Core Viewpoint - The strategic restructuring of MicroPort Medical and its subsidiary, HeartLink Medical, aims to create a comprehensive cardiac product platform to enhance market competitiveness and operational efficiency amid industry challenges [1][2][10] Company Overview - HeartLink Medical, once valued at HKD 52.9 billion, has seen its market capitalization plummet by nearly 90% to approximately HKD 6 billion [2][4] - MicroPort Medical has faced significant financial pressure, accumulating losses of USD 1.811 billion (approximately RMB 13.1 billion) from 2020 to 2023, alongside substantial R&D expenditures totaling RMB 23.24 billion [5][6] Financial Performance - HeartLink Medical reported a revenue of RMB 362 million in 2024, marking a 7.54% increase from 2023, while its net loss narrowed significantly by 89.51% to RMB 49.446 million [4] - MicroPort Medical's financial targets include achieving approximately RMB 10 billion in revenue with a loss of RMB 2 billion in 2024, aiming for profitability by 2025 [6] Strategic Rationale - The merger of MicroPort's CRM business with HeartLink's structural heart disease operations is intended to leverage existing international sales networks, reduce redundant costs, and enhance product offerings [2][10] - The integration aims to create a unique platform that addresses both structural heart disease and rhythm management, potentially attracting long-term capital focused on the cardiovascular sector [2][6] Market Context - The TAVI market in China is projected to grow rapidly, with an expected compound annual growth rate of 53.1%, reaching RMB 5.0557 billion by 2025 [8][9] - The restructuring is seen as a critical move to challenge international competitors like Edwards Lifesciences and Medtronic in the Chinese market [9] Challenges and Risks - The integration of two distinct business units poses risks related to operational synergy, valuation balance, and potential regulatory scrutiny regarding antitrust issues [7][8] - HeartLink Medical's cash balance of RMB 801 million as of June 2024 necessitates careful management of resources between CRM business recovery and TAVI capacity expansion [10]

Group 1 - The biopharmaceutical B-class stocks experienced a rally, with notable increases in stocks such as Clover Biopharma-B, Kelun-Biotech, and Xintong Medical-B, the latter seeing a peak increase of nearly 21% before settling at over 6% [2] - The surge in Xintong Medical's stock price is attributed not only to sector trends but also to the news that MicroPort Medical is considering merging its CRM business with Xintong Medical [2] - MicroPort Medical's stock also saw a significant increase, jumping nearly 7% on the same day [3] Group 2 - On July 16, Xintong Medical announced that its board received a non-binding proposal from its controlling shareholder, MicroPort Medical, regarding a strategic restructuring of the CRM business [4] - MicroPort Medical's CRM business focuses on developing, manufacturing, and selling products for diagnosing and managing arrhythmias and heart failure, including pacemakers and defibrillators [4] - The merger aims to enhance internal resource integration, improve competitiveness, and create long-term value for the group and its stakeholders [4] Group 3 - The merger is expected to create a comprehensive cardiac product platform, offering a diverse range of products from CRM solutions to structural heart disease products [6] - By establishing this diversified product platform, the group aims to enhance its global market development capabilities and strengthen its positioning in respective segments [6] - The merger is also anticipated to generate synergies through shared international marketing and sales channels, expanding business scale and growth potential [6] Group 4 - Overall, the merger represents an internal business adjustment for MicroPort Medical, aimed at consolidating cardiac-related operations and fostering collaborative development [7] - Both MicroPort Medical and Xintong Medical are currently in a loss-making position, and this restructuring may help them achieve profitability sooner [7] - Market feedback has been positive, with both companies' stock prices rising, although Xintong Medical's stock experienced a significant pullback, indicating some divergence in investor sentiment [8]

Group 1 - The Hong Kong biopharmaceutical stocks continue to show strong performance, with notable increases in share prices [1] - Clover Biopharmaceuticals (02197.HK) surged nearly 24%, while Innovent Biologics (09939.HK) rose over 20% [1] - Lepu Biopharmaceutical (02157.HK) and HeartCare Medical (02160.HK) both increased by over 10%, and Kelun-Biotech (06990.HK) saw a rise of more than 8.5% [1]

