JenaValve Announces Late-Breaking Data from the ALIGN-AR Pivotal Trial Meeting Safety and Efficacy Endpoints

IRVINE, Calif., October 24, 2023 – JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced results from the ALIGN-AR Pivotal Trial for the Trilogy THV System in high-risk patients with symptomatic, severe aortic regurgitation (AR).

The trial met prespecified non-inferiority criteria for its primary safety endpoint and primary efficacy endpoint. Outcomes were presented by Dr. Vinod Thourani (Piedmont Heart Institute, Atlanta, GA) during the opening Late-Breaking Clinical Trial sessions at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium in San Francisco, CA.

ALIGN-AR Investigators concluded that Trilogy THV performance was excellent with large EOA and low transvalvular gradients, as well as low paravalvular regurgitation (0% ≥ moderate at 1 year). In addition, echocardiography demonstrated significant improvement in LV remodeling, and patients reported sustained improvement in quality of life (QoL) and heart failure functional status through 1 year.

“We are encouraged to see the significant LV mass reduction at over 20% and substantial improvement in quality of life in the ALIGN-AR pivotal trial results,” said Torsten P. Vahl, MD, Principal Investigator of the ALIGN-AR trial. “Pending U.S. regulatory approval, we look forward to being able to offer the Trilogy THV System to our patients with ssAR.”

“We are incredibly pleased to share the ALIGN-AR results, which demonstrate safety and efficacy as well as exceptional technical performance and reversal of heart enlargement with the Trilogy THV system,” said Dr. Duane Pinto, Chief Medical Officer at JenaValve. “We would especially like to thank the ALIGN-AR investigators and site participants for their tremendous work and impact for patients with aortic regurgitation.”

“In addition to its safety profile, the Trilogy THV system offered exceptional hemodynamic and technical performance in the ALIGN-AR trial,” said Raj Makkar, MD, Cedars Sinai. “I am excited that patients with ssAR may have the option to receive TAVR and its benefits in the future.”

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.

For additional information on the ALIGN-AR Trial Please visit jenavalve.com.

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 (formerly Edmond de Rothschild Investment 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