[Company Overview](index=1&type=section&id=Company%20Overview) [Financial Summary and Performance Highlights](index=1&type=section&id=Financial%20Summary%20and%20Performance%20Highlights) MicroPort CardioFlow Medtech reported H1 2025 unaudited interim results, with revenue up 2.7% to RMB 229.1 million and net loss significantly narrowed to RMB 2.2 million, driven by global commercialization and operational efficiency Financial Summary for the Six Months Ended June 30, 2025 | Metric | 2025 (RMB thousand) | 2024 (RMB thousand) | Y-o-Y Change (%) | | :--- | :--- | :--- | :--- | | Revenue | 229,103 RMB thousand | 223,138 RMB thousand | +2.7% | | Gross Profit | 160,922 RMB thousand | 158,224 RMB thousand | +1.7% | | Profit/(Loss) from Operations | 3,817 RMB thousand | (28,480) RMB thousand | 扭虧為盈 | | Loss for the Period | (2,197) RMB thousand | (57,753) RMB thousand | 虧損大幅收窄 | | Loss per Share (RMB cents) | (0.09) RMB cents | (2.40) RMB cents | 虧損大幅收窄 | - Overseas revenue rapidly grew by **235.3%**, primarily driven by the global commercialization of VitaFlow Liberty® and Alwide® Plus[5](index=5&type=chunk) - AnchorMan® Left Atrial Appendage Occluder System and delivery system steadily advanced commercialization in China, with new revenue contributions from Europe[5](index=5&type=chunk) - Net loss significantly reduced, primarily due to revenue and gross profit growth, improved operational efficiency, and gain on deemed disposal of equity interest after associate 4C Medical's Series D financing[5](index=5&type=chunk) [Operating Review and Business Development](index=3&type=section&id=Operating%20Review%20and%20Business%20Development) [Industry Overview](index=3&type=section&id=Industry%20Overview) In H1 2025, China's structural heart disease sector saw TAVI and LAAO procedure growth amid innovation, but faces challenges from competition and centralized procurement - New TAVI products launched, with academic exchanges, patient education, and procedure promotion jointly boosting efforts, driving steady growth in surgical penetration and industry scale[6](index=6&type=chunk) - Left atrial appendage occlusion achieved breakthroughs in technological innovation and domestic substitution, leveraging the 'catheter ablation + left atrial appendage occlusion' one-stop surgery promotion, leading to rapid growth in surgical volume[6](index=6&type=chunk) - The industry faces challenges from intensified competition leading to price adjustments and centralized volume-based procurement policies[6](index=6&type=chunk) [Product Pipeline](index=4&type=section&id=Product%20Pipeline) The company has 7 approved products in TAVI and LAAO, with various TAVI, TMV, TTV, LAAO, and VSR products in development, holding exclusive China commercialization rights for 4C Medical's TMV/TTV - As of the announcement date, the company's self-developed product portfolio includes **7 approved products**: VitaFlow®, VitaFlow Liberty®, VitaFlow Liberty® Flex, Alwide® Plus, AccuSniperTM, AnchorMan® Left Atrial Appendage Occluder System, and AnchorMan® Left Atrial Appendage Delivery System[11](index=11&type=chunk) - The company collaborates with 4C Medical to develop TMV and TTV products, holding exclusive commercialization rights for these products in China[11](index=11&type=chunk) [Approved Products](index=4&type=section&id=Approved%20Products) The company has multiple TAVI products (VitaFlow®, VitaFlow Liberty®, VitaFlow Liberty® Flex) and accessory products (Alwide® Plus), plus the AnchorMan® LAAO system, with NMPA/CE certifications and global commercialization - VitaFlow Liberty® newly obtained registration approvals in Kazakhstan, Latvia, Sweden, Ecuador, and Brazil, accumulating approvals in **22 countries/regions**[9](index=9&type=chunk) - AnchorMan® Left Atrial Appendage Occluder System obtained CE approval, becoming the only left atrial appendage occluder system to date with both **CE-MDR and NMPA dual certifications**[9](index=9&type=chunk) - Alwide® Plus obtained CE mark in August 2025, accumulating registration approvals in **14 countries or regions**[9](index=9&type=chunk) [VitaFlow®](index=5&type=section&id=VitaFlow%C2%AE) VitaFlow®, the company's first-gen TAVI product, approved by NMPA in 2019, shows excellent 5-year and 8-year safety and efficacy, outperforming other Chinese TAVI products - VitaFlow® was approved by NMPA in July 2019 and commercialized in China in August[14](index=14&type=chunk) - 5-year follow-up results released in July 2022 showed **18.2% all-cause mortality** and **2.1% severe stroke event incidence**[14](index=14&type=chunk) - 8-year follow-up results released in 2024 showed **39.1% all-cause mortality** and **20.6% cardiac mortality**, outperforming other TAVI products in China[14](index=14&type=chunk) [VitaFlow Liberty®](index=6&type=section&id=VitaFlow%20Liberty%C2%AE) VitaFlow Liberty®, the second-gen TAVI product, features a unique retrievable delivery system, won design awards, and is NMPA/CE approved, registered in 20 overseas countries - VitaFlow Liberty® is a second-generation TAVI product with a retrievable delivery system, allowing up to **three retrievals** to improve surgical success rates[16](index=16&type=chunk) - The product won the German Red Dot Product Design Award and the Italian A'Design Award[16](index=16&type=chunk) - Approved by NMPA in August 2021, CE certified in April 2024, and registered in **20 overseas countries/regions**[16](index=16&type=chunk) [VitaFlow Liberty® Flex](index=6&type=section&id=VitaFlow%20Liberty%C2%AE%20Flex) VitaFlow Liberty® Flex, the third-gen TAVI product, NMPA approved in Dec 2024, is the world's only true coaxial steerable self-expanding aortic valve delivery system, offering precise solutions for complex cases - VitaFlow Liberty® Flex was approved by NMPA in December 2024, becoming the world's **only 'true' coaxial steerable self-expanding aortic valve delivery system**[17](index=17&type=chunk) - Features **3D spatial steering function** and Capsule segment steerability, ensuring coaxial valve release and stable, precise implantation[17](index=17&type=chunk) - Excellent early exploratory clinical implantation results, with **significant improvement in 30-day follow-up indicators**, and widespread acclaim for real-world clinical performance[17](index=17&type=chunk) [Alwide® Plus](index=7&type=section&id=Alwide%C2%AE%20Plus) Alwide® Plus, the second-gen cardiac valve balloon dilatation catheter, compatible with three generations of TAVI products, offers ultra-low compliance and high puncture resistance for safer procedures - Alwide® Plus is a second-generation cardiac valve balloon dilatation catheter, compatible with the company's **three generations of TAVI products**[18](index=18&type=chunk) - Key features include **ultra-low compliance, high burst pressure, rapid inflation/deflation, and excellent puncture resistance**[18](index=18&type=chunk) - Approved by NMPA in August 2021, obtained CE mark in August 2025, and subsequently received registration approvals in **12 overseas countries or regions**[18](index=18&type=chunk) [AnchorMan® Left Atrial Appendage Occluder System](index=7&type=section&id=AnchorMan%C2%AE%20Left%20Atrial%20Appendage%20Occluder%20System) AnchorMan® LAAO System is an interventional solution for non-valvular AF stroke prevention, featuring a semi-closed structure for stable anchoring, reduced tissue damage, and improved sealing - AnchorMan® Left Atrial Appendage Occluder System and delivery system is an interventional medical solution for **stroke prevention in non-valvular atrial fibrillation**[19](index=19&type=chunk) - Features **12 '3D folding' units** at the tail forming a semi-closed structure with the mesh, addressing the clinical pain point of traditional plug-type occluder sheaths deeply entering the left atrial appendage[19](index=19&type=chunk) - The device's distal end is rounded and soft, reducing left atrial appendage tissue damage; the dense nitinol mesh design enhances sealing effect, and offers **both push and pull release methods**[19](index=19&type=chunk) [Products Under Development](index=7&type=section&id=Products%20Under%20Development) The company is advancing innovative products including fourth-gen TAVI, AR, MR, TR, next-gen LAAO, and the world's first VSR product for post-MI VSP, aiming to expand its portfolio and market leadership - VitaFlow Liberty® Pro is the **fourth-generation product** in the VitaFlow series, aiming to enhance safety and efficacy, and offer better options in terms of low profile, durability, and hemodynamics[20](index=20&type=chunk) - VitaFlow® SELFValveTM is a TMVR product for MR patients, with **dozens of human implantations and up to two-year postoperative follow-ups completed**, and human application and validation are being advanced in multiple centers[23](index=23&type=chunk) - VitaManTM is the **world's first and only ventricular septal reconstruction product** designed for post-myocardial infarction ventricular septal perforation, aiming to fill market gaps and enhance brand influence[27](index=27&type=chunk) [VitaFlow Liberty® Pro](index=7&type=section&id=VitaFlow%20Liberty%C2%AE%20Pro) VitaFlow Liberty® Pro, the fourth-gen VitaFlow product, is in R&D, aiming for enhanced safety, efficacy, low profile, durability, and hemodynamics - VitaFlow Liberty® Pro is the VitaFlow series fourth-generation product, currently in the R&D and design phase[20](index=20&type=chunk) - The product will continue technical features such as steerability and strong support, and continuously strive for improvements in safety

