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].