JenaValve Technology, Inc. (“JenaValve” or the “Company”), developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced a strategic investment and exclusive technology licensing agreement with Peijia Medical Limited (HKEX: 9996) in China. 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 innovative Trilogy® TAVR systems in the Greater China region to treat patients suffering from either severe symptomatic aortic regurgitation (AR) or severe symptomatic aortic stenosis (AS).

“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,” said John Kilcoyne, JenaValve’s CEO. “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 enrollent remains on track as we diligently work to achieve our ultimate goal of receiving U.S. FDA approval for the Trilogy Heart Valve System.”

“With the addition of the TrilogyTM, Peijia will have a more comprehensive product portfolio to better serve patients with aortic valve diseases in China,” said Dr. Yi Zhang, Peijia’s Chairman and Chief Executive Officer. “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 TM 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,” said Dr. Yi Zhang.