YOKNEAM ILIT, Israel and MARLBOROUGH, Mass., Aug. 2, 2016 /PRNewswire/ — Leading exoskeleton manufacturer and developer ReWalk Robotics (NASDAQ: RWLK) announced the initiation of its U.S. Food and Drug Administration (FDA) Section 522 post-market study with the Stanford University School of Medicine listed as the lead study center. Dr. Matthew Smuck, associate professor of orthopaedic surgery and medical director of rehabilitation services for Stanford Health Care, will serve as lead investigator. The trial has already enrolled two patients

The 522 study will follow 60 patients for one year, and will include as many as 15 centers across the country. ReWalk has contracted with Oracle, the industry leader in electronic data capture systems (EDS), to oversee the data management of the study.

“ReWalk is pleased the study is underway with patients enrolled at the lead investigator site. We believe this will contribute to the growing body of data supporting the benefits of exoskeleton technology, and this study will serve to underscore the impact of exoskeleton technology on the health and well-being of the end user,” said Larry Jasinski, President and CEO of ReWalk Robotics.

ReWalk Robotics is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with Spinal Cord Injury (SCI) to stand upright and walk. ReWalk is the first exoskeleton system to receive FDA clearance for use in the home as well as in the rehabilitation setting. ReWalk received FDA clearance in June 2014.