Core Viewpoint - Suzhou Tongxin Medical Technology Co., Ltd. has submitted its IPO application to the Shanghai Stock Exchange, marking a significant step in the artificial heart industry as it aims to capitalize on the growing demand for heart failure treatments [1][7]. Company Overview - Founded by Chen Chen in 2008, Tongxin Medical focuses on the innovation of ventricular assist devices, specifically the implantable left ventricular assist device (LVAD) [1]. - The company has developed a product matrix that includes one product approved for market, one in the registration phase, one in clinical trials, one in preclinical research, and two in design development [1]. Product Details - The first product, the CH-VAD, is China's first approved full magnetic levitation implantable artificial heart, with its iterative version, CH-VAD Plus, expected to be approved by early 2026 [1]. - In the U.S. market, the new generation BrioVAD has received FDA approval to enter clinical trials, making it the first active implantable medical device from China to achieve this milestone [2]. Financial Performance - The average price of CH-VAD has decreased from 459,600 CNY in 2022 to 362,300 CNY in the first half of 2025, reflecting the company's strategy to expand its customer base during a period of rapid industry growth [4]. - Sales revenue for CH-VAD increased from 8.27 million CNY in 2022 to 67.06 million CNY in 2024, with over 670 implants completed across more than 80 hospitals [5]. - Despite revenue growth, the company remains in a loss-making position, with net losses of 189 million CNY, 306 million CNY, and 372 million CNY for the years 2022, 2023, and 2024, respectively [5]. Funding and Ownership - The company has completed multiple rounds of financing, with the latest round in July 2023 involving participation from several investment firms [6]. - Chen Chen, the actual controller, holds 30.95% of the voting rights, while other significant shareholders include Baiyang Group (16.73%) and Sequoia China (8.53%) [7]. Industry Context - The artificial heart sector is experiencing a collective IPO window, with other companies like Shenzhen Core Medical and Hangzhou Hetang Health also preparing for IPOs or securing significant funding [7].

Core Viewpoint - Tongxin Medical Technology Co., Ltd. is preparing for an IPO on the Sci-Tech Innovation Board, aiming to raise 1.064 billion yuan primarily for global clinical trials of its implantable left ventricular assist system (LVAS), next-generation product development, production base construction, and working capital [2]. Company Overview - Established in 2008, Tongxin Medical focuses exclusively on ventricular assist devices (VAD), commonly referred to as "artificial hearts," which are considered "crown-level products" in high-end medical devices due to their complex integration of various engineering disciplines [2][3]. - The company has chosen a long-term investment strategy in a single technology line, resulting in a development pace characterized by long R&D cycles, slow commercialization, and high validation costs [2]. Product Development - The core product is the fully magnetic levitation implantable LVAS, which provides continuous circulatory support for end-stage heart failure patients. Its design minimizes mechanical contact, reducing blood shear damage and thrombus formation risks [5]. - The product received approval from the National Medical Products Administration in November 2021, marking a significant transition from engineering prototypes to clinical products [5]. Fundraising Allocation - The IPO proceeds of 1.064 billion yuan will be allocated primarily to core product initiatives, with 695 million yuan designated for global clinical trials and registration of the BrioVAD project [7][9]. - Additional funds will support next-generation LVAS development (190 million yuan), production base construction (130 million yuan), and working capital (50 million yuan) [9]. Financial Performance - Tongxin Medical is currently in a loss-making phase, with revenues increasing from 8.61 million yuan in 2022 to 77.35 million yuan in 2024, while net losses have also escalated [10][12]. - The company’s financial structure reflects a common pattern in the artificial heart sector, where high upfront costs for R&D and clinical trials precede commercialization [12]. Governance Structure - The company is controlled by its founder, Chen Chen, who holds approximately 30.95% of the voting rights, significantly influencing strategic planning and technological direction [13][15]. - The shareholder structure includes long-term institutional investors, providing a supportive capital foundation for future development [15]. Conclusion - The IPO represents a transition for Tongxin Medical from domestic breakthroughs to global validation, with future success hinging on the completion of high-quality global clinical trials and the demonstration of the safety and stability of its technology [16].

