IRVINE, Calif., March 18, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of differentiated pericardial transcatheter aortic valve replacement (TAVR) systems for the treatment of aortic valve disease, announces the appointment of Jane Metcalf to Vice President, Regulatory Affairs and Quality, effective immediately. Ms. Metcalf comes to JenaValve with over 30 years of experience in the medical device industry providing leadership in areas of regulatory affairs, clinical and quality assurance.
“Jane has a strong track record of successfully developing strategies for worldwide regulatory approvals of innovative devices,” said JenaValve CEO John Kilcoyne. “I am excited Jane is joining us at this pivotal time as we continue to enroll patients into our ALIGN-AR clinical trial and move forward in our efforts to commercialize our TrilogyTM heart valve for the treatment of aortic regurgitation. Her leadership will be critical to the success of JenaValve and our ability to expand patient and physician awareness.”
Prior to joining JenaValve, Ms. Metcalf served as Vice President of Regulatory Affairs and Quality Assurance at Sonendo Medical. Previously, she held senior leadership positions at emerging growth companies, including Interventional Spine, Rebound Therapeutics and Viseon Spine. Ms. Metcalf received a B.S. degree in chemical engineering from the University of Massachusetts, Amherst and an MBA from the University of California, Irvine.
JenaValve has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA), which allows for priority review of the ALIGN Clinical Trial for the treatment of symptomatic, severe aortic regurgitation (AR) and AR-dominant mixed aortic valve disease. JenaValve’s TAVR System is differentiated in that no other transcatheter valve device is currently available for patients suffering from severe aortic regurgitation who are at high risk for open heart surgery. Following completion of the HDE portion of the trial, patient enrollment is expected to continue in support of a Premarket Approval (PMA) application to the FDA. The company is also pursuing CE mark approval for both aortic stenosis and aortic regurgitation.
About the JenaValve Transfemoral TAVR System
The JenaValve Pericardial TAVR System consists of a Pericardial Aortic Valve and Transfemoral Delivery System. The bioprosthesis comprises a self-expanding nitinol stent with a porcine pericardial valve manufactured using state-of-the-art tissue processing techniques. The transfemoral delivery catheter is designed to deliver the bioprosthesis using a simple stepped approach with anatomic positioning over the native valve. The System is available in three sizes intended for aortic annulus diameters from 21mm to 27mm.
The JenaValve Pericardial TAVR System is an investigational device in the United States and internationally.
JenaValve Technology, Inc., with locations in Irvine, California, Leeds, U.K. and Munich, Germany, develops and manufactures transcatheter aortic valve replacement (TAVR) systems to treat patients suffering from aortic valve disease. The Company is in clinical development of its next generation transfemoral TAVR system in both the U.S. and CE mark countries for treating patients with aortic stenosis and/or aortic regurgitation.
JenaValve is backed by Bain Capital Life Sciences as well as European and Asian investors, including Andera Partners (formerly Edmond de Rothschild Investment Partners), Gimv (Euronext: GIMB), Legend Capital, NeoMed Management, RMM, Valiance Life Sciences and VI Partners.
Additional information is available at www.jenavalve.com.