Core Viewpoint - The company is considering a non-binding proposal to restructure its CRM business by merging it with the operations of MicroPort Cardiac Rhythm Management, aiming to enhance competitiveness and create long-term value for stakeholders [1][2] Group 1: Business Overview - The company, along with its subsidiaries, is a leading medical device group focused on the innovation, manufacturing, and sales of high-end medical devices globally, with business segments including cardiovascular intervention, orthopedic medical devices, CRM, and others [1] - The CRM business is dedicated to developing global leading CRM solutions, primarily involved in the research, manufacturing, and sales of products for diagnosing, treating, and managing arrhythmias and heart failure, including pacemakers, defibrillators, and cardiac resynchronization therapy devices [1] Group 2: Strategic Benefits of the Merger - The merger of the two businesses will help establish a cardiac product platform, offering a diversified product line that includes CRM products and structural heart disease solutions, enhancing the company's global market development capabilities [2] - By merging the two businesses, the company aims to create synergies that will expand the scale and growth potential of the combined operations, improving revenue, profitability, and cash flow [2] - The unified financial management resulting from the merger will enhance capital efficiency and fundraising capabilities, while promoting the diversified product platform in international markets to increase recognition of the related value and growth potential [2]

Core Insights - The article highlights the recent acquisition by Heart通医疗 of the remaining 49% stake in Shanghai Zhaoxin, making it a wholly-owned subsidiary, with a total acquisition cost of RMB 170 million [1][2]. Company Overview - Heart通医疗, established in 2009 and officially registered in 2015, focuses on innovative medical devices for structural heart diseases, with its headquarters in Shanghai and listed on the Hong Kong Stock Exchange in 2021 [2]. - The company emphasizes research and innovation, developing a comprehensive range of transcatheter and surgical solutions for structural heart diseases, including products for transcatheter aortic valve implantation (TAVI) [2]. Market Performance - Shanghai Zhaoxin specializes in left atrial appendage-related medical devices, with its core product, the AnchorMan left atrial appendage occlusion system, receiving NMPA approval for market entry in January 2024 [5][6]. - The TAVI series products of Heart通医疗 are already in over 650 hospitals across China, and the company has expanded its international presence to nearly a hundred hospitals in countries like Argentina, Colombia, and Switzerland [4]. Product Development - The AnchorMan left atrial appendage occlusion system has shown promising clinical results, achieving a 98.1% clinical success rate and a 100% left atrial appendage occlusion success rate in a one-year follow-up study [7].

Financial Performance - The company reported a revenue of RMB 5.0 billion for the fiscal year 2024, representing a year-over-year increase of 15%[19] - The company reported a net profit margin of 18% for 2024, an increase from 15% in the previous year[19] - Revenue for the year ended December 31, 2024, reached RMB 361,565 thousand, an increase of 7.9% compared to RMB 336,215 thousand in 2023[49] - Gross profit for 2024 was RMB 251,210 thousand, up from RMB 229,931 thousand in 2023, reflecting a growth of 9.2%[49] - Operating loss improved to RMB (62,620) thousand in 2024 from RMB (313,651) thousand in 2023, indicating a significant reduction in losses[49] - The company reported a net loss of RMB (53,267) thousand for 2024, significantly improved from a net loss of RMB (471,534) thousand in 2023[49] - Basic and diluted loss per share for 2024 was RMB (0.02), an improvement from RMB (0.20) in 2023[49] Market Expansion and Strategy - The company plans to expand its market presence in Southeast Asia, targeting a 25% increase in market share by 2026[28] - The company aims to expand its market presence through strategic acquisitions and partnerships in the healthcare industry[18] - The company is focused on expanding its market presence and enhancing its R&D capabilities, particularly in the field of cardiovascular medical devices[51] - The company plans to deepen its market share in the global structural heart disease treatment sector through enhanced hospital coverage and patient screening initiatives in 2025[47] - The company plans to enhance its TAVI product sales in China, where market penetration is significantly low, by increasing promotion efforts for its left atrial appendage occluder products[117] - The company plans to expand its overseas business by hiring local agents or distributors to penetrate local markets[173] Research and Development - The company has invested RMB 200 million in R&D for new technologies, focusing on minimally invasive surgical devices[28] - The company is focused on research and development (R&D) to enhance its product offerings in the medical technology sector[20] - The company emphasizes research and development, aiming to establish a technology innovation system that integrates industry, academia, and research[33] - The company is actively pursuing clinical trials, including first-in-man (FIM) studies for its innovative medical products[14] - The