Group 1 - The core point of the article is that HeartLink Medical-B (02160.HK) has received CE mark approval for its Alwide Plus cardiac balloon dilation catheter, indicating compliance with health, safety, and environmental standards in the European Economic Area [1] - As of August 18, 2025, HeartLink Medical-B's stock closed at HKD 1.62, reflecting a 9.46% increase with a trading volume of 26.61 million shares and a turnover of HKD 41.78 million [1] - The stock has low attention from investment banks, with no ratings given in the past 90 days [1] Group 2 - HeartLink Medical-B has a market capitalization of HKD 3.571 billion, ranking 12th in the medical device II industry [1] - Key financial metrics for HeartLink Medical-B compared to the medical device I industry average are as follows: - ROE: -2.16% vs. -8.48% (20th rank) - Market capitalization: HKD 3.571 billion vs. HKD 5.866 billion (12th rank) - Revenue: HKD 362 million vs. HKD 1.236 billion (19th rank) - Net profit margin: -14.73% vs. -18.01% (20th rank) - Gross profit margin: 69.48% vs. 55.19% (65th rank) - Debt ratio: 16.97% vs. 27.72% (10th rank) [1]

Core Viewpoint - The company has received CE mark approval for its Alwide® Plus balloon dilation catheter, enhancing its product offerings in the transcatheter aortic valve implantation (TAVI) market in Europe [1][2]. Group 1: Product Features and Benefits - Alwide® Plus is designed to expand calcified aortic valves prior to TAVI, reducing the challenges associated with valve shaping during the procedure [2]. - Key features include ultra-low compliance for precise balloon expansion, high burst pressure for effectively opening severely calcified areas, rapid inflation/deflation to minimize blood flow interruption, and excellent puncture resistance for enhanced safety during the procedure [2]. Group 2: Market Impact and Strategic Importance - The CE mark approval will optimize treatment options for TAVI in Europe, contributing to increased overseas revenue for the company and facilitating the commercialization of its VitaFlow Liberty® transcatheter aortic valve and delivery system in Europe [2]. - Alwide® Plus is the fourth self-developed product to receive CE mark approval, enriching the company's product matrix in the structural heart disease market in Europe and demonstrating its technological capabilities and strategic foresight in global market expansion [3].

Core Viewpoint - The company has received CE mark approval for its Alwide Plus balloon dilation catheter, enhancing its product offerings in the transcatheter aortic valve implantation (TAVI) market in Europe [1][2]. Group 1: Product Features and Benefits - Alwide Plus is designed to expand calcified aortic valves prior to TAVI, reducing the challenges associated with valve shaping during the procedure [2]. - Key features include ultra-low compliance for precise balloon expansion, high burst pressure for effectively opening severely calcified areas, rapid filling and deflation to minimize blood flow interruption, and excellent puncture resistance for enhanced safety during the procedure [2]. Group 2: Market Impact and Strategic Importance - The CE mark approval will optimize treatment options for TAVI in Europe, contributing to increased overseas revenue for the company [2]. - Alwide Plus is the fourth self-developed product to receive CE mark approval, enriching the company's product matrix in the structural heart disease market in Europe [3]. - The approval demonstrates the company's leading technological reserves and R&D capabilities in the global structural heart disease medical device sector, enhancing its competitive edge in the international high-end medical device market [3].

Core Viewpoint - The company has received CE mark approval for its Alwide® Plus cardiac balloon dilation catheter, enhancing its product offerings in the transcatheter aortic valve implantation (TAVI) market in Europe [1][2]. Group 1: Product Features and Benefits - Alwide® Plus is designed to expand calcified aortic valves prior to TAVI, reducing the challenges associated with valve shaping during the procedure [2]. - Key features include ultra-low compliance for precise balloon expansion, high burst pressure for effectively opening severely calcified areas, rapid inflation/deflation to minimize blood flow interruption, and excellent puncture resistance for enhanced safety during the procedure [2]. Group 2: Market Impact and Strategic Importance - The CE mark approval will optimize treatment options for TAVI in Europe, contributing to increased overseas revenue for the company and facilitating the commercialization of its VitaFlow Liberty® transcatheter aortic valve and delivery system in Europe [2]. - Alwide® Plus is the fourth self-developed product to receive CE mark approval, enriching the company's product matrix in the structural heart disease market in Europe and demonstrating its technological and research capabilities [3]. - The synergy among the four CE-marked products is expected to promote their respective commercialization processes, enhancing the company's competitiveness in the international high-end medical device market [3].

