沛嘉医疗-B(09996)发布公告，本公司已入组ReachTactile机器人辅助经导管主动脉瓣置换(TAVR)系统(该 系统)首例患者。于2025年9月17日，北部战区总医院的韩雅玲院士团队成功完成首例患者治疗，利用 ReachTactile机器人辅助TAVR系统为一名重度主动脉瓣狭窄患者植入TaurusElite经导管主动脉瓣膜。该 系统的注册临床试验是一项前瞻性、多中心、随机对照、非劣效性研究，旨在评估ReachTactile机器人 辅助TAVR系统及其一次性手术包在TAVR手术中的安全性及有效性。是次试验结果将纳入本公司未来 向国家药品监督管理局(药监局)提交的注册申请。 ReachTactile是本公司内部研发的机器人辅助TAVR系统，为TAVR治疗提供创新、高性价比的解决方 案。可模块化移动的设计适配于传统的血管介入导管室，允许一名心脏病专家以亚毫米级的精度操作多 台器械。该系统搭载的力传感机制可提供即时触觉反馈，有助于在复杂的血管条件下的器械导航通行。 基于主从控制布局能够有效降低术者辐射暴露等职业健康风险。同时，基于以太网的远程控制功能可实 现跨地域手术操作及操作培训。 ...

（原标题：沛嘉医疗-B(09996)：ReachTactile?机器人辅助TAVR系统多中心注册临床试验的首例患者治疗） 智通财经APP讯，沛嘉医疗-B(09996)发布公告，本公司已入组ReachTactile机器人辅助经导管主动脉瓣置换(TAVR)系统(该系统)首例患者。于2025 年9月17日，北部战区总医院的韩雅玲院士团队成功完成首例患者治疗，利用ReachTactile机器人辅助TAVR系统为一名重度主动脉瓣狭窄患者植入 TaurusElite经导管主动脉瓣膜。该系统的注册临床试验是一项前瞻性、多中心、随机对照、非劣效性研究，旨在评估ReachTactile机器人辅助TAVR 系统及其一次性手术包在TAVR手术中的安全性及有效性。是次试验结果将纳入本公司未来向国家药品监督管理局(药监局)提交的注册申请。 ReachTactile是本公司内部研发的机器人辅助TAVR系统，为TAVR治疗提供创新、高性价比的解决方案。可模块化移动的设计适配于传统的血管介 入导管室，允许一名心脏病专家以亚毫米级的精度操作多台器械。该系统搭载的力传感机制可提供即时触觉反馈，有助于在复杂的血管条件下的 器械导航通行。基于主从控 ...

Core Viewpoint - The Hong Kong innovative medical device sector has seen significant growth this year, with the Hang Seng Healthcare Index rising over 50% year-to-date, driven by profit recovery and valuation adjustments [1][3]. Group 1: Market Dynamics - The National Medical Products Administration (NMPA) has announced ten measures to support the innovation and development of high-end medical devices, further enhancing long-term investment expectations for innovative medical device companies [1][3]. - The current investment environment is warming, leading to increased focus on the validation of innovative technologies and their commercial potential [3][9]. Group 2: Company Performance - Peijia Medical (09996) has experienced a stock price increase of over 95% year-to-date, significantly outperforming the index and bringing its market capitalization to around HKD 5 billion [1][3]. - The company has established itself as a leading brand in the Chinese transcatheter aortic valve replacement (TAVR) market, with a market share increase from 5% in 2021 to over 25% currently [4][10]. Group 3: Product Development and Innovation - Peijia Medical is advancing its product pipeline, with its second-generation TAVI product nearing market approval and its third-generation product expected to enter the market in the first half of next year [4][10]. - The company has a robust pipeline that includes innovative technologies such as non-glutaraldehyde cross-linked valves and shockwave calcification reconstruction technology, positioning it well against competitors [10][12]. Group 4: Market Potential - The TAVR market in China is projected to grow significantly, with an expected compound annual growth rate (CAGR) of 36.6% from 2021 to 2030, reaching approximately 109.5 billion yuan by 2030 [9][11]. - The current TAVR penetration rate in China is only 5.7% of the global total, indicating substantial growth potential for the market [11]. Group 5: Future Outlook - Peijia Medical aims to solidify its position as the leading TAVR brand in China by expanding its product offerings and increasing market share to 25-30% by 2025 [4][12]. - The company is also pursuing international expansion, with plans to apply for CE certification for its products and engage in global clinical studies [12][13].