在估值层面，核心医疗成立以来已完成 6 轮融资。2025 年 4 月，公司完成 D 轮融资，对应估值约 35.45 亿元；2025 年 8 月发生的股权转让， 对应估值约 33.88 亿元 。 在第五套上市标准"预计市值不低于 40 亿元"的要求下，其最终能否满足市值门槛，仍有待市场与发行环节进一步验证。 财务方面， 公司目前尚未实现盈利 。2022—2024 年及 2025 年上半年，核心医疗营业收入分别为 0 元、1655.03 万元、9368.84 万元和 7047.76 万元；同期归 母净利润分别为 -1.78 亿元、-1.70 亿元、-1.32 亿元和 -7275.14 万元。 2026年2月2日，上交所官网显示， 深圳核心医疗科技股份有限公司 科创板 IPO 申请状态更新为 "已问询" 。 核心医疗的 IPO 申请于 2025 年 11 月 6 日获受理，保荐机构为 华泰联合证券 。公司采用 科创板第五套上市标准申报 ，是该标准重启后，以创新医疗器械为主营 方向进入审核阶段的代表性企业之一。 招股书显示，核心医疗成立于 2016 年，主要从事人工心脏及机械循环辅助装置等高端创新医疗器械的研发与产业 ...

在科创板IPO排队的企业中，目前已有两家专注于人工心脏研发的厂商，分别为苏州同心医疗科技股份 有限公司（以下简称"同心医疗"）、深圳核心医疗科技股份有限公司（以下简称"核心医疗"）。两家公 司虽均未实现盈利，但各自正带着不同的产品布局，争取资本市场的认可。 目前，人工心脏在国内市场仍处于早期发展阶段，尚未形成成熟的竞争格局。在同心医疗和核心医疗的 招股书中，均将彼此列为人工心脏领域的主要参与企业。目前，同心医疗、核心医疗均有核心产品实现 上市，不过，报告期内，相关产品均出现销售价格下降的情况。目前，核心医疗IPO进度稍快，已进入 问询阶段。 科创板IPO相继获受理 据核心医疗招股书，2023—2024年及2025年上半年，该公司商业化产品植入式左心室辅助系统的销售收 入分别为1655.03万元、9368.84万元、7047.76万元，销售数量分别为57台、379台、307台，平均销售单 价分别为29.04万元/台、24.72万元/台、22.96万元/台。 核心医疗方面表示，2024年度及2025年上半年，公司商业化产品植入式左心室辅助系统的平均销售单价 较2023年度有所下降，主要原因为公司为进一步开发覆盖全 ...

在科创板IPO排队的队伍中，目前已有两家专注于人工心脏研发的厂商，分别为苏州同心医疗科技股份有限公司（以下简称"同心医疗"）、深圳核心医疗科 技股份有限公司（以下简称"核心医疗"）。两家公司虽均未实现盈利，但各自带着不同的产品布局，正在争取资本市场的认可。目前，人工心脏于国内市场 仍处于早期发展阶段，尚未形成成熟的竞争格局。在两家公司的招股书中，均把对方列为人工心脏领域的主要参与企业。目前，同心医疗、核心医疗均有核 心产品实现上市，不过，报告期内，相关产品均出现了销售价格下降的情况。目前，核心医疗IPO进度稍快，已进入问询阶段。 在北京中医药大学卫生健康法治研究与创新转化中心主任邓勇看来，人工心脏厂商密集冲刺科创板IPO，是行业商业化早期的必然选择。人工心脏研发投入 大、周期长，IPO成为获取低成本资金、推进临床研发、扩大产能与商业化的关键途径。同时，抢占"国产人工心脏第一股"的先发优势，能带来品牌溢价与 市场卡位红利，契合政策支持创新器械、国产替代加速的行业窗口期。 核心产品销售价格下降 | 公司全称 | 苏州同心医疗科技股份有限公司 | 受理E | | --- | --- | --- | | 公司简称 | ...

