同心医疗科创板IPO获受理，以全磁悬浮技术领跑人工心脏赛道

Core Viewpoint - The company, Suzhou Tongxin Medical Technology Co., Ltd., has received acceptance for its IPO application on the Sci-Tech Innovation Board, focusing on the development and commercialization of full magnetic levitation ventricular assist devices, positioning itself as a global competitor in the artificial heart market [1][2]. Group 1: Company Overview - Founded in 2008, the company specializes in full magnetic levitation artificial hearts, leveraging independent technology and operational entities in China, the U.S., and Europe to establish a global business framework [1]. - The company's first product, CH-VAD, entered the special approval process for innovative medical devices in China in 2016 and became the first approved full magnetic levitation artificial heart in China in November 2021 [2][3]. Group 2: Market Context - Heart failure is a critical cardiovascular disease affecting over 60 million people globally, with a 50% annual mortality rate for late-stage heart failure, making artificial hearts a vital treatment option due to limited donor availability for heart transplants [2]. - The artificial heart industry has high entry barriers, with full magnetic levitation technology recognized as the mainstream approach, dominated by Abbott's HeartMate3, leaving a gap for Chinese companies [2]. Group 3: Product Performance - CH-VAD has shown superior performance in clinical settings, with over 670 implantations across more than 80 hospitals in China, and sales revenue projected to grow from 8.27 million yuan in 2022 to 67.06 million yuan in 2024 [3]. - The product features innovative designs that enhance blood compatibility and reduce infection rates, demonstrating excellent safety and reliability with no reported pump thrombosis or failures during clinical studies [3]. Group 4: Global Strategy - The company aims for global market expansion, aligning its R&D and clinical strategies with international standards, and has established a cross-national R&D team to support this goal [4]. - The BrioVAD, a next-generation device, has received FDA approval for clinical trials, marking a significant milestone as the first active implantable medical device from China to enter U.S. clinical trials [5]. - The company is also pursuing market entry in Europe and Japan, with plans for clinical trials and expanding indications for pediatric heart failure [5].