JenaValve Enters Licensing Agreement With Peijia Medical in China

January 18, 2022—JenaValve Technology, Inc. announced a strategic investment and exclusive technology licensing agreement with Peijia Medical Limited in China.

JenaValve advised that under the terms of the agreement, Peijia has made a cash and equity investment in JenaValve and will commit additional capital and royalty payments based upon various milestone achievements in exchange for exclusive rights to develop and commercialize JenaValve’s Trilogy transcatheter aortic valve replacement (TAVR) system in the Greater China region to treat patients with either severe symptomatic aortic regurgitation (AR) or severe symptomatic aortic stenosis (AS).

JenaValve, a developer and manufacturer of TAVR systems, is based in Irvine, California, with European headquarters in Munich, Germany. JenaValve's Trilogy transfemoral TAVR system received CE Mark approval for the treatment of AR and AS. It was launched in Europe in October 2021. In the United States, Trilogy is limited by law to investigational use only. Trilogy is being evaluated in the ALIGN-AR premarket approval (PMA) clinical trial, conducted under an FDA investigational device exemption (IDE).

Peijia, which is based in Suzhou, Jiangsu Province, People’s Republic of China, announced it entered the TAVR market in April 2021 with the approval of the TaurusOne system by China’s National Medical Products Administration. TaurusOne was followed by Chinese approval of the TaurusElite retrievable TAVR system in July and the third-generation TaurusNXT device in September.

“We are clearly excited about our new partnership with Peijia Medical and the opportunity to bring our innovative TAVR technology to potentially millions of patients in China,” commented JenaValve’s CEO John Kilcoyne, the company’s press release. “The capital raised associated with this partnership provides JenaValve additional funding to support our ALIGN-AR PMA clinical trial, as well as our strategy to accelerate expansion of our current commercial activities in Europe. I am pleased to say, that following IDE approval of the ALIGN-AR trial in August 2021, patient enrollment remains on track as we diligently work to achieve our ultimate goal of receiving United States FDA approval for the Trilogy heart valve system.”

Yi Zhang, PhD, Peijia’s Chairman and Chief Executive Officer, stated, “With the addition of the Trilogy, Peijia will have a more comprehensive product portfolio to better serve patients with aortic valve diseases in China. Currently, there are no transfemoral TAVR devices approved for aortic regurgitation in China; however, some patients with severe aortic regurgitation have to be treated by off-label use of TAVR devices as they are not eligible for open heart surgery. The Trilogy system provides a new treatment option to doctors and brings hope to aortic regurgitation patients. The investment in and collaboration with JenaValve solidifies Peijia’s commitment and market-leading position in the structural heart field in China.”