JenaValve Technology announced today that it completed the initial closing of a $100 million Series C financing round.
Irvine, California-based JenaValve develops and manufactures differentiated transcatheter aortic valve replacement (TAVR) systems.
The company intends to use proceeds from the financing to complete its FDA investigational device exemption (IDE) premarket approval (PMA) study to garner FDA approval for the Trilogy heart valve system. JenaValve designed Trilogy for high surgical risk patients with symptomatic, severe aortic regurgitation (AR).
Additionally, the company plans to use the proceeds to bolster its real-world data development initiatives in Europe. JenaValve also plans 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.,” CEO John Kilcoyne said in a news release. “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.”
Bain Capital Life Sciences led the financing round. It included participation from existing investors Andera Partners, Valiance Advisors, Gimv, Cormorant Asset Management, RMM and Venture Incubator. New investors included Pictet Alternative Advisors SA, Qatar Investment Authority (QIA), Innovatus Capital Partners, and Peijia Medical Limited.
“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,” said Dr. Andrew Hack, 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.”