ReWalk Robotics (NSDQ:RWLK) said yesterday that it won FDA 510(k) clearance for its ReStore soft exo-suit system intended for rehabilitation therapy.
The Marlborough, Mass.-based company touted the clearance as being the first by the FDA for a soft exo-suit system intended for use in treating stroke survivors with mobility challenges.
The ReStore exo-suit features a soft, garment-like design and is intended to adaptively synchronize with a patient’s natural gait to enable functional gait training activities, ReWalk Robotics said. The system also allows therapists to adjust and optimize treatment using real-time analytics.
“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. 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,” CEO Larry Jasinski said in a press release.
Clearance by the FDA came supported by a multi-center clinical trial of the system, ReWalk Robotics said. The company added that it expects to publish the results of the study later this year.
“We are very encouraged by our initial experience and positive impact of ReStore in gait training for persons with stroke residual disabilities. 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,” trial investigator Dr. Alberto Esquenazi of Moss Rehab said in a prepared statement.
Late last month, ReWalk Robotics said that it won CE Mark clearance in the European Union for its ReStore soft exo-suit.
