Peijia to maintain exclusive rights in Greater China to commercialize JenaValve's Trilogy Transcatheter Heart Valve (THV) System

SUZHOU, China, July 25, 2024 /PRNewswire/ -- Peijia Medical Limited (Peijia, (9996.HK)), a leading Chinese domestic player in the high-growth transcatheter valve therapeutics and neurovascular interventions markets, today commented on the expected acquisition of JenaValve Technology, Inc. ("JenaValve"), an exclusive technology licensing partner of Peijia, by Edwards Lifesciences ("Edwards").

On July 24, 2024, Edwards announced that it had entered into an agreement to acquire JenaValve, a pioneer in the transcatheter treatment of aortic regurgitation (AR), a deadly disease that impacts a significant and growing population and is currently untreated today. JenaValve presented positive results of its U.S. pivotal trial for the treatment of symptomatic, severe AR in high-risk patients late last year. Edwards will accelerate development of this novel technology with the goal to enable earlier patient access. Edwards anticipates U.S. Food and Drug Administration (FDA) approval of the JenaValve Trilogy Heart Valve System in late 2025, which will represent the first approved therapy for patients suffering from AR.

In late 2021, Peijia and JenaValve entered into a collaboration and license agreement wherein Peijia obtained the exclusive rights to develop, manufacture and commercialize the Trilogy THV System for AR and Aortic Stenosis (AS) in Greater China. Peijia also became a minority shareholder of JenaValve. Subsequently, Peijia elected to re-brand the technology to be TaurusTrio and carried out a pivotal clinical trial for severe AR in China. The patient enrollment of the trial was successfully completed in January 2024.

"Peijia would like to congratulate the teams at both JenaValve and Edwards on this announcement," said Dr. Michael Zhang, Chairman and Chief Executive Officer of Peijia Medical. "We became a proud partner of JenaValve to develop an improved AR treatment before the groundbreaking TCT announcement of the ALIGN-AR trial results. The evidence of ALIGN-AR not only demonstrated to the medical community that an AR TAVR could be available soon, but also greatly strengthened the awareness toward AR among doctors. The world-leading TAVR player, Edwards, acquiring JenaValve endorses the future prospect of the technology, and we believe this will accelerate the development of AR TAVR globally."

As a result of the proposed acquisition, Peijia will maintain the exclusive license for the JenaValve Trilogy THV System in Greater China. Peijia also maintains the right to further develop its AR pipeline and products on the basis of JenaValve's IP independently in Greater China.

Dr Zhang continued, "With continued access to JenaValve's Trilogy THV System, Peijia is proud to be at the forefront of the Chinese market, where we are meeting a substantial clinical need for a complete transcatheter valve therapeutics pipeline. Our product portfolio covers all major replacement and repair systems across the spectrum of regurgitation and stenosis conditions. We will continue to see growth opportunities within TAVR while providing patients and physicians access to innovative technologies and superior care throughout China."

About Peijia

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 sixteen neurointerventional devices commercialized in China and various innovative product candidates at different stages of development. For more information about Peijia visit peijiamedical.com/about.