PEIJIA-B (09996) announced that on December 11, 2025, the company received approval from China's National Medical Products Administration (NMPA) for the registration application of its TaurusTrio™ Transcatheter Aortic Valve (TAV) system. This follows the company's earlier announcement dated January 14, 2022.
The TaurusTrio™ TAV system was developed and manufactured by PEIJIA-B under an exclusive license agreement with JenaValve Technology, Inc. (JenaValve), based on its Trilogy™ Transcatheter Heart Valve (THV) system. Designed specifically for trans-femoral treatment of patients with severe native aortic regurgitation (AR), the system addresses a critical unmet clinical need. Unlike aortic stenosis patients, AR patients often lack calcified tissue for TAV anchoring, limiting their treatment options.
The system incorporates proprietary locator key technology, enabling secure anchoring by attaching to native valve leaflets—even in the absence of calcified tissue—while ensuring proper commissural alignment. JenaValve's Trilogy™ THV system received CE mark approval in May 2021 and, as of the announcement date, has been used in over 1,000 commercial procedures in real-world clinical practice.
PEIJIA-B anticipates the successful launch of the TaurusTrio™ TAV system in China, which is expected to provide a safe and effective treatment option for severe AR patients, fulfilling a significant unmet medical demand.