ReWalk Exo-Suit Gets Green Light in U.S., Europe to Aid Stroke Recovery

ReWalk Robotics, a company with offices in Marlborough, Massachusetts and Yokneam Ilit, Israel, won FDA approval and a CE mark for its ReStore Exo-Suit, clearing the device for sale in the United States and EU countries.

The ReStore Exo-Suit had its beginnings at Harvard’s Wyss Institute for Biologically Inspired Engineering. It is made of a soft wrap that is placed around a lower leg that is affected by a stroke, a backpack-like control center, and a matching app that lets rehab specialists adjust its settings.

As the patient steps across the floor with the affected leg, the ReStore Exo-Suit pulls on that leg to make sure that the step is performed properly. The system provides both strength and guided timing, which helps the patient relearn how to walk correctly. Interestingly, unlike rigid exoskeletons, the device does not interfere with a person’s natural movement and feels less like one is inside a robot.

The ReStore Exo-Suit is being made available directly to rehab centers, so patients won’t be able to train on their own. “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, in a published statement. “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.”

In addition to being a walking aid during therapy, the suit gathers a great deal of data during each patient session. This can help rehab specialists to evaluate their patients and to adjust the kind of therapies that are administered to achieve the best results.