SUZHOU, China, Jan. 29, 2024 /PRNewswire/ — Peijia Medical Limited (Peijia, (9996.HK)), a leading Chinese domestic player in the high-growth transcatheter valve therapeutic and neurointerventional procedural medical device markets, today announced the completion of patient enrollment and implantation of the TaurusTrioTM Transcatheter Aortic Valve Replacement (TAVR) system clinical trial. TaurusTrioTM is a part of the licensed-in TrilogyTM Heart Valve System for Aortic Regurgitation (AR) from JenaValve Technology, Inc.
The multi-center trial utilized the TaurusTrioTM TAVR system to treat pure AR in 116 patients across 13 hospitals within China and is designed to assess the safety and efficacy of the TAVR system in treating patients with native symptomatic, severe AR, who were deemed to be at high or greater risk for surgical aortic valve replacement. Results of the clinical trial will be included Peijia’s future submission of registration application to the National Medical Products Administration (NMPA).
In January 2022, Peijia and JenaValve entered into a technology licensing agreement wherein Peijia obtained the exclusive rights to develop and commercialize the TrilogyTM Heart Valve System in the Greater China region under the TaurusTrioTM brand.
“We are very pleased to have completed patient enrollment in the trial sooner than anticipated, having performed all implantations within approximately six months of the first procedure in July,” said Dr. Michael Zhang, Chairman and Chief Executive Officer of Peijia Medical. “There is a substantial clinical need for a pure AR solution in China, and as our partnership with JenaValve evolves we look forward to providing even more patients the opportunity to access innovative technology and superior care.”
Dr. Michael Zhang continued, “Following the exceptional results of the Trilogy ALIGN-AR Pivotal Trial as presented by JenaValve in a Late-Breaking Clinical Trial presentation at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium, we remain encouraged about the trial design here in China. The TaurusTrioTM TAVR system represents a significant commercial opportunity for Peijia’s structural heart division, and we are eager to announce the results of this domestic trial as a part of our mission to improve patient care and outcomes across China.”
“We are excited to see the TaurusTrioTM trial advance, bringing Peijia and JenaValve one step closer to our shared goal of delivering innovative TAVR technology to potentially millions of patients in China,” said John Kilcoyne, Chief Executive Officer of JenaValve. Congratulations to the Peijia team. The pace of enrollment in this trial was exceptional and outstanding news for all those suffering from aortic regurgitation.”
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 two generations of TAVR systems and fifteen neurointerventional devices commercialized in China and various innovative product candidates at different stages of development. For more information about Peijia visit peijiamedical.com/about.