AnchorMan®左心耳封堵器系统及其导引系统
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心通医疗-B(02160):Alwide Plus心脏瓣膜球囊扩张导管获得CE标志批准
智通财经网· 2025-08-18 15:03
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].
心通医疗-B(02160):Alwide® Plus心脏瓣膜球囊扩张导管获得CE标志批准
智通财经网· 2025-08-18 15:02
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].
心通医疗上半年净亏损收窄约83%,VitaFlow Liberty海外收入增长两倍以上
Cai Jing Wang· 2025-08-08 04:35
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]
心通医疗-B(02160.HK)料上半年净亏损同比收窄不低于83%
Jin Rong Jie· 2025-08-08 01:42
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]
心通医疗-B(02160)发盈警 预期上半年净亏损同比减少不低于83%
智通财经网· 2025-08-07 14:55
Core Viewpoint - The company expects to achieve a net loss of no more than RMB 10 million in the first half of 2025, representing a year-on-year reduction of not less than 83% [1] Group 1: Financial Performance - The reduction in net loss is primarily attributed to the sales of VitaFlow Liberty® transcatheter aortic valve and its delivery system in over 20 countries/regions, with overseas revenue increasing by more than two times year-on-year [1] - The commercial progress of the AnchorMan® left atrial appendage occluder system and its guiding system in China is steadily advancing, having obtained CE marking and commercialized in Europe during the reporting period, contributing to revenue growth [1] Group 2: 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 generated income from the sale of part of its equity [1]