The Institutional Review Boards of five leading US research institutions have approved ReWalk Robotics Ltd‘s clinical study of the ReStore soft exo-suit device for stroke rehabilitation, according to an announcement.
The five research centers participating in the study include: Shirley Ryan AbilityLab in Chicago; Spaulding Rehabilitation Hospital in Boston, 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; and Kessler Foundation in West Orange, NJ.
“We expect that the expansion of our clinical study to these renowned research organizations will bring the ReStore exo-suit closer to CE and FDA clearance,” says ReWalk CEO Larry Jasinski, in a media release from Israel-based ReWalk Robotics Ltd.
”The ReStore will offer an immediate and cost-effective solution for the more than three million stroke patients in the US with lower limb disabilities. We are thrilled to be partnering with the most prestigious institutions in the world to bring our product to market.”
Arun Jayaraman, PT, PhD, who is director of the Max Nader Lab for Rehabilitation Technologies & Outcomes Research at Shirley Ryan AbilityLab, is the study’s lead investigator.
“The ReWalk ReStore is an unobtrusive wearable robotic technology that can seamlessly interact with and enhance everyday clinical care, allowing stroke patients to walk effectively and efficiently,” he says.
ReWalk anticipates commercializing the ReStore device for use by stroke patients in Europe and the United States in the first half of 2019, subject to the timing and receipt of CE mark and FDA clearance, respectively. Enrollment for the multi-center study is underway, per the release.
For more information about the ReWalk ReStore exo-suit or the clinical study, visit ReWalk Robotics Ltd.
[Source(s): ReWalk Robotics Ltd, PR Newswire]