据第三方机构数据统计，中国三尖瓣返流患者人数由2016年的860万人增加至2020年的920万人，且预期于2030年将增加至1060万人。由于三尖瓣关闭在早期不具有容易被筛查到的临床表现，患者通常到病变中晚期才会被检出，因此三尖瓣返流患者总数可能被低估。针对三尖瓣反流，「健世科技」原创的经导管三尖瓣置换系统LuX-Valve预计近期将完成全部注册临床试验入组，有望成为国际第一款获批用于治疗三尖瓣返流的介入人工瓣膜。Minimally invasive intervention of structural heart disease is the golden track in the field of cardiovascular disease.
It is reported that Jianshi Technology has recently completed a new round of financing of hundreds of millions of dollars. This round of financing is led by Hillhouse Venture Capital and Chunhua Capital. The funds raised will be used for multicenter clinical trials, new product pipeline development and capacity expansion.
Founded in 2011, Jianshi Technology is a high-tech medical device company specializing in the field of structural heart disease. At present, the company's products mainly include transcatheter tricuspid valve replacement and repair, aortic valve replacement, mitral valve replacement and repair and heart failure products.
According to statistics from third-party agencies, the number of tricuspid regurgitation patients in China increased from 8.6 million in 2016 to 9.2 million in 2020, and is expected to increase to 10.6 million in 2030. Because tricuspid valve closure does not have easily screened clinical manifestations in the early stage, patients are usually not detected until the middle and late stages of the disease, so the total number of patients with tricuspid regurgitation may be underestimated. For tricuspid regurgitation, the original transcatheter tricuspid valve replacement system LuX-Valve of Jianshi Technology is expected to complete all registered clinical trials in the near future, and is expected to become the first interventional artificial valve approved for the treatment of tricuspid regurgitation in the world.
In addition, for minimally invasive interventional therapy of cardiac valvular disease, Jianshi Technology's product system also includes: China's second product for the treatment of severe aortic regurgitation, transcatheter aortic valve replacement system Ken-Valve, which can be used specifically for aortic valve regurgitation (or with stenosis). It was used clinically in 2019 and has entered the stage of pre-market registered clinical research. Transcatheter interventional valvular clamp (edge-to-edge) repair system JensClip, which has the first core transmission and locking structure design in the world, and meets the treatment needs of mitral and tricuspid regurgitation. Long-term animal experiments have been completed, and the safety, effectiveness and maneuverability of the product have been preliminarily verified.
In addition, transcatheter mitral valve repair system MitraPatch and atrial septal stent system MicroFlux are currently preparing for feasibility clinical trials.
With regard to the development plan, Jianshi Technology is expected to complete the layout of the structural heart track product line in the next three years, and gradually push it into clinical practice. The tricuspid valve of Jianshi Technology is expected to be commercialized in 2023, four products will be launched in 2024, and three new products will be launched in 2025 and 2026 respectively.
Zheng Jiaqi, managing director of Fang Chunhua Capital, said: minimally invasive intervention technology for structural heart disease has great potential and is a golden track in the cardiovascular field. Jianshi Technology, as the leading platform enterprise with complete solution of valvular interventional therapy in China, has a number of international pioneering technologies and is making smooth clinical progress.
Editor: Tang Yuting
