SAN CLEMENTE, Calif., December 17, 2018/PR Newswire – ROX Medical, Inc. (ROX), a privately held medical device company pioneering a minimally-invasive therapy for hypertension, today announced the appointment of Jonathan Sackner-Bernstein, MD as its Chief Medical Officer and Executive Vice President of Clinical and Regulatory Affairs.
Dr. Sackner-Bernstein brings experiences as engineer, cardiologist, clinical investigator, regulator and innovator to the ROX team. Following his academic career (primarily at Columbia University), Sackner-Bernstein shifted to developing his product development skills. He built and ran a Phase 1 clinical research unit, served in a senior role at the FDA, ran clinical/regulatory for a stem cell therapeutic and consulted for DARPA. Prior to joining ROX, Sackner-Bernstein served as consultant to a wide range of device, drug and biologic companies.
Dr. Sackner-Bernstein was recruited to the FDA’s Center for Devices as the number 2 in scientific/clinical matters. He led teams across a diverse portfolio – spanning from innovation programs to the post-market safety transformation. Sackner-Bernstein led several Center and Agency level interactions with other Federal Agencies and international regulatory authorities. Following separation from Federal service, Sackner-Bernstein was recruited by DARPA to support the launch of their new Biological Technologies Office.
“Dr. Sackner-Bernstein is a broadly experienced physician and seasoned medical device executive with clinical, FDA and medical device company background,” commented CEO Michael MacKinnon. “We are thrilled to have Dr. Sackner-Bernstein join the executive team at ROX Medical to progress this exciting technology to the market and potentially become the standard of care in hypertension.”
“The ROX Coupler represents a transformative opportunity in the treatment of hypertension,” explained Sackner-Bernstein. “As angioplasty forever altered the management of coronary disease, so I believe ROX has the opportunity to do for hypertension. Who wouldn’t want to join the team in such a pursuit?”
About ROX Medical, Inc., ROX® Medical has developed an implantable device and therapy intended to treat uncontrolled high blood pressure. Blood pressure reduction is achieved by diverting a small amount of blood flow from the arterial system into the venous system. The ROX Coupler is a small stent-like device that is placed between the artery and vein located in the upper thigh. The Coupler is about the size of a dime and is easily placed using standard catheter techniques. ROX Medical is conducting the CONTROL HTN-2 clinical trial in the United States for hypertension (visit www.controlhtn2.com for more information). The ROX Medical Coupler is commercially available in Europe under CE mark.