Core Viewpoint - Tongxin Medical aims to transform the competitive landscape of the artificial heart market globally through innovative technologies and solutions for advanced heart failure treatment [2]. Group 1: Company Overview - Tongxin Medical, established in 2018, focuses on addressing the urgent need for effective treatments for advanced heart failure patients and aims to become a leader in the global artificial heart sector [2]. - The company has set up operational entities in China, the United States, and Europe, with its core product being the implantable artificial heart [3]. Group 2: Product Development and Market Position - In China, Tongxin Medical's first full magnetic levitation left ventricular assist system, CH-VAD, has been approved for market entry, making it the first of its kind in the country [4]. - The next iteration, CH-VAD Plus, is expected to receive approval in early 2026, while the BrioVAD system has gained FDA approval for clinical trials in the U.S. [4]. - In Europe, the company has submitted an application for the BrioLife clinical study, anticipated to start in the first half of 2026 [4]. - As of the date of the prospectus, over 670 CH-VAD implants have been completed in China, and 108 patients have undergone BrioVAD implantation across 22 centers in the U.S. [5]. Group 3: Competitive Landscape - The full magnetic levitation artificial heart technology is the most widely used globally, with CH-VAD being the first approved in China [6]. - By the end of 2024, Tongxin Medical is projected to hold a 26.9% market share in the domestic implantable artificial heart market [6]. - The BrioVAD product is designed to be smaller and lighter than competitors, with potential advantages in blood compatibility, infection resistance, and patient quality of life, and is currently undergoing head-to-head clinical trials against Abbott's HeartMate 3 [6]. Group 4: Investment and Financial Backing - Since its inception, Tongxin Medical has attracted investments from notable institutions such as Sequoia China, Gao Rong Capital, and others [7].

Core Viewpoint - The article discusses the controversy surrounding the terminology and classification of artificial heart pump technologies, particularly the term "full magnetic suspension," which has implications for patient safety and scientific transparency [1][10]. Industry Overview - Heart failure is a terminal stage of cardiovascular disease, with approximately 5% of cases progressing to severe heart failure. The World Health Organization estimates around 64.3 million heart failure patients globally, with about 13 million in China [2]. - Artificial hearts serve as a "life pump" for end-stage heart failure patients, designed to replace the heart temporarily or permanently, facilitating blood circulation [2]. - There are two types of artificial hearts: partial replacement and total artificial hearts, with the latter being more advanced in terms of technology [2]. Technology Classification - Blood pump bearings are categorized into three main types: contact sliding bearings, fluid dynamic bearings, and magnetic bearings. The latter operates without contact, relying solely on magnetic forces [3]. - The term "full magnetic suspension" is considered the industry benchmark, associated with advanced and safe technologies. However, the precise definition of this term is under dispute [3][10]. - Kurt Dasse emphasizes that if a device requires fluid dynamic effects for stability, it cannot be classified as "full magnetic suspension" [3]. Clinical Implications - The ambiguity surrounding the definition of "full magnetic suspension" may affect the accurate assessment of device performance by clinicians and researchers [10]. - Abbott's HeartMate 3 is highlighted as a benchmark in the industry, demonstrating significant clinical advantages over other devices [11]. - A systematic review comparing three ventricular assist devices showed that HeartMate 3 had the best performance across all major clinical endpoints, reinforcing the link between technology choice and clinical outcomes [11]. Market Competition - Abbott leads the global market with its HeartMate 3 product, while Chinese companies are increasingly participating in the artificial heart sector, with several products approved since 2021 [12][13]. - Major domestic companies are adopting different technological routes, with notable products like the CH-VAD and CorHeart 6 entering the market [12][13]. - The potential market for artificial hearts in China is substantial, with projections indicating that by 2033, the number of implant surgeries could exceed 25,000, corresponding to a market size of over 5.5 billion yuan [14]. Future Outlook - The choice of technology route will significantly influence industry competition, with full magnetic suspension technology being a key focus area [14]. - The transparency and standardization of technology definitions are crucial for building trust among companies and ensuring accurate evaluations by researchers and clinicians [14][15]. - Ongoing discussions aim to standardize definitions and identify high-risk components in various designs, which is essential for independent assessments and patient safety [15].