company is developing a TMVR product for MR patients, with multiple human implantations completed and ongoing clinical applications[101] - The company is in the design phase for the fourth generation of the VitaFlow series, focusing on safety and effectiveness improvements[99] Product Development and Innovation - New product launches included the AccuSniper™ and AltaValve™, expected to contribute an additional RMB 500 million in revenue in 2025[28] - The company has established a comprehensive innovation R&D layout covering TAVI products, left atrial appendage occluders, TMV products, TTV products, and surgical support products[36] - The company’s R&D efforts have led to the approval of the VitaFlow Liberty®Flex, a unique self-expanding transcatheter aortic valve delivery system, further solidifying its leadership in the TAVI field[46] - The company is focusing on efficient resource integration and project planning to accelerate the development of revenue-generating products while achieving long-term R&D milestones[87] - The product pipeline includes seven certified products and various TAVI, TMVR, and left atrial appendage products at different development stages[88] Acquisitions and Partnerships - A strategic acquisition of 4C Medical Technologies, Inc. was announced, expected to enhance the company's product portfolio and increase revenue by 30% over the next three years[28] - The company is involved in the acquisition of Shanghai Zuoxin, with a share transfer agreement dated January 1, 2024, related to this acquisition[18] - The company successfully acquired 51% of Shanghai ZuoXin, enhancing its commercialization capabilities for new products like AnchorMan®[43] - The company has entered into a share transfer agreement to acquire 51% of Shanghai Zoxin for approximately RMB 141.32 million, making it a subsidiary[112] Regulatory Compliance and Certifications - The company is committed to complying with the Corporate Governance Code as per the Listing Rules[12] - The company’s products are certified under CE marking, indicating compliance with health, safety, and environmental standards in the European Economic Area[12] - The VitaFlow Liberty® product received CE certification, becoming the first "Made in China" TAVI system approved for the European market[42] - The AnchorMan® system is the only left atrial appendage occlusion device in China to receive both NMPA and CE certifications[85] Financial Stability and Investments - The company has secured a credit facility of RMB 5 million from Bank of Communications, aimed at supporting operational expansion[10] - The company has a loan agreement with Kowei Medical for a principal amount of RMB 10 million, with a term of two years starting from the drawdown date[16] - Total assets as of December 31, 2024, amounted to RMB 2,675,762 thousand, a slight increase from RMB 2,577,108 thousand in 2023[50] - Total liabilities decreased to RMB 454,073 thousand in 2024 from RMB 242,245 thousand in 2023, indicating improved financial stability[50] Employee and Management Insights - Wu女士 has over 13 years of experience in the medical industry and private equity investment, currently serving as Managing Director at CICC Capital since January 2019[60] - Zhou Mr. has over 30 years of international banking experience and has held senior financial positions in Fortune 500 companies, including CFO at UTAC Holdings Ltd.[61] - Yao Ms. joined the group as Senior Director of R&D on February 1, 2024, with over ten years of experience in high-risk cardiovascular implant product development[69] - The company has a total of 430 full-time employees as of December 31, 2024, with 10.70% in R&D and 36.74% in marketing and sales[111] Market Trends and Challenges - In 2024, the structural heart disease industry in China is steadily growing due to policy support, market demand, and medical insurance access, despite facing complex economic conditions and intensified competition[84] - The number of qualified surgical centers for TAVI procedures has increased, leading to a further rise in surgical penetration rates[84] - The left atrial appendage occlusion procedure has seen significant advancements in evidence-based research, clinical applications, and new technology development, contributing to rapid growth in surgical volume[84] Corporate Social Responsibility - The company is committed to sustainable development and compliance with environmental laws and regulations in China[163] - The group made charitable donations amounting to RMB 38.0 million for the year ending December 31, 2024[185]

报名：首届全球眼科大会 | 议程更新 报名：首届全球骨科大会 | 议程更新 报名：首届全球心血管大会 | 奖项申报 合作伙伴征集：2025全球手术机器人大会 心未来 2025年3月30日， 心通医疗 发布截至2024年12月31日止年度业绩公告。 # 财报数据 # 关于心通 医疗 2024年公司实现收入 3.62亿 元，同比增长 7.5% ，收入增长主要得益于 二代主瓣产品及主动脉瓣膜球囊 在全球市场的持续商业化，特别是TAVI产品在海外市场的收入快速增长。 此外，子公司佐心医疗的左 心耳封堵器在中国正式商业化，为集团带来新的收入贡献。分地区来看，公司24年国内收入3.38亿元， 同比增长4.0%；海外地区实现收入0.24亿元，同比增长108.3%。经计算，公司H2实现收入1.38亿元，同 比下降13.4%。 公司24年实现毛利率 69.5% ，同比增加 1.1 pct ， 主要得益于公司采取的有效降本控费措施，以及业务 增长带来的规模效应。 公司24年归母净利润亏损 0.49亿 元，同比亏损收窄 89.5% ， 亏损大幅收窄主要得益于：收入增长、生 产成本下降及毛利率提升；公司通过统筹内外部资源、发挥集中效 ...

