随着冲击波瓣膜治疗系统进入创新通道，其产业化进程将进一步加快。沛嘉医疗董事长兼CEO张一 博士表示，将全力推进该技术的临床转化，争取早日让这一创新成果惠及广大患者。 王建安院士表示，该技术具有多重应用价值：对于年轻患者，可避免早期植入人工瓣膜；对于高龄 患者，可以避免植入物相关及抗板抗凝药物管理带来的风险。刘先宝教授表示，对于复杂钙化病例，可 作为术前预处理手段；对于部分患者，甚至可能成为独立的治疗方案。这种灵活性使其有望改变现有瓣 膜疾病的管理策略。 沛嘉医疗董事长兼CEO张一博士表示："这是继我们的智程瓣膜机器人系统成功进入创新通道后， 沛嘉医疗在结构性心脏病创新治疗领域取得的又一重要里程碑。冲击波技术入选创新通道，印证了我们 坚持原研技术创新的价值。这不仅是一次技术路径的变革，更是治疗理念的升级——从'置换'到'修 复'，从'植入'到'无植入'。" 作为国内结构性心脏病介入治疗领域领军企业，沛嘉医疗已构建起覆盖主动脉瓣、二尖瓣、三尖瓣 的多层次、前瞻性产品管线。在主动脉瓣领域，形成了从市场开拓到技术引领的完整矩阵：从首款 TAVR产品TaurusOne成功打开市场，到采用非醛交联干瓣技术的TaurusN ...

机构：中信建投证券 研究员：贺菊颖/王在存/郑涛/李虹达 核心观点 研发管线布局丰富，多款创新产品即将迎来商业化兑现公司近期公告多款产品取得研发进展，包括 GeminiOne 经导管缘对缘修复系统（T E ER）、ReachTactile 机器人辅助TAVR 系统、Sutra Hemi-valve 经导管二尖瓣修复系统、经股入路的主动脉瓣反流介入置换系统Taurus T rio以及非醛交联干瓣TAVR 产 品TaurusNXT 等，其中主动脉瓣反流介入置换系统TaurusTrio、GeminiOn e 经导管缘对缘修复系统以及 非醛交联干瓣TAVR 产品TaurusNXT 有望于2025 年底至2026 年陆续获批并实现商业化，助力公司营收 在明年加速增长。 脏瓣膜介入领域居于领先地位，TAVR 产品自21 年Q4 商业化以来，临床反馈良好，介入瓣膜产品快速 放量，市场份额持续提升；另外公司在主动脉瓣、二尖瓣和三尖瓣治疗领域具有全面深入的产品研发布 局，持续巩固公司在心脏瓣膜领域的领先地位；公司预计在25 年底26 年初有三款重磅产品在国内获批 并实现商业化，助力公司整体业绩恢复快速增长趋势。公司神经介入业务 ...

Core Viewpoint - The company has initiated the first patient enrollment for the ReachTactile robotic-assisted transcatheter aortic valve replacement (TAVR) system, marking a significant milestone in its clinical trial process [1] Group 1: Clinical Trial Details - The clinical trial is a prospective, multi-center, randomized controlled, non-inferiority study aimed at evaluating the safety and efficacy of the ReachTactile robotic-assisted TAVR system and its disposable surgical kit [1] - The first successful treatment using the ReachTactile system was completed on September 17, 2025, by a team led by Academician Han Yaling at the Northern Theater General Hospital [1] Group 2: System Features and Innovations - The ReachTactile system is an internally developed robotic-assisted TAVR solution that offers innovative and cost-effective options for TAVR treatment [1] - Its modular and mobile design is compatible with traditional interventional catheterization rooms, allowing a cardiologist to operate multiple instruments with sub-millimeter precision [1] - The system features a force sensing mechanism that provides real-time tactile feedback, aiding in instrument navigation under complex vascular conditions [1] - The master-slave control layout effectively reduces the operator's radiation exposure and associated occupational health risks [1] - The Ethernet-based remote control functionality enables cross-regional surgical operations and training [1]

Group 1 - The company Peijia Medical-B (09996) has announced the enrollment of the first patient in the clinical trial for the ReachTactile robotic-assisted transcatheter aortic valve replacement (TAVR) system [1] - The first successful treatment using the ReachTactile system was completed on September 17, 2025, by a team led by Academician Han Yaling at the Northern Theater General Hospital, implanting a TaurusElite transcatheter aortic valve in a patient with severe aortic stenosis [1] - The clinical trial is a prospective, multi-center, randomized controlled, non-inferiority study aimed at evaluating the safety and efficacy of the ReachTactile robotic-assisted TAVR system and its disposable surgical kit [1] Group 2 - The ReachTactile system is an internally developed robotic-assisted TAVR solution that offers innovative and cost-effective options for TAVR treatment [1] - The system features a modular mobile design that fits traditional vascular intervention catheter rooms, allowing a cardiologist to operate multiple instruments with sub-millimeter precision [1] - The force sensing mechanism provides immediate tactile feedback, aiding in instrument navigation under complex vascular conditions, while the master-slave control layout effectively reduces radiation exposure risks for the operator [1]

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].