JenaValve Announces First Trilogy Heart Valve Systems Implanted in Asia

IRVINE, Calif. -- JenaValve Technology, Inc., developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, announced the completion of the first two Trilogy Heart Valve System implantations in Asia. The two procedures were performed by Dr. Michael Lee and team at Queen Elizabeth Hospital in Hong Kong in conjunction with Peijia Medical, JenaValve’s China distribution partner.

Dr. Michael Lee, Dr. Ivan Wong, and Dr. Angus Chui, under the proctorship of Professor Andreas Baumbach of the Barts Heart Centre and Queen Mary University of London, successfully completed their first two cases in approximately 25 minutes. Both cases resulted in significantly improved hemodynamics immediately post-procedure.

“The Trilogy Heart Valve System is a highly innovative treatment option licensed for both severe aortic regurgitation (AR) and severe aortic stenosis (AS) patients in Asia. We are inspired that the Trilogy procedure was quite predictable due to the valve’s solid anchoring and locator technology. The acute results of our first two cases on patients with inoperable AR were successful,” said Dr. Michael Lee, Head of Cardiology, Consultant Cardiologist at Queen Elizabeth Hospital. “These two AR cases are the first implantations with an on-label TAVI transfemoral system in Asia. We do hope that the Trilogy technique could save more patients who are suffering from severe AR related disease in the future.”

“We are thrilled about the first commercial implants of the Trilogy Heart Valve System in Hong Kong. These cases mark a major milestone for the clinical use of Trilogy in Asia,” said John Kilcoyne, JenaValve Chief Executive Officer. “We look forward to continuing our partnership with Peijia Medical in the greater China region to provide a TAVR solution to the significant number of patients who suffer from severe, symptomatic aortic regurgitation.”

“This is an important accomplishment for Peijia Medical in expanding its commercial market. We are committed to serving more clinical centers with cutting-edge, unique, and innovative technologies, allowing for greater treatment options for more patients,” said Dr. Yi Zhang, Peijia Medical President, and Chief Executive Officer. “From an international perspective, Peijia Medical will keep creating a local medical innovation ecosystem and promote the further implementation of innovative devices and revolutionary therapies in the structural heart field.”

Peijia Medical entered into a license and development agreement with JenaValve in December 2021 to collaborate in the creation and development of certain proprietary medical device products for minimally invasive treatment of both severe AR and AS. Under the agreement, JenaValve granted Peijia Medical an exclusive license and other rights to develop, manufacture and commercialize the products in the greater China region. Together, JenaValve and Peijia Medical are committed to benefiting patients across Asia.

About JenaValve
JenaValve Technology, Inc. is a medical device company focused on the design, development, and commercialization of innovative transcatheter heart valve solutions for the treatment of patients suffering from heart valve disease. The Company’s Trilogy^® Heart Valve System is a transcatheter aortic valve replacement (TAVR) system designed to treat patients with symptomatic, severe aortic regurgitation (ssAR) and symptomatic, severe aortic stenosis (ssAS) in high surgical risk patients. The Trilogy System received CE Mark approval in May 2021, providing European physicians with the first TAVR device with true dual-disease treatment capabilities.

JenaValve received Breakthrough Device Designation from the FDA to facilitate the review of ALIGN-AR, a pivotal trial in the U.S., as part of its PMA application for the Trilogy Heart Valve System for the treatment of ssAR in high surgical risk patients. If approved, the Trilogy System would become the first and only TAVR system in the U.S. indicated for the treatment of AR.

JenaValve is headquartered in Irvine, California, with additional locations in Leeds, U.K., and Munich, Germany.

JenaValve is backed by Bain Capital Life Sciences, Andera Partners (formerly Edmond de Rothschild Investment Partners), Valiance Life Sciences, Rosetta Capital, Cormorant Asset Management, Legend Capital, NeoMed Management, RMM, VI Partners, Pictet Alternative Advisors SA, Qatar Investment Authority (QIA), Innovatus Capital Partners, and Peijia Medical Limited.

US: CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.

Additional information is available at www.jenavalve.com.