Core Viewpoint - The recent approval of China's first interventional artificial heart marks a significant milestone in the domestic medical technology sector, with multiple companies actively engaged in the development of artificial heart products [3][6][15]. Group 1: Product Development and Market Dynamics - Shenzhen Core Medical Technology Co., Ltd. has received approval from the National Medical Products Administration (NMPA) for its interventional artificial heart product, which is part of a growing market with over ten companies involved in similar developments [3][15]. - The interventional artificial heart, also known as the percutaneous ventricular assist device (pVAD), is currently dominated by Abiomed's Impella, which has not yet received approval in China [5][6]. - Core Medical's previous product, the CorHeart6, has a market share exceeding 45% in the domestic market for implantable artificial hearts (LVAD) as of 2024 [6][15]. Group 2: Technical Controversies - The CorHeart6 product has faced technical disputes regarding its classification as a "fully magnetic levitation" device, with experts arguing that it only utilizes "magnetic levitation bearings," which could impact patient outcomes [7][9]. - Concerns have been raised about the safety of similar technologies, with past instances of devices using magnetic levitation bearings being withdrawn from the market due to safety issues [9]. Group 3: Market Potential and Growth - The global market for artificial hearts is projected to grow from $970 million in 2019 to $2.07 billion by 2024, with a compound annual growth rate (CAGR) of 16.4%, and is expected to reach $9.82 billion by 2033 [15][16]. - The interventional artificial heart market is anticipated to expand significantly due to a higher number of potential patients compared to implantable devices, which are limited by surgical complexity and patient eligibility [12][14]. - The number of high-risk percutaneous coronary intervention (PCI) procedures is expected to reach 221.7 million globally by 2024, with a CAGR of 12.1% from 2019 to 2024, indicating a growing demand for interventional artificial hearts [14][15]. Group 4: Industry Challenges and Future Directions - The artificial heart sector is characterized as a "slow track" due to long development cycles, complex clinical validations, and stringent regulatory requirements, making profitability challenging for companies [16]. - Experts emphasize the need for ongoing research into the hemodynamic effects of artificial hearts, as they differ significantly from natural hearts in blood flow dynamics [16]. - Future advancements in artificial heart technology are expected to focus on wireless, miniaturized, and intelligent designs to enhance patient outcomes and expand applications [16].

Core Insights - The latest interventional artificial heart product approved by the National Medical Products Administration (NMPA) comes from Shenzhen Core Medical Technology Co., Ltd. [1] - The approval marks a significant milestone in the development of domestic artificial hearts, with over a dozen companies currently engaged in this field [1][10] - Core Medical's previous artificial heart product, CorHeart6, has recently faced technical disputes regarding its classification as a "fully magnetic levitation" device [2][4] Company Overview - Core Medical's CorHeart6, a left ventricular assist device (LVAD), holds over 45% market share in China as of 2024 [2] - The company’s CorHeart6 was approved for sale in China in 2023, differing from the newly approved interventional artificial heart in terms of indications and surgical approach [5] - Core Medical is positioned in a competitive landscape with several other companies, including Tongling Bionic and Heartking Medical, also developing interventional artificial heart products [10] Industry Landscape - The global market for artificial hearts is projected to grow from $970 million in 2019 to $2.07 billion by 2024, with a compound annual growth rate (CAGR) of 16.4% [10] - The interventional artificial heart market is expected to see significant growth due to the increasing number of high-risk percutaneous coronary interventions (PCI), projected to reach 221.7 million globally by 2024 [10] - The Chinese market for artificial hearts is anticipated to exceed 11 billion RMB by 2033, driven by the approval of new products [10] Technical Disputes - Core Medical's CorHeart6 has been criticized for potentially misleading terminology regarding its technology, which could impact patient outcomes [2][4] - Concerns have been raised about the safety of devices using "magnetic levitation bearing" technology, with precedents of similar products being withdrawn from the market due to safety issues [4] Market Dynamics - The interventional artificial heart is seen as a less invasive option compared to LVADs, which require more complex surgical procedures and long-term patient management [8] - The market for interventional artificial hearts is expected to attract more companies, but the high technical barriers may limit successful commercialization [11] - Experts emphasize the need for ongoing research into the hemodynamic effects of artificial hearts, as they differ significantly from natural hearts [11]

