Peijia Medical Limited (HKEX: 9996) is pleased to announce its strategic investment and exclusive in-licensing agreement with JenaValve Technology, Inc. Under the terms of the agreement, Peijia has made a cash and equity investment in JenaValve and will commit additional capital based upon development milestones in exchange for exclusive rights to develop and commercialize JenaValve’s innovative TrilogyTM transcatheter aortic valve replacement (TAVR) systems in the Greater China region to treat patients suffering from aortic regurgitation (AR) or aortic stenosis (AS). JenaValve will also be eligible for future royalty payments on sales.

JenaValve Technology, Inc., is headquartered in Irvine, California, with additional locations in Leeds, U.K., and Munich, Germany, is a pioneer in the TAVR field. Its patented locator technology is designed to align the valve with the native anatomy and secure the valve by clipping onto the native valve leaflets, minimizing the potential for valve migration. The company received a CE Mark in May 2021 for the treatment of both aortic regurgitation (AR), and aortic stenosis (AS) the first and only transfemoral TAVR device in the world approved for AR. Additionally, JenaValve has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), which allows for priority review of the ALIGN-AR Clinical Trial for the treatment of symptomatic, severe aortic regurgitation (AR) who are at  high risk for open heart surgery.

“With the addition of the TrilogyTM Heart Valve System, 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. According to Frost & Sullivan, there were approximately 3.9 million patients in China in 2020 suffering from aortic regurgitation.

“We are excited to find the right partner and look forward to working with Peijia to bring the Trilogy TM heart valve system to China as soon as possible,” said John Kilcoyne, JenaValve’s Chief Executive Officer. “We could not be more pleased to collaborate with such an innovative company and with an established track record of successful technology transfer. We are very excited to work with our new partner to potentially benefit millions of patients in China with the Trilogy TM Heart Valve System.”

Source: Company Press Release