BEIJING, Sept. 1, 2025 /PRNewswire/ — Jenscare Scientific Co., Ltd. (“Jenscare” or the “Company”) (HKEX: 9877), an innovative medical device company with TTVR breakthroughs, achieved milestones in its product portfolio globally, and just released its interim results for 2025H1 ended June 30, 2025.
Business Overviews:
In 2025H1, significant progress was achieved across its product pipeline in the interventional treatment for tricuspid, aortic and mitral valve diseases, establishing a diversified and high-potential product portfolio. More importantly, the Company continued to expand its global business layout, enhancing product influence and clinical application scale, thereby laying a solid foundation for sustainable high-speed growth.
The global registration and clinical progress of LuX-Valve Plus TTVR system achieves key milestones in China, Europe, and U.S.
In China, the multicenter registration clinical trial of LuX-Valve Plus is in the long-term follow-up phase and shows excellent clinical results. Randomized controlled trial (RCT) of optimized medical therapy (OMT) conducted in China has completed subject enrollment. The application for NMPA registration has been submitted and accepted, entering registration review stage. The Company is actively advancing the NMPA registration process of LuX-Valve Plus and strives to obtain the NMPA registration certificate soon.
In Europe, LuX-Valve Plus has completed 6-month follow-up of the global multicenter clinical trial TRINITY Study for CE Marking and is currently under registration review. The 30-day clinical follow-up results of TRINITY Study were officially released at EuroPCR 2025, indicating favorable clinical results. The 30-day clinical follow-up results in large annulus patients in the TRNITY Study were released at New York Valves 2025. The results showed that both groups of patients (large annulus patients and small annulus patients) demonstrated outstanding outcomes. The wide range of application of LuX-Valve Plus provides an excellent treatment option, particularly for patients of annular dilation with severe TR. The 6-month follow-up outcome of TRINITY Study is expected to be released at TCT 2025.
In the United States, LuX-Valve Plus was selected to participate in the FDA’s Total Product Life Cycle Advisory Program (TAP) pilot. Its FDA IDE early feasibility study (EFS) has completed subject enrollment and has received reimbursement for device and related costs from CMS. The Company is actively advancing the progress to obtain approval for the Pivotal Study.
The commercialization of Ken-Valve TAVR system is advancing rapidly, with continuous growth in both hospital coverage and implantations
Ken-Valve has quickly gained market access after its approval by NMPA in 2025H1. The Company …