Core Viewpoint - The approval of the TaurusTrio transcatheter aortic valve (TAV) system by the National Medical Products Administration of China represents a significant advancement in treatment options for patients with severe aortic regurgitation (AR) [1][2] Group 1: Product Development and Approval - The TaurusTrio TAV system received approval on December 11, 2025, for its registration application [1] - The system is developed and manufactured by the company based on an exclusive license obtained from JenaValve Technology, Inc. for the Trilogy transcatheter heart valve (THV) system [1] - The TaurusTrio TAV system is specifically designed for treating patients with severe AR via the femoral artery approach, addressing a significant clinical need due to limited treatment options for AR patients [1] Group 2: Clinical Background and Market Potential - The Trilogy THV system, which serves as the basis for the TaurusTrio, received CE mark certification in May 2021 and has been used in over 1,000 commercial surgeries in real-world clinical practice as of the announcement date [2] - The company anticipates that the successful launch of the TaurusTrio TAV system in China will provide a safe and effective treatment option for patients suffering from severe AR, fulfilling a major unmet clinical demand [2]

Core Viewpoint - The company has received approval from the National Medical Products Administration of the People's Republic of China for the registration application of the TaurusTrio™ Transcatheter Aortic Valve (TAV) system, which is designed to treat patients with severe aortic regurgitation (AR) [1] Group 1: Product Development and Approval - The TaurusTrio™ TAV system is developed and manufactured based on an exclusive license from JenaValve Technology, Inc. for the Trilogy™ Transcatheter Heart Valve (THV) system [1] - The system is specifically designed for treating patients with severe aortic regurgitation via the transfemoral approach, addressing a significant unmet clinical need [1] Group 2: Technical Features - Unlike patients with aortic stenosis, AR patients typically lack calcified tissue for TAV anchoring, which limits treatment options [1] - The system utilizes proprietary positioning key technology to achieve stable anchoring even in the absence of calcified tissue, ensuring proper alignment of the valve [1] Group 3: Market Potential - The Trilogy™ THV system received CE mark certification in May 2021 and has been used in over 1,000 commercial procedures in real-world clinical practice as of the announcement date [1] - The company anticipates that the successful launch of the TaurusTrio™ TAV system in China will provide a safe and effective treatment option for patients with severe AR [1]