Core Insights - The successful treatment of a child with restrictive cardiomyopathy using a "dual artificial heart implantation + heart transplant" marks a significant breakthrough in China's pediatric end-stage heart failure treatment and domestic artificial heart application [2] - This operation is the lightest successful case globally in similar surgeries, showcasing over a decade of technological accumulation and integration in China's artificial heart industry [2] Market Overview - The global ventricular assist device market is projected to reach approximately $2.2 billion in 2024 and $2.5 billion by 2025 [2] - The Chinese market, although starting later, is experiencing rapid growth, with an expected market size of 33.2 million yuan for implantable ventricular assist devices in 2024 [2] - Multiple domestic companies have received approval for market entry, and Beijing has included artificial hearts in Class A medical insurance reimbursement as of September 2024, with nationwide implementation expected by March 2025 [2] Technological Advancements - The innovative approach taken by Tianjin TEDA International Cardiovascular Hospital and Aerospace TaiXin Technology involves a second-generation magnetic levitation artificial heart, which enhances reliability by eliminating electronic systems that could fail [5][6] - The design modifications for the artificial heart to accommodate the child's small heart chamber included reducing the thickness from 25 mm to 11 mm and the overall weight to below 75 grams, representing a significant engineering breakthrough for pediatric usability [6] Unique Treatment Approach - The surgery also filled a global gap by introducing a dedicated right heart pump, allowing for a dual heart system in pediatric patients, which previously had limited options and often relied on heart transplants [7] - This transition from external dependency to fully implanted systems significantly reduces infection risks and enhances patient mobility, redefining the quality of life for patients [7]

Core Viewpoint - Shenzhen Core Medical Technology Co., Ltd. has received acceptance for its IPO application on the Sci-Tech Innovation Board, marking it as the first innovative medical device company to be accepted under the new listing standards [1][10] Group 1: Product and Market Position - The company’s flagship product, the Corheart®6, is the smallest and lightest full magnetic levitation artificial heart globally, filling a gap in pediatric heart failure treatment in China [1][10] - The market share for Corheart®6 is projected to exceed 45.9% in 2024, increasing to 52.86% in the first five months of 2025 [1][10] - Despite the potential market size for heart failure treatment, actual market penetration remains low due to high treatment costs and limited clinical awareness [4][14] Group 2: Financial Performance - The company reported revenues of 16.55 million, 93.68 million, and 70.47 million from 2023 to the first half of 2025, indicating growth but still a small overall scale [6][15] - Cumulative losses over three and a half years reached 553 million, primarily due to high R&D expenditures and significant share-based payment expenses [6][15] - Operating cash flow has been negative, relying on external financing, with net cash flow from operating activities of -108 million, -89 million, and -84 million from 2023 to the first half of 2025 [7][16] Group 3: Product Dependency and Risks - The company’s revenue is heavily reliant on the Corheart®6, with all income derived from this single product, while other products are still in development stages [2][11] - The average selling price of Corheart®6 has decreased from 290,400 yuan per unit in 2023 to 247,200 yuan in 2024, reflecting a decline of approximately 14.86% [4][13] - Customer concentration is increasing, with the top five customers accounting for 80.70% of sales by the first half of 2025, highlighting a significant dependency on major clients [4][13] Group 4: Production Capacity and Expansion Plans - The company has established a production capacity of 1,100 units annually, but actual production in the first half of 2025 was only 367 units, resulting in a capacity utilization rate of about 67% [5][14] - Despite underutilized capacity and low cumulative sales of less than 800 units, the company plans to invest 139 million in expanding its production base for artificial hearts [5][14]

