【文/王力 编辑/周远方】 近日，天津泰达国际心血管病医院宣布，患有限制型心肌病的患儿小妮在接受"双人工心脏植入+心脏移植"的阶梯式治疗后顺利康复出院。这不仅是国内首 例、全球同类手术中体重最轻的成功案例，更标志着中国在儿童终末期心衰救治及国产人工心脏应用领域实现关键突破。 南京市儿童医院的医护人员与患儿交流互动图片来自新华社 按照国际通行方案，这类患儿通常只能选择德国产品柏林心（Berlin Heart EXCOR）——一款获得FDA批准的体外气动辅助系统，也是目前全球唯一可用于 婴幼儿的心脏装置。然而，柏林心的设计理念源于50年前的第一代人工心脏技术。其工作原理是通过粗大的管路从腹部穿入再穿出，依赖气压驱动的活塞瓣 膜结构维持血液循环。这意味着患儿必须24小时连接一台冰激凌车大小的外部设备，无法自由活动、无法洗澡、感染风险极高。对于正处于成长关键期的儿 童而言，这种生活质量几乎是不可接受的。 泰达心血管病医院联合航天泰心科技选择了一条完全不同的技术路线。他们使用的国产第二代磁悬浮人工心脏"火箭心"，采用双电机全磁悬浮结构，转子凭 借三维磁场的几何布局在"纯物理状态"下实现自稳定漂浮，无需有源磁悬浮轴承、电 ...

炒股就看金麒麟分析师研报，权威，专业，及时，全面，助您挖掘潜力主题机会！ 近日，深圳核心医疗科技股份有限公司（以下简称"核心医疗"）科创板IPO申请获受理。作为科创板第 五套上市标准重启后首家获受理的创新医疗器械企业，公司凭借全球体积最小、重量最轻的全磁悬浮人 工心脏Corheart®6，填补了国内儿童心衰治疗空白，2024年以超过45.9%的终端植入量市占率位居行业 第一，2025年前五个月更攀升至52.86%。 然而，对招股书等相关资料进行梳理后发现，公司目前仍存在诸多隐忧，包括单一产品及大客户依赖明 显、销售规模有限连年亏损、产能利用率不足、递表前夕股权转让价格显著下滑等，公司的商业化之路 仍面临挑战。 独苗产品销售价格持续走低 产能利用率低仍募资扩产 产品方面，公司产品结构较为单一，所有营收均来自于唯一商业化产品Corheart®6。目前，公司另有多 款在研产品，但仅1款介入式产品处于注册审批阶段，预计2026年获批，其余多数仍处临床前研究，距 离商业化遥遥无期。 | 临床味油 | 应用 | 1286 | 选盘在其体能图 | ME | | | 除假 | | 《纽诗》 | | --- | --- | - ...

目前，全球VAD市场基本上由雅培HeartMate 3全磁悬浮人工心脏垄断。自2017年上市以来，HeartMate 3累计植入超过40000例，年收入约10亿美元，成为人工心脏领域的绝对垄断者。 雅培的地位，是技术和市场的双重选择——全磁悬浮技术通过磁场控制转子在空气中完全悬浮，叶轮与 周围"零"机械接触，避免摩擦和挤压血液带来的血细胞损伤，即解决了"血液相容性"的问题。因此，相 较于其它技术路径，全磁悬浮技术在改善患者生存结局方面展现出了显著优势。 在中国，同心医疗同样选择了这一技术路径——早在2008年建立之初，同心医疗就聚焦全磁悬浮技术的 突破，其自主研发的全磁悬浮人工心脏慈孚VAD于2021年11月获得国家药品监督管理局（NMPA）批准 上市，成为国内首个获批上市拥有完备自主知识产权的全磁悬浮式人工心脏。 国产全磁悬浮人工心脏，有望迈向国际化儿科应用新阶段——11月17日，同心医疗宣布，在今年的美国 心脏协会科学年会（2025 AHA）上，针对儿童心力衰竭患者的Brio4Kids临床试验研究者会议正式召 开。此举标志着其美国临床试验核心产品BrioVAD正式进入美国儿科市场探索。 这一场景，是中国L ...

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].

