Core Viewpoint - The 31st International Society for Mechanical Circulatory Support (ISMCS) annual meeting in Vienna focused on advancements in rotary blood pumps and related mechanical circulatory support systems, emphasizing the need for standardized terminology and definitions in the industry [1][3]. Group 1: Industry Developments - The meeting featured experts from multiple countries discussing the core topic of "Understanding Bearing Technologies in Contemporary Durable Rotary Blood Pumps," aiming to clarify concepts and unify terminology in artificial heart bearing technology [3][4]. - Heart failure, often referred to as the "cancer" of the cardiovascular field, affects over 60 million people globally, with a 50% five-year mortality rate upon diagnosis, comparable to that of malignant tumors [3][4]. Group 2: Challenges and Solutions - The lack of standardized terminology and clear definitions has hindered effective communication among industry experts, researchers, and clinicians, impacting the accurate understanding and evaluation of product performance [4]. - The conference underscored the importance of establishing a unified and scientific classification framework for bearing technologies, which could serve as a basis for future industry white papers and regulatory assessments [4][5]. Group 3: Key Contributions - Dr. Marvin Slepian, former president of the American Society for Artificial Internal Organs (ASAIO) and ISMCS, highlighted the need for clear technical definitions and industry consensus to promote healthy industry development [5]. - Dr. Chen Chen from Suzhou Tongxin Medical presented on the stability of magnetic and hydrodynamic bearings in blood pumps, emphasizing the critical relationship between bearing stability and blood damage, using the BrioVAD as a case study [5].

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 ...

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 Insights - Tongxin Medical has completed a strategic financing round exceeding 100 million USD, aimed at accelerating international expansion, product innovation, and domestic commercialization [1][3]. Company Overview - Established in 2008 and headquartered in Suzhou, Jiangsu, Tongxin Medical specializes in the research, production, and sales of ventricular assist devices (VAD) [3]. - The company has developed a comprehensive quality management system for high-end medical devices, complying with Chinese and international standards, and has obtained necessary certifications [3]. Product Introduction - The company successfully launched the next-generation ultra-small full magnetic levitation artificial heart, the Cizhi® VAD, which received approval from the National Medical Products Administration in November 2021, marking it as China's first fully magnetic levitation implantable left ventricular assist device with complete independent intellectual property rights [4]. - Clinical studies indicate that the long-term clinical outcomes of Cizhi® VAD surpass both domestic products and current overseas full magnetic levitation VAD clinical research results [4]. Clinical Research Data - The 2-year survival rates for Cizhi® VAD are reported as follows: 93% in the Fuwai Hospital long-term results study, 91.6% in a real-world multicenter study, and 85.1% in a cohort study, compared to 78.8% in U.S. studies [5]. - Adverse event rates for Cizhi® VAD show lower incidences of complications such as stroke (6%), gastrointestinal bleeding (2%), and cable infection (16%) compared to U.S. counterparts [5]. Recent Developments - In February 2024, the new product BrioVAD received FDA approval for clinical trials, becoming the first active implantable medical device from China to achieve this milestone [6]. - By June 2025, BrioVAD successfully completed the safety phase of clinical trials in the U.S. and is set to initiate large-scale confirmatory studies across 60 leading clinical centers, with costs covered by U.S. federal insurance [6].

Core Viewpoint - The recent financing progress of Suzhou Tongxin Medical Technology Co., Ltd., a subsidiary of Bluefan Medical, is expected to accelerate its IPO process, particularly with the recent reactivation of the fifth set of standards on the Sci-Tech Innovation Board, which could significantly enhance the company's market position in the artificial heart sector [2][6][7]. Group 1: Company Overview - Suzhou Tongxin Medical, established in July 2008, focuses on the research, production, and sales of innovative ventricular assist devices (VADs), aiming to commercialize VADs globally [3]. - The company's flagship product, the CH-VAD, is the first domestically approved full magnetic levitation VAD in China, receiving regulatory approval in November 2021 [3][4]. - The CH-VAD has shown superior clinical outcomes compared to Abbott's HeartMate 3, particularly in survival rates and compatibility with blood [4]. Group 2: Product Development and Innovation - Tongxin Medical is advancing its product line with the BrioVAD, a durable VAD designed for long-term support of heart failure patients, which has received FDA approval for clinical trials in the U.S. [5]. - The BrioVAD is undergoing a head-to-head clinical trial against Abbott's HeartMate 3, marking a significant milestone in the treatment of advanced heart failure [5]. Group 3: Market Potential and Financial Backing - The market for artificial hearts in China is substantial, with approximately 13.7 million heart failure patients aged 35 and above, highlighting a significant demand for VADs due to a severe imbalance between heart transplant supply and demand [6]. - Tongxin Medical has successfully completed eight rounds of financing, raising over 1 billion RMB, indicating strong market confidence and support from investors [6][8]. - The company has a diverse shareholder structure, including prominent investment firms and strategic investors, which positions it well for future growth and commercialization [8].