JenaValve Technology has announced that it has completed the initial closing of a US$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 an investigational device exemption (IDE) premarket approval (PMA) study to obtain US Food and Drug Administration (FDA) approval for its Trilogy transcatheter aortic valve implantation (TAVI) 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 US market opportunity. This financing provides sufficient capital for us to conclude our ALIGN-AR clinical trial and prepare for a commercial launch in the US,” 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 US launch.
“We are clearly thrilled by the strong support demonstrated from this outstanding group of existing and new global investors that recognise the significant market opportunity for our Trilogy heart valve system technology,” concluded Kilcoyne.