Core Viewpoint - The announcement by Tongxin Medical regarding the Brio4Kids clinical trial marks a significant step towards international pediatric applications of their full magnetic levitation artificial heart, BrioVAD, indicating a shift from filling domestic gaps to competing globally in the left ventricular assist device (LVAD) market [1][6]. Group 1: Technology and Market Position - Heart failure, often referred to as the "cancer of cardiovascular diseases," affects approximately 64 million people globally, with about 8.9 million patients over 35 in China, and the incidence is on the rise [2]. - The global VAD market is currently dominated by Abbott's HeartMate 3, which has been implanted in over 40,000 cases since its launch in 2017, generating annual revenues of around $1 billion [2][3]. - Tongxin Medical has focused on full magnetic levitation technology since its establishment in 2008, achieving significant advancements with its self-developed artificial heart, the Cizhi VAD, which received approval from the National Medical Products Administration (NMPA) in November 2021 [3][4]. Group 2: Clinical Data and Performance - Clinical data from Tongxin Medical's products show a one-year and two-year survival rate of 91.3%, compared to Abbott's 86.6% and 79% respectively, highlighting the effectiveness of their technology [4]. - The company has the fewest global lead wires (4) and the thinnest diameter (3.3mm) for its percutaneous cables, resulting in a significantly lower long-term infection risk, with an infection event rate of only 0.07 per patient per year [5]. Group 3: International Expansion and Regulatory Milestones - Following the withdrawal of Medtronic's HVAD from the market, there has been a call for new competitors, leading to Tongxin Medical's FDA approval for clinical trials of BrioVAD, marking it as the first Chinese active implantable medical device to receive such approval [6][7]. - The Brio4Kids clinical trial aims to address pediatric heart failure, expanding Tongxin Medical's reach in the U.S. market and showcasing its leadership in high-end ventricular assist technology [7][8]. - The company has established a robust clinical trial framework, with 60 research centers and 800 participants enrolled, demonstrating its commitment to meeting stringent U.S. regulatory standards [7].

Core Viewpoint - The resumption of the fifth set of IPO standards on the Sci-Tech Innovation Board has led to significant developments for innovative medical device companies, with Shenzhen Core Medical Technology Co., Ltd. being the first to have its IPO application accepted under these new standards, focusing on artificial hearts [1][2]. Company Overview - Core Medical specializes in artificial hearts, reporting a revenue of 94 million yuan in 2024, which represents a growth of over 400% year-on-year, despite a net loss of 132 million yuan during the same period [1]. - The revenue surge is attributed to the successful market launch of its magnetic levitation implantable left ventricular assist device, Corheart® 6, which has generated substantial income [1][4]. Product Details - Corheart® 6 is the first commercially available third-generation magnetic levitation artificial heart, recognized for being the smallest and lightest of its kind globally, weighing only 0.8 kg, which is nearly 50% lighter than its competitor, Abbott's HeartMate 3 [3][4]. - The production cost of Corheart® 6 is approximately 70,000 yuan per unit, with a selling price of 247,200 yuan, resulting in a gross margin close to 70% [9]. Market Challenges - The high price of Corheart® 6, along with the overall surgical costs reaching up to 700,000 yuan, limits the affordability for many patients in China, posing a challenge for its commercialization [1][9]. - Core Medical faces competition not only from Abbott but also from domestic companies like Tongxin Medical and Aerospace Taiheart, which have already launched their products [6][11]. International Expansion - To expand its market, Core Medical aims to penetrate overseas markets, particularly the U.S., where it has yet to initiate clinical trials for Corheart® 6, although it has received approvals in Colombia and Ukraine [6][7]. - The company has other products, such as DuoCor® 2 and CorVad® 4.0/6.0, which are expected to gain approval in the U.S. by 2030, indicating a longer timeline for revenue realization [7]. Industry Landscape - The global heart failure market is projected to grow, with the number of heart failure patients expected to rise from 62.98 million in 2024 to 71.51 million by 2033, presenting a significant opportunity for artificial heart technologies [11]. - However, the emergence of alternative therapies, such as minimally invasive atrial shunt devices, poses additional competition for artificial heart products [11].

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]

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].