中期報告 2025 2025 INTERIM REPORT INTERIM REPORT 2025 中期報告 MicroPort CardioFlow Medtech Corporation 微創心通醫療科技有限公司 CMY CM MY CY CMY K CardioFlow IR2025 Full Cover V01A_10mm_OP.pdf 1 23/9/2025 下午12:54 目錄 | | | 8 公司資料 10 總裁報告 13 財務摘要 14 管理層討論及分析 30 企業管治及其他資料 56 核數師致董事會的獨立審閱報告 57 綜合損益表 58 綜合損益及其他全面收益表 59 綜合財務狀況表 61 綜合權益變動表 63 簡明綜合現金流量表 64 未經審核中期財務報告附註 釋義及技術詞彙表 | 「4C Medical」 | 指 | 4C Medical Technologies, Inc.，一家根據特拉華州法律註冊成立的公司， | | --- | --- | --- | | | | 主要從事二尖瓣及三尖瓣器械的研發 | | 「AccuSniperTM」 | 指 | AccuSniperTM雙層球囊擴張 ...

Core Insights - Southbound funds reduced their holdings in HeartCare Medical-B (02160.HK) by 77,000 shares on September 18, 2025, marking a continuous trend of selling over the past trading days [1] - Over the last 5 trading days, there has been a total net reduction of 215,000 shares, and in the last 20 trading days, the cumulative net reduction reached 2.876 million shares [1] - As of now, southbound funds hold 112 million shares of HeartCare Medical-B, which accounts for 4.63% of the company's total issued ordinary shares [1] Company Overview - HeartCare Medical Technology Co., Ltd. specializes in providing comprehensive medical solutions for treating structural heart diseases [2] - The company's main business involves the research and commercialization of transcatheter and surgical solutions in the field of structural heart disease [2] - The product pipeline includes transcatheter aortic valve implantation (TAVI) series products, AnchorMan left atrial appendage closure (LAAC) products, transcatheter mitral valve (TMV) products, transcatheter tricuspid valve (TTV) products, and surgical support products, with operations in both domestic and international markets [2]

股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 FF301 公司名稱: 微创心通医疗科技有限公司 呈交日期: 2025年9月3日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 02160 | 說明 | 普通股 | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | 法定/註冊股本 | | | 上月底結存 | | | 10,000,000,000 | USD | 0.000005 | USD | | 50,000 | | 增加 / 減少 (-) | | | 0 | | | USD | | 0 | | 本月底結存 | | | 10,000,000,000 | USD | | 0.000005 USD | | 50,000 | 截至月份: 2025年8月31日 狀態: 新提交 本月底法定/註冊股本總額： USD 50,000 ...

Summary of Key Points from the Conference Call Company Overview - **Company**: 新通医疗 (Xintong Medical) - **Industry**: Medical Devices, specifically focusing on structural heart disease solutions Financial Performance - **Revenue**: Approximately 230 million, a year-on-year increase of 3% [2][11] - **Net Loss**: Reduced by over 96%, from 57 million in H1 2024 to just over 2 million in H1 2025 [11] - **Operating Loss**: Decreased by 81%, from 36 million to approximately 7 million [11] - **Gross Margin**: Stable at around 70% [11][15] - **Cash Reserves**: Exceeded 1.3 billion, indicating strong operational stability [2][3] Market Performance - **Overseas Revenue Growth**: Increased by over 235%, with the IEM region contributing 62% of overseas income [2][12] - **China Market Position**: Maintained the leading market share with 2,146 implants completed, entering 45 new centers [5][11] - **Product Performance**: The left atrial appendage occluder product, 安可迈 (Anke Mai), achieved 750 implants, with a 107% increase in H1 2025 [6][11] Strategic Initiatives - **Product Development**: Focus on innovative solutions for structural heart disease, with 7 products approved in China and 4 in Europe [7][8] - **Acquisition**: Acquired 51% of Shanghai Zhuoxin to enhance the left atrial appendage occluder business [10] - **Global Expansion**: Plans to deepen global registration and commercialization efforts, targeting Asia, Europe, and the Americas [8][13] Competitive Strategy - **Cost Control**: Implemented strict cost control measures to maintain profitability amidst competitive pressures [5][11] - **Market Penetration**: Increased the number of independent operators and enhanced sales efficiency, with a 26% increase in per capita implant volume [5][11] - **Academic Collaboration**: Engaged in academic exchanges to promote global resource collaboration and expand market reach [4] Future Outlook - **Growth Projections**: Expected to maintain a gross margin of around 70% and reduce operating losses further [15] - **Market Expansion**: Aiming for significant growth in overseas markets, with expectations of doubling overseas revenue [14][19] - **CRM Business Integration**: Anticipated benefits from the strategic restructuring of the CRM business, enhancing product pipeline and global reach [10][16] Regulatory and Clinical Impact - **Clinical Guidelines**: New guidelines from the American College of Cardiology positively influence the demand for left atrial appendage occluders [18] - **Market Penetration**: Current penetration rate for left atrial appendage occlusion in China is approximately 0.34%, with significant growth potential as awareness and technology improve [18] Conclusion - **Overall Performance**: Despite market challenges, the company has demonstrated resilience and strategic foresight, positioning itself for sustainable growth and increased market share in both domestic and international markets [34]

报告期内，集团录得净亏损人民币220万元，较截至2024年6月30日止六个月的亏损人民币5780万元显著 减少，该减少主要是由于(i)收入及毛利稳定增长；(ii)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(iii)集团的联营公司4C Medical完成D轮融资后，视作出售其股权所产生的收 益。 格隆汇8月29日丨心通医疗-B(02160.HK)发布公告，截至2025年6月30日止六个月，集团录得收入人民币 2.291亿元，同比增加2.7%，主要是由于报告期内，VitaFlow Liberty®及Alwide®Plus在全球商业化的持 续推进，促进了集团的海外收入较2024年同期快速增长235.3%。此外，于报告期内，集团的 AnchorMan®左心耳封堵系统及AnchorMan®左心耳导引系统在中国的商业化进展稳步推进，且随后在 欧洲实现商业化，亦为集团带来新增收入贡献。 ...

公告称，收入增加主要是由于于报告期内，集团的VitaFlow Liberty经导管主动脉瓣膜及可回收输送系统 在全球商业化方面的持续推进促进了海外收入的大幅增长;及集团的AnchorMan左心耳封堵系统及 AnchorMan左心耳导引系统在中国和海外的商业化进展稳步推进。 心通医疗-B(02160)发布截至2025年6月30日止6个月的中期业绩，该集团取得收入2.29亿元，同比增加 2.67%;公司权益股东应占亏损216.3万元，同比减少96.17%;每股基本亏损0.09分。 ...

公告称，收入增加主要是由于于报告期内，集团的VitaFlow Liberty®经导管主动脉瓣膜及可回收输送系 统在全球商业化方面的持续推进促进了海外收入的大幅增长;及集团的AnchorMan®左心耳封堵系统及 AnchorMan®左心耳导引系统在中国和海外的商业化进展稳步推进。 智通财经APP讯，心通医疗-B(02160)发布截至2025年6月30日止6个月的中期业绩，该集团取得收入2.29 亿元，同比增加2.67%;公司权益股东应占亏损216.3万元，同比减少96.17%;每股基本亏损0.09分。 ...

[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]