“JenaValve is completing enrollment of its phase II CE mark trial, including the first procedure with our latest transfemoral delivery system, and the necessary funding to proceed with our strategic objectives. We have also obtained alignment with the FDA on the company’s design of several U.S. clinical studies involving new generations of our TAVR technology and delivery systems. The timing of Laura joining is critical as we start to expand our clinical program in the U.S.,” CEO Victoria E. Carr-Brendel, Ph.D., said. “Her deep relationships with key opinion leaders and worldwide clinical expertise on mitral and aortic valve disease will be invaluable as we accelerate our clinical development. Our strategic intent is that JenaValve technologies become available to treat the full spectrum of aortic valve disease in patients across the world.”
Brenton has devoted more than 30 years in life sciences, including over two decades in the medical device industry. Most recently, Brenton was vice president, Clinical Affairs, at Harpoon Medical, a clinical stage medical device company focused on the development and commercialization of transcatheter beating heart mitral valve repair technology. Prior to that, she held senior leadership positions in medical, clinical and regulatory affairs at Symetis SA, Direct Flow Medical, and Boston Scientific Corporation, where she gained extensive experience in TAVR and interventional cardiology. Brenton will be based at JenaValve’s corporate headquarters in Irvine, Calif., with oversight of both the U.S. and European clinical and professional education programs.
“I am excited to join JenaValve at an important stage in the clinical development of its differentiated TAVR system. I believe there are still unmet clinical needs in TAVR, especially in the lower surgical risk and aortic insufficiency patients, which JenaValve is uniquely positioned to address,” said Brenton. “I believe the technology can make a real impact in the lives of patients.”
JenaValve Technology Inc., with locations in Irvine, Calif.; Leeds, England; and Munich, Germany; develops, manufactures and markets 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, consisting of the Everdur valve and Coronatix transfemoral delivery system, in both the United States and CE-Mark countries for treating patients with aortic stenosis and/or aortic regurgitation. The company’s first generation transapical system, consisting of the JenaValve valve plus Cathlete PLUS delivery system, was commercialized under CE Mark approval for aortic valve stenosis and for the unique indication to treat patients suffering from aortic valve regurgitation. JenaValve is backed by U.S., European and Asian investors, including Edmond de Rothschild Investment Partners, Gimv (a Euronext-listed investment company), Legend Capital, NeoMed Management, Omega Funds, RMM, Valiance Life Sciences and VI Partners.