NEWS: Developer of Transcatheter Aortic Valve Replacement System Raises $50M
The Irvine developer and manufacturer of the a transcatheter aortic valve replacement system has raised $50 million in equity financing led by Bain Capital Life Sciences.
Additional participants in the financing for JenaValve Technology included existing investors Andera Partners, Gimv, Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners, according to a press release issued today.
As a result of the investment, Andrew Hack, managing director of Bain Capital, is now on the company’s board of directors.
John Kilcoyne is the CEO of JenaValve.
The company recently received “Breakthrough Device” designation from the FDA, which allows for priority review its upcoming clinical trial.
The company claims its system is “differentiated” because its transcatheter valve device has FDA approval for patients suffering from severe AR, who are at high risk for surgery,
The company believes this “is a multi-billion-dollar market opportunity.”
The funding also supports its plans to file for U.S. Humanitarian Device Exemption approval in the second half of the year.
At this time, the JenaValve system is an “investigational device,” and not available for sale here or internationally.
JenaValve also has locations in the U.K. and in Germany.