中国创新医械，已经站在了全球投资市场的主战场 文｜《财经》记者 凌馨 编辑 | 王小 进入2026年，沉寂四年的创新医疗器械，终于迎来属于自己的小热点。 按照一般经验，一级市场总会成为二级市场乃至整个板块投资趋势的风向标。医疗器械行业是否迎来了 复苏时刻？中国创新医疗器械是否和创新药一样，也具备了全球前沿的创新能力？ 在新春之际，《财经》就此与北芯生命的第一大机构股东红杉中国的董事总经理曹弋博进行了一场对 话。 走出"独立行情" 《财经》：北芯生命在科创板IPO吸引了很多知名私募基金参与"打新"，这会否成为一种医械投资新现 象？ 曹弋博：其实相较于"打新"，可能更值得关注的是科创板的战略投资者制度，这个制度让机构可以更加 积极地参与其中。以前的A股发行制度下，机构能某种程度参与定价，但很难拿到额度。科创板借鉴了 香港的一些发行制度，给愿意长线参与的投资人更多机会。 创新医疗器械有它的特点。创新药的投资收益天花板更高，但也面临高风险和长期不会盈利的挑战，但 在二级市场投资人中，有相当大一部分是希望公司快速盈利的。这类风险偏好较低的人，对能够更快带 来现金流的公司比较感兴趣，就会更加积极地参与创新医疗器械的战略配 ...

Core Viewpoint - Shenzhen Core Medical Technology Co., Ltd. is the first innovative medical device company to be accepted for IPO under the fifth set of listing standards of the Sci-Tech Innovation Board, aiming to raise 1.217 billion yuan for various projects, including R&D and marketing network development [1][6] Group 1: Company Overview - Core Medical is a leader in China's artificial heart industry, holding multiple "first" titles [4] - The company has several products included in China's special review process for innovative medical devices, leading the field in terms of the number of products [5] - The Corheart 6, the world's smallest and lightest commercialized magnetic levitation implantable artificial heart, was approved for market in June 2023, with a projected market share of over 45% in 2024 [5] Group 2: Financial Performance - The company reported revenues of 16.55 million yuan, 93.69 million yuan, and 70.48 million yuan for the years 2023, 2024, and the first half of 2025, respectively, with net losses of 170 million yuan, 132 million yuan, and 72.75 million yuan during the same periods [8] - Cumulative losses since 2022 have exceeded 500 million yuan [8] - Gross margins for the reporting periods were 66.25%, 69.66%, and 72.09%, consistent with industry averages [9] Group 3: Investment and Financing - Prior to the IPO, Core Medical attracted investments from several prominent institutions, including Hillhouse Capital and Zhengxin Valley Investment [2][14] - The company completed a D-round financing of over 100 million USD in April 2025, marking the largest market-based financing in China's innovative medical device sector for that year [16]

中新网北京2月11日电(记者 赵方园)被誉为医疗器械"皇冠上的明珠"的人工心脏，迎来了资本化加速 期。 从股权结构来看，同心医疗控股股东、实际控制人为陈琛，其合计控制公司30.95%的表决权。 然而，耀眼的技术突破背后，是严峻的商业化现实。同心医疗正处于典型的"高研发、高增长、高亏 损"困境之中。 近日，上交所官网信息披露，苏州同心医疗科技股份有限公司(以下简称"同心医疗")科创板IPO审核状 态变更为已问询，向"国产人工心脏第一股"发起冲刺。 招股书显示，2022年至2025年上半年，其营收分别约861.15万元、5045.32万元、7735.05万元和7207.14 万元；同期净亏损分别为1.89亿元、3.06亿元、3.72亿元，以及1.93亿元，三年半累计亏损超10.6亿元。 其核心产品CH-VAD，是我国首个获批上市的全磁悬浮植入式人工心脏。 这不是科幻片，而是国产人工心脏的现实突破。 | 项目 | 2025.6.30/ | 2024.12.31/ | 2023.12.31/ | 2022.12.31/ | | --- | --- | --- | --- | --- | | | 2025年1-6月 | ...