Core Viewpoint - The article emphasizes the necessity for a unified language in the medical technology field, particularly regarding the terminology used for blood pump bearing technologies, to ensure ethical communication and patient safety [2][3]. Group 1: Importance of Terminology - Accurate terminology in medical devices is crucial as it directly impacts clinical decisions and patient safety [2]. - The inconsistency in terminology, particularly regarding "fully magnetically levitated" blood pumps, can lead to misunderstandings among manufacturers, clinicians, and regulators [3][4]. - The call for a standardized language is essential as more Chinese medical devices enter international markets, facing diverse regulatory and cultural challenges [3][4]. Group 2: Case Study of Blood Pump Technologies - The article discusses a specific case involving the CorHeart 6 blood pump, which was described differently by industry representatives and independent experts, highlighting the need for open scientific discussions to resolve such discrepancies [3][4]. - The classification of blood pump bearings is critical, with three fundamental types identified: contact-type plain bearings, hydrodynamic bearings, and magnetic bearings [6][22]. - The differences between magnetic and hydrodynamic bearings are significant, particularly regarding their impact on hemocompatibility and blood damage characteristics [10][27]. Group 3: Recommendations for Manufacturers - Manufacturers are urged to ensure that their descriptions align with international consensus and that the terminology used in marketing and technical documents is clear and consistent [4][5]. - It is recommended that manufacturers disclose the rotor suspension methods of their products, including any combination of magnetic and hydrodynamic support, to promote transparency [5][18]. - The article advocates for the establishment of an independent working group to standardize definitions and classifications of blood pump technologies to enhance scientific clarity and patient safety [12][32].

Core Insights - The field of xenotransplantation has made significant advancements in 2025, achieving breakthroughs that surpass the last century's progress [1] - A genetically edited pig kidney was successfully transplanted into a patient, Tim Andrews, who survived for 271 days, setting a new record for pig kidney transplants [1][2] - The comparison with a historical case from 1964 shows only a marginal improvement in survival time for xenotransplantation over 60 years [2] Group 1: Historical Context and Comparisons - The previous record for xenotransplantation was held by a female teacher who survived 269 days after receiving a chimpanzee kidney [2][3] - The advancements in genetic editing and immunosuppressive therapies have contributed to the increased survival time of xenotransplant patients [2][3] Group 2: Challenges and Limitations - Current challenges in xenotransplantation include immune rejection, infection risks, and biological compatibility issues [6][7] - The use of genetically modified pigs is preferred over primates due to ethical concerns, biological safety risks, and practical breeding considerations [5][6] Group 3: Technological and Regulatory Hurdles - Gene editing techniques have limitations, including the potential for new antigen production and the complexity of determining effective gene combinations [8][9] - Immunosuppressive drugs currently used are not specifically designed for xenotransplantation, leading to complications such as infections and organ toxicity [11][12] Group 4: Future Prospects and Comparisons with Artificial Organs - The development of artificial organs, particularly artificial hearts, is progressing rapidly, with several products nearing market readiness [13][15] - In contrast, the development of artificial kidneys and livers faces significant challenges, making them less competitive with xenotransplantation at this stage [16][17] Group 5: Expert Opinions and Future Directions - Experts believe that achieving a one-year functional survival for xenotransplanted organs could lead to broader acceptance and further advancements in the field [18]

Core Insights - The field of xenotransplantation has made significant advancements in 2025, surpassing breakthroughs achieved in the past century, particularly highlighted by the case of a genetically edited pig kidney functioning in a human for 271 days [1][2] - The comparison between the recent pig kidney transplant and a historical chimpanzee kidney transplant reveals only a marginal improvement in survival time, raising questions about the progress in xenotransplantation compared to other medical advancements like artificial hearts [1][5] Summary by Sections Historical Context - The longest survival record for a kidney transplant from a chimpanzee was set in 1964, lasting 269 days, while the recent pig kidney transplant extended this record to 271 days [2][5] - The historical context shows that despite over 60 years of research, the improvement in survival time for xenotransplantation has been minimal when compared to advancements in other areas of organ transplantation [1][5] Technological Advancements - The recent case of Tim Andrews demonstrates the potential of genetically edited pig kidneys, which have been modified to enhance compatibility with human immune systems [1][9] - The use of modern immunosuppressive therapies has allowed for longer survival times in xenotransplantation, indicating progress in managing immune rejection [6][10] Challenges and Limitations - The field faces significant challenges, including the need for more effective immunosuppressive drugs specifically designed for xenotransplantation, as current medications are primarily developed for same-species transplants [15][17] - The approval process for clinical trials in xenotransplantation varies significantly between countries, with the U.S. having a more structured approach compared to China's relatively unregulated environment [17] Future Prospects - The potential for xenotransplantation to provide a sustainable source of organs is promising, especially given the increasing demand for organ transplants and the shortage of human donors [10][18] - The development of artificial organs, particularly artificial hearts, is advancing rapidly, which may create competition for xenotransplantation in the future [18][22] Ethical and Practical Considerations - Ethical concerns regarding the use of primate organs have shifted the focus to pigs, which are more practical for large-scale organ production and genetic modification [9][19] - The complexity of developing artificial kidneys and livers remains a significant barrier, with current technologies not yet capable of producing viable implantable organs [22][23]

