US-based medical devices manufacturer and distributor JenaValve Technology has raised $50m in an equity financing led by Bain Capital Life Sciences.

JenaValve is engaged in the development and manufacturing of JenaValve Pericardial Transcatheter Aortic Valve Replacement (TAVR) system for the treatment of aortic valve disease.

The pericardial TAVR system includes a bioprosthesis comprised of a self-expanding nitinol stent with a porcine pericardial valve manufactured using advanced tissue processing techniques.

Bain Capital Life Sciences is an investment firm focused on biopharmaceutical, specialty pharmaceutical, medical device, diagnostics and life science technology companies across the world.

The transfemoral TAVR system developer is carrying out an international multicentre clinical program for the treatment of severe AR and AR-dominant mixed aortic valve disease in patients who are at high risk for surgery.

Once the Humanitarian Device Exemption (HDE) portion of the trial is completed, the company intends to continue the patient enrolment to support the submission of a Premarket Approval (PMA) application to the FDA under the Breakthrough Device program.

In addition, the company is also expected to apply for the CE mark approval of both its aortic stenosis and aortic regurgitation devices in the second half of 2020.

Bain Capital managing director Andrew Hack will join JenaValve Board of Directors

Along with Bain Capital, the existing investors including Andera Partners, Gimv, Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners also participated in the funding round.

In addition, Bain Capital managing director Andrew Hack will be appointed as a member of JenaValve board of directors.

Hack said: “I’m delighted to join the JenaValve Board as the Company works to gain approval for a solution to a significant unmet medical need. JenaValve’s focus on advancing a breakthrough technology with the ability to improve patient lives embodies the characteristics we seek at Bain Capital Life Sciences.

“We are committed to providing both financial assistance and oversight in support of JenaValve’s success.”