Core Viewpoint - Shenzhen Core Medical Technology Co., Ltd. has entered the IPO inquiry stage on the Sci-Tech Innovation Board, marking it as a representative enterprise in the innovative medical device sector [1][2]. Company Overview - Core Medical was established in 2016 and focuses on the research and industrialization of high-end innovative medical devices, particularly artificial hearts and mechanical circulatory support devices [2][5]. - The company aims to raise 1.217 billion yuan, primarily for the development of cutting-edge products, construction of an artificial heart industrialization base, marketing network, and digital system [2]. Financial Performance - Core Medical has not yet achieved profitability, with revenues of 0 yuan in 2022, 16.55 million yuan in 2023, 93.69 million yuan in 2024, and 70.48 million yuan in the first half of 2025. Corresponding net losses were -178 million yuan, -170 million yuan, -132 million yuan, and -72.75 million yuan [3]. - The company has completed six rounds of financing since its inception, with a valuation of approximately 3.545 billion yuan after the D round in April 2025 and around 3.388 billion yuan during a share transfer in August 2025 [2]. Product Matrix - Core Medical has developed a comprehensive product matrix from implantable to interventional systems, including the Corheart® 6, DuoCor®, and CorVad® series, targeting over 60 million heart failure patients globally [5][9]. - The Corheart® 6, an implantable left ventricular assist device, received NMPA approval in June 2023 and is designed for end-stage heart failure patients [12]. Competitive Landscape - Core Medical's products are positioned against competitors like Abbott's HeartMate 3 and other domestic devices, with a focus on innovative features and clinical data supporting their efficacy [12][13][16][20]. - The company is recognized for its advanced technology in miniaturizing artificial hearts, enhancing its competitiveness in the international market [5][7]. Investment and Financing - In April 2025, Core Medical completed a D round financing exceeding 100 million USD, marking one of the largest market-oriented financings in China's innovative medical device sector that year [10]. - The company has received multiple rounds of institutional investment and is supported by recognized professional institutional investors [10]. Regulatory and Market Considerations - As the inquiry phase begins, Core Medical's market valuation, commercial sustainability, and profitability path are expected to be key areas of regulatory focus, providing important reference points for similar innovative medical device companies [3][22].

Core Viewpoint - Shenzhen Core Medical's IPO application has been accepted, marking the first innovative medical device company to be accepted under the newly restarted fifth standard of the Sci-Tech Innovation Board [1] Company Overview - Core Medical specializes in artificial hearts, with its flagship product, Corheart 6, being the fourth approved artificial heart in China and the latest domestic product to market as of June 2023 [1] - Corheart 6 has achieved a national market share exceeding 45% by 2024, making it the leading product in the industry [1][4] - The company has undergone six rounds of financing, attracting investments from notable institutions such as Hillhouse Capital and Zhengxin Valley [1] Market Dynamics - The primary application of artificial hearts is in heart failure, with over 15 million heart failure patients in China by 2024, including over 1.5 million in end-stage heart failure [2] - The number of heart transplants in China is limited, with only 1,064 procedures performed in 2024, leading many patients to opt for artificial hearts as a transitional or long-term solution [2] Product Performance - Corheart 6 has become the most implanted artificial heart in China, achieving over 1,000 implants, making it the second globally to reach this milestone after Abbott's HeartMate 3 [1][4] - The product is noted for being the smallest and lightest magnetic levitation implantable artificial heart, which facilitates smaller surgical incisions and faster patient recovery [5][6] Financial Aspects - The gross margin for artificial hearts remains above 72%, with the average factory price of Corheart 6 decreasing from 290,000 yuan in 2023 to nearly 230,000 yuan by 2025 [7] - Recent policy changes have included artificial hearts in medical insurance reimbursement lists, significantly reducing out-of-pocket costs for patients [7] Future Developments - Core Medical is developing the world's first magnetic levitation dual-heart assist device, DuoCor 2, which is currently in clinical evaluation and expected to enter special review procedures in November 2024 [9] - The company is also working on an interventional artificial heart product, CorVad, anticipated to be the first approved interventional artificial heart in China by the first quarter of 2026 [9]