JenaValve is a clinical-stage medical device company developing the first transcatheter heart valve technology that is uniquely designed for the minimally invasive treatment of both severe aortic regurgitation and stenosis.
JenaValve is focused on the design, development, and commercialization of innovative transcatheter heart valve solutions for the treatment of patients suffering from heart valve disease.
JenaValve was founded in Germany in 2006 by Hans-Reiner Figulla and Markus Ferrari. The company is headquartered in Irvine, California, with additional locations in Leeds, U.K., and Munich, Germany.
JenaValve'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.
JenaValve is currently enrolling patients in THE ALIGN AR Clinical Program focused on treating patients with severe, symptomatic aortic regurgitation and THE ALIGN AS clinical program for patients with severe, symptomatic aortic stenosis.
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.
JenaValve is backed by Bain Capital Life Sciences, Andera Partners, Qatar Investment Authority (QIA), Cormorant Asset Management, Gimv, Pictet Alternative Advisors SA, Legend Capital, NeoMed Management, Venture Incubator, RMM, Valiance Life Sciences, and others. The company raised $100M in Series C round on Aug 31, 2022. This brings JenaValve's total funding to $299.1M to date.