JenaValve Announces Late-Breaking Data from the ALIGN-AR Pivotal Trial

IRVINE, Calif. and CHICAGO, March 31, 2025 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, presented results from an expanded cohort of 500 patients in the ALIGN-AR Pivotal Trial for the Trilogy THV System in high-risk patients with symptomatic, severe aortic regurgitation (AR).

The late-breaking clinical trial results—representing the largest prospective study of Transcatheter Aortic Valve Replacement (TAVR) in AR to date—underscore the safety and efficacy of the Trilogy™ Transcatheter Heart Valve System in high-surgical-risk patients with severe, symptomatic AR. The analysis includes procedural and 30-day safety outcomes from 500 patients across the ALIGN-AR study and its continued access protocol (CAP), along with one-year follow-up data on more than 300 patients, including 180 from the core ALIGN-AR trial. In this expanded cohort, the composite 30-day primary safety endpoint was 26.2%, with an upper one-sided 97.5% confidence interval of 30.1%, significantly below the prespecified non-inferiority margin of 40.5%. Additionally, one-year mortality was 8.1%, well below the study’s predefined performance goal of 25%.

“The robust results from this large, 500-patient cohort provide compelling evidence for the clinical value of the Trilogy valve,” said Dr. Raj Makkar, MD, Cedars-Sinai Medical Center and highest enrolling investigator. “We now have a device success rate of over 95% across 500 patients compared to the success rates of 80 to 85% with available TAVR valves when used in AR patients. This represents a significant advancement in TAVR technology that may fundamentally improve treatment pathways for this patient population.”

“We are incredibly pleased to share these ALIGN-AR results,” said John Kilcoyne, CEO of JenaValve. “These expanded data demonstrate consistent performance of the Trilogy System, potentially offering severe aortic regurgitation patients, who are poor surgical candidates, a path to life-saving treatment. We are eagerly anticipating the approval of Trilogy and the opportunity to bring this innovative solution to patients.”

“Our ongoing commitment to addressing the critical unmet needs of AR patients continues with the current enrollment of the ARTIST RCT,” said Duane Pinto, MD, MPH, Chief Medical Officer at JenaValve. “This pivotal study aims to provide clinicians with essential comparative insights into TAVR replacement using the Trilogy valve as a potential alternative to surgical interventions. The encouraging results from our ALIGN-AR trial have reinforced our motivation to comprehensively evaluate the Trilogy System’s performance across an expanded patient population.”

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