Houston, Texas (March 21, 2018) – Procyrion, Inc., a clinical-stage medical device company developing the first catheter-deployed, intra-aortic pump for ambulatory use, AortixTM, today announced the appointment of Elisabeth (Beth) Neely, RAC, as Senior Vice President of Clinical and Regulatory Affairs. In this role, Neely will proactively develop, lead and drive the execution of a global regulatory and clinical strategy with a focus on efficient, rapid and timely approval of the novel Aortix device. Neely brings to Procyrion more than 20 years of experience as a global regulatory affairs leader, having played a key role in the approval of neuromodulation and cardiac devices.
“Beth brings a depth of experience that we believe will be invaluable as we advance our clinical and regulatory strategies for Aortix as a potential first-in-class tool to address enormous unmet clinical needs in NYHA Class III-IVa heart failure patients,” said Benjamin Hertzog, chief executive officer of Procyrion. “Over the course of her career with Abbott and St. Jude Medical, Beth has an accomplished track record of working closely with the FDA and other regulatory bodies to achieve regulatory results for a number of cardiac therapies. Her significant expertise in the heart failure space will be pivotal as we work to bring Aortix to market.”
“After seeing Procyrion’s notable progress in advancing a significant, differentiated therapeutic for heart failure patients, I joined the team in anticipation of contributing to the next stages of this progress,” said Neely. “There is real potential for Aortix to become a frontline treatment and I’m honored to participate in Procyrion’s successful transition to a global commercial entity.”
Most recently, Neely served as Division Vice President of Regulatory Affairs for Abbott’s Cardiac Arrhythmias and Heart Failure business unit. Previously, at St. Jude Medical, she oversaw a global regulatory affairs organization with a team of 150 located in North America, South America, Europe, Australia, and Asia. She was responsible for regulatory submissions and approvals for all St. Jude Medical products and gained FDA approval and CE marking for the first app-based and wireless neuromodulation programming system leveraging Apple™ technology. Prior to her role as VP of Global Regulatory Affairs, Neely was responsible for regulatory affairs for St. Jude Medical’s Implantable Electronic Systems Division for Cardiac Rhythm Management and Neuromodulation. In her role as VP of Regulatory Affairs she managed several IDE, 510K and PMA filings across various FDA branches resulting in numerous product clearances and approvals.
Neely received her BS in Biomedical Engineering and a BA in Spanish from Texas A&M University.
Houston-based medical device firm Procyrion, Inc. is developing the first catheter-deployed, intra-aortic pump for ambulatory use. The device is designed to rest and heal the heart by reducing afterload while simultaneously improving blood flow to vital organs. This groundbreaking cardiology tool, conceived by cardiologist Dr. Reynolds M. Delgado, III, medical director of Mechanical Support Devices in Heart Failure at the Texas Heart Institute, is expected to provide a minimally invasive treatment option for millions of chronic heart failure patients. For more information, visit www.procyrion.com or call 713.579.9227.