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 ...

Core Viewpoint - The stock of HeartFlow Medical-B (02160) rose over 4% ahead of its mid-year earnings announcement, with expectations of a significant reduction in net losses for the first half of 2025 compared to the previous year [1] Group 1: Earnings Announcement - HeartFlow Medical-B plans to hold a board meeting on August 28 to consider and approve its mid-year earnings [1] - The company anticipates a net loss of no more than RMB 10 million for the first half of 2025, representing a year-on-year decrease of at least 83% [1] Group 2: Revenue Drivers - The reduction in net losses is attributed to the sales of the VitaFlow Liberty transcatheter aortic valve and its delivery system in over 20 countries, resulting in more than a twofold increase in overseas revenue [1] - The commercial progress of the AnchorMan left atrial appendage occluder system and its guiding system in China has been steady, with the product obtaining CE marking and achieving commercialization in Europe during the reporting period, contributing to revenue growth [1] Group 3: Operational Efficiency - The company has enhanced operational efficiency through continuous optimization of resource allocation and active cost management [1] - The group's 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 generated income from the perceived sale of part of its equity [1]

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。 ...

Core Viewpoint - The company anticipates a significant reduction in net loss for the first half of the year, projecting a loss not exceeding RMB 10 million, which represents a decrease of at least 83% compared to the same period last year [1] Group 1: Financial Performance - The expected net loss for the reporting period is projected to be less than RMB 10 million, marking a reduction of no less than 83% [1] - The reduction in net loss is primarily attributed to the sales of the VitaFlow Liberty® transcatheter aortic valve and its delivery system, which have been sold in over 20 countries/regions overseas, resulting in more than a twofold increase in overseas revenue compared to the same period last year [1] Group 2: Product Development and Commercialization - The AnchorMan® left atrial appendage occluder system and its delivery system are making steady progress in commercialization in China, having received CE marking and achieved commercialization in Europe during the reporting period, contributing to revenue growth [1] Group 3: Operational Efficiency - The company has enhanced operational efficiency through continuous optimization of resource allocation and active cost management measures [1] - The company's associate, 4C Medical Technologies, Inc, completed a Series D financing round, resulting in a decrease in the company's equity stake in 4C Medical, which is recognized as a gain from the partial sale of equity [1]

Core Viewpoint - The company expects a net loss of no more than RMB 10 million for the six months ending June 30, 2025, representing a decrease of at least 83% compared to the same period in 2024 [1] Group 1: Financial Performance - The anticipated net loss reduction is primarily attributed to the sales of VitaFlow Liberty® transcatheter aortic valve and its retrievable delivery system in over 20 countries/regions [1] - Revenue from overseas markets has more than doubled compared to the six months ending June 30, 2024 [1] Group 2: Product Development and Commercialization - The AnchorMan® left atrial appendage occluder system and its guiding system are making steady progress in commercialization in China [1] - The company obtained CE marking for the AnchorMan® system and has commenced commercialization in Europe during the reporting period [1] Group 3: Operational Efficiency - The company has implemented measures to optimize resource allocation and actively manage expenses, which have further enhanced operational efficiency [1] - The equity stake in the joint venture 4C Medical has decreased following its completion of Series D financing, resulting in recognized gains from the partial sale of shares [1]