Miami, Florida — 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.

迈阿密，佛罗里达州 —— 2025年6月13日（环球新闻社）—— InspireMD公司（纳斯达克股票代码：NSPR），CGuard® Prime颈动脉支架系统的开发者，该系统用于预防中风，今天宣布公司已获得根据欧洲医疗器械法规（MDR）的CE标志批准，适用于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 late embolic events by trapping debris against the vessel wall, preventing plaque prolapse and embolization that can cause stroke..

CGuard Prime® 结合了广泛的用户反馈进行开发，优化了已验证的 CGuard 支架的输送和部署。凭借其专有的 MicroNet™ 网状结构，CGuard 旨在通过将碎屑固定在血管壁上，减少早期和晚期栓塞事件，防止可能导致中风的斑块脱垂和栓塞。

“Securing CE Mark certification under the EU MDR is a major milestone that demonstrates InspireMD’s commitment to advancing our next generation platforms, regulatory rigor, and execution,” said Marvin Slosman, CEO of InspireMD. “This approval clears the path for the commercial launch of CGuard™ Prime EPS across our current CE marked served markets, taking a pivotal step forward in our growth as a commercial-stage company and further strengthening our leadership in carotid stenting innovation.

“获得欧盟MDR下的CE标志认证是一个重要的里程碑，展示了InspireMD致力于推进我们下一代平台、监管严格性和执行力的承诺，”InspireMD首席执行官马文·斯洛斯曼表示。“这项批准为CGuard™ Prime EPS在我们当前CE标志认证市场的商业推出扫清了道路，标志着我们作为一家商业阶段公司成长的关键一步，并进一步巩固了我们在颈动脉支架创新领域的领导地位。”

Additionally, this is the same platform that we intend to launch in the United States later this year, subject to FDA approval, enabling greater scale as we move towards offering a unified platform across our served markets”.

此外，这与我们计划在今年晚些时候在美国推出的平台相同，但需获得FDA的批准，这将使我们能够在为所服务的市场提供统一平台的过程中实现更大的规模。

About CGuard

关于CGuard

The CGuard Embolic Prevention System (EPS) is a novel mesh-covered carotid stent designed to widen narrowed carotid arteries in patients who are at high risk for complications from surgery and need a less invasive treatment and to improve patient safety through sustained embolic protection. CGuard combines the largest open-cell frame of available carotid stents with the smallest mesh pore size, preventing plaque prolapse and embolization through the stent, for lasting protection demonstrated beyond five years..

CGuard栓塞预防系统（EPS）是一种新型的覆网颈动脉支架，旨在为手术并发症高风险患者扩张狭窄的颈动脉，提供一种侵入性较小的治疗方式，并通过持续的栓塞保护提高患者的安全性。CGuard结合了现有颈动脉支架中最大的开放式框架和最小的网孔尺寸，防止斑块通过支架脱垂和栓塞，实现了超过五年的持久保护。

About InspireMD, Inc.

关于InspireMD公司

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.

InspireMD 旨在利用其专有的 MicroNet™ 技术，通过提供卓越的急性治疗效果和持久、无中风的长期疗效，使其产品成为颈动脉支架手术的行业标准。InspireMD 的普通股在纳斯达克以股票代码 NSPR 进行报价。

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