Core Insights - The completion of the TARGET confirmatory clinical study with 150 patients marks a significant milestone for Cardiovalve in the treatment of tricuspid regurgitation, advancing its path towards CE MDR approval [1][2] - Cardiovalve is a self-developed transcatheter replacement product that can treat both mitral and tricuspid regurgitation, offering enhanced safety and applicability for approximately 95% of patients [1] Group 1 - The TARGET confirmatory clinical study is a prospective, multi-center, single-arm study conducted across over 30 cardiovascular centers in Europe (mainly Germany, Italy, Spain), the UK, and Canada [1] - Cardiovalve features a unique design with a maximum 55mm valve ring and a short valve frame that effectively reduces the risk of left ventricular outflow tract obstruction [1] Group 2 - The board believes that the completion of the clinical trial is a major milestone for the product's market entry and represents significant progress in innovative therapies for tricuspid regurgitation globally [2] - The company aims to leverage its established advantages in research, production, and commercialization in the global structural heart disease field to expedite the clinical registration and approval of innovative products like Cardiovalve [2]

Core Insights - The completion of the TARGET confirmatory clinical study with 150 patients marks a significant milestone for Cardiovalve in the treatment of tricuspid regurgitation, advancing its path towards CE MDR approval [1][2] - Cardiovalve is a self-developed transcatheter replacement product that can treat both mitral and tricuspid regurgitation, offering enhanced safety and suitability for approximately 95% of patients [1] - The company aims to leverage its established advantages in research, production, and commercialization in the global structural heart disease field to expedite the global clinical registration and approval of innovative products like Cardiovalve [2] Summary by Sections Clinical Study - The TARGET confirmatory clinical study is a prospective, multi-center, single-arm study conducted across over 30 cardiovascular centers in Europe (mainly Germany, Italy, Spain), the UK, and Canada, successfully enrolling 150 patients [1] - The study's completion is viewed as a major advancement in innovative therapies for tricuspid regurgitation on a global scale [2] Product Features - Cardiovalve features a unique design with a maximum 55mm valve ring, significantly improving treatment safety and reducing the risk of left ventricular outflow tract obstruction [1] - The product's operation is straightforward, requiring only three steps: positioning, anchoring, and releasing [1] Strategic Goals - The company is committed to advancing the global clinical registration development process for innovative products, including Cardiovalve, to benefit more patients and achieve its internationalization strategy [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之內容概不負責， 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之任何損失承擔任何責任。 杭州啓明醫療器械股份有限公司 TARGET確證性臨床研究是針對三尖瓣反流的患者的一項前瞻性、多中心、單臂研 究，該 研 究 在 歐 洲（主 要 於 德 國、義 大 利、西 班 牙）、英 國 及 加 拿 大30餘家心血管中 心進行，共計招募150名患者。 Cardiovalve是一款自主研發、同時可用於治療二尖瓣反流和三尖瓣反流的經導管介 入置換產品。與同類產品相比，Cardiovalve經股靜脈的入路方式顯著提升了治療安 全 性，產 品 最 大55mm的大瓣環設計適用約95%的 患 者 群 體，同 時，其 獨 特 的 短 瓣 架設計可有效降低心室流出道梗阻風險。Cardiovalve操作簡單、安全、可複製性強， 只需定位、錨定、釋放三個步驟完成。 – 1 – 董 事 會 深 信，Cardiovalve完 成 歐 洲 確 證 性 臨 床 試 驗 ...