JenaValve Completes Enrollment in the ALIGN-AR IDE Clinical Trial

IRVINE, Calif., September 14, 2022 — JenaValve Technology, Inc., developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced the successful completion of patient enrollment in the ALIGN-AR Pivotal trial.

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 Heart Valve System in high-risk patients with symptomatic, severe aortic regurgitation (ssAR). Results from the study are intended to support a future Premarket Approval (PMA) submission to the U.S. Food and Drug Administration (FDA).

“Completing the ALIGN-AR trial is a significant step forward for the cardiology community in addressing an unmet need for patients suffering from significant AR,” said Martin B. Leon, MD, Global Program Chair for the trial. “The unique design of the Trilogy System has the potential to address the shortcomings of existing TAVR devices when treating high surgical risk AR patients, enabling physicians to address a critical and long-overdue need for a minimally invasive solution that can meaningfully improve a patient’s quality of life.”

“This is a potentially game-changing clinical trial for the treatment of ssAR in a significant patient population which has not been addressed by other solutions,” said Raj Makkar, MD, leading enroller for the trial and Vice-President, Cardiac Interventions and Innovation at Cedars-Sinai Medical Center. “If approved, the Trilogy System will be the only transcatheter device indicated for the treatment of ssAR patients, with a potential to become the standard of care for these patients.”

“I am thrilled to see enrollment completed in this first-of-its-kind study. This milestone is a significant step towards our goal of helping ssAR patients with the Trilogy System,” said John Kilcoyne, JenaValve’s CEO. “We are grateful for the diligence and support of all who have enabled us to reach this point. A special thank you to our patients, physicians, investigators, investors, and the JenaValve team for their commitment to the trial and for sharing our vision of advancing the scientific evidence for the treatment of symptomatic, severe AR,” added Kilcoyne. “We also thank the FDA for their ongoing contribution and look forward to working closely together towards the successful completion of the next steps.”

About JenaValve

JenaValve Technology, Inc. is a medical device company focused on the design, development, and commercialization of innovative transcatheter heart valve solutions for the treatment of patients suffering from heart valve disease. The Company’s Trilogy™ Heart Valve System is a transcatheter aortic valve replacement (TAVR) system designed to treat patients with symptomatic, severe aortic regurgitation (ssAR) and symptomatic, severe aortic stenosis (ssAS) in high surgical risk patients. The Trilogy System received CE Mark approval in May 2021, providing European physicians, for the first time, a device with true dual-disease treatment capabilities.

JenaValve received Breakthrough Device Designation by the FDA to facilitate the review of ALIGN-AR, a pivotal trial in the U.S., as part of its PMA application for the Trilogy Heart Valve System for the treatment of ssAR in high surgical risk patients. If approved, the Trilogy System would become the first and only TAVR system in the U.S. to be indicated for the treatment of AR.

JenaValve is headquartered in Irvine, California, with additional locations in Leeds, U.K., and Munich, Germany.

JenaValve is backed by Bain Capital Life Sciences, Andera Partners (formerly Edmond de Rothschild Investment Partners), Valiance Life Sciences, Gimv, 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.

Additional information is available at www.jenavalve.com.

Affiliations:

Martin B. Leon, MD, Professor of Cardiology and Director, Center for Interventional Vascular Therapy at the Columbia University Irving Medical Center, NY Presbyterian Hospital

Raj Makkar, MD, Vice-President, Cardiac Interventions and Innovation at Cedars Sinai Medical Center.

US: CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.

Contact:
Investor Relations
Leigh Salvo
leigh@gilmartinir.com