ReWalk Robotics Ltd. announced that its innovative ReWalk Personal Exoskeleton technology has received clearance from the Food and Drug Administration for use on stairs and curbs in the United States, making it the only personal exoskeleton to receive FDA clearance for this indication. The clearance follows the FDA's designation of the device as a "Breakthrough Device" in recognition of its unprecedented ability to provide ambulatory access to environments containing stairs and curbs for paralyzed individuals with spinal cord injury ("SCI"). This revolutionary advancement combines the robust mechanical design of the ReWalk Exoskeleton with its proprietary stair climbing software to enable users with access to a wide array of everyday environments, allowing them to participate in more walking activities in their daily lives and more opportunities to experience the health benefits of walking.

This feature has been available in Europe since initial CE Clearance, and real-world data from a cohort of 47 European users throughout a period of over seven years and consisting of over 18,000 stair steps was collected to demonstrate the safety and efficacy of this feature and support the FDA submission. ReWalk looks forward to expanding the possibilities for its users in the United States with this recent FDA clearance.