Core Insights - Shenzhen Core Medical Technology Co., Ltd. is pioneering the "next-generation artificial heart" in China's medical device innovation landscape, transitioning from "follow-up innovation" to "original innovation" [1] - The company is the only global entity with products approved for both implantable and interventional artificial hearts, marking a significant shift in the global artificial heart sector towards "Made in China" [1] Product Innovation - The first commercial product, Corheart 6, is the world's smallest and lightest full magnetic suspension implantable artificial heart, utilizing innovative technologies to enhance clinical value [2] - Corheart 6 employs "time-sharing dynamic axial full magnetic suspension control technology," significantly simplifying the structure of the magnetic suspension motor and overcoming traditional limitations in size and power consumption [2] Clinical Data and Validation - Long-term follow-up studies involving 50 patients across 12 clinical centers show a 2-year survival rate of 86% for Corheart 6, outperforming the HeartMate 3's 76.9% [3] - Corheart 6 is one of the few implantable artificial hearts in China to disclose long-term follow-up data based on registered clinical trials, reinforcing its safety and effectiveness [3] Market Position and Growth - Corheart 6 has quickly become the most implanted artificial heart in China, with over a thousand clinical applications, despite not being the first approved domestic product [4] - The global market for short-term artificial hearts is projected to grow from $2.07 billion in 2024 to $9.82 billion by 2033, with a compound annual growth rate (CAGR) of 18.9% [6] Strategic Expansion - Core Medical is expanding its product line to include interventional artificial hearts, with CorVad being the first domestically approved product in this category, targeting a previously untapped market [6] - The company is positioned to leverage its innovative technologies to create a comprehensive product portfolio that meets the full cycle of heart failure treatment needs [7] Global Outreach - Core Medical has established a clinical network across Asia, Europe, and America, achieving over 1,200 global implantations, setting a record for Chinese artificial heart companies in overseas approvals [9] - The company aims to enhance its research and development capabilities through its upcoming IPO, which seeks to raise up to 1.217 billion yuan for product development and industrialization projects [8]

Core Viewpoint - Suzhou Tongxin Medical Technology Co., Ltd. has submitted its IPO application to the Shanghai Stock Exchange, marking a significant step in the artificial heart industry as it aims to capitalize on the growing demand for heart failure treatments [1][7]. Company Overview - Founded by Chen Chen in 2008, Tongxin Medical focuses on the innovation of ventricular assist devices, specifically the implantable left ventricular assist device (LVAD) [1]. - The company has developed a product matrix that includes one product approved for market, one in the registration phase, one in clinical trials, one in preclinical research, and two in design development [1]. Product Details - The first product, the CH-VAD, is China's first approved full magnetic levitation implantable artificial heart, with its iterative version, CH-VAD Plus, expected to be approved by early 2026 [1]. - In the U.S. market, the new generation BrioVAD has received FDA approval to enter clinical trials, making it the first active implantable medical device from China to achieve this milestone [2]. Financial Performance - The average price of CH-VAD has decreased from 459,600 CNY in 2022 to 362,300 CNY in the first half of 2025, reflecting the company's strategy to expand its customer base during a period of rapid industry growth [4]. - Sales revenue for CH-VAD increased from 8.27 million CNY in 2022 to 67.06 million CNY in 2024, with over 670 implants completed across more than 80 hospitals [5]. - Despite revenue growth, the company remains in a loss-making position, with net losses of 189 million CNY, 306 million CNY, and 372 million CNY for the years 2022, 2023, and 2024, respectively [5]. Funding and Ownership - The company has completed multiple rounds of financing, with the latest round in July 2023 involving participation from several investment firms [6]. - Chen Chen, the actual controller, holds 30.95% of the voting rights, while other significant shareholders include Baiyang Group (16.73%) and Sequoia China (8.53%) [7]. Industry Context - The artificial heart sector is experiencing a collective IPO window, with other companies like Shenzhen Core Medical and Hangzhou Hetang Health also preparing for IPOs or securing significant funding [7].