Core Viewpoint - Shenzhen Core Medical's IPO application has been accepted, marking the first innovative medical device company to be accepted under the newly restarted fifth standard of the Sci-Tech Innovation Board [1] Company Overview - Core Medical specializes in artificial hearts, with its flagship product, Corheart 6, being the fourth approved artificial heart in China and the latest domestic product to market as of June 2023 [1] - Corheart 6 has achieved a national market share exceeding 45% by 2024, making it the leading product in the industry [1][4] - The company has undergone six rounds of financing, attracting investments from notable institutions such as Hillhouse Capital and Zhengxin Valley [1] Market Dynamics - The primary application of artificial hearts is in heart failure, with over 15 million heart failure patients in China by 2024, including over 1.5 million in end-stage heart failure [2] - The number of heart transplants in China is limited, with only 1,064 procedures performed in 2024, leading many patients to opt for artificial hearts as a transitional or long-term solution [2] Product Performance - Corheart 6 has become the most implanted artificial heart in China, achieving over 1,000 implants, making it the second globally to reach this milestone after Abbott's HeartMate 3 [1][4] - The product is noted for being the smallest and lightest magnetic levitation implantable artificial heart, which facilitates smaller surgical incisions and faster patient recovery [5][6] Financial Aspects - The gross margin for artificial hearts remains above 72%, with the average factory price of Corheart 6 decreasing from 290,000 yuan in 2023 to nearly 230,000 yuan by 2025 [7] - Recent policy changes have included artificial hearts in medical insurance reimbursement lists, significantly reducing out-of-pocket costs for patients [7] Future Developments - Core Medical is developing the world's first magnetic levitation dual-heart assist device, DuoCor 2, which is currently in clinical evaluation and expected to enter special review procedures in November 2024 [9] - The company is also working on an interventional artificial heart product, CorVad, anticipated to be the first approved interventional artificial heart in China by the first quarter of 2026 [9]

Core Viewpoint - The "artificial heart" is experiencing a rapid capitalization phase as the "1+6" reform of the Sci-Tech Innovation Board is implemented, with Shenzhen Core Medical Technology Co., Ltd. (referred to as "Core Medical") having its IPO application accepted by the Shanghai Stock Exchange after two and a half years of listing guidance [2][3]. Company Overview - Core Medical is the third company to apply under the fifth set of listing standards after the resumption announced by the chairman of the China Securities Regulatory Commission [3]. - The flagship product, Corheart 6, is the smallest and lightest commercialized magnetic levitation implantable artificial heart globally, approved by the NMPA in June 2023, with a projected market share exceeding 45% in 2024 [3][8]. - Core Medical is the fastest company in the domestic artificial heart sector to undergo capitalization, aiming to become the first publicly listed "domestic artificial heart" company [3][10]. Product Development - Core Medical has developed five implantable and six interventional artificial heart products, with one implantable product already commercialized and two interventional products in the registration approval stage [7]. - Corheart 6 is noted for its compact size and light weight, showing unique clinical value in pediatric heart failure, and is the first implantable artificial heart product for children in China [7][8]. - The product has received positive evaluations from the NMPA for its innovative design, which reduces surgical incision size and recovery time for patients [8]. Market Position - Core Medical's Corheart 6 has achieved a 52.86% market share in implantations from January to May 2025, significantly outperforming competitors [11]. - The company has completed six rounds of financing, with notable investors including Hillhouse Capital and Zhengxin Valley, indicating strong market confidence [11][12]. - Core Medical is currently the only company in the industry that has entered the IPO review stage, while competitors are still in earlier stages of the listing process [12]. Financial Performance - Despite its leading position, Core Medical's financials show significant losses, with revenues of 0 million, 16.55 million, 93.69 million, and 70.48 million from 2022 to the first half of 2025, and net losses of -178 million, -170 million, -132 million, and -72.75 million respectively [14]. - The high R&D expenditures, which accounted for over 700% of revenue in 2023, and the declining sales prices of its products are contributing factors to the losses [14]. Regulatory Environment - Recent developments have seen artificial hearts included in medical insurance reimbursement lists in several regions, which may impact market dynamics [15]. - The National Medical Insurance Administration has initiated discussions with several companies, including Core Medical, regarding pricing risks and reimbursement policies [16].

随着科创板"1+6"改革落地，"人工心脏"作为医械行业皇冠上的明珠，正在迎来资本化加速 期。 11月6日，在进行上市辅导备案两年半后，深圳核心医疗科技股份有限公司（下称"核心医 疗"）的IPO申请获得了上交所科创板受理。 由于报告期内尚未盈利，核心医疗采用的是科创板第五套上市标准。其是证监会主席吴清宣布 重启第五套标准后，以此标准申报的第三家企业。 核心医疗的重磅产品Corheart 6是全球范围内体积最小、重量最轻的商业化磁悬浮植入式人工 心脏，于2023年6月获NMPA批准上市，以终端植入量计量，2024年全国市占率超45%，位居 行业第一，累计植入量已突破千例。 目前，国内共有5款植入式人工心脏产品获批，包含国内企业永仁心医疗、苏州同心医疗、航 天泰心、核心医疗、心擎医疗和1家外资机构雅培。 核心医疗是国内人工心脏企业中资本化进 程最快的公司，有望冲刺"国产人工心脏"第一股。 14年前，余顺周从哈工大博士毕业后，前往美国加州大学戴维斯分校机械工程专业深造。 一次偶然的机会，余顺周接触人工心脏领域，开始作为资深工程师在美国顶级人工心脏公司任 职，并参与了多个人工心脏产品开发，其中就包括Heartmate ...

