JenaValve Announces New, Late-Breaking Results from the ALIGN-AR Trial Published in The Lancet and Presented at PCR London Valves

IRVINE, Calif., November 24, 2025

JenaValve Technology, Inc., developer and manufacturer of the TrilogyTM Transcatheter Heart Valve (THV) System, today announced results from an expanded cohort of 700 patients from the ALIGN-AR pivotal trial for the Trilogy THV System in high-risk patients with symptomatic, severe aortic regurgitation (AR). These results were published in The Lancet and simultaneously presented as part of the Late-Breaking Clinical Trial sessions at PCR London Valves.

The extended ALIGN-AR trial represents the largest ever prospective dataset of a dedicated TAVR device for AR patients, providing critical insight on the procedural and longer-term outcomes of TAVR in patients with AR, a population that has long been without viable options. The trial met prespecified noninferiority criteria for its primary safety endpoint and primary efficacy endpoints. Results were presented by Dr. Raj Makkar, MD, Cedars-Sinai Medical Center, during the Late-Breaking Clinical Trial sessions at PCR London Valves.

As demonstrated in the initial 180 patient pivotal cohort, the expanded study, which included 520 continued access patients, achieved non-inferiority for the 30-day primary safety composite endpoint of 24%, well below the performance goal of 40.5%. The study also achieved superiority on the one-year efficacy endpoint of all-cause mortality of 7.7%, significantly outperforming the 25.0% performance benchmark. Overall technical success was high at 94.9% compared to 74%-86% in studies where offlabel devices are used.

There were no intraprocedural deaths in the 700 patients enrolled in the study. At 30 days, the stroke rate was 0.6% and all-cause mortality was 1.6%. Given the advanced age and elevated risk profile of this population, the outcomes are particularly compelling: observed mortality was less than half of the predicted rate based on a surgical risk score. Almost all patients entered the trial with moderate-tosevere or greater AR. At 30 days, moderate aortic regurgitation occurred in just 3 patients, and no patients had experienced severe aortic regurgitation. The published study is available here.

“These results confirm that TAVR for high-risk patients with severe AR is quickly becoming a reality, offering a much-needed treatment option for individuals who have had limited alternatives,” said Raj Makkar, MD, Cedars-Sinai Medical Center, and principal investigator in ALIGN-AR. “We observed profound reductions in aortic regurgitation, excellent valve hemodynamics, and clear evidence of myocardial remodeling, along with meaningful improvements in functional status and quality of life sustained for up to two years. This therapy has the potential to change patients’ lives.”

“These outcomes exemplify the ALIGN-AR investigators’ commitment to excellence and highlight the performance of the Trilogy device.” said Duane Pinto, MD, MPH, Chief Medical Officer at JenaValve. “I am thrilled to see this validation of the years of extraordinary effort supporting the development of Trilogy system. In particular, I am appreciative of the patients, research coordinators, physicians, and the FDA who have contributed immensely to this effort and look forward to bringing the benefits of TAVR to this high-risk group of patients with aortic regurgitation.”

“We are incredibly proud to have presented the ALIGN-AR trial results at PCR London Valves, which represents a major advancement in treatment for patients with severe aortic regurgitation,” said John Kilcoyne, CEO of JenaValve. “The strength and consistency of these data demonstrate the need for a dedicated TAVR solution for AR patients, particularly in light of recent updates to the European ESC guidelines. As U.S. guidelines and regulatory evaluations continue to evolve, I believe a dedicated AR device, like the Trilogy, has the potential to expand access to effective therapy for this historically underserved population.”

The ALIGN-AR trial is a landmark prospective, single-arm investigation device exemption (IDE) study designed to assess the safety and efficacy of the Trilogy THV System in high-risk patients with symptomatic, severe AR. JenaValve continues to enroll high-risk patients in the continued access protocol of the ALIGN-AR trial and has commenced the ARTIST Trial, studying TAVR for AR with the Trilogy valve versus surgical aortic valve replacement in patients with moderate-to-severe or severe aortic regurgitation.

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