IRVINE, Calif.--(BUSINESS WIRE)--JenaValve Technology, Inc., a next-generation heart-valve technology company, committed to providing state-of-the-art transcatheter aortic valve replacement (TAVR) technologies to cardiology professionals and to the broadest spectrum of patients with aortic valve disease, today announced the appointment of veteran medical device executive Janet M. Fauls as Vice President of Regulatory Affairs.
“JenaValve is at a critical juncture as we enter 2016 and kick off several important clinical studies involving new embodiments of our TAVR technology and delivery systems. Ms. Fauls joins us at just the right time and with a wealth of relevant experience,” said Chief Executive Officer Victoria E. Carr-Brendel, Ph.D. “Her worldwide regulatory expertise will be critical to JenaValve as we execute our clinical studies and the subsequent global regulatory submissions. Ultimately, our goal is to make our heart valve technologies available to the full spectrum of patients with aortic valve disease.”
Ms. Fauls, who has nearly 30 years of regulatory and clinical affairs experience, will be based at JenaValve’s corporate headquarters in Irvine, California. Most recently, Ms. Fauls served as Vice President of Global Regulatory Affairs for Endologix, Inc. in Irvine, California. Prior to Endologix, Ms. Fauls held management positions of increasing responsibility in regulatory and clinical affairs positions at major global medical technology companies including Edwards Life Sciences, Cardiogenesis Corporation and Allergan, Inc. Ms. Fauls earned B.S. in Chemistry from the University of California at Santa Barbara.
“Joining JenaValve at this pivotal point in clinical development is a unique opportunity,” said Ms. Fauls. “I believe the technology can make a real impact on the lives of patients with aortic valve disease and is capable of changing the landscape in one of the most exciting and active markets in medical technology today.”
About JenaValve
JenaValve Technology, with operating locations in Irvine, California, Leeds, England and Munich, Germany, develops, manufactures and markets transcatheter aortic valve replacement (TAVR) systems to treat a broad spectrum of patients suffering from aortic valve disease. The Company’s Transapical TAVR system, consisting of the JenaValve valve system plus Cathlete PLUS delivery system, has CE Mark approval for aortic valve stenosis and for the unique indication to treat patients suffering from aortic valve insufficiency. JenaValve currently markets this product in Europe and other selected markets worldwide. JenaValve is backed by world-class U.S., European and Asian investors, including Atlas Venture, Edmond de Rothschild Investment Partners, Gimv (a Euronext-listed investment company - ticker: GIMB), Legend Capital, NeoMed Management, Omega Funds, RMM, Sunstone Capital, Valiance and VI Partners. Additional information is available at www.jenavalve.com.