Financial Performance - For the fiscal year ending December 31, 2024, the company's revenue was RMB 361.6 million, representing a 7.5% increase from RMB 336.2 million for the fiscal year ending December 31, 2023[5]. - The company recorded a net loss of RMB 53.3 million for the fiscal year ending December 31, 2024, a significant reduction from a loss of RMB 471.5 million in the previous year[6]. - Gross profit increased by 9.3% to RMB 251.2 million, with a gross margin of 69.5%, up 1.1 percentage points from 68.4% in the previous year[5]. - The company's revenue for the year ending December 31, 2024, was RMB 361.6 million, an increase of 7.5% compared to RMB 336.2 million for the year ending December 31, 2023, driven by the commercialization of VitaFlow Liberty® and Alwide® Plus[45]. - The total comprehensive loss for the year was RMB 24.6 million, significantly improved from RMB 434.7 million in the previous year[74]. - The company reported a pre-tax loss of RMB 4,002,000 for 2024, slightly down from RMB 4,147,000 in 2023[86]. - The basic loss per share for the year ended December 31, 2024, was RMB 49,446,000, significantly improved from RMB 471,534,000 in 2023, indicating a reduction in losses[95]. - The company reported a net loss of RMB 208.153 million for 2024, compared to a loss of RMB 159.088 million in 2023[114]. Product Development and Innovation - The company has developed a product portfolio that includes 7 certified products, such as VitaFlow® and VitaFlow Liberty®, along with various TAVI, TMV, and TTV products at different development stages[11]. - The third-generation TAVI product, VitaFlow Liberty® Flex, received NMPA approval in December 2024, marking it as the world's only true coaxial self-expanding transcatheter aortic valve delivery system[9]. - The innovative design of VitaFlow Liberty® allows for multiple recoveries during the procedure, improving placement accuracy and overall success rates[16]. - The company is actively pursuing strategic partnerships for advanced products and technologies in the structural heart disease field, with the TMVR product AltaValve™ receiving two breakthrough device designations from the FDA[10]. - The company continues to focus on developing other in-progress products, including TAVI and left atrial appendage occluders, to reinforce its leadership in the structural heart device market[40]. - The company is developing the AccuSniper™ dual-layer balloon dilation catheter and the AltaValve™ transcatheter mitral valve replacement device[143]. - The company has developed the fourth generation TAVI product, VitaFlow® IV, which is part of its innovative product line[148]. Market Expansion and Commercialization - The TAVI products achieved substantial progress in global commercialization, entering over 80 new hospitals in China and nearly 100 hospitals in countries such as Argentina, Colombia, and Italy[8]. - TAVI products have been commercialized in 18 countries, entering over 650 hospitals in China and nearly 100 overseas, with more than 450 independent operators in China[28]. - The company aims to enhance its TAVI product sales in China by increasing hospital coverage and improving patient referral processes, targeting underdeveloped patient needs in lower-tier cities[36]. - The company aims to leverage its strong clinical data to support the global expansion of its products[14]. - The company has obtained CE mark and registration approvals for VitaFlow Liberty® in 17 overseas countries, supporting its international strategy[38]. - The company is focused on expanding its market presence through innovative