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ReWalk Robotics, the Marlborough manufacturer of robotic medical devices for people with lower limb disabilities, received the first European clearance of a suit for stroke rehabilitation.
The clearance for the Restore suit to help stroke patients recover is the first clearance for the product in the world. The company has limited clearances for a separate suit to help spinal cord injury patients walk.
The company anticipates a U.S. Food and Drug Administration approval of the system later this year.
According to early trading Wednesday, investors anticipate the clearance leading to strong sales. The stock on the Nasdaq jumped more than 24% to about $3.70 per share around 10:30 a.m.
According to the company, the soft, garment-like design allows for a range of movements with plantarflexion propulsion assistance adapting to the user’s natural gait.
Physical therapists can adjust and optimize treatments using real-time analytics.
In a statement, CEO Larry Jasinski said the system revolutionizes physical therapy for stroke victims.
''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,” Jasinski said.
In a press release, the company said the system will be priced significantly lower than previous exoskeleton suits.
In a March interview with WBJ, Jasinski said the ReStore would cost around $20,000 compared to $100,000 for the ReWalk suit, which helps spinal cord injury patients walk.
That ReWalk suit is approved in both the U.S. and Europe with a majority of the systems being placed via a select few health insurers and the U.S. Department of Veterans Affairs.
The ReStore will be available in Europe via direct purchase and third-party leasing.
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Worcester Business Journal presents a special commemorative edition celebrating the 300th anniversary of the city of Worcester. This landmark publication covers the city and region’s rich history of growth and innovation.
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