Core Insights - The company HeartLink Medical-B (02160.HK) announced that its AlwidePlus cardiac balloon dilation catheter has received CE marking approval, indicating compliance with health, safety, and environmental standards for products sold in the European Economic Area [1][2] Group 1: Product Features - AlwidePlus is a self-developed surgical accessory designed to dilate calcified aortic valves prior to transcatheter aortic valve implantation (TAVI), reducing the challenges associated with valve shaping during the procedure [1] - Key features of AlwidePlus include: - Ultra-low compliance for precise balloon expansion, minimizing vascular damage [1] - High burst pressure performance to effectively expand severely calcified areas, addressing the high calcification characteristics of patients [1] - Rapid filling and deflation capabilities to minimize prolonged blood flow interruption, reducing pacing time and surgical risks [1] - Excellent puncture resistance to ensure safety during balloon expansion, enhancing the user experience for operators [1] Group 2: Market Impact - The CE marking approval for AlwidePlus will provide an optimized treatment option for TAVI procedures in Europe, contributing to incremental overseas revenue for the company [2] - This approval will facilitate the commercialization of the VitaFlow Liberty transcatheter aortic valve and its retrievable delivery system in Europe, while also accelerating the registration process in other global markets [2] - The developments align with the company's strategy to deepen its overseas market presence [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 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進展 及產品註冊進度的情況。 本 公 司 董 事 會（「董事會」）欣 然 宣 佈，Alwide® Plus心臟瓣膜球囊擴張導管 （「Alwide® Plus」）已獲得CE標誌（表明歐洲經濟區內所售產品符合健康、安全及 環保標準的認證標誌）批准。 （ 於 開 曼 群 島 註 冊 成 立 的 有 限 公 司 ） （股份代號：2160） 自願公告 ALWIDE® PLUS心臟瓣膜球囊擴張導管之CE標誌批准 Alwide® Plus為本公司自主研發的手術配套產品，用於在經導管主動脈瓣植入 術（「TAVI」）前擴張鈣化的主動脈瓣膜，降低在TAVI手術中進行瓣膜成形術的 挑戰 ...

（原标题：港股异动 | 心通医疗-B(02160)午前涨超4% 将于本月底发布业绩 预期上半年净亏损同比减少 不低于83%） 消息面上，心通医疗-B拟于8月28日举行董事会会议考虑及批准中期业绩。此前，心通医疗-B发布公 告，该集团预期2025年上半年取得净亏损不高于人民币1000万元，同比减少不低于83%。 公告称，净亏损减少主要是由于：VitaFlow Liberty经导管主动脉瓣膜及可回收输送系统已在海外20余个 国家╱地区实现销售，来自海外的收入同比增长两倍以上；AnchorMan左心耳封堵器系统及其导引系统 在中国的商业化进展稳步推进，并于报告期内获得CE标志并在欧洲实现商业化，共同贡献了收入增 量；集团通过持续优化资源配置、积极管控各项费用等措施进一步提升运营效率；及集团的联营公司 4C Medical Technologies, Inc完成D轮融资，集团于4C Medical的股权比例下降，获得视作出售部分股权 的收益。 智通财经APP获悉，心通医疗-B(02160)午前涨超4%，截至发稿，涨4.05%，报1.54港元，成交额1622.65 万港元。 ...

Core Viewpoint - HeartFlow Medical-B (02160) is expected to report a significant reduction in net loss for the first half of 2025, projecting a loss not exceeding RMB 10 million, which represents a year-on-year decrease of no less than 83% [1] Financial Performance - The company anticipates a net loss reduction primarily due to the sales of the VitaFlow Liberty transcatheter aortic valve and its retrievable delivery system, which has been sold in over 20 countries/regions, resulting in a year-on-year revenue increase of over 200% [1] - The AnchorMan left atrial appendage occluder system and its guiding system have made steady progress in commercialization in China, achieving CE marking and commercializing in Europe during the reporting period, contributing to revenue growth [1] Operational Efficiency - The company has improved operational efficiency through continuous optimization of resource allocation and active cost management measures [1] - The joint venture 4C Medical Technologies, Inc. completed a Series D financing round, leading to a decrease in the company's equity stake in 4C Medical, which is recognized as a gain from the partial sale of equity [1]

格隆汇8月15日丨心通医疗-B(02160.HK)公告，公司将于2025年8月28日(星期四)举行董事会会议，以考 虑及批准(其中包括)公司及其附属公司截至2025年6月30日止6个月中期业绩及其发布。 ...

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。 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） 董事會召開日期 微創心通醫療科技有限公司（「本公司」）董事（「董事」）會（「董事會」）謹此宣佈， 本公司將於2025年8月28日（星期四）舉行董事會會議，以考慮及批准（其中包括） 本公司及其附屬公司截至2025年6月30日止六個月之中期業績及其發佈。 承董事會命 微創心通醫療科技有限公司 主席 陳國明 中國上海，2025年8月15日 截至本公告日期，執行董事為張瑞年先生、趙亮先生及閆璐穎女士； 非執行董事為 陳國明先生、張俊傑先生及吳夏女士；及獨立非執行董事為周嘉鴻先生、孫志祥女士及 胡冰山博士。 ...