Core Viewpoint - The "artificial heart" is experiencing a rapid capitalization phase as the "1+6" reform of the Sci-Tech Innovation Board is implemented, with Shenzhen Core Medical Technology Co., Ltd. (referred to as "Core Medical") having its IPO application accepted by the Shanghai Stock Exchange after two and a half years of listing guidance [2][3]. Company Overview - Core Medical is the third company to apply under the fifth set of listing standards after the resumption announced by the chairman of the China Securities Regulatory Commission [3]. - The flagship product, Corheart 6, is the smallest and lightest commercialized magnetic levitation implantable artificial heart globally, approved by the NMPA in June 2023, with a projected market share exceeding 45% in 2024 [3][8]. - Core Medical is the fastest company in the domestic artificial heart sector to undergo capitalization, aiming to become the first publicly listed "domestic artificial heart" company [3][10]. Product Development - Core Medical has developed five implantable and six interventional artificial heart products, with one implantable product already commercialized and two interventional products in the registration approval stage [7]. - Corheart 6 is noted for its compact size and light weight, showing unique clinical value in pediatric heart failure, and is the first implantable artificial heart product for children in China [7][8]. - The product has received positive evaluations from the NMPA for its innovative design, which reduces surgical incision size and recovery time for patients [8]. Market Position - Core Medical's Corheart 6 has achieved a 52.86% market share in implantations from January to May 2025, significantly outperforming competitors [11]. - The company has completed six rounds of financing, with notable investors including Hillhouse Capital and Zhengxin Valley, indicating strong market confidence [11][12]. - Core Medical is currently the only company in the industry that has entered the IPO review stage, while competitors are still in earlier stages of the listing process [12]. Financial Performance - Despite its leading position, Core Medical's financials show significant losses, with revenues of 0 million, 16.55 million, 93.69 million, and 70.48 million from 2022 to the first half of 2025, and net losses of -178 million, -170 million, -132 million, and -72.75 million respectively [14]. - The high R&D expenditures, which accounted for over 700% of revenue in 2023, and the declining sales prices of its products are contributing factors to the losses [14]. Regulatory Environment - Recent developments have seen artificial hearts included in medical insurance reimbursement lists in several regions, which may impact market dynamics [15]. - The National Medical Insurance Administration has initiated discussions with several companies, including Core Medical, regarding pricing risks and reimbursement policies [16].

随着科创板"1+6"改革落地，"人工心脏"作为医械行业皇冠上的明珠，正在迎来资本化加速 期。 11月6日，在进行上市辅导备案两年半后，深圳核心医疗科技股份有限公司（下称"核心医 疗"）的IPO申请获得了上交所科创板受理。 由于报告期内尚未盈利，核心医疗采用的是科创板第五套上市标准。其是证监会主席吴清宣布 重启第五套标准后，以此标准申报的第三家企业。 核心医疗的重磅产品Corheart 6是全球范围内体积最小、重量最轻的商业化磁悬浮植入式人工 心脏，于2023年6月获NMPA批准上市，以终端植入量计量，2024年全国市占率超45%，位居 行业第一，累计植入量已突破千例。 目前，国内共有5款植入式人工心脏产品获批，包含国内企业永仁心医疗、苏州同心医疗、航 天泰心、核心医疗、心擎医疗和1家外资机构雅培。 核心医疗是国内人工心脏企业中资本化进 程最快的公司，有望冲刺"国产人工心脏"第一股。 14年前，余顺周从哈工大博士毕业后，前往美国加州大学戴维斯分校机械工程专业深造。 一次偶然的机会，余顺周接触人工心脏领域，开始作为资深工程师在美国顶级人工心脏公司任 职，并参与了多个人工心脏产品开发，其中就包括Heartmate ...

由于报告期内尚未盈利，核心医疗采用的是科创板第五套上市标准。其是证监会主席吴清宣布重启第五 套标准后，以此标准申报的第三家企业。 核心医疗的重磅产品Corheart6是全球范围内体积最小、重量最轻的商业化磁悬浮植入式人工心脏，于 2023年6月获NMPA批准上市，以终端植入量计量，2024年全国市占率超45%，位居行业第一，累计植 入量已突破千例。 目前，国内共有5款植入式人工心脏产品获批，包含国内企业永仁心医疗、苏州同心医疗、航天泰心、 核心医疗、心擎医疗和1家外资机构雅培。核心医疗是国内人工心脏企业中资本化进程最快的公司，有 望冲刺"国产人工心脏"第一股。哈工大博士将迎首个IPO 核心医疗的发展史，也是一名理工学霸的"创业史"。 核心医疗创始人余顺周出生于1978年，1996-2007本硕博就读于哈尔滨工业大学机械制造及其自动化专 业。 十四年前，余顺周从哈工大博士毕业后，前往美国加州大学戴维斯分校机械工程专业深造。 随着科创板"1+6"改革落地，"人工心脏"作为医械行业皇冠上的明珠，正在迎来资本化加速期。 11月6日，在进行上市辅导备案两年半后，深圳核心医疗科技股份有限公司(下称"核心医疗")的IPO申 ...

Core Insights - CorWave has successfully completed the world's first human implantation of its innovative LVAD based on unique wave membrane technology in Australia, marking a significant milestone in sustainable mechanical circulatory support technology [1][2][4] - The CorWave LVAD is designed to significantly reduce common severe complications associated with existing LVADs, such as stroke, bleeding, heart failure, and valve disease, while improving patient quality of life and promoting heart function recovery [4][9] - The device operates at an average blood flow rate of 5-6 L/min, providing comprehensive support for patients with advanced heart failure, and is capable of dynamically adjusting blood flow based on the patient's condition [9][12] Clinical Research - CorWave LVAD has demonstrated excellent preclinical results, having safely operated in animal models for six months without any device-related complications or thrombosis, indicating its potential for clinical application [18] - The device's unique control algorithms allow for synchronized support with the patient's heartbeat, enhancing its reliability and safety [18] Market Overview - The global LVAD market was valued at approximately $2.38 billion in 2023 and is projected to grow to $5.5 billion by 2035, with a compound annual growth rate (CAGR) of 7.23% [18][20] - North America held the largest market share in 2020, while the Asia-Pacific region is expected to achieve the highest CAGR of 19.3% in the coming years due to improvements in medical facilities and government support for medical technology [20] Competitor Landscape - As of now, four domestic companies have received approval for implantable LVADs in China, including Yongrenxin Medical, Tongxin Medical, Aerospace Taixin, and Core Medical [21] - Yongrenxin Medical's EVAHEART is the only approved artificial heart in China that can be used for both short-term and long-term treatment, showcasing significant clinical success [22][24] - Tongxin Medical's CH-VAD, which utilizes next-generation magnetic levitation technology, has broken Abbott's monopoly in the market and has gained international recognition for its performance [29]