medical technologies and products[148]. Research and Development - The company continues to enhance its R&D capabilities, focusing on projects that can quickly generate revenue while also advancing long-term projects[10]. - Research and development costs decreased by 35.4% to RMB 153.4 million for the year ending December 31, 2024, down from RMB 237.3 million for the year ending December 31, 2023, due to a prudent adjustment of project priorities and resource allocation[49]. - The total amount of government grants received in 2024 was RMB 8,944,000, an increase from RMB 3,585,000 in 2023, indicating enhanced support for R&D projects[85]. - The company emphasizes the importance of research and development in enhancing its product offerings[146]. Strategic Acquisitions - The company acquired a 51% stake in Shanghai Zuoxin, expanding its business into the high-growth potential segment of non-valvular atrial fibrillation stroke prevention[8]. - The company agreed to acquire 51% of Shanghai Zoxin for approximately RMB 141.32 million, making it a subsidiary after completion[33]. - The company plans to acquire all shares of Shanghai Xinyong for no more than RMB 380 million, which was approved by shareholders on September 30, 2024[33]. - The company acquired 100% equity of Shanghai Xinyong Medical Technology Co., Ltd. for a total consideration of RMB 377 million, completed in December 2024[103]. - The company acquired 51% of CardioAdvent for a total cash consideration of RMB 141,317,000, completed on January 31, 2024[122]. Operational Efficiency - The company has established a quality management system and improved manufacturing efficiency through advanced operational practices[27]. - The company has developed a multi-supplier strategy for raw materials to enhance supply chain resilience and reduce costs[27]. - Distribution costs decreased by 26.1% to RMB 164.8 million for the year ending December 31, 2024, from RMB 223.0 million for the year ending December 31, 2023, as the company enhanced operational efficiency while expanding sales[51]. - Administrative expenses decreased by 18.0% to RMB 57.6 million for the year ending December 31, 2024, down from RMB 70.2 million for the year ending December 31, 2023, due to strict control measures[52]. Governance and Compliance - The company has adopted and complied with the Corporate Governance Code throughout the reporting period[129]. - The company confirmed compliance with applicable laws and regulations, including the Companies Ordinance and Listing Rules, during the reporting period[131]. - The board of directors includes a diverse group of experienced professionals, ensuring strong governance and oversight[149]. Employee and Operational Metrics - As of December 31, 2024, the company had 430 full-time employees, a decrease from 592 employees as of December 31, 2023, with 10.70% in R&D and 36.74% in marketing and sales[32]. - The treatment solution promotion team has over 160 full-time employees, focusing on innovative transcatheter and surgical treatment solutions for structural heart diseases[29].

合作伙伴征集：2025全球手术机器人大会 报名：首届全球眼科大会 | 暂定议程 报名：首届全球心血管大会 | 奖项报名倒计时 报名：首届全球骨科大会 | 奖项报名倒计时 2025年3月6日，微创心通医疗科技有限公司（02160.HK，简称"心通医疗"）发布了2024年度盈利预 告。 微创心通医疗科技有限公司 （02160.HK，简称"心通医疗"）是中国领先的医疗器械企业，专注于 结构性心脏 病领域创新的经导管及手术解决方案的研发和商业化 。作为 微创医疗科学有限公司（00853.HK）旗下子公司 ，心通医疗起源于其2009年成立的瓣膜预研项目，于2015年成立" 上海微创 心通医疗科技有限公司"，2021 年2月在香港联交所主板上市。 心通医疗VitaFlow ® 系列经导管主动脉瓣植入（TAVI）产品，凭借其独特的产品设计和优异的临床表现，已 进入中国近600家核心医院，其第二代TAVI产品VitaFlow Liberty ® 是全球唯一商业化的电动可回收TAVI产 品。 # 财务数据 心通医疗 预计2024年 亏损人民币 3000万至6000万元 ， 同比亏损收窄 87%-94% ，由此计算，公司24年 ...

