MIAMI, July 09, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Prime carotid stent system for the prevention of stroke, today announced the official commercial launch of the CGuard Prime carotid stent system in the U.S., following its premarket application (PMA) approval from the U.S. Food and Drug Administration (FDA). The CGuard Prime was engineered specifically to minimize both early and late embolism risk by effectively trapping potential emboli against the arterial wal ...

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 ...

Core Points - InspireMD, Inc. has received CE Mark approval for the CGuard® Prime EPS under the European Medical Device Regulation, marking a significant milestone for the company [1][3] - The CGuard® Prime system is designed to enhance deliverability and deployment while reducing embolic events through its proprietary MicroNet™ mesh technology [2][4] - The approval paves the way for commercial launch in CE marked markets and is expected to facilitate a U.S. launch later this year, pending FDA approval [3] Company Overview - InspireMD aims to establish its MicroNet™ technology as the industry standard for carotid stenting, focusing on acute results and long-term stroke-free outcomes [5] - The CGuard Embolic Prevention System is designed for patients at high risk for surgical complications, offering a less invasive treatment option [4] - InspireMD's common stock is traded on Nasdaq under the ticker symbol NSPR, and the company actively shares important investor information on its website [5]

Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)MIAMI, June 03, 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 the appointment of Michael Lawless, an industry veteran, as Chief Financial Officer, effective on or prior to June 30, 2025 (the “Effective Date”). On the Effective Date, Mr. Lawless will succeed Craig Shore, who has served as Chief Financi ...

Summary of InspireMD Inc (NSPR) Conference Call Company Overview - **Company**: InspireMD Inc (NSPR) - **Industry**: Medical Devices, specifically focusing on carotid stenting technology Key Points and Arguments 1. **Focus on FDA Approval**: The company is currently focused on the impending FDA approval and commercialization of its next-generation carotid stent technology [3][24] 2. **Innovative Technology**: The new self-expanding carotid stent features a unique mesh outer layer called Micronet, which aims to prevent plaque from causing post-procedure strokes [5][6] 3. **Market Opportunity**: The carotid stenting market in the U.S. is approximately $1 billion, with recent CMS coverage expansion allowing standard risk patients to access stenting procedures, significantly broadening the market [7][8] 4. **Endovascular Procedures Growth**: There is a notable shift from open surgery to endovascular procedures, with current estimates showing around 60,000 endovascular procedures being performed, split roughly between TCAR and CAS [11][22] 5. **Clinical Data**: The company has clinical data from over 2,000 patients and has completed a pivotal FDA trial, reporting a 0.95% major adverse event rate at 30 days and 1.93% at one year [6][17] 6. **Real-World Evidence**: InspireMD has treated over 60,000 patients outside the U.S. and has published real-world evidence that supports the consistency of its clinical trial results [18] 7. **Multidisciplinary Approach**: The company collaborates with a board of thought-leading physicians from various specialties to guide its strategy in treating carotid disease [15] 8. **Funding and Growth Strategy**: In May 2023, InspireMD raised $113 million to support its commercial launch plan, indicating strong financial backing for future growth [27] 9. **Market Dynamics**: The company believes it is entering the market at an opportune time due to recent CMS coverage expansions, which had previously hindered growth in the carotid intervention space [31] Additional Important Information - **Transition to Commercial Viability**: InspireMD is transitioning from an invention-focused company to a commercially viable growth story, aiming to leverage its innovative products in the market [28] - **Clean Capital Structure**: The company has a clean cap table and is listed on NASDAQ under the ticker NSPR, which is favorable for attracting investors [28] - **Historical Context**: The carotid intervention market was once seen as a billion-dollar opportunity, but previous coverage limitations stunted growth until recent changes [30][31]

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 ...

Core Viewpoint - InspireMD, Inc. is set to present at the Bank of America 2025 Healthcare Conference, highlighting its focus on carotid artery disease treatment and stroke prevention through its CGuard™ Prime carotid stent system [1]. Company Overview - InspireMD, Inc. develops the CGuard™ Prime carotid stent system aimed at treating carotid artery disease and preventing strokes [1]. - The company utilizes its proprietary MicroNet® technology to establish its products as the industry standard for carotid stenting, emphasizing superior acute results and long-term stroke-free outcomes [2]. Event Details - The presentation at the Bank of America 2025 Healthcare Conference is scheduled for May 14, 2025, at 1:15 PM Eastern Time / 10:15 AM Pacific Time [1]. - A live audio webcast and replay of the presentation will be available for 90 days on the company's website [2].

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 ...