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JenaValve Announces ALIGN-AR Pivotal Data to be Presented During the Late-Breaking Clinical Trial Sessions at TCT 2023
IRVINE, Calif., September 19, 2023 – JenaValve Technology, Inc., developer and manufacturer of the Trilogy™ Transcatheter Heart Valve (THV) System, today announced that data from the ALIGN-AR Pivotal Trial will be presented by Dr. Vinod Thourani (Piedmont Heart Institute, Atlanta, GA) during the Late-Breaking Clinical Trial sessions at the 2023 Transcatheter Cardiovascular Therapeutics (TCT) Annual Scientific Symposium in San Francisco, CA. The presentation will take place on Tuesday, October 24th, at 12:06 PM Pacific Time.
Prior to the data presentation, at 11:00 AM Pacific Time, a procedure using the CE Mark approved Trilogy THV System will be shown via broadcast from the University of Cologne. Additionally, a symposium focusing on the Trilogy THV System as a solution to address the unmet need in aortic regurgitation (AR) is scheduled for Thursday, October 26th at 2:15 PM Pacific Time.
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 or JenaValve, visit the JenaValve team at Booth #215 at TCT.
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
