Core Viewpoint - MicroPort Cardiac Rhythm Management-B (02160) has announced that its next-generation implantable cardioverter-defibrillator (ICD) TILEN/EYLEN is set to enter the NMPA's special review process, potentially becoming the first domestically approved MRI-safe ICD with independent intellectual property rights in China [1][2] Group 1: Product Development - TILEN/EYLEN is a core product of a national key research and development project initiated by the Ministry of Science and Technology, aimed at filling a technological gap in the domestic market [1] - The ICD features automatic MRI functionality, significantly reducing patient discomfort caused by asynchronous modes and simplifying the MRI scanning process [1] - It includes remote follow-up capabilities based on low-power Bluetooth technology, enhancing patient compliance through a complete solution supported by domestic data centers [1] Group 2: Market Impact - Sudden Cardiac Death (SCD) is a leading cause of death globally, and ICDs have been proven to be the most effective measure for preventing SCD by restoring normal heart rhythm during life-threatening arrhythmias [2] - The company's PLATINIUM™ series ICD products received NMPA approval in September 2024, marking the first domestically approved ICD and providing more options for SCD prevention and treatment for Chinese patients [2] - The entry of TILEN/EYLEN into the NMPA green channel is expected to accelerate the domestic production process of MRI-safe ICDs [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，概不就因本公告全部或任何部分內容而產生或 因依賴該等內容而引致的任何損失承擔任何責任。 MicroPort CardioFlow Medtech Corporation 微創心通醫療科技有限公司 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股份代號：2160） 自願公告 — 植入式心律轉復除顫器進入 創新醫療器械特別審查程序 本公告乃由微創心通醫療科技有限公司（「本公司」，連同其附屬公司統稱「本 集團」）自願作出，以知會本公司股東及潛在投資者有關本集團最新業務和新 產品開發進展。 本公司董事會（「董事會」）欣然宣佈，近日，國家藥品監督管理局「NMPA」醫療 器械技術審評中心發佈《創新醫療器械特別審查申請審查結果公示（2026年第3 號）》，擬同意本集團旗下新一代植入式心律轉復除顫器（「ICD」）TILEN/EYLEN （泰然╱怡然）進入創新醫療器械特別審查程序（「NMPA綠色通道」）。據此， TILEN/EYLEN（泰然╱怡然）有望成為國內首款獲批的具備自主知識產權的 ...