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].