, 2025 08:30 AM ET Speaker0 Good morning and welcome to InspireMD's First Quarter twenty twenty five Earnings Conference Call. Currently, all participants are in a listen only mode. We will be facilitating a question and answer session towards the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Webb Campbell from Gilmartin Group for introductory disclosures. Speaker1 Thank you for ...

Management to host investor conference call today, May 9th, at 8:30am ETMIAMI, May 09, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime carotid stent system for the treatment of carotid artery disease and prevention of stroke, today announced financial and operating results for the first quarter ended March 31, 2025. Business Highlights: Continued engagement with the U.S. Food and Drug Administration (FDA) on the Premarket Approval (PMA) application for the CGuard Prim ...

NSPR (NASDAQ:NSPR) Q4 2024 Earnings Conference Call March 12, 2025 8:30 AM ET Company Participants Marvin Slosman - CEO Craig Shore - CFO Shane Gleason - CCO Webb Campbell - IR, Gilmartin Group Conference Call Participants Adam Maeder - Piper Sandler Frank Takkinen - Lake Street Capital Markets Richard Nesbitt - InspireMD Operator Hello and welcome to InspireMD's fourth quarter 2024 earnings conference call. [Operator instructions]. I would now like to turn the call over to Webb Campbell from Gilmartin Grou ...