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June 28, 2018

ReWalk Robotics expands clinical study; eyes 2019 sales

Courtesy ReWalk's prototype for a system to help stroke patients walk.

ReWalk Robotics in Marlborough hopes to offer its robotic exoskeleton suit for stroke patients by July 2019 and just got a boost as five leading U.S. research institutions have approved the company’s clinical study of its device.

Five institutions, including the Spaulding Rehabilitation Hospital in Boston in partnership with Boston University College of Health and Rehabilitation Services, will participate in the clincial study of the Restore soft exo-suit, which is designed to be a versatile gait therapy solution with the ability to adjust and optimize a patient’s treatment using real-time analytics.

The system is powered from waist-mounted motors transmitting power to key joints in the legs. Sensors clipped to the patient’s shoes transmit real-time information to a physical therapist, who can then adjust the suit’s assistance level using a smartphone.

ReWalk said the suit will cost under $20,000.

Commercial sales in the U.S. and Europe are expected to begin in the first half of 2019.

The expansion of the clinical study, which was initially launched in April with Spaulding, will bring the product closer to electronics certification and U.S. Food & Drug Administration approval, said ReWalk CEO Larry Jasinski.

"The ReStore will offer an immediate and cost-effective solution for the more than 3 million stroke patients in the U.S. with lower limb disabilities,” he said. “We are thrilled to be partnering with the most prestigious institutions in the world to bring our product to market."

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