Shengde Medical Secures Tens of Millions in Pre-B Funding to Advance AI-Driven Innovative Solutions for Heart Valve Disease

Recently, 36Kr learned that NanjingSaint MedicalNanjing Saint Medical Technology Co., Ltd. ("Saint Medical" for short) announced that it has completed a Pre-B round of financing worth tens of millions of yuan, led by Nanjing Jinpu Consumption Intelligent Construction Equity Investment Fund Partnership (L.P.), with Wuxi Capital Group Co., Ltd. participating in the investment. This round of financing will accelerate the nationwide implementation of the company’s industrial closed loop in digital healthcare, innovative devices, and medical services within the structural heart disease field, promoting the development and expansion of minimally invasive cardiovascular surgeries in China. In July this year, the company announced the completion of a nearly 100-million-yuan Series A round of financing.

From 2021 to 2022, the sharp cooling of investment in healthcare, particularly in innovative drugs and innovative medical devices, became a widespread phenomenon. Clinical value and operability have become the sole "gold standard" for venture capital firms investing in medical devices. Amid such a financing winter, Saint Medical's ability to raise funds against the trend highlights its innovation and competitiveness in the structural heart disease market—a sector with a very high growth ceiling and extremely low current penetration.

Currently,The core product of Saint Medical, the innovative structurally conforming transcatheter aortic valve system (Xcor), along with the structural heart disease auxiliary decision-making system (Tavigator CDSS) developed by Toweimoxin Data Technology under Saint Medical, have successively entered the clinical stage. Currently in the animal testing and product testing stages are also the sutureless expandable bioprosthetic valve system (Alive), the transcatheter mitral/tricuspid valve replacement system (Neocor), and the automatically deployable balloon-expandable interventional valve system (Infinicor)., and so on. All of the above products are independently developed by the R&D teams in both China and Germany, which is different from the traditional License-in model of Sino-foreign cooperation.Saint Medical and Topomimic Heart Company own complete intellectual property rights for all products globally.

Saint Medical focuses on the field of valvular disease, a major cardiovascular condition in an aging society and one of the largest global cardiovascular markets. In 2019, there were approximately 210 million patients with valvular heart disease globally, resulting in about 2.6 million deaths; it is estimated that China has 36.3 million patients, expected to increase to 40.2 million by 2025, representing a vast patient population. Compared to the global landscape, China’s valvular disease sector, despite over a decade of development, remains in its early stages, with the penetration rate of TAVR (Transcatheter Aortic Valve Replacement) in China being less than 1%.

According to data from the National Center for Cardiovascular Diseases, among the fewer than 100,000 valve replacement surgeries performed annually in China, surgical procedures—especially mechanical valve implantations—dominate. For example, in aortic valve treatment, the first transcatheter aortic valve replacement (TAVR) was performed in China in 2010, and the first TAVR medical device certification was issued in 2017. However, in 2020, all hospitals in China combined conducted only 3,645 TAVR procedures; in 2021, approximately 6,500 cases were performed; and in 2022, third-party estimates predicted around 7,000 to 8,000 cases. The overall clinical penetration rate remains below 1%, with fewer than 100 clinical teams capable of independently performing TAVR procedures.

Saint Medical's transcatheter aortic valve product, Xcor, innovatively introduces a support arm technology that achieves structural alignment, allowing the valve to be released simply and accurately at the aortic annulus position. It features low operational difficulty and self-centering adjustment capability, offering superior results compared to radial force anchoring methods. Its indications cover both simple stenotic lesions and regurgitation lesions. Moreover, all self-expanding interventional valves currently on the market release the left ventricular end first, followed by the ascending aorta end, which requires lengthy preparation, involves complex operations, and is prone to slippage. In contrast, Xcor proposes a unique staged, retrievable, top-down release mechanism, providing stable hemodynamic properties and precise placement, avoiding the risk of valve displacement under blood flow impact, and significantly reducing procedural difficulty and operational risks.As of October 2022, the Xcor valve has completed all feasibility clinical trials at hospitals such as West China Hospital of Sichuan University, Beijing Anzhen Hospital affiliated to Capital Medical University, and the Second Xiangya Hospital of Central South University. Formal clinical trials are currently being conducted across more than 12 centers.

Tavigator CDSS, a surgical analysis and decision-support software for valve diseases based on CT imaging co-developed by Top Medical Data Technology and Professor Wu Yongjian's team from Fuwai Hospital, Chinese Academy of Medical Sciences, has achieved fully automatic multi-target segmentation of the aortic root structure. Based on the segmentation results, it performs 3D reconstruction and uses algorithms to automatically locate the aortic sinus base, determine the virtual aortic annulus plane, identify the patient’s native aortic valve leaflet type, automatically extract centerlines and determine other key planes, automatically detect coronary ostia, and automatically identify calcified tissues. Building on these functions, the software further enables fully automated calculation and analysis of key anatomical plane parameters, calcium volume, aortic angulation, optimal angiographic projection angles, and other critical features. To date, Tavigator CDSS has been applied in scientific research collaborations at several top medical centers, including Fuwai Hospital of the Chinese Academy of Medical Sciences, Beijing Anzhen Hospital, West China Hospital of Sichuan University, and Xijing Hospital of Air Force Medical University.

Currently, the company has a team of more than 90 people, with the R&D team accounting for 50%. Dr. Ma Chenming, the founder, graduated from Peking University Health Science Center and has worked at the Berlin Heart Center, German Heart Center, and Technical University of Munich. He has performed hundreds of interventional/surgical valve operations both in China and internationally and has a deep understanding of almost all clinical and R&D aspects of heart diseases. The core team also includes clinical experts from top-tier tertiary hospitals, senior artificial intelligence algorithm & product managers, and medical device registration regulation experts.