- JenaValve Technology, a developer and manufacturer of the JenaValve Pericardial Transcatheter Aortic Valve Replacement (TAVR) System, has raised $50 million
JenaValve Technology — a developer and manufacturer of the JenaValve Pericardial Transcatheter Aortic Valve Replacement (TAVR) System for the treatment of aortic valve disease — announced it has raised $50 million in equity financing led by Bain Capital Life Sciences.
And additional investors that joined this funding round included existing investors Andera Partners, Gimv, Legend Capital, NeoMed Management, RMM, Valiance Life Sciences, and VI Partners. Plus the company also announced it named Bain Capital managing director Andrew Hack, MD, PhD to its Board of Directors.
“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,” said JenaValve Chief Executive Officer John Kilcoyne. “This announcement comes on the heels of receiving Breakthrough Device designation from the U.S. 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 U.S. Humanitarian Device Exemption (HDE) approval in the second half of 2020.”
JenaValve is now conducting a global multicenter clinical program for the treatment of patients with severe AR and AR-dominant mixed aortic valve disease who are at high risk for surgery. After the completion of the HDE portion of the trial, patient enrollment will continue in support of submitting a Premarket Approval (PMA) application to the FDA under the Breakthrough Device program. And JenaValve also anticipates filing the JenaValve for CE mark approval for both aortic stenosis and aortic regurgitation in the second half of 2020.
“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,” added Dr. Hack.
Dr. Hack served as a Managing Director at Bain Capital Life Sciences since 2019. Previously, Dr. Hack served as Chief Financial Officer of Editas Medicine and as a healthcare portfolio manager at Millennium Management. Before that, Dr. Hack was a securities analyst at a number of healthcare-focused hedge funds and investment banks. And Dr. Hack received an MD and a PhD in molecular genetics and cell biology from the University of Chicago.
