本报（chinatimes.net.cn）记者郭怡琳 于娜 北京报道 在人工心脏领域，一封关切函激起关于科学透明、术语严谨与患者安危的层层波澜。 近日，国际人工器官联合会官方期刊《Artificial Organs（人工器官）》刊登了标题为"Expression of Concern（关切函）"的致编辑信，矛头直指当前人工心脏血泵技术术语使用混乱。一枚仅90克重的人工 心脏，能否被冠以"全磁悬浮"之名，成为全球顶尖科学家和企业交锋的焦点。 据悉，该文作者为美国人工器官学会终身成就奖获得者Kurt Dasse博士。其严厉指出，"CorHeart 6的核 心技术被独立专家描述为'配备了磁力辅助的双流体动力轴承的离心泵'。"而该产品制造商宣称为"全磁 悬浮装置"。 Kurt Dasse接受《华夏时报》记者采访时表示，"我撰写此文旨在提高业界意识。随着新的机械辅助装置 进入市场，有必要对装置血液相容性产生重大影响的基础技术描述、分类和透明度进行标准化。轴承技 术的差异直接影响血液损伤机制，甚至关系到患者安全。更具体地说，需要规范描述血泵中用于主要运 行模式的轴承类别。" 术语迷雾 心力衰竭是一种心血管病发展到终末期的 ...

技术的发展，总会带来语言的发展。各个行业，都会面临同一个古老而普遍的问题—— 我们应该如何用统一 的语言去描述技术 ？ 历史上，无论是蒸汽机、电磁学、计算机，还是今日的人工智能，每一次技术突破，都会倒逼我们创造词汇、 定义词汇，最终统一词汇。 在医疗技术领域，这一问题尤为突出。每一个名词，都是医生在临床上去做判断 的依据 ， 直接作用于人体、作用于生命 。 因此，"语言的准确"不是学术的洁癖，而是伦理和安全的底线。医生、工程师、监管者必须在同一套语言下 进行沟通，创新才能真正落地。 思宇MedTech 编辑团队在近期 发表的 文献中注意到一个典型案例： 国际机械循环辅助学会（ISMCS）的官 方会刊 —— Artificial Organs 刊登 了一篇 标 题 为 "Expression of Concern" 的致编辑信。作者从工程与 临床的双重视角出发，呼吁全球范围内 统一血泵轴承技术的术语与定义 ，并举例说明当前行业内部分设备 在" 全 磁悬浮"表述上的不一致。 心室辅助装置（ Ventricular Assist Device, VAD ，常被称之为"人工心脏" ） 是一种植入体内、持 续推动血液流 ...

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]

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 ...

Summary of Cadrenal Therapeutics Conference Call Company Overview - **Company**: Cadrenal Therapeutics (Ticker: CVKD) - **Focus**: Development of novel anticoagulant drugs to address gaps in anticoagulation therapy, particularly for high-risk patients and orphan indications [2][15] Industry Context - **Market Size**: The global oral anticoagulation market is approximately $38 billion, with the U.S. market accounting for about $20 billion. Cadrenal targets a specific segment worth around $2 billion, focusing on orphan and high-risk indications [3][4] Key Products and Developments Tecarfarin - **Description**: A next-generation vitamin K antagonist designed for chronic use, with orphan drug and fast track designations for end-stage kidney disease (ESKD), atrial fibrillation (AFib), and left ventricular assist devices [4][7] - **Clinical Trials**: Tecarfarin has been studied in 11 clinical trials involving over 1,000 patients. The largest study, EMBRACE AC, showed that tecarfarin provided better or equivalent coagulation control compared to warfarin, with no thrombotic events and a low incidence of bleeding [8][9] - **Unique Features**: Unlike warfarin, tecarfarin is not metabolized by the hepatic cytochrome P450 system, leading to more predictable drug levels and fewer drug-drug interactions. It is also unaffected by poor kidney function, making it suitable for patients with severe kidney disease [6][9] Fornixum - **Description**: An intravenous factor XIa inhibitor acquired by Cadrenal, designed for acute care settings. It is differentiated by its fast-on, fast-off pharmacokinetics, making it suitable for precise control in hospital environments [6][12] - **Development Status**: Fornixum has completed two phase 1 studies and targets complex cardiac surgery as its primary indication [7][14] Market Opportunities - **Target Indications**: Cadrenal is focusing on high-risk areas where current therapies are inadequate, such as ESKD, AFib, and patients with mechanical heart valves [3][4] - **Regulatory Designations**: Tecarfarin has received orphan drug designation, providing seven years of exclusivity post-approval, and fast track designation for ESKD and AFib [7][15] Future Plans - **Clinical Trials**: A phase 2 study for tecarfarin in dialysis patients is planned to begin enrollment in early 2026, followed by a registration study in 2027. An additional phase 2 study for left ventricular assist devices is also targeted for late 2026 [13][14] - **Strategic Goals**: The primary goal for 2026 is to optimize the formulation of Fornixum for complex cardiac surgery applications [14] Conclusion - **Commitment**: Cadrenal Therapeutics aims to improve anticoagulation management standards through its innovative products, tecarfarin and Fornixum, addressing significant market gaps in both chronic and acute care settings [15]