Primary Study End Points of Device Safety and Feasibility Received Positive Results; Majority of Participants Experienced Clinically Meaningful Walking Speed Improvements
MARLBOROUGH, Mass., June 22, 2020 /PRNewswire/ -- ReWalk Robotics, Ltd. (NASDAQ:RWLK) ("ReWalk" or the "Company"), a manufacturer of robotic medical devices for individuals with lower limb disabilities, today announced the publication of the results of its multi-center clinical study of the ReStore Exo-Suit for rehabilitation of individuals with lower limb disability due to stroke. The study examined patient safety and explored functional walking outcomes in stroke survivors who completed a series of gait training sessions with the ReStore device.
This research was conducted primarily to support the Company's successful application to the U.S. Food and Drug Administration (FDA) for clearance of the ReStore Exo-Suit, which was issued in June 2019. The company also received CE Marking for the device in May 2019.
The findings of the study were published in the June issue of the Journal of NeuroEngineering and Rehabilitation, and were the result of investigation by five leading U.S. rehabilitation institutions:
- Shirley Ryan AbilityLab in Chicago, IL;
- Spaulding Rehabilitation Hospital in Boston, MA, in partnership with Boston University College of Health and Rehabilitation Sciences: Sargent College;
- MossRehab Stroke and Neurological Disease Center in Elkins Park, PA;
- TIRR Memorial Hermann in Houston, TX; and
- Kessler Foundation in West Orange, NJ.