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沛嘉医疗-B(09996.HK):ReachTactile™机器人辅助TAVR系统多中心注册临床试验首例患者治疗
Ge Long Hui· 2025-09-26 11:03
Core Viewpoint - The company has successfully enrolled the first patient in the clinical trial for the ReachTactile™ robotic-assisted transcatheter aortic valve replacement (TAVR) system, marking a significant milestone in its development and potential market entry [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 patient treatment was successfully completed on September 17, 2025, by a team led by Academician Han Yaling at the Northern Theater Command General Hospital [1] Group 2: Product 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 devices with sub-millimeter precision [1] - The system features a force sensing mechanism that provides real-time tactile feedback, aiding in device navigation under complex vascular conditions [1] - The master-slave control layout effectively reduces radiation exposure risks for operators, enhancing occupational health safety [1] - The Ethernet-based remote control capability allows for cross-regional surgical operations and training [1]
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
智通财经网· 2025-09-26 10:59
Core Viewpoint - The company has successfully enrolled the first patient in the clinical trial for the ReachTactile™ robotic-assisted TAVR system, marking a significant milestone in its development and potential market entry [1][2]. Group 1: Clinical Trial Details - The clinical trial for the ReachTactile™ robotic-assisted TAVR system is a prospective, multi-center, randomized controlled, non-inferiority study aimed at evaluating the safety and efficacy of the system and its disposable surgical kit in TAVR procedures [1]. - The first patient treatment was successfully completed on September 17, 2025, by a team led by Academician Han Yaling at the Northern Theater Command General Hospital [1]. Group 2: Product Features and Innovations - ReachTactile™ is an internally developed robotic-assisted TAVR system that offers an innovative and cost-effective solution for TAVR treatment [2]. - The system features a modular design that is compatible with traditional interventional catheterization rooms, allowing a cardiologist to operate multiple instruments with sub-millimeter precision [2]. - It includes a force sensing mechanism that provides real-time tactile feedback, aiding in instrument navigation under complex vascular conditions [2]. - The system's master-slave control layout effectively reduces the operator's radiation exposure and associated occupational health risks [2]. - Additionally, the Ethernet-based remote control functionality enables cross-regional surgical operations and training [2].
沛嘉医疗(09996) - 自愿公告 - ReachTactile机器人辅助TAVR系统多中心註册临...
2025-09-26 10:55
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確 性或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部分內容而產生或 因倚賴該等內容而引致的任何損失承擔任何責任。 Peijia Medical Limited 本 公 司 董 事(「董 事」)會(「董事會」)欣 然 宣 佈,本 公 司 已 入 組ReachTactile™機 器 人 輔 助 經 導 管 主 動 脈 瓣 置 換(「TAVR」)系 統(「該系統」)首 例 患 者。於2025 年9月17日,北部戰區總醫院的韓雅玲院士團隊成功完成首例患者治療, 利 用ReachTactile™機器人輔助TAVR系統為一名重度主動脈瓣狹窄患者植入 TaurusElite®經導管主動脈瓣膜。該系統的註冊臨床試驗是一項前瞻性、多中心、 隨機對照、非劣效性研究,旨在評估ReachTactile™機器人輔助TAVR系統及其 一次性手術包在TAVR手術中的安全性及有效性。是次試驗結果將納入本公司 未來向國家藥品監督管理局(「藥監局」)提交的註冊申請。 – 1 – 沛嘉醫療有限公司 ( 於 開 曼 群 島 註 冊 成 立 的 有 限 公 ...
沛嘉医疗(09996) - 致非登记股东之通知信函及回条 - 以电子方式发佈公司通讯之安排的提示函
2025-09-25 11:18
Peijia Medical Limited 沛嘉醫療有限公司 (Incorporated in the Cayman Islands with limited liability) (於開曼群島註冊成立的有限公司) (Stock Code 股份代號: 9996) September 25, 2025 Dear non-registered shareholder(s), Reminder Letter regarding the Arrangement of Electronic Dissemination of Corporate Communications Should you have any queries relating to this letter, please contact the Company at +86 (512) 8187 7166 during business hours from 9:00 a.m. to 6:00 p.m. (Hong Kong time), Mondays to Fridays, excluding public holidays. Yours fa ...
沛嘉医疗(09996) - 致登记股东之通知信函及回条 - 以电子方式发佈公司通讯之安排的提示函
2025-09-25 11:06
Solicitation of electronic contact details Peijia Medical Limited 沛嘉醫療有限公司 (Incorporated in the Cayman Islands with limited liability) (於開曼群島註冊成立的有限公司) (Stock Code 股份代號: 9996) Dear registered shareholder(s), September 25, 2025 Reminder Letter regarding the Arrangement of Electronic Dissemination of Corporate Communications With reference to the notification letter of Peijia Medical Limited (the "Company") dated 12 November 2024 titled "Arrangement of Electronic Dissemination of Corporate Communications", th ...
