ReWalk Robotics (NSDQ:RWLK) said today that it won CE Mark clearance in the European Union for its ReStore soft exo-suit designed for use in stroke rehabilitation.
The Marlborough, Mass.-based company touted the clearance as the first for a soft exo-suit in the region.
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 ReStore revolutionizes post stroke gait training, providing key advantage to clinics, therapists and patients. 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 device’s affordability and versatility make an attractive solution for a broader range of the rehabilitation market than previous technologies. 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. 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,” ReWalk CEO Larry Jasinski said in a press release.
Last month, ReWalk Robotics reported in an SEC filing that it raised approximately $4.3 million in a new round of financing.