Major Milestone: Zhenyi Medical's NeoNova® Transcatheter Mitral Valve Edge-to-Edge Repair System Receives NMPA Approval
Trulive
Structural Heart Disease Device Developer
Recently, Trulive's wholly-owned subsidiary Hangzhou Duanyou Medical Technology Co., Ltd.NeoNova® Transcatheter Mitral Valve Clip System Approved for Marketing by the National Medical Products Administration (NMPA) (Registration Certificate No. 20253130304)! This product is the first domestically-produced innovative product in China to clinically achieve the ability of delivering two valves through a single sheath and has received support from a national key special project. Its key core technologies have all been independently developed by the company, which owns full independent intellectual property rights. It further breaks the monopoly of imported products in the field of valve intervention and provides a safer, more effective, and accessible Chinese solution for mitral regurgitation patients worldwide.
Mitral regurgitation is the most common heart valve disease. In China, the number of patients with moderate to severe mitral regurgitation exceeds 10 million, and this figure continues to grow as the population ages. Despite the large number of patients, the penetration rate of surgical treatment in China is less than 1%, characterized by a high incidence rate, low awareness, and low treatment rate.The interventional technology of edge-to-edge repair, as the only technique currently validated globally for its safety and efficacy through large-scale, long-term clinical trials., which has been highly regarded in the field of mitral valve treatment. As an emerging minimally invasive interventional technique, transcatheter mitral valve edge-to-edge repair has brought revolutionary changes to the treatment of mitral regurgitation and offered hope to patients worldwide with moderate to severe mitral regurgitation as well as those at high surgical risk or with contraindications.
NeoNova® Transcatheter Mitral Valve Clip System is a valve repair product independently developed by Trulive. The product not onlyCan be used for mitral valve repair as well as tricuspid valve repair treatment., which is currently the first product in China to achieve the ability of "one sheath, two valves."OwnExcellent guidewire control and bending ability with outstanding instrument stability and maneuverability.`, and Trulive continues to tackle key processes, products`The entire life cycle is completed by local enterprises., with advantages in performance and price, will break the monopoly of overseas products in terms of technology and cost, promote the high-quality development of domestically produced high-end medical devices, and allow more doctors and patients to benefit from domestically produced high-end interventional medical devices.
Currently, the NeoNova® system has treated hundreds of patients with mitral regurgitation in China, earning high recognition and praise from authoritative experts in the field. Following its recent approval for marketing, the product will leverage its strong advantages and promising future to carry out broader, continuous, and in-depth clinical applications across China, while accelerating its internationalization process to gradually promote the global clinical application of the product. A higher stage, a brand-new journey — in the future, Trulive will always carry the vision of becoming a "world-class medical innovation enterprise," continuously launching more advanced and higher-quality products and solutions, contributing Chinese strength to global healthcare development and human health.
From product concept to successful implementation, the NeoNova® system has been a labor of love for the team. As China's first valve repair product capable of achieving dual-valve functionality with a single sheath, NeoNova® boasts exceptional bending control, precise transmission, and accurate positioning capabilities. These features further shorten the learning curve for operators, enhancing both the safety and effectiveness of procedures, and providing significant support in treating mitral valve diseases. This will allow more patients suffering from mitral valve disease to regain their health. The successful NMPA approval and market launch of the product marks a solid step forward in the company’s development within the cardiovascular disease field. It also strengthens the team’s resolve to continue exploring unknown areas of cardiovascular care. In the future, we will remain on the path of innovation, developing more high-quality, innovative products made in China, and offering safer and superior innovative solutions to patients with valvular diseases and clinical practitioners.
Trulive Chief Technology Officer
Wei Yongqiang
Trulive adheres to the development philosophy of "Striving for perfection, bearing the weight of billions," and has consistently focused on the field of cardiovascular diseases, which have extremely high mortality and disability rates, and where the domestic market remains a blank slate. After years of continuous effort, our product portfolio has flourished in multiple areas, overcoming several "bottleneck" challenges. Our proprietary technology has achieved multiple "firsts in China" and "only in China" milestones. Clinically, several products have entered the harvest phase and received widespread acclaim from authoritative experts, doctors, and patients.
This time, the NeoNova® system is the first marketed product of Trulive's high-end interventional medical devices for structural heart disease, and it is also one of the first domestically produced mitral valve edge-to-edge repair systems in China. This product is highly significant for both the company and the industry’s development. The product's market launch will enhance the company’s standing in medical technology and the capital markets. In the future, we will leverage the product’s first-mover advantage to accelerate the company’s commercialization process, achieve rapid growth in performance and a continuous increase in market share, ensure the company smoothly transitions through its development cycle, and promote high-quality and sustainable development.
Trulive Chairman
Wen Jing
-End-
Trulive
Jiangsu Trulive Medtech Co., Ltd. focuses on the field of cardiovascular diseases, which have extremely high mortality and disability rates and remain a gap in the domestically produced market. Its business comprehensively covers multiple interventional treatment areas such as heart valves, peripherals, and coronary arteries. It is a platform enterprise that takes the lead in providing a one-stop innovative solution for blood flow management on a global scale. With strong research and development capabilities and an experienced, complete operational team, Trulive Medtech has developed high-quality domestically produced medical devices with independent intellectual property rights and comprehensive solutions, filling the gap in China’s high-end cardiovascular interventional medical device market. This provides more advanced and diverse treatment options for Chinese doctors and patients. Meanwhile, Trulive Medtech, rooted in China while strategically expanding globally, continues to upgrade with technological innovation and development. The company accelerates the expansion of its global commercial network, offering "Chinese solutions" and contributing "Chinese wisdom" in many细分 markets within the cardiovascular intervention field that have long been monopolized by imported products.
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