"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,'' said ReWalk CEO Larry Jasinski. ''The ReStore will offer an immediate and cost-effective solution for the more than three million stroke patients in the U.S. with lower limb disabilities. We are thrilled to be partnering with the most prestigious institutions in the world to bring our product to market."
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. The five research centers participating in the study include:
- The Shirley Ryan AbilityLab in Chicago, Ill.;
- Spaulding Rehabilitation Hospital in Boston, Mass., 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, Texas; and
- Kessler Foundation in West Orange, N.J.
"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," explained Arun Jayaraman, PT, Ph.D. who is Director of the Max Nader Lab for Rehabilitation Technologies & Outcomes Research at Shirley Ryan AbilityLab and lead investigator for the study.
This first-of-its-kind device unveiled in 2017, the novel ReStore soft exo-suit is the second product developed by ReWalk. Designed to be a versatile, cost-effective gait therapy solution, the ReStore provides therapists with the ability to adjust and optimize a patient's treatment using real-time analytics. The ReStore promotes an improved gait with coordinated plantarflexion and dorsiflexion assistance to a patient's impaired foot and ankle. Power is transmitted from waist belt-mounted motors through cables to attachment points on the calf and an insole which is placed in the patient's shoe. Sensors clipped to the patient's shoes detect motion and inform timing of the assistance. Using a handheld smartphone controller, a trained therapist is able to adjust assistance level, monitor key metrics such as session progress and gait symmetry, and record standard gait training assessments. The company has announced pricing of under $20,000 for the device.