沛嘉医疗(09996) - 2025 - 中期财报
2025-09-25 10:47
(於開曼群島註冊成立之有限公司) 股份代號: 9996 中期報告 Interim Report Interim Report 2025 中期報 告 目錄 | 2 | 公司資料 | | --- | --- | | 4 | 財務摘要 | | 5 | 業務摘要 | | 9 | 管理層討論及分析 | | | 補充資料 | | 63 | 簡明綜合財務報表審閱報告 | | | 簡明綜合損益及其他全面收益表 | | | 簡明綜合財務狀況表 | | | 簡明綜合權益變動表 | | | 簡明綜合現金流量表 | | | 簡明綜合財務報表附註 | | 100 | 釋義 | | 33 64 65 67 68 70 | | 公司資料 董事會 執行董事 張一博士 (董事長兼首席執行官) 張葉萍太太 葉紅女士 非執行董事 關繼峰先生 陳飛先生 楊俊先生 獨立非執行董事 Stephen Newman OESTERLE博士 Robert Ralph PARKS先生 葉偉明先生 衛華誠先生 審核委員會 葉偉明先生 (主席) 關繼峰先生 Robert Ralph PARKS先生 衛華誠先生 薪酬委員會 Robert Ralph PARKS先生 ( ...
商业医疗险报告一:见微知著,医保承压下商保或为破局之法
Ping An Securities· 2025-09-22 10:03
Investment Rating - The report maintains an "Outperform" rating for the biopharmaceutical industry [1] Core Viewpoints - The growth of healthcare expenses, which reached 9.06 trillion yuan in 2023, is outpacing GDP growth, indicating that commercial health insurance may provide a solution to the pressures faced by the medical insurance system [3][15] - The commercial health insurance sector is expected to grow significantly, with premiums projected to reach 97.74 billion yuan by 2024, driven by low penetration rates and the need for additional funding sources [20][24] - Policies are increasingly supportive of commercial health insurance, particularly in relation to innovative drugs, which are now being included in the commercial health insurance directory [71][76] Summary by Sections Part 1: Healthcare Financing System - The healthcare financing system in China consists of government, social, and personal contributions, with social contributions being the main driver for future growth [10][15] Part 2: Growth of Health Insurance - The commercial health insurance market is expected to fill a significant funding gap, with an estimated shortfall of over 1.7 trillion yuan by 2030 [21][22] - Medical insurance is the primary source of compensation within commercial health insurance, with a compensation rate of approximately 68.79% in 2022 [27][31] Part 3: Core Products of Medical Insurance - The report highlights the importance of medical insurance as a key focus area, noting that it directly compensates for medical expenses, unlike critical illness insurance [31][35] Part 4: Policy Support for Health Insurance Development - A series of policies since 2009 have aimed to promote the development of commercial health insurance, with specific targets for market size and coverage [71][72] Part 5: Investment Recommendations - The report suggests focusing on innovative drug companies with rich pipelines, DTP pharmacies, and companies in the TPA industry, as well as innovative medical devices and high-end medical service providers [77]
苏州工业园区创新联合体观察|沛嘉医疗:生态融合助推高端医疗器械产业创新突围
Zhong Guo Jin Rong Xin Xi Wang· 2025-09-18 06:38
Core Insights - The article emphasizes the importance of innovation consortia in enhancing core competitiveness and overcoming key technological challenges in industries, particularly in the context of Suzhou Industrial Park's efforts in the high-end medical device sector [1][10]. Group 1: Innovation Consortium Structure - The Suzhou Interventional Medical Technology Innovation Consortium, led by Peijia Medical, integrates leading enterprises, innovative companies, research institutions, incubators, and investment funds to create a comprehensive innovation ecosystem [1][3]. - The consortium focuses on collaborative efforts to tackle "bottleneck" technologies in the medical device field, enhancing resource flow and sharing through cross-regional cooperation [3][9]. Group 2: Resource Integration and Infrastructure - Peijia Medical's global headquarters spans approximately 67,000 square meters, serving as a hub for R&D, production, and training, thus facilitating efficient resource integration [2]. - The consortium has established six high-level innovation platforms, including provincial and municipal engineering research centers, to support rapid technology transfer and innovation [6][10]. Group 3: Talent Acquisition and Collaboration - The consortium actively recruits high-level talent globally, focusing on strategic scientists and top professionals to enhance its innovation capabilities [8][9]. - Collaborative projects, such as the development of advanced biomaterials for heart valves, demonstrate the consortium's ability to transform innovative ideas into market-ready products [7][10]. Group 4: Industry Collaboration and Ecosystem Development - The consortium employs a model that combines industry capital, incubation, and empowerment to provide comprehensive support for startups, fostering a full-chain ecosystem from R&D to commercialization [12][13]. - The integration of companies like Zhixian Technology into the consortium exemplifies successful collaboration across the supply chain, enhancing opportunities for innovation and growth in the medical device sector [11][12]. Group 5: Future Directions and Growth - The Suzhou Industrial Park aims to further develop its innovation ecosystem by encouraging the formation of more innovation consortia, focusing on deep integration of technology and industry [14].
