JenaValve Raises $100M in Series C Funding


JenaValve, an Irvine, CA-based developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, raised $100M in Series C funding.

The round was led by Bain Capital Life Sciences with participation from existing investors Andera Partners, Valiance Advisors, Gimv, Cormorant Asset Management, RMM, and Venture Incubator. New investors joining the syndicate included Pictet Alternative Advisors SA, Qatar Investment Authority (QIA), Innovatus Capital Partners, and Peijia Medical Limited.

The company intends to use the funds to complete its investigational device exemption (IDE) premarket approval (PMA) study to obtain FDA approval for its Trilogy Heart Valve System, a treatment for high surgical risk patients with symptomatic, severe aortic regurgitation (AR). In addition, JenaValve will use the proceeds to bolster its real-world data development initiatives in Europe, as well as to expand its worldwide manufacturing capabilities.

Led by CEO John Kilcoyne, JenaValve Technology 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 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 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.

The company also operates locations in Leeds, U.K., and Munich, Germany.