科创板第五套标准重启后迎首家创新医疗器械企业申报，核心医疗携11款人工心脏产品“闯关”

Core Points - Shenzhen Core Medical Technology Co., Ltd. has become the first innovative medical device company to submit an IPO application under the reactivated fifth set of listing standards for the Sci-Tech Innovation Board [1][5] - The company focuses on providing comprehensive, innovative, and high-quality artificial heart products, addressing significant clinical needs in acute and chronic heart failure [3][4] - Core Medical has developed 5 implantable and 6 interventional artificial heart products, with one implantable product already commercialized and two interventional products in the registration approval stage [3][4] Financial Performance - Core Medical has not yet achieved profitability, with projected revenues of approximately 0, 16.55 million, 93.69 million, and 70.48 million CNY for the years 2022 to 2025, and net losses of approximately -178 million, -170 million, -132 million, and -72.75 million CNY for the same periods [4] - As of June 30, the company reported cumulative undistributed profits of -367 million CNY, indicating ongoing financial challenges [4] Market Position and Challenges - The artificial heart industry in China is still in its early development stages, with commercialization affected by factors such as clinical penetration, discipline development, surgical promotion, and patient payment capabilities [4] - Core Medical aims to become the first company to obtain approval for interventional artificial heart products in China, facing challenges in product promotion, market education, and brand building [4][5] IPO Details - The company plans to raise up to 1.217 billion CNY through its IPO, with funds allocated for research and development of circulatory support products, establishment of an artificial heart industrialization base, marketing network and digital construction, and working capital [5] - Core Medical meets the listing standards set forth in the Sci-Tech Innovation Board's regulations, which emphasize technological advancement and research capabilities over short-term financial metrics [5]