同心医疗冲刺科创板：有望打破全球植入式人工心脏领域垄断，红杉、高榕为股东

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].