Business
FDA Issues Clearance for the ReStore(TM) Exo-Suit, the First Soft Robotic System for Stroke Therapy
MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel, June 4, 2019 /PRNewswire/ -- ReWalk Robotics, Ltd. (Nasdaq: RWLK) ("ReWalk" or the "Company"), a leading
About this update from Lifeward Ltd.
[{"type":"text","content":"MARLBOROUGH, Mass. and YOKNEAM ILIT, Israel, June 4, 2019 /PRNewswire/ -- ReWalk Robotics, Ltd. (Nasdaq: RWLK) (\"ReWalk\" or the \"Company\"), a leading manufacturer of robotic medical devices for individuals with lower limb disabilities, announced today that the U.S. Food and Drug Administration (\"FDA\") has cleared the Company's ReStore soft exo-suit system for sale to rehabilitation centers across the United States. ReStore is the only soft exo-suit with FDA clearance, and is intended for use in the treatment of stroke survivors with mobility challenges. Stroke is a leading cause of disability, which affects approximately 17 million people worldwide each year (1), and as many as 80% of people who have had a stroke will suffer from gait impairments. (2)\n\n \n\"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,\" said ReWalk CEO Larry Jasinski. \"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 accessable 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.\"\nIn 2018, ReWalk launched a multi-center clinical study of the ReStore system across five of the country's leading rehabilitation centers. This data was submitted to the FDA in ReStore's 510(k) submission, and ReWalk expects to publish the results of the clinical study later this year. \n\"We are very encouraged by our initial experience and positive impact of ReStore in gait training for persons with stroke residual disabilities,\" said Moss Rehab's Chief Medical Officer Alberto Esquenazi, MD, who was one of the investigators in the multi-center trial. \"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.\" \nThe patented soft exo-suit technology was originally developed at Harvard University's Wyss Institute for Biologically Inspired Engineering where it also underwent initial clinical testing that demonstrated its potential to improve walking for stroke survivors. ReWalk ...