Distribution Agreements and Partnerships - MicroPort CardioFlow Medtech Corporation entered a distribution framework agreement with KOWA Medical, granting exclusive rights to distribute KOWA products in China from July 19, 2024, to December 31, 2025[7]. - The company plans to expand its market presence through strategic partnerships and potential acquisitions in the cardiovascular device sector[9]. - The company has secured a loan agreement with KOWA Medical for RMB 10 million, with an interest rate equivalent to the one-year LPR as of the agreement date[9]. Financial Performance - The total revenue for the six months ended June 30, 2024, was RMB 223.138 million, compared to RMB 176.442 million for the same period in 2023, representing a year-on-year increase[29]. - The gross profit for the same period was RMB 158.224 million, up from RMB 116.623 million in the previous year[29]. - Revenue increased by 26.5% from RMB 176.4 million for the six months ended June 30, 2023, to RMB 223.1 million for the six months ended June 30, 2024, driven by increased hospital admissions for TAVI products and the launch of new products[69]. - The company reported a loss of RMB 57,753 thousand, a substantial reduction compared to RMB 179,402 thousand in the prior year[183]. - The net cash used in operating activities for the six months ended June 30, 2024, was RMB 84,854 thousand, an improvement from RMB 125,212 thousand in the previous year[194]. Product Development and Innovation - The company is actively developing new technologies, including the AltaValve™ and Alwide® Plus, aimed at enhancing minimally invasive heart procedures[7]. - The introduction of the AnchorMan® left atrial appendage systems is expected to capture a significant market share in the upcoming quarters[11]. - The TMVR product AltaValve™ has received two breakthrough device designations from the FDA for treating moderate to severe mitral regurgitation, with an investigational device exemption (IDE) approved for a new pivotal study[34]. - The company is accelerating new product development in structural heart disease, including TAVI and next-generation surgical support products, to strengthen its market leadership[63]. Market Expansion and Strategy - Future outlook includes a projected revenue growth of 15% for the next fiscal year, driven by new product launches and market expansion strategies[9]. - The company aims to achieve a market penetration rate of 20% in the Chinese cardiovascular device market by the end of 2025[11]. - The company is focused on improving financial health by increasing revenue, reducing costs, and achieving breakeven as soon as possible[66]. Research and Development - MicroPort CardioFlow is focusing on enhancing its research and development capabilities to accelerate the launch of innovative medical devices[9]. - The R&D team consists of approximately 90 members, focusing on innovative technologies and materials applicable to the product portfolio, supported by cross-functional project teams[48]. - Research and development activities, including clinical trials and product registrations, accounted for 423.9 million, which is 15.6% of the total budget, with a focus on expanding the VitaFlow product line[170]. Regulatory Approvals and Certifications - VitaFlow Liberty® received CE certification and achieved commercial implantation, marking it as the first "Made in China" TAVI system to enter the European market[23]. - The AnchorMan® left atrial appendage occlusion system received approval from the National Medical Products Administration on January 5, 2024, becoming the only semi-closed left atrial appendage occluder approved in China[26]. - The company has obtained registration approvals for TAVI products in 12 countries, with nearly 100 hospitals in Argentina, Colombia, Thailand, Russia, Chile, and Switzerland[23]. Operational Efficiency - The sales expense ratio decreased by 10.1 percentage points year-on-year, resulting in a significant increase in commercial profit[23]. - The company achieved healthy and sustainable business growth by coordinating internal and external resources and enhancing operational efficiency[22]. - The company has established a robust quality management system and introduced operational excellence (OPEX) principles to enhance manufacturing efficiency[52]. Shareholder and Capital Management - Major shareholder Shanghai MicroPort holds a beneficial interest of 1,112,855,680 shares, representing 46.13% of the company[95]. - The company believes it has sufficient funds to meet its operating capital and capital expenditure needs for 2024[88]. - The company actively reviews and manages its capital structure to balance higher borrowing levels with shareholder returns and capital stability[87]. Employee Incentives and Stock Options - The share incentive plan was adopted on June 27, 2023, to replace the stock option plan and aims to motivate eligible participants to contribute to the company's long-term development[99][100]. - The total number of shares available for issuance under the share plan is 213,998,549, representing approximately 8.87% of the total issued shares as of the mid-term report date[108]. - The company has granted a total of 12,883,977 stock options, with 11,575,361 options remaining unexercised as of the reporting period[123]. Corporate Governance - The company has adopted the Corporate Governance Code as the basis for its governance practices, ensuring high standards of corporate governance[160]. - The audit committee, composed of three independent non-executive directors, reviewed the interim report and confirmed compliance with relevant accounting standards[163]. - The company plans to continue regular reviews of its corporate governance practices to maintain high standards[160].