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ReWalk Robotics' exo-suit gets CE marking
ReStore Exo-Suit by ReWalk Robotics, a manufacturer of robotic medical devices for lower limb disabilities, has received CE marking. This is the first clearance of a soft exo-suit, a next generation medical device which can serve a larger and more diverse patient population facing mobility challenges. ReStore Exo-Suit is used for stroke rehabilitation.
The marking means the device can now be sold to rehabilitation clinics in the European Union.
ReStore's soft, garment-like design allows variability of movement which combines with first-of-its-kind plantarflexion propulsion assistance that adaptively synchronises with the patient's natural gait to facilitate functional gait training activities. The device also provides therapists the ability to adjust and optimise a patient's treatment using real-time analytics.
"The ReStore revolutionises post stroke gait training, providing key advantage to clinics, therapists and patients," said ReWalk CEO Larry Jasinski. ''We developed this design through collaboration with the Wyss Institute at Harvard because of the unique opportunity to combine extensive depth of the supporting science and clinician involvement in designing the ideal system for stroke therapy in the clinic."
The company announced that ReStore will be priced significantly lower than the first generation of rigid exoskeleton technologies, and can be used to treat a broad range of stroke rehabilitation patients. ReWalk will offer direct purchase and third party leasing programmes for the ReStore in the EU.
"The device's affordability and versatility make an attractive solution for a broader range of the rehabilitation market than previous technologies," Jasinski added. "Considering the high prevalence of stroke and the need for more effective and efficient clinical solutions, the marketplace for the ReStore is significant and holds immense promise for the continued innovation of care."
ReStore is ReWalk's second marquee device, joining the ReWalk Personal 6.0—a robotic exoskeleton for home use by individuals with paralysis from a spinal cord injury. The expansion to soft exo-suits gives ReWalk a diverse offering of innovative technologies, and expands the company's impact to millions of patients worldwide.
ReWalk intends to leverage its existing sales, training and service teams to commercialise the ReStore Exo-Suit. To date, ReWalk has placed nearly 550 exoskeletons in 26 countries and trained more than 270 rehabilitation clinics to conduct exoskeleton training worldwide.
"The soft suit technology is the first of a series of designs from the clinic for stroke therapy. It will also serve as a basis for a home therapy design that can be managed from the clinic, in addition to entering testing for treatment of Multiple Sclerosis and Parkinson's disease. The family of Soft-Exosuits are our foundation for revenue and financial growth of this company and for the industry as a whole," said Jasinski. (SV)