The company said it plans to use the funds to complete the research needed to gain approval from the U.S. Food and Drug Administration (FDA) for its Trilogy Heart Valve System for high-risk patients with symptomatic, severe aortic regurgitation (AR) and launch that system in the United States. The funds will also go toward improving the company’s data development and manufacturing efforts.
“JenaValve is committed to becoming the first and only FDA-approved transfemoral transcatheter valve system indicated for symptomatic, severe AR, addressing an estimated multi-billion-dollar U.S. market opportunity,” John Kilcoyne, JenaValve CEO, said in a statement. “This financing provides sufficient capital for us to conclude our ALIGN-AR clinical trial and prepare for a commercial launch in the U.S.”
The financing round was led by Bain Capital Life Sciences, but also included a mix of existing investors (Andera Partners, Valiance Advisors, Gimv, Cormorant Asset Management, RMM and Venture Incubator) and first-time investors (Pictet Alternative Advisors SA, Qatar Investment Authority, Innovatus Capital Partners and Peijia Medical Limited).
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