Core Viewpoint - The announcement by Tongxin Medical regarding the Brio4Kids clinical trial marks a significant step towards international pediatric applications of their full magnetic levitation artificial heart, BrioVAD, indicating a shift from filling domestic gaps to competing globally in the left ventricular assist device (LVAD) market [1][6]. Group 1: Technology and Market Position - Heart failure, often referred to as the "cancer of cardiovascular diseases," affects approximately 64 million people globally, with about 8.9 million patients over 35 in China, and the incidence is on the rise [2]. - The global VAD market is currently dominated by Abbott's HeartMate 3, which has been implanted in over 40,000 cases since its launch in 2017, generating annual revenues of around $1 billion [2][3]. - Tongxin Medical has focused on full magnetic levitation technology since its establishment in 2008, achieving significant advancements with its self-developed artificial heart, the Cizhi VAD, which received approval from the National Medical Products Administration (NMPA) in November 2021 [3][4]. Group 2: Clinical Data and Performance - Clinical data from Tongxin Medical's products show a one-year and two-year survival rate of 91.3%, compared to Abbott's 86.6% and 79% respectively, highlighting the effectiveness of their technology [4]. - The company has the fewest global lead wires (4) and the thinnest diameter (3.3mm) for its percutaneous cables, resulting in a significantly lower long-term infection risk, with an infection event rate of only 0.07 per patient per year [5]. Group 3: International Expansion and Regulatory Milestones - Following the withdrawal of Medtronic's HVAD from the market, there has been a call for new competitors, leading to Tongxin Medical's FDA approval for clinical trials of BrioVAD, marking it as the first Chinese active implantable medical device to receive such approval [6][7]. - The Brio4Kids clinical trial aims to address pediatric heart failure, expanding Tongxin Medical's reach in the U.S. market and showcasing its leadership in high-end ventricular assist technology [7][8]. - The company has established a robust clinical trial framework, with 60 research centers and 800 participants enrolled, demonstrating its commitment to meeting stringent U.S. regulatory standards [7].

Core Viewpoint - The resumption of the fifth set of IPO standards on the Sci-Tech Innovation Board has led to significant developments for innovative medical device companies, with Shenzhen Core Medical Technology Co., Ltd. being the first to have its IPO application accepted under these new standards, focusing on artificial hearts [1][2]. Company Overview - Core Medical specializes in artificial hearts, reporting a revenue of 94 million yuan in 2024, which represents a growth of over 400% year-on-year, despite a net loss of 132 million yuan during the same period [1]. - The revenue surge is attributed to the successful market launch of its magnetic levitation implantable left ventricular assist device, Corheart® 6, which has generated substantial income [1][4]. Product Details - Corheart® 6 is the first commercially available third-generation magnetic levitation artificial heart, recognized for being the smallest and lightest of its kind globally, weighing only 0.8 kg, which is nearly 50% lighter than its competitor, Abbott's HeartMate 3 [3][4]. - The production cost of Corheart® 6 is approximately 70,000 yuan per unit, with a selling price of 247,200 yuan, resulting in a gross margin close to 70% [9]. Market Challenges - The high price of Corheart® 6, along with the overall surgical costs reaching up to 700,000 yuan, limits the affordability for many patients in China, posing a challenge for its commercialization [1][9]. - Core Medical faces competition not only from Abbott but also from domestic companies like Tongxin Medical and Aerospace Taiheart, which have already launched their products [6][11]. International Expansion - To expand its market, Core Medical aims to penetrate overseas markets, particularly the U.S., where it has yet to initiate clinical trials for Corheart® 6, although it has received approvals in Colombia and Ukraine [6][7]. - The company has other products, such as DuoCor® 2 and CorVad® 4.0/6.0, which are expected to gain approval in the U.S. by 2030, indicating a longer timeline for revenue realization [7]. Industry Landscape - The global heart failure market is projected to grow, with the number of heart failure patients expected to rise from 62.98 million in 2024 to 71.51 million by 2033, presenting a significant opportunity for artificial heart technologies [11]. - However, the emergence of alternative therapies, such as minimally invasive atrial shunt devices, poses additional competition for artificial heart products [11].