JenaValve Technology, manufacturer of JenaValve Pericardial Transcatheter Aortic Valve Replacement (TAVR) System to treat aortic valve disease, has raised $50m through an equity financing led by Bain Capital Life Sciences.

Existing investors Andera Partners, Gimv, Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners also participated in the financing round.

JenaValve’s chief executive officer John Kilcoyne said: “We are pleased to complete this financing led by new investor Bain Capital Life Sciences, a well-respected name in healthcare, as well as strong participation from our existing venture investors.”

“This announcement comes on the heels of receiving Breakthrough Device designation from the US Food and Drug Administration (FDA), which allows for priority review of our Align Clinical Trial for the treatment of symptomatic, severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease.

“Our TAVR system is differentiated in that no other transcatheter valve device has FDA approval for patients suffering from severe AR who are at high risk for surgery, which we believe is a multi-billion-dollar market opportunity. This financing supports our ongoing clinical program and plans to file for US Humanitarian Device Exemption (HDE) approval in the second half of 2020.”

The firm also appointed Bain Capital managing director Andrew Hack to the JenaValve board of directors.

JenaValve is carrying out a global multicentre clinical programme to treat patients suffering from severe AR and AR-dominant mixed aortic valve disease at high risk for surgery.

Upon HDE approval, the company will continue to enrol patients to support the submission of a premarket approval (PMA) application to the FDA under the Breakthrough Device programme.

It expects to file the device for CE mark approval for both aortic stenosis and aortic regurgitation in the second half of this year.