Heart valve maker JenaValve Technology has raised $50 million in new venture capital funding, not long after receiving a breakthrough device designation from the FDA for its transcatheter aortic valve replacement (TAVR) system.
The equity financing was led by Bain Capital life Sciences, with additional participation from the company’s previous backers, Andera Partners, Gimv, Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners.
The proceeds will support the Irvine, California-based company’s ongoing clinical program—including an international trial in patients with severe aortic regurgitation and stenosis who would be at high risk for open surgery.
JenaValve plans to submit a humanitarian device exemption application to the FDA in the latter half of this year, according to CEO John Kilcoyne, who described that indication as “a multi-billion-dollar market opportunity.”
“We are clearly encouraged by this positive decision by the FDA regarding the expedited review of our unique TAVR system for patients suffering from severe aortic regurgitation who are at high risk for surgery and for which no transcatheter valve device is labeled or approved in the U.S.,” Kilcoyne said in a statement (PDF) following the January designation. “We look forward to continued collaborative interactions with the FDA as we move to finalize our clinical development program.”
In addition, the company also plans to apply for CE markings this year in both aortic stenosis and regurgitation.
“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,” said Andrew Hack, managing director of Bain Capital Life Sciences, who joins the company’s board of directors. “We are committed to providing both financial assistance and oversight in support of JenaValve’s success.”
JenaValve’s pericardial TAVR system includes a bioprosthetic valve and a self-expanding nitinol stent, delivered via the femoral artery, that is designed to be retrieved and repositioned during a procedure. It features a low-profile design without stent mesh, to lower the risk of blocking the entrances to the heart’s coronary arteries. A previous version of the valve, delivered via the transapical route, received a CE mark in 2011.