Recently, the first batch of patient implantations in the U.S. Food and Drug Administration (FDA)-approved TRINITY pivotal trial of the Company's independently developed LuX-Valve Plus Transcatheter Tricuspid Valve Replacement (TTVR) System were successfully completed. This achievement marks a significant breakthrough in the product's U.S. pivotal trial and represents another important milestone in advancing the Group's internationalization strategy, following the recent CE certification of LuX-Valve Plus under the EU Medical Device Regulation (MDR).

LuX-Valve Plus is the world’s first TTVR system that has obtained EU MDR CE certification and received FDA approval for a head-to-head randomized controlled trial against the EVOQUE system. The U.S. pivotal trial of LuX-Valve Plus is a prospective, global, multicenter, randomized controlled clinical trial conducted across the United States, Canada, and multiple European countries. The trial is primarily designed to evaluate the safety and effectiveness of LuX-Valve Plus in treating patients with severe tricuspid regurgitation.

LuX-Valve Plus has demonstrated favorable safety and effectiveness in clinical trials conducted in China, Europe, and other regions, as well as in its U.S. Early Feasibility Study (EFS). The clinical data have further validated the product’s design concept and technological advantages. Based on its innovative design and excellent clinical performance, LuX-Valve Plus’s U.S. pivotal trial has received active participation and support from dozens of clinical centers across multiple countries. The company will continue to advance the clinical trial process efficiently.

LuX-Valve Plus is innovatively designed to address the unmet clinical needs for patients with severe tricuspid regurgitation. The system adopts a transvascular access approach, further minimizing damage to cardiac tissue. Its radial-force independent septal anchoring design facilitates postoperative right heart remodeling and substantially mitigates the risk of pacemaker implantation. The self-adaptive fabric skirt reduces postoperative paravalvular leakage. The multi-dimensionally steerable delivery system enables precise valve deployment during procedures. Offered in seven sizes ranging from 40 mm to 70 mm, it addresses a wide range of unmet clinical needs for tricuspid regurgitation treatment.

With its innovative technologies and clinical value, the LuX-Valve product series have been selected for the European Expert Panel Scientific Advice Pilot, received FDA Breakthrough Device Designation, admitted to the FDA Total Product Life Cycle Advisory Program, and entered the NMPA Special Review Procedure for Innovative Medical Devices.

Currently, the LuX-Valve product series have been successfully implanted in more than 1,000 patients worldwide, addressing significant unmet clinical needs, particularly for patients with complex tricuspid valve anatomy who previously had limited treatment options. Jenscare is committed to advancing this innovative Chinese technology to benefit more patients worldwide with severe tricuspid regurgitation and to contributing to the advancement of interventional treatment for structural heart disease globally.

Dr. Azeem Latib, Montefiore Hospital, said:

“Performing the first case in the TRINITY U.S. pivotal trial is an exciting milestone for our team at Montefiore. The LuX-Valve Plus expands treatment to patients who previously had limited options because of a large annulus or poor imaging. Dr. Edwin Ho and I believe the procedure is straightforward to learn and can be performed consistently across patients. We look forward to enrolling more patients and bringing this innovative therapy to those who need it.”

Mr. Eric Pan, Executive Director and Chief Executive Officer of Jenscare Group, said:

“I am delighted to announce the successful first batch of patient implantation of LuX-Valve Plus in our U.S. pivotal clinical trial. This milestone progress in the trial represents another major breakthrough in Jenscare’s global development strategy. Moving forward, we will keep collaborating closely with top clinicians and partners worldwide, striving to deliver this domestically developed Chinese medical innovation to patients suffering from tricuspid regurgitation across the globe and improve their quality of life.”

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