Irvine, California — November 24, 2025 — Leads & Copy — JenaValve Technology, Inc. has announced the publication of results from an expanded cohort of 700 patients from the ALIGN-AR pivotal trial in The Lancet, which were also presented at PCR London Valves. The trial assessed the Trilogy™ Transcatheter Heart Valve (THV) System in high-risk patients with symptomatic, severe aortic regurgitation (AR).
The ALIGN-AR trial, the largest prospective dataset for a TAVR device in AR patients, met prespecified non-inferiority criteria for its primary safety and efficacy endpoints. Dr. Raj Makkar, MD, Cedars-Sinai Medical Center, presented the results at PCR London Valves.
The expanded study, including 520 continued access patients, demonstrated non-inferiority for the 30-day primary safety composite endpoint, with a rate of 24% compared to the performance goal of 40.5%. The one-year efficacy endpoint of all-cause mortality showed superiority at 7.7%, outperforming the 25.0% benchmark. Overall technical success was 94.9%, compared to 74%-86% in studies using off-label devices.
The study reported no intraprocedural deaths among the 700 patients. The 30-day stroke rate was 0.6%, and all-cause mortality was 1.6%. These outcomes were observed in a patient population with advanced age and elevated risk profiles. At 30 days, only 3 patients experienced moderate aortic regurgitation, and none experienced severe aortic regurgitation.
Dr. Makkar stated that TAVR for high-risk patients with severe AR is becoming a reality, offering a needed treatment option for individuals with limited alternatives. The therapy resulted in reductions in aortic regurgitation, excellent valve hemodynamics, evidence of myocardial remodeling, and improvements in functional status and quality of life sustained for up to two years.
Dr. Duane Pinto, MD, MPH, Chief Medical Officer at JenaValve, expressed his excitement regarding the validation of the Trilogy device and thanked the patients, research coordinators, physicians, and the FDA for their contributions.
John Kilcoyne, CEO of JenaValve, highlighted the significance of the ALIGN-AR trial results presented at PCR London Valves and the need for a dedicated TAVR solution for AR patients, referencing the European ESC guidelines. He believes the Trilogy device can expand access to effective therapy for this underserved population as U.S. guidelines and regulatory evaluations evolve.
JenaValve is enrolling high-risk patients in the continued access protocol of the ALIGN-AR trial and has started the ARTIST Trial, which studies TAVR for AR with the Trilogy valve versus surgical aortic valve replacement.
JenaValve Technology, Inc. focuses on developing THV solutions for heart valve disease. Its Trilogy THV System has CE Mark approval for treating symptomatic, severe AR, and symptomatic, severe aortic stenosis in high-surgical-risk patients. In the US, the Trilogy THV System is for investigational use only. JenaValve is headquartered in Irvine, California, with 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
Source: JenaValve
