JenaValve Technology announced that it raised $50 million in equity financing as it develops and manufactures the JenaValve pericardial transcatheter aortic valve replacement (TAVR) system for treating aortic valve disease.
Bain Capital Life Sciences led the funding round, while Andera Partners, Gimv, Legend Capital, NoMed Management, RMM, Valiance Life Sciences and VI Partners all participated, according to a news release out Feb. 5.
The JenaValve TAVR system won FDA breakthrough device designation last month for treating severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. The FDA is set to provide the Irvine, Calif.–based company with priority review and interactive communication regarding device development and clinical trial protocols.
JenaValve said it is conducting a global trial for the TAVR system and will look to submit a pre-market approval application under the breakthrough device program. The company also plans to file the system for CE Mark approval for both AR and aortic stenosis in the second half of 2020, according to a news release.
“This announcement comes on the heels of receiving Breakthrough Device designation from the [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,” JenaValve CEO John Kilcoyne said in the news release. “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.”
JenaValve also announced that Bain Capital managing director Dr. Andrew Hack joined the company’s board of directors, following the financing round.
Hack previously served as CFO at Editas Medicine and as a healthcare portfolio manager at Millennium Management before he became a managing director at Bain Capital last year.
“We welcome Dr. Hack to our board and look forward to Bain Capital’s contribution to governance and strategy,” Kilcoyne said. “Andrew’s industry knowledge and experience, as well as his success as an institutional investor and chief financial officer will add valuable perspectives to our board.”
“I’m delighted to join the JenaValve Board as the company works to gain approval for a solution to a significant unmet medical need,” added Hack. “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.”