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 ...