Financing Secures Funding to Complete ALIGN-AR Clinical Trial, Continue E.U. Real World Evidence Development, and Prepare for a U.S. Commercial Launch
IRVINE, Calif., Aug. 31, 2022 (GLOBE NEWSWIRE) — JenaValve Technology, Inc. (“JenaValve or the “Company”), developer and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced that it has completed the initial closing of a $100 million Series C financing. The financing was led by Bain Capital Life Sciences and included 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.
Proceeds from the financing will enable JenaValve to complete the Company’s 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.
“JenaValve is committed to becoming the first and only FDA-approved transfemoral transcatheter valve system indicated for symptomatic, severe aortic regurgitation, addressing an estimated multi-billion-dollar U.S. market opportunity. This financing provides sufficient capital for us to conclude our ALIGN-AR clinical trial and prepare for a commercial launch in the U.S.,” said John Kilcoyne, CEO. “Additionally, this financing further enhances our ability to leverage our commercial sales in Europe to expand our real-world body of evidence in Europe for the treatment of both symptomatic, severe aortic regurgitation (AR) and aortic stenosis (AS) in high surgical risk patients, while also expanding our manufacturing capabilities worldwide, in preparation of a U.S. launch.
“We are clearly thrilled by the strong support demonstrated from this outstanding group of existing and new global investors that recognize the significant market opportunity for our Trilogy Heart Valve System technology,” concluded Kilcoyne.
“We continue to maintain conviction in the strength of JenaValve’s differentiated technology, its prospects for entering the U.S. market, and potential for substantial long-term value creation,” commented Andrew Hack, MD, PhD, Managing Director of Bain Capital and member of JenaValve’s Board of Directors. “I’m excited that Bain Capital Life Sciences is able to stand alongside an impressive group of committed investors to provide a significant capital infusion that will support JenaValve’s exciting future.”
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 (“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. 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.
Contact:
Investor Relations
Leigh Salvo
Leigh@gilmartinir.com
