Sam Brusco, Associate Editor09.01.22
JenaValve has completed a $100 million Series C funding round, led by Bain Capital Life Sciences and included participation from existing investors Andera Partners, Valiance Advisors, Gimv, Cormorant Asset Management, RMM, and Venture Incubator.
Proceeds will be used, according to the company, to complete the investigational device exemption (IDE) premarket approval (PMA) study to gain FDA approval for the Trilogy heart valve system. JenaValve will also use proceeds to boost real-world data initiatives in Europe and expand 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.,” John Kilcoyne, JenaValve’s CEO told the press. “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, Ph.D., 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.”
Proceeds will be used, according to the company, to complete the investigational device exemption (IDE) premarket approval (PMA) study to gain FDA approval for the Trilogy heart valve system. JenaValve will also use proceeds to boost real-world data initiatives in Europe and expand 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.,” John Kilcoyne, JenaValve’s CEO told the press. “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, Ph.D., 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.”