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].