Core Viewpoint - Tongxin Medical Technology Co., Ltd. is preparing for an IPO on the Sci-Tech Innovation Board, aiming to raise 1.064 billion yuan primarily for global clinical trials of its implantable left ventricular assist system (LVAS), next-generation product development, production base construction, and working capital [2]. Company Overview - Established in 2008, Tongxin Medical focuses exclusively on ventricular assist devices (VAD), commonly referred to as "artificial hearts," which are considered "crown-level products" in high-end medical devices due to their complex integration of various engineering disciplines [2][3]. - The company has chosen a long-term investment strategy in a single technology line, resulting in a development pace characterized by long R&D cycles, slow commercialization, and high validation costs [2]. Product Development - The core product is the fully magnetic levitation implantable LVAS, which provides continuous circulatory support for end-stage heart failure patients. Its design minimizes mechanical contact, reducing blood shear damage and thrombus formation risks [5]. - The product received approval from the National Medical Products Administration in November 2021, marking a significant transition from engineering prototypes to clinical products [5]. Fundraising Allocation - The IPO proceeds of 1.064 billion yuan will be allocated primarily to core product initiatives, with 695 million yuan designated for global clinical trials and registration of the BrioVAD project [7][9]. - Additional funds will support next-generation LVAS development (190 million yuan), production base construction (130 million yuan), and working capital (50 million yuan) [9]. Financial Performance - Tongxin Medical is currently in a loss-making phase, with revenues increasing from 8.61 million yuan in 2022 to 77.35 million yuan in 2024, while net losses have also escalated [10][12]. - The company’s financial structure reflects a common pattern in the artificial heart sector, where high upfront costs for R&D and clinical trials precede commercialization [12]. Governance Structure - The company is controlled by its founder, Chen Chen, who holds approximately 30.95% of the voting rights, significantly influencing strategic planning and technological direction [13][15]. - The shareholder structure includes long-term institutional investors, providing a supportive capital foundation for future development [15]. Conclusion - The IPO represents a transition for Tongxin Medical from domestic breakthroughs to global validation, with future success hinging on the completion of high-quality global clinical trials and the demonstration of the safety and stability of its technology [16].

Core Viewpoint - The recent approval of China's first interventional artificial heart marks a significant milestone in the domestic medical technology sector, with multiple companies actively engaged in the development of artificial heart products [3][6][15]. Group 1: Product Development and Market Dynamics - Shenzhen Core Medical Technology Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for its interventional artificial heart product, which is part of a growing market with over ten companies involved in similar developments [3][15]. - The interventional artificial heart, also known as the percutaneous ventricular assist device (pVAD), is currently dominated by Abiomed's Impella, which has not yet received approval in China [5][6]. - Core Medical's previous product, the CorHeart6, has a market share exceeding 45% in the domestic market for implantable artificial hearts (LVAD) as of 2024 [6][15]. Group 2: Technical Controversies - The CorHeart6 product has faced technical disputes regarding its classification as a "fully magnetic levitation" device, with experts arguing that it only utilizes "magnetic levitation bearings," which could impact patient outcomes [7][9]. - Concerns have been raised about the safety of similar technologies, with past instances of devices using magnetic levitation bearings being withdrawn from the market due to safety issues [9]. Group 3: Market Potential and Growth - The global market for artificial hearts is projected to grow from $970 million in 2019 to $2.07 billion by 2024, with a compound annual growth rate (CAGR) of 16.4%, and is expected to reach $9.82 billion by 2033 [15][16]. - The interventional artificial heart market is anticipated to expand significantly due to a higher number of potential patients compared to implantable devices, which are limited by surgical complexity and patient eligibility [12][14]. - The number of high-risk percutaneous coronary intervention (PCI) procedures is expected to reach 221.7 million globally by 2024, with a CAGR of 12.1% from 2019 to 2024, indicating a growing demand for interventional artificial hearts [14][15]. Group 4: Industry Challenges and Future Directions - The artificial heart sector is characterized as a "slow track" due to long development cycles, complex clinical validations, and stringent regulatory requirements, making profitability challenging for companies [16]. - Experts emphasize the need for ongoing research into the hemodynamic effects of artificial hearts, as they differ significantly from natural hearts in blood flow dynamics [16]. - Future advancements in artificial heart technology are expected to focus on wireless, miniaturized, and intelligent designs to enhance patient outcomes and expand applications [16].

Core Insights - The latest interventional artificial heart product approved by the National Medical Products Administration (NMPA) comes from Shenzhen Core Medical Technology Co., Ltd. [1] - The approval marks a significant milestone in the development of domestic artificial hearts, with over a dozen companies currently engaged in this field [1][10] - Core Medical's previous artificial heart product, CorHeart6, has recently faced technical disputes regarding its classification as a "fully magnetic levitation" device [2][4] Company Overview - Core Medical's CorHeart6, a left ventricular assist device (LVAD), holds over 45% market share in China as of 2024 [2] - The company’s CorHeart6 was approved for sale in China in 2023, differing from the newly approved interventional artificial heart in terms of indications and surgical approach [5] - Core Medical is positioned in a competitive landscape with several other companies, including Tongling Bionic and Heartking Medical, also developing interventional artificial heart products [10] Industry Landscape - The global market for artificial hearts is projected to grow from $970 million in 2019 to $2.07 billion by 2024, with a compound annual growth rate (CAGR) of 16.4% [10] - The interventional artificial heart market is expected to see significant growth due to the increasing number of high-risk percutaneous coronary interventions (PCI), projected to reach 221.7 million globally by 2024 [10] - The Chinese market for artificial hearts is anticipated to exceed 11 billion RMB by 2033, driven by the approval of new products [10] Technical Disputes - Core Medical's CorHeart6 has been criticized for potentially misleading terminology regarding its technology, which could impact patient outcomes [2][4] - Concerns have been raised about the safety of devices using "magnetic levitation bearing" technology, with precedents of similar products being withdrawn from the market due to safety issues [4] Market Dynamics - The interventional artificial heart is seen as a less invasive option compared to LVADs, which require more complex surgical procedures and long-term patient management [8] - The market for interventional artificial hearts is expected to attract more companies, but the high technical barriers may limit successful commercialization [11] - Experts emphasize the need for ongoing research into the hemodynamic effects of artificial hearts, as they differ significantly from natural hearts [11]

