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 ...

Core Viewpoint - The company reported a revenue of RMB 471 million for the fiscal year ending December 31, 2024, while focusing on the structural heart disease sector and enhancing its clinical development pipeline [1] Group 1: Financial Performance - The company achieved a revenue of RMB 471 million during the reporting period [1] Group 2: Product Development and Clinical Trials - The company has established a product pipeline consisting of ten innovative devices targeting heart valve diseases, with a focus on interventional treatments [2] - The product lineup includes four commercialized TAVR products and one TPVR product, along with two catheter-based surgical accessories [2] - Clinical trials are ongoing for new generation TAVR products and innovative devices that can be used for both TMVR and TTVR [2] Group 3: Clinical Milestones - The company has made significant progress in global clinical research projects, achieving multiple important milestones [1] - The first self-expanding TAVR product, Venus-PowerX, and the first balloon-expandable TAVR product, Venus-Vitae, have commenced clinical trials [1] - The Cardiovalve product has shown excellent safety and efficacy in key clinical studies in Europe, receiving positive feedback from overseas experts [1]

医疗器械的历史，是科技突破与医学进步交织的史诗。从公元前3400年战国时期的青铜"砭镰"，到18世纪的 手工骨锯、19世纪首台听诊器，再到20世纪人工心脏瓣膜等高精尖器械。这也是一场跨越世纪的产业角逐。 21世纪，全球医疗器械产业迈入高端化、全球化、资本化的新阶段。中国的医疗器械企业正在试图打破欧美 企业的长期垄断，但这也对自身组织能力、技术创新提出了更高要求。 在这场产业角逐中，启明医疗是如何选择产品赛道、制定国际化策略，并在企业治理层面优化自身，以适应全 球竞争的？ 思宇根据林总的访谈撰写本文给业内参考。毕竟，在医疗科技创新加速发展的今天，启明医疗的 探索不仅关乎自身的成长，也折射出整个中国医疗器械行业的未来趋势。 # 启明医疗的产品管线：创新、突破与聚焦 "从主动脉瓣到肺动脉瓣，再到二尖瓣、三尖瓣，我们的产品布局并非偶然，而是基于技术、专利和市场准入 的综合考量。"林浩昇在访谈中回忆道，"这些瓣膜治疗方案在技术上存在高度协同，适用于同一类手术体 系。当第一个产品成功落地并形成规模后，我们顺理成章地进行下一步的拓展。" 启明医疗的产品线布局，经历了 从单一主动脉瓣膜的突破到"四瓣一体"的协同，从国内市场主 ...