JENAVALVE TECHNOLOGY

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 (“AR”) and aortic stenosis (“AS”) in high surgical risk patients. The Trilogy Sy... stem 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 U.S. Food and Drug Administration (FDA) to facilitate the review of ALIGN-AR, a pivotal trial in the U.S., as part of its premarket approval (“PMA”) application for the Trilogy Heart Valve System for the treatment of symptomatic, severe aortic regurgitation (AR) in high surgical risk patients. If approved, Trilogy would become the first and only TAVR system in the U.S. to be indicated for the treatment of AR patients. JenaValve is headquartered in Irvine, California, with additional locations in Leeds, U.K., and Munich, Germany. Additional information is available at www.jenavalve.com. US: CAUTION – Investigational device. Limited by Federal (or United States) law to investigational use.More