ReStore Exosuit, the First Soft Robotic System for Stroke Therapy Gets FDA Clearance

ReStore Exosuit
Image: ReWalk Robotics

Stroke is a leading cause of disability, which affects approximately 17 million people worldwide each year, and as many as 80% of people who have had a stroke will suffer from gait impairments.

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ReWalk Robotics, a leading manufacturer of robotic medical devices for people with lower limb disabilities, received FDA clearance for its ReStore™ soft exosuit system for sale to rehabilitation centers across the United States. ReStore is the only soft exosuit with FDA clearance, and is intended for use in the treatment of stroke survivors with mobility challenges, the company said in a press release.

“The exo-suit achieves our commercial goal to offer a functional and affordable system that can be utilized in the ‘Main Street’ clinics in every community,” said ReWalk CEO Larry Jasinski. “With a launch price of $28,900 as well as leasing options, ReStore offers cutting edge innovation with features that redefine therapy at a price that is accessible for a broader range of clinics than existing robotic technologies. The current gait training reimbursement codes enable immediate penetration and sales growth as part of our pathway to become a break even and profitable company.”

The technology was originally developed at Harvard University’s Wyss Institute for Biologically Inspired Engineering. The system, comprised of a soft garment-like design, connects to a lightweight waist pack and mechanical cables that help lift the patient’s affected leg in synchronized timing with their natural walking pattern. ReStore provides targeted assistance to the patient during forward propulsion (plantarflexion) and ground clearance (dorsiflexion), two key phases of the gait cycle. The device also provides the physical therapists with extensive data during gait training with ReStore to inform strategies to optimize a patient’s treatment and progress using real-time analytics.

Woman walking with an exosuit
Image: Rewalk Robotics (PR News)

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“We are very encouraged by our initial experience and positive impact of ReStore in gait training for persons with stroke residual disabilities,” said Moss Rehab’s Chief Medical Officer Alberto Esquenazi, MD, who was one of the investigators in the multi-center trial. “By training the patient walking pattern in a more correct way, the expectation is that the brain will re-learn and better restore the walking function lost after a stroke.”

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