Exoskeleton Developer ReWalk Receives FDA Clearance for its Stroke Rehabilitation Suit

Nasdaq-listed ReWalk Robotics Ltd., which develops wearable robotic systems that help people walk again after injuries and strokes, has received clearance from the U.S. Food and Drug Administration (FDA) for the sale of ReStore, an exo-suit used to treat stroke survivors with impaired mobility, the company announced Tuesday. In the U.S., the ReStore suit will have a launch price of $28,900, ReWalk said, adding they will offer leasing options. Last week, ReStore was granted the CE mark, clearing it for sale to rehabilitation clinics in the E.U.

Founded in 2001, ReWalk has two product lines. The first, a rigid-frame exoskeleton for people who cannot walk on their own due to spinal cord injuries, has been on the market for several years. ReStore, the company’s new product line, is a soft-frame suit meant for stroke victims learning to regain motor skills in their lower limbs. The suit uses software and mechanical means to prop up the lower body at critical joints. Rewalk is based in Marlborough, Massachusetts and Yokneam Illit, Israel, and has approximately 60 employees, according to Pitchbook data.