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]

Core Viewpoint - The company reported a revenue of RMB 229.1 million for the six months ending June 30, 2025, representing a year-on-year increase of 2.7%, driven by the global commercialization of VitaFlow Liberty® and Alwide®Plus, which significantly boosted overseas revenue by 235.3% compared to the same period in 2024 [1] Financial Performance - The company recorded a net loss of RMB 2.2 million, a significant reduction from the net loss of RMB 57.8 million for the six months ending June 30, 2024 [1] - The improvement in net loss was attributed to stable growth in revenue and gross profit, enhanced operational efficiency through resource optimization and cost control measures, and income generated from the equity sale of its associate company 4C Medical after completing a Series D financing round [1]

Core Viewpoint - The company reported a revenue of 229 million, reflecting a year-on-year increase of 2.67%, while the loss attributable to equity shareholders decreased by 96.17% to 2.163 million [1] Financial Performance - Revenue for the six months ending June 30, 2025, was 229 million, up 2.67% year-on-year [1] - Loss attributable to equity shareholders was 2.163 million, a significant reduction of 96.17% compared to the previous year [1] - Basic loss per share was 0.09 cents [1] Business Development - The increase in revenue was primarily driven by the ongoing global commercialization of the VitaFlow Liberty transcatheter aortic valve and its retrievable delivery system, which significantly boosted overseas revenue [1] - The commercialization progress of the AnchorMan left atrial appendage occlusion system and the AnchorMan left atrial appendage guiding system in both China and overseas markets is steadily advancing [1]

Core Viewpoint - The company reported a revenue of 229 million, reflecting a year-on-year increase of 2.67%, while the loss attributable to equity shareholders decreased by 96.17% to 2.163 million [1] Revenue Performance - The increase in revenue is primarily attributed to the ongoing global commercialization of the VitaFlow Liberty® transcatheter aortic valve and its retrievable delivery system, which significantly boosted overseas revenue [1] - The steady progress in the commercialization of the AnchorMan® left atrial appendage occlusion system and the AnchorMan® left atrial appendage guiding system in both China and overseas markets also contributed to revenue growth [1]

[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].