Core Viewpoint - The company has received confirmation from the National Medical Products Administration of China regarding the acceptance of its registration application for the GeminiOne® Transcatheter Edge-to-Edge Repair (TEER) system [1] Company Summary - GeminiOne® is an innovative TEER device developed in-house by the company [1] - The device features a unique sliding groove mechanical structure that maintains a smaller implant size and delivery system while achieving a longer grasping arm length [1] - Additional innovations include an independent leaflet capture function that reduces surgical complexity, an automatic locking mechanism to prevent repeated locking and unlocking during the procedure, and a multi-angle release design that accommodates a wider range of anatomical structures [1]

Core Viewpoint - The company has received confirmation from the National Medical Products Administration of China regarding the acceptance of its registration application for the GeminiOne transcatheter edge-to-edge repair (TEER) system [1] Group 1: Product Innovation - GeminiOne is an internally developed innovative TEER device featuring a unique sliding groove mechanical structure that maintains a smaller implant size and delivery system while achieving a longer grasping arm length [1] - The device includes innovative features such as an independent leaflet capture function that reduces surgical complexity, an automatic locking mechanism to prevent repeated locking and unlocking during the procedure, and a multi-angle release design that accommodates a wider range of anatomical structures [1]

Core Viewpoint - The company has received confirmation from the National Medical Products Administration of China regarding the acceptance of its registration application for the GeminiOne® Transcatheter Edge-to-Edge Repair (TEER) system [1] Group 1: Product Innovation - GeminiOne® is an internally developed innovative TEER device featuring a unique sliding groove mechanical structure that maintains a small implant size and delivery system while achieving a longer grasping arm length [1] - The device includes an independent leaflet capture function that reduces surgical complexity, an automatic locking mechanism to prevent repeated locking and unlocking during the procedure, and a multi-angle release design that accommodates a wider range of anatomical structures [1]

Peijia Medical Limited 沛嘉醫療有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股 份 代 號：9996） 自願公告 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。 – 1 – 本公司可能最終無法成功開發及營銷GeminiOne®TEER系統。本公司股東及潛 在投資者於買賣本公司股份時務請審慎行事。 承董事會命 沛嘉醫療有限公司 董事長兼執行董事 張一博士 香港，2025年10月10日 於本公告日期，董事會包括執行董事張一博士、張葉萍太太及葉紅女士；非執行董事關繼 峰先生、陳飛先生及楊俊先生；及獨立非執行董事Stephen Newman OESTERLE博士、Robert Ralph PARKS先生、葉偉明先生及衛華誠先生。 國家藥監局受理GeminiOne®經導管緣對緣修復系統的註冊申請 本公告乃由沛嘉醫療有限公司（「本公司」，連同其附屬公司統稱「本集團」）自 願作出，為本公司股東及潛在投資者提供有 ...

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 截至月份: 2025年9月30日 狀態: 新提交 致：香港交易及結算所有限公司 公司名稱: 沛嘉醫療有限公司 (「本公司」)（於開曼群島註冊成立的有限公司） 呈交日期: 2025年10月2日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09996 | 說明 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 1,000,000,000 | USD | | 0.0001 USD | | 100,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 1,000,000,000 | USD | | 0.0001 USD | | 100,000 | 本月底 ...

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 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]

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].

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 ...