JenaValve Announces Publication of ALIGN-AR Pivotal Trial Results in The Lancet

IRVINE, Calif., March 28, 2024 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced the publication of results from the ALIGN-AR Pivotal Trial in The Lancet. The ALIGN-AR trial is a prospective, multicenter study evaluating the use of JenaValve’s Trilogy transcatheter heart valve in high-risk patients with symptomatic moderate-to-severe or severe aortic regurgitation.

As presented at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium, the ALIGN-AR trial met prespecified non-inferiority criteria for its primary safety endpoint and primary efficacy endpoint. Investigators concluded that the Trilogy THV system showed a high technical success rate and promising safety profile, as well as low morbidity and mortality at 1-year follow up. Further, investigators noted that Trilogy “provided favorable hemodynamics, with low mean gradients and paravalvular leak rates and significant clinical improvement,” and found “substantial improvements in patient-reported outcomes and left-ventricular remodeling” with its use.

“The ALIGN-AR study demonstrated both safety and effectiveness of treating native aortic regurgitation with JenaValve’s Trilogy THV system, a dedicated transcatheter heart valve to treat patients with symptomatic moderate-to-severe or severe aortic regurgitation who are at high risk for mortality or complications after surgical aortic valve replacement. The observed short-term clinical and hemodynamic outcomes are very promising, as are signs of left ventricular remodeling,” said Vinod H. Thourani, MD, principal investigator of the ALIGN-AR trial and the Bernie Marcus Chairman of the Department of Cardiovascular Surgery, Piedmont Heart Institute, Atlanta, Georgia. “We hope to have the opportunity to use this valve, pending regulatory approval, for patients who are indicated and have limited surgical options.”

“We are incredibly pleased to see the formal publication of ALIGN-AR results in The Lancet. In addition to meeting its primary safety and efficacy endpoints, the THV system demonstrated exceptional technical performance and reversal of cardiac damage caused by aortic regurgitation,” said Dr. Torsten Vahl, Columbia University Irving Medical Center, an ALIGN-AR principal investigator and the primary author of the manuscript. “We would like to thank the ALIGN-AR investigators and site participants for their tremendous work and impact on patients during the course of this trial, and in the many discussions it has inspired since.”

“The Trilogy System fills an unmet need for our patients with symptomatic aortic regurgitation. Initially, we didn’t know how many patients there would be, as TAVR was never truly an option for these patients, but as the trial progressed and awareness improved, I saw firsthand a substantial increase in the number of patients with AR,” said Raj Makkar, MD, Cedars Sinai, the highest enroller in the ALIGN-AR trial. “If approved, I believe that there are more patients that could benefit from this therapy than we ever thought before.”

“I am proud of the patients, investigators, JenaValve staff, and countless others who helped achieve this extraordinary milestone in expanding transcatheter therapies for patients with aortic regurgitation. The positive outcomes reported from the ALIGN-AR trial in The Lancet usher in a new era for these patients.” Said Duane Pinto, MD, MPH, Chief Medical Officer at JenaValve.

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. Results from the study are intended to support a Premarket Approval submission to the U.S. Food and Drug Administration (FDA). If approved, the Trilogy THV System would become the first and only transcatheter aortic valve replacement (TAVR) system in the U.S. indicated for the treatment of symptomatic, severe AR.

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.

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.

Investor Relations Contact:
Marissa Bych
marissa@gilmartinir.com