MIAMI, June 24, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (the “Company”) (Nasdaq: NSPR), developer of the CGuard Prime Carotid Stent System for the prevention of stroke, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket application (PMA) approval of the CGuard Prime Carotid Stent System in the United States. The PMA approval is backed by best-in-class evidence from the Company’s C-GUARDIANS pivotal trial, first presented at the Leipzig Interventional Course (LINC) in May ...

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 ...

MIAMI, June 13, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the company has received CE Mark approval under the European Medical Device Regulation (MDR) for the CGuard® Prime EPS. CGuard® Prime was developed incorporating extensive user feedback and optimizes deliverability and deployment of the proven CGuard stent. With its proprietary MicroNet™ mesh, CGuard is designed to reduce both early and la ...

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 Company Participants Webb Campbell - Vice PresidentMarvin Slosman - CEOCraig Shore - CFOShane Gleason - Chief Commercial Officer Conference Call Participants Adam Maeder - Managing Director & Senior Research AnalystFrank Takkinen - Senior Research Analyst Operator 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 ...

InspireMD Inc (NSPR) Q1 2025 Earnings Call May 09, 2025 08:30 AM ET Company Participants Webb Campbell - Vice PresidentMarvin Slosman - CEOCraig Shore - CFOShane Gleason - Chief Commercial Officer Conference Call Participants Adam Maeder - Managing Director & Senior Research AnalystFrank Takkinen - Senior Research Analyst Operator 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 ...

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 ...

InspireMD, Inc. (NSPR) came out with a quarterly loss of $0.22 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to loss of $0.21 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -29.41%. A quarter ago, it was expected that this company would post a loss of $0.20 per share when it actually produced a loss of $0.19, delivering a surprise of 5%.Over the last four quarters, the company has surpassed c ...

Exhibit 99.1 InspireMD Reports First Quarter 2025 Financial Results — Management to host investor conference call today, May 9, at 8:30am ET — Miami, FL — May 9, 2025 – 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: Marvin Slosman, CEO of InspireMD, commented: "In the first quarter we contin ...