IRVINE, Calif., April 01, 2026 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy® Transcatheter Heart Valve (THV) System, today announced the successful first cases and official U.S. commercial launch of the Trilogy THV System, following the U.S. Food and Drug Administration’s (FDA) recent premarket approval (PMA) for the treatment of patients with symptomatic, severe aortic regurgitation (ssAR) who are at high or greater risk for surgical aortic valve replacement (SAVR). The first commercial U.S. procedures were performed simultaneously at NewYork-Presbyterian/Columbia University Irving Medical Center by Dr. Torsten Vahl, at Cedars-Sinai Medical Center by Dr. Raj Makkar and at Piedmont Heart Institute by Dr. Vinod Thourani. The Trilogy THV System is the first and only transcatheter device in the United States with a dedicated indication for high-risk aortic regurgitation (AR) – a historically underserved and underdiagnosed patient population that, until now, had no approved transcatheter treatment option. With its official launch, JenaValve begins a new era in the treatment of AR in America, bringing a minimally invasive, purpose-built solution to the patients who need it most. “It is an honor to have been on this journey with Trilogy from the very first implants of the ALIGN-AR trial to FDA approval and the very first commercial implants” said Dr. Torsten Vahl, director of translational research and interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center and national PI of the ALIGN-AR trial. “This is a significant achievement for the field and more importantly, for the many thousands of high-risk AR patients that finally have TAVR available as an option to them.” “These first cases are a defining moment for the many Americans who have been suffering from severe aortic regurgitation,” said Raj Makkar, MD, Cedars-Sinai Medical Center, and highest enroller in the ALIGN-AR trial. “I have seen firsthand how many patients need a dedicated treatment option like Trilogy. With this groundbreaking FDA approval and commercial launch, I believe we will soon gain a clearer understanding of how many patients can truly benefit from this important therapy.” “We finally have the option of TAVR for AR patients at high-risk of surgery.,” said Dr. Vinod H. Thourani, Chairman of Cardiovascular Surgery at Piedmont Heart Institute and national PI of the ALIGN-AR trial. “I am excited for what this means for the future of AR treatment because this now opens the door to whether or not we expand this treatment beyond high-risk patients. The randomized ARTIST trial which we are enrolling now will give us the critical answers to that question.” “The commercial launch of Trilogy in the United States is the beginning of a transformation in how we identify, diagnose, and treat aortic regurgitation,” said Peter Spadaro, Chief Commercial Officer of JenaValve. “We have assembled a world-class commercial organization to introduce the Trilogy valve to hospitals throughout the country to ensure patients have access to this therapy. The unmet need is enormous, and we are already experiencing strong demand. We are committed to reaching every patient who can benefit from the Trilogy System, while prioritizing patient outcomes and safety as we expand access to this game changing technology.” About the Trilogy® THV SystemThe Trilogy THV System is the first and only transcatheter heart valve in the United States indicated for native, symptomatic, severe aortic regurgitation in patients who are judged by a Heart Team to be at high or greater risk for surgical aortic valve replacement. The Trilogy THV System received CE Mark in 2021, and has now been used in more than 1,200 commercial procedures in Europe. The Trilogy System was purpose-built to address the unique anatomical challenges of aortic regurgitation. Unlike conventional TAVR valves that rely on annular calcification for anchoring — which is typically absent in AR patients — the Trilogy System features three proprietary radiopaque locators that attach directly to the native aortic leaflets, enabling secure and stable implantation even in the absence of calcium. The locators also provide commissural alignment for precise valve positioning and ensure a reliable seal to minimize paravalvular regurgitation. The system’s large, open-cell nitinol frame is designed to preserve future coronary access. Dr. Vahl discloses that he previously served as a paid consultant to JenaValve, and reports institutional funding to Columbia University from JenaValve. About JenaValveJenaValve 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 (AS) who are at high surgical risk. The Trilogy THV System bears the CE Mark for the treatment of AR and AS and is FDA approved for the treatment of AR. 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. Additional information is available at www.jenavalve.com. JenaValve Contact:Daniel Sun dsun@jenavalve.com Investor Contacts:Marissa Bych or Webb CampbellGilmartin Group LLCWebb@Gilmartinir.com