由于报告期内尚未盈利，核心医疗采用的是科创板第五套上市标准。其是证监会主席吴清宣布重启第五 套标准后，以此标准申报的第三家企业。 核心医疗的重磅产品Corheart6是全球范围内体积最小、重量最轻的商业化磁悬浮植入式人工心脏，于 2023年6月获NMPA批准上市，以终端植入量计量，2024年全国市占率超45%，位居行业第一，累计植 入量已突破千例。 目前，国内共有5款植入式人工心脏产品获批，包含国内企业永仁心医疗、苏州同心医疗、航天泰心、 核心医疗、心擎医疗和1家外资机构雅培。核心医疗是国内人工心脏企业中资本化进程最快的公司，有 望冲刺"国产人工心脏"第一股。哈工大博士将迎首个IPO 核心医疗的发展史，也是一名理工学霸的"创业史"。 核心医疗创始人余顺周出生于1978年，1996-2007本硕博就读于哈尔滨工业大学机械制造及其自动化专 业。 十四年前，余顺周从哈工大博士毕业后，前往美国加州大学戴维斯分校机械工程专业深造。 随着科创板"1+6"改革落地，"人工心脏"作为医械行业皇冠上的明珠，正在迎来资本化加速期。 11月6日，在进行上市辅导备案两年半后，深圳核心医疗科技股份有限公司(下称"核心医疗")的IPO申 ...

Core Viewpoint - The introduction of a lightweight, 45-gram domestic "artificial heart" represents a significant advancement in pediatric cardiac care, addressing the critical shortage of donor hearts for children suffering from severe heart failure [1][2][3] Group 1: Product Development and Innovation - The new artificial heart is the smallest and lightest magnetic levitation dual ventricular assist device (VAD) globally, being 50% smaller than the previous smallest model [2] - This device is specifically designed for children weighing between 10 to 30 kilograms and with a body surface area of less than 1.0 square meter [5] - The development of this pediatric VAD took five years and was a collaborative effort between medical teams and Shenzhen Core Medical [7] Group 2: Clinical Application and Challenges - The current supply-demand ratio for pediatric heart transplants in China is approximately 1:50, highlighting the urgent need for effective VAD solutions [3][6] - The mortality rate for children waiting for heart transplants can reach 40%, emphasizing the importance of VADs in extending survival time [1][6] - The use of VAD technology has been shown to reduce the mortality rate of children on transplant waiting lists from 38% to 13% [6] Group 3: Regulatory and Financial Aspects - The cost of the domestic artificial heart ranges from 500,000 to 700,000 yuan, with total expenses for surgery and devices estimated between 800,000 to 1,000,000 yuan [8] - Some regions in China have included artificial heart implantation in their medical insurance reimbursement lists to alleviate patient financial burdens [8][9] - The integration of VAD technology into clinical practice faces challenges, including the need for specialized training and monitoring protocols for pediatric patients [9][10] Group 4: Future Directions - Continuous monitoring and potential for reoperation are necessary for children with implanted artificial hearts due to their growth and changing physiological needs [10] - The industry is focusing on improving clinical technology systems and management plans to enhance the affordability and accessibility of these innovative medical devices [2][6]

Core Viewpoint - Suzhou Tongxin Medical Technology Co., Ltd. successfully exported a batch of implantable left ventricular assist devices (commonly known as "artificial hearts") worth over 1 million USD to the United States, marking a significant achievement in China's medical device industry and showcasing its international competitiveness [1] Group 1: Company Achievements - The artificial heart is the first and only active implantable medical device in China to receive clinical trial approval in the United States, highlighting its unique position in the market [1] - In the past month, the product was also exported to Hong Kong, becoming the first domestically produced "artificial heart" for clinical use in Hong Kong and Macau [1] Group 2: Government Support - The Suzhou Customs has provided targeted support for the production characteristics of the "artificial heart," utilizing various platforms and services to assist the company in customs clearance and regulatory compliance [1] - The company has benefited from the optimized business environment and customs support policies, achieving nearly 50 million CNY in export value in the first seven months of this year [1] Group 3: Financial Impact - The company reported significant cost savings, with one transaction saving nearly 1 million CNY in taxes due to efficient processing of processing trade business procedures [1]