JenaValve Announced ESC Guidelines Recognize TAVI as Class IIb Recommendation for Aortic Regurgitation

IRVINE, Calif., September 10, 2025

JenaValve Technology, Inc., developer and manufacturer of the TrilogyTM Transcatheter Heart Valve (THV) System, today announced that the newly published guidelines from the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) include transcatheter aortic valve implantation (TAVI) as a treatment option for patients with severe, symptomatic aortic regurgitation (AR) when ineligible for surgery. This decision marks the first formal recommendation for TAVI in AR guidelines.

JenaValve is currently the only company with an approved transcatheter valve indicated for AR in Europe. The ALIGN-AR Pivotal Trial for the Trilogy THV System helped inform the updated guidelines with two papers using ALIGN-AR data cited in support of the recommendation.

“I’m encouraged to see ESC and EACTS place renewed focus on aortic regurgitation, acknowledging the profound unmet need in this patient population,” said John Kilcoyne, CEO of JenaValve. “The updated guidelines expand opportunities for intervention, providing a clear recommendation for imaging and diagnosis. This represents a meaningful advancement in patient care for those suffering from severe symptomatic, high risk aortic regurgitation.”

“As the only transcatheter valve indicated for aortic regurgitation, TrilogyTM offers a lifeline to patients who until now had few viable options,” said Duane Pinto, MD, MPH, Chief Medical Officer at JenaValve. “These updated guidelines mark a pivotal step in expanding access to care and affirm our mission: to ensure patients with AR, who have long been an underserved community, can finally receive the treatment they need and deserve.”

“The updated guidelines bring important focus to improving care for patients with aortic regurgitation,” said Prof. Dr. Stephan Baldus, Cologne University Hospital “As interventional cardiologists, our priority is ensuring patients have access to therapies that can change and save their lives. It’s encouraging to see these guidelines acknowledge such a vulnerable population, and Trilogy’s dedicated indication is helping to advance the field and expand treatment options.”

About JenaValve

JenaValve Technology, Inc. is a medical device company focused on the design, development, and commercialization of innovative THV solutions for the treatment of patients suffering from heart valve disease. The Company’s Trilogy THV System is a TAVR system designed to treat patients with symptomatic, severe AR and symptomatic, severe aortic stenosis who are at high surgical risk. The Trilogy THV System received CE Mark approval, providing European physicians with the first TAVR device with true dual-disease treatment capabilities. In the US, the Trilogy THV System is limited to investigation use only.

JenaValve is headquartered in Irvine, California, with additional locations in Leeds, United Kingdom, and Munich, Germany.

JenaValve is backed by Bain Capital Life Sciences, Andera 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

JenaValve Contact:
Daniel Sun
dsun@jenavalve.com