Core Viewpoint - The company, HeartFlow Medical-B (02160), is experiencing a decline in stock price ahead of its mid-year performance announcement, with a projected net loss for the first half of 2025 not exceeding RMB 10 million, representing a year-on-year decrease of at least 83% [1] Financial Performance - The company anticipates a significant reduction in net loss due to increased sales of the VitaFlow Liberty transcatheter aortic valve and delivery system in over 20 countries/regions, with overseas revenue more than doubling [1] - The commercial progress of the AnchorMan left atrial appendage occluder system and its guiding system in China is steady, and it has received CE marking for commercialization in Europe, contributing to revenue growth [1] Operational Efficiency - Continuous optimization of resource allocation has further enhanced operational efficiency [1] - The completion of D-round financing by the joint venture 4C Medical has resulted in a decrease in the company's shareholding, which is recognized as a gain from the sale of equity [1]

Core Viewpoint - HeartFlow Medical-B (02160) experienced a nearly 7% drop before earnings announcement, currently down 4.2% at HKD 1.37, with a trading volume of HKD 11.31 million [1] Financial Performance - The company plans to hold a board meeting on August 28 to approve its interim results [1] - HeartFlow Medical issued a profit warning, expecting a net loss of no more than RMB 10 million for the first half of 2025, representing a year-on-year decrease of no less than 83% [1] Revenue Drivers - 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 [1] - Revenue from overseas markets has increased by more than two times [1] - The commercial progress of the AnchorMan left atrial appendage occluder system and its guiding system in China is steadily advancing, with CE marking obtained for commercialization in Europe, contributing to revenue growth [1] Operational Efficiency - Continuous optimization of resource allocation has further enhanced operational efficiency [1] - The completion of D-round financing by the joint venture 4C Medical has resulted in a decrease in the company's shareholding, leading to recognized gains from the sale of equity [1]

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。 ...