又20起合作达成!医疗器械BD月报首发
思宇MedTech· 2025-09-14 01:08
Core Viewpoint - The article discusses the evolving landscape of the medical device industry in China, highlighting the importance of business development (BD) strategies that go beyond mere numbers to encompass strategic partnerships, market expansion, and technological integration [1][24]. Group 1: Key Trends in Medical Device BD - The primary keywords for the period from July to September include cross-border introduction and global distribution, strategic cooperation, and capital and cross-industry integration [2]. - Companies are accelerating market expansion and ecosystem building through transactions across various fields, including cardiovascular, neuro-intervention, ophthalmology, IVD, and critical care [3]. Group 2: Representative Events - A total of 20 significant events were summarized, showcasing a "multi-line advancement" scenario in the industry [4]. - Notable collaborations include: - Nanjing Jianxin Medical and Heqi Family Office focusing on medical device R&D and wealth management [6]. - Olympus and Xingchenhai Medical signing a global distribution agreement for disposable urology products [6]. - He’s Eye Group and Zeiss China Medical forming a strategic partnership to enhance ophthalmic surgical technology [6]. Group 3: Cross-Border and Global Distribution - Cross-border transactions remain a hot topic, with domestic companies leveraging global markets for growth while foreign giants introduce Chinese innovations [9]. - The partnership between Ruichao Dinkai Group and Beijing Amite focuses on vascular intervention products, marking a new phase in safety standards [7]. Group 4: Strategic Cooperation and Channel Expansion - Strategic cooperation is increasingly focused on building ecosystems rather than single product breakthroughs, with companies forming partnerships in fields like ophthalmology, IVD, and diagnostics [19]. - The collaboration between Wanfu Biological and Beiden Medical aims to match products with non-public medical channels effectively [15]. Group 5: Capital Support and Cross-Industry Integration - Capital is becoming an invisible driver of medical device BD, with partnerships exploring new models for medical device distribution [20]. - The collaboration between Beijing Huamai Supply Chain Management and Hongyi Consulting aims to create a one-stop service for medical device distribution [20]. Group 6: Smart Hospitals and Full-Chain Coordination - The focus on smart hospitals and full-chain coordination is becoming a priority for large enterprises, integrating supply chains, academic promotion, and clinical needs [23]. - Collaborations like that of Ruibo Zehou Technology and China National Pharmaceutical Group aim to develop automated systems for smart hospitals [21]. Conclusion - The medical device industry in China is transitioning from a "single product-driven" phase to a more diversified approach supported by capital, channels, and ecosystems, indicating a long-term growth trajectory [24].
港股公告掘金 | 阿里巴巴-W公布32亿美元零息可转换优先票据定价 初始转换价格为每股美国存托股193.15美元
Zhi Tong Cai Jing· 2025-09-11 15:22
Major Events - Alibaba-W (09988) announced the pricing of $3.2 billion zero-coupon convertible preferred notes, with an initial conversion price of $193.15 per American depositary share [1] - Peijia Medical-B (09996) reported the first human clinical trial implantation of the Sutra Hemi-valve transcatheter mitral valve repair system [1] - Corning Jereh Pharmaceutical-B (09966) received acceptance from the National Medical Products Administration for the new drug application of KN026 (Anni monoclonal antibody injection) [1] - Nissin Foods (01475) invested 30.68 million yuan to acquire two plots of land in Zhuhai for the construction of new production facilities [1] - Nocoda Technology (00519) signed a cooperation agreement for low-altitude economic intelligent drones [1] Financial Data - Country Garden Holdings (00754) reported total contract sales of approximately 9.902 billion yuan for the first eight months, a year-on-year decrease of 15.56% [1] - China General Nuclear Power Corporation (01811) completed a power generation of 1,543.7 GWh in August, a year-on-year decrease of 5.7% [1] - Xinte Energy (00956) achieved a cumulative power generation of 9.8787 million MWh in the first eight months, a year-on-year increase of 10.55% [1] - Oceanwide Holdings (03377) reported a cumulative contracted sales amount of approximately 16.44 billion yuan for the first eight months, a year-on-year decrease of 25.88% [1]