No interventional mitral valve or tricuspid valve products have been approved in China so far. Xinyi Medical has entered this untapped market with its "one valve, two positions, four applications" technology and completed its angel round of financing.
Xinyi Medical has completed its angel round of financing, focusing on interventional mitral/tricuspid valve replacement and tissue repair materials
A new player has joined the structural heart disease interventional device track; investors of this round are Qingyun Chuangtu and Rushan Capital, with the financing amount undisclosed.
Xinyi Medical (Xinyi Medical Technology (Shaoxing) Co., Ltd.), an R&D enterprise of interventional devices for structural heart diseases, completed its angel round of financing in March 2026, with investors being Qingyun Chuangtu and Rushan Capital, and the financing amount has not been disclosed temporarily. The company's core interventional mitral valve product has completed registration inspection and animal experiments, and clinical trials are being advanced.
I. Focus on interventional devices for structural heart diseases, core products enter the clinical stage
Xinyi Medical is an enterprise focusing on the R&D and production of structural heart disease and cardiovascular interventional devices. Its main business entity was established in 2021 (formerly Xinyi Medical Technology (Beijing) Co., Ltd.), completed the industrial and commercial registration of the Shaoxing entity in December 2025. Its headquarters and production base are located in Zhuji, Shaoxing, Zhejiang, and the R&D center is located in Beijing.
The company's core products are interventional mitral/tricuspid valve replacement devices and tissue repair materials. According to the company, its core products take the lead in adopting the interventional mitral/tricuspid valve technology of "dry preloading + multi-path integration": the dry treatment is designed to reduce toxic residues and calcification of valve materials, and improve the service life of implanted valves; valve preloading can simplify preoperative preparation and reduce costs; one product can cover both mitral and tricuspid valve positions, and is compatible with two surgical paths of transapical and transfemoral, namely "one valve for two positions and four uses", which expands the product's indications and clinical application scenarios.
II. The mitral and tricuspid valve replacement market has broad space, and domestic products are still in the early stage
According to the epidemiological research data of Frost & Sullivan, Soochow Securities and Fuwai Hospital cited in Xinyi Medical's business plan, the population base of mitral and tricuspid valve diseases is huge, with tens of millions of domestic patients every year, and the potential market size reaches tens of billions of yuan.
In terms of industry progress, on the international market, Edwards' interventional tricuspid valve product Evoque was approved by the FDA in December 2023, Abbott's Tendyne and Edwards' SAPIEN M3 were approved by the FDA in May and December 2025 respectively; according to the disclosure of the company's business plan, no interventional mitral/tricuspid valve product has been approved in China so far, and most domestic enterprises are in the stage of clinical trials or early R&D. According to the company, its transfemoral interventional mitral valve project is in the first echelon in China.
III. Senior team and solid R&D accumulation
Jin Chang, founder and general manager, is a doctor of biomedical engineering from Beihang University, postdoctoral fellow of basic medicine in Chinese PLA General Hospital, and associate researcher. He has 20 years of experience in R&D and project management of Class III medical devices, and nearly 15 years of experience in R&D of valve-related products, and has led the whole process development of 3 valve products from design to certification. The core team also includes: Chen Jie (Head of Marketing and Clinical Affairs, master of Beijing Normal University, with nearly 20 years of clinical marketing experience), Wang Yufei (Head of Quality and Operation, with 25 years of experience in production quality management of drugs and medical devices), Li Ke (Head of R&D, master of University of Science and Technology Beijing, with nearly 15 years of experience in material and interventional device development).
The company has been rated as National High-tech Enterprise, Zhongguancun High-tech Enterprise, Innovative Small and Medium-sized Enterprise, and Sci-tech Small and Medium-sized Enterprise; according to the company's disclosure, as of the compilation of the business plan, a total of 23 patents have been applied for, and 9 have been authorized (including 5 invention patents, 3 utility model patents and 1 design patent).
IV. Product pipeline and commercialization pace
According to the product commercialization schedule disclosed by the company: the valve sizer (Class I) for aortic repair is planned to obtain certification in 2025; a series of lead management products such as mechanical sheath, locking wire and snare are planned to obtain certification in 2027; the transapical interventional mitral valve and biological patch are planned to obtain certification in 2029; the transfemoral interventional mitral valve is planned to obtain certification in 2030; the interventional tricuspid valve is planned to obtain certification in 2031; the expandable sutureless aortic valve and interventional aortic repair material are planned to obtain certification in 2032. The company plans to promote R&D certification and product sales in stages, and gradually build a product platform covering "valve + material + catheter" products.
Interventional devices for structural heart diseases are one of the tracks that have attracted high attention in the medical device field in recent years. Domestic interventional mitral/tricuspid valve products are still in the initial stage on the whole. Xinyi Medical enters this market with the technology of "dry preloading + multi-path integration", and its clinical progress and certification pace are worthy of continuous attention.