ReWalk Robotics has 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. 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,” 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.”

ReWalk said the ReStore will be priced significantly lower than the first generation of rigid exoskeletons. Restore can be used to treat a broad range of stroke rehabilitation patients. ReWalk will offer direct purchase and third party leasing programs 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. 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 reported last month in an SEC filing that it raised approximately $4.3 million in a new round of financing.

ReStore is ReWalk’s second device, joining the ReWalk Personal 6.0 exoskeleton for home use by individuals with paralysis from a spinal cord injury. The expansion to soft exo-suits gives ReWalk a diverse offerings. ReWalk intends to leverage its existing sales, training and service teams to commercialize the ReStore eco-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,” said Jasinski. “The family of Soft-Exosuits are our foundation for revenue and financial growth of this company and for the industry as a whole.”