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].

Core Viewpoint - The article highlights the rapid capitalization of the artificial heart sector in China, particularly focusing on Shenzhen Core Medical Technology Co., Ltd. (Core Medical), which has recently had its IPO application accepted by the Shanghai Stock Exchange's Sci-Tech Innovation Board after two and a half years of preparatory work [1][8]. Group 1: Company Overview - Core Medical's flagship product, Corheart 6, is the smallest and lightest commercialized magnetic levitation implantable artificial heart globally, approved for market in June 2023, with a projected market share exceeding 45% in 2024 [1][6]. - The company has developed five implantable and six interventional artificial heart products, with one implantable product already commercialized and two interventional products in the registration phase [5][6]. Group 2: Market Position and Competition - Core Medical is positioned as the fastest capitalizing company in the domestic artificial heart market, aiming to become the first publicly listed domestic artificial heart company [1][8]. - Despite being a latecomer, Core Medical's Corheart 6 achieved a 52.86% market share in implantations from January to May 2025, outperforming competitors like Everheart and Abbott [10][11]. Group 3: Financial Performance - Core Medical's revenue from 2022 to the first half of 2025 shows a growth trajectory from zero to approximately 70.48 million yuan, but the company has consistently reported net losses, with a projected loss of 72.75 million yuan for the first half of 2025 [12][13]. - The company's R&D expenditures are substantial, with ratios to revenue exceeding 700% in 2023, indicating a heavy investment in product development [13]. Group 4: Regulatory and Market Dynamics - Recent developments have seen artificial hearts included in medical insurance reimbursement lists in several regions, which could enhance market penetration for Core Medical's products [14][15]. - The company faces potential risks related to pricing pressures and reimbursement policies, which could significantly impact sales and profitability if not managed effectively [15].

Core Insights - The article highlights the rapid capitalization phase of the artificial heart sector in China, particularly focusing on Shenzhen Core Medical Technology Co., Ltd. (Core Medical), which has recently had its IPO application accepted by the Shanghai Stock Exchange's Sci-Tech Innovation Board after two and a half years of preparation [2][8] - Core Medical's flagship product, Corheart6, is noted as the smallest and lightest commercialized magnetic levitation implantable artificial heart globally, having received NMPA approval in June 2023 and projected to capture over 45% of the national market share by 2024 [2][5] Company Overview - Core Medical is recognized as the fastest capitalizing company among domestic artificial heart manufacturers, aiming to become the first publicly listed company in the "domestic artificial heart" category [2][4] - The company has developed multiple products, including five implantable and six interventional artificial heart products, with Corheart6 being the only one currently commercialized [4][9] Product Development - Corheart6 has been praised for its innovative design, which includes a simpler structure and lower power consumption, leading to quicker patient recovery and a broader applicable demographic [5][10] - The company is also expanding internationally, with Corheart6 expected to receive approvals in Colombia and Ukraine in 2024, and has submitted a CE registration application for the European market [5][10] Market Position - Despite being a latecomer to the market, Core Medical's Corheart6 has achieved a significant market share, with a 52.86% implantation rate from January to May 2025, outperforming competitors [7][9] - The company has completed six rounds of financing, with notable investors including Hillhouse Capital and Prosperity7 Ventures, indicating strong market confidence [8] Financial Performance - Core Medical's financials show a trend of increasing revenue but also 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, alongside net losses of 1.78 billion, 1.7 billion, 1.32 billion, and 727.51 million in the same periods [9] - The company's strategy of low pricing to gain market share has raised concerns about its long-term profitability, as the average selling price of Corheart6 has decreased over the years [9][10] Regulatory Environment - Recent developments have seen artificial hearts included in medical insurance reimbursement lists in several regions, which could impact the market dynamics and pricing strategies for Core Medical [10][11] - The company faces potential risks related to dynamic adjustments in provincial medical insurance policies, which could affect product sales and profitability [11]

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]