07:30 ET Peijia Medical Receives NMPA Approval for TaurusTrio Transcatheter Aortic Valve System, Pioneering Treatment for Aortic Regurgitation in China

, /PRNewswire/ -- Peijia Medical (9996.HK), a leading Chinese domestic company in the high-growth transcatheter valve therapeutics and neurovascular interventions markets, announced that its TaurusTrio Transcatheter Aortic Valve (TAV) system received approval from the National Medical Products Administration (NMPA) of China on December 11, 2025. The TaurusTrio TAV system is developed and manufactured by Peijia Medical under an exclusive license from JenaValve Technology, Inc. (JenaValve) for its Trilogy Transcatheter Heart Valve (THV) System. It is designed to treat patients with native symptomatic severe aortic regurgitation (AR) via transfemoral access. Unlike in patients with aortic stenosis, in patients with AR, there is often no calcification for the TAV to anchor onto, leaving AR patients with limited treatment options. The TaurusTrio system incorporates JenaValve's proprietary locator technology, which enables stable anchoring by engaging the native aortic leaflets even in the absence of calcium, while ensuring commissural alignment. The one-year clinical results from the TaurusTrio ALTER-AR study demonstrated a technical success rate of 99.1%, with 0% all-cause mortality at 30 days and only 2.6% at one year. Patients showed significant cardiac function improvement, with 91.7% recovering to NYHA class I/II at six months. The incidence of moderate or greater paravalvular leak was 0% at one year, and indicators such as LVEDV and LVM showed significant reverse remodeling, validating the device's long-term safety and efficacy. "Historically, many patients with severe, pure AR who are ineligible for surgery have lacked an ideal interventional treatment—leaving a significant unmet clinical need," said Dr. Yi Zhang, Chairman and CEO of Peijia Medical. "By proactively introducing JenaValve's unique locator technology, we directly tackled the core challenge of 'unstable anchoring'. This gives physicians a vital new tool and finally offers patients a dedicated, long-awaited solution, moving AR treatment decisively into a new phase. The approval also exemplifies our strategy to commercialize cutting-edge technologies and build a local innovation ecosystem, reflecting the deep integration of global expertise and Chinese execution." John Kilcoyne, CEO of JenaValve, commented: "It is a great pleasure to witness the NMPA approval of TaurusTrio, which validates the extraordinary effort invested over the years to introduce this system to China. As the leading transcatheter valve for AR, TaurusTrio provides new hope to millions of patients who previously had few viable options. This achievement reaffirms our shared goal with Peijia Medical: to ensure that patients with AR, a long-underserved community, finally receive the treatment they need and deserve. On behalf of the entire JenaValve team, I would like to extend our sincere appreciation to the Peijia China team. Together, let us continue to advance our shared mission of improving patients' lives." JenaValve's Trilogy THV System received CE Mark approval in May 2021 and has been used in over 1,000 commercial procedures. Results from an expanded cohort of 700 patients from the ALIGN-AR pivotal trial for the Trilogy THV System in high-risk patients with symptomatic, severe AR were published in The Lancet and presented at PCR London Valves last month. The approval of TaurusTrio is a major milestone for Peijia Medical, reflecting its dedication to structural heart disease innovation, respect for intellectual property, and commitment to addressing clinical needs. This achievement also signifies a key technological breakthrough in China's interventional treatment landscape. As a dedicated device for AR, TaurusTrio offers patients the prospect of longer survival and a better quality of life. With its wider clinical adoption, AR care in China will enter an era of precision, minimally invasive therapy—strengthening patient protection and exemplifying a collaborative model for domestic medical device innovation. About the Company Peijia Medical (9996.HK) was established in 2012 and is headquartered in Suzhou, China. Peijia Medical focuses on the high-growth interventional procedural medical device market in China and aims to become a world-renowned medical device platform that provides comprehensive treatment solutions for structural heart and neurovascular diseases. The Company now has four TAVR systems and near twenty neurointerventional devices registered in China and various innovative product candidates at different stage of development. For more information about Peijia visit peijiamedical.com/about. SOURCE Peijia Medical