Core Insights - The successful treatment of a child with restrictive cardiomyopathy using a "dual artificial heart implantation + heart transplant" marks a significant breakthrough in China's pediatric end-stage heart failure treatment and domestic artificial heart application [2] - This operation is the lightest successful case globally in similar surgeries, showcasing over a decade of technological accumulation and integration in China's artificial heart industry [2] Market Overview - The global ventricular assist device market is projected to reach approximately $2.2 billion in 2024 and $2.5 billion by 2025 [2] - The Chinese market, although starting later, is experiencing rapid growth, with an expected market size of 33.2 million yuan for implantable ventricular assist devices in 2024 [2] - Multiple domestic companies have received approval for market entry, and Beijing has included artificial hearts in Class A medical insurance reimbursement as of September 2024, with nationwide implementation expected by March 2025 [2] Technological Advancements - The innovative approach taken by Tianjin TEDA International Cardiovascular Hospital and Aerospace TaiXin Technology involves a second-generation magnetic levitation artificial heart, which enhances reliability by eliminating electronic systems that could fail [5][6] - The design modifications for the artificial heart to accommodate the child's small heart chamber included reducing the thickness from 25 mm to 11 mm and the overall weight to below 75 grams, representing a significant engineering breakthrough for pediatric usability [6] Unique Treatment Approach - The surgery also filled a global gap by introducing a dedicated right heart pump, allowing for a dual heart system in pediatric patients, which previously had limited options and often relied on heart transplants [7] - This transition from external dependency to fully implanted systems significantly reduces infection risks and enhances patient mobility, redefining the quality of life for patients [7]

Core Viewpoint - Shenzhen Core Medical Technology Co., Ltd. has received acceptance for its IPO application on the Sci-Tech Innovation Board, marking it as the first innovative medical device company to be accepted under the new listing standards [1][10] Group 1: Product and Market Position - The company’s flagship product, the Corheart®6, is the smallest and lightest full magnetic levitation artificial heart globally, filling a gap in pediatric heart failure treatment in China [1][10] - The market share for Corheart®6 is projected to exceed 45.9% in 2024, increasing to 52.86% in the first five months of 2025 [1][10] - Despite the potential market size for heart failure treatment, actual market penetration remains low due to high treatment costs and limited clinical awareness [4][14] Group 2: Financial Performance - The company reported revenues of 16.55 million, 93.68 million, and 70.47 million from 2023 to the first half of 2025, indicating growth but still a small overall scale [6][15] - Cumulative losses over three and a half years reached 553 million, primarily due to high R&D expenditures and significant share-based payment expenses [6][15] - Operating cash flow has been negative, relying on external financing, with net cash flow from operating activities of -108 million, -89 million, and -84 million from 2023 to the first half of 2025 [7][16] Group 3: Product Dependency and Risks - The company’s revenue is heavily reliant on the Corheart®6, with all income derived from this single product, while other products are still in development stages [2][11] - The average selling price of Corheart®6 has decreased from 290,400 yuan per unit in 2023 to 247,200 yuan in 2024, reflecting a decline of approximately 14.86% [4][13] - Customer concentration is increasing, with the top five customers accounting for 80.70% of sales by the first half of 2025, highlighting a significant dependency on major clients [4][13] Group 4: Production Capacity and Expansion Plans - The company has established a production capacity of 1,100 units annually, but actual production in the first half of 2025 was only 367 units, resulting in a capacity utilization rate of about 67% [5][14] - Despite underutilized capacity and low cumulative sales of less than 800 units, the company plans to invest 139 million in expanding its production base for artificial hearts [5][14]