ReWalk Robotics, a provider of technologies that enable mobility and wellness in rehabilitation and daily life for individuals with neurological conditions, announced today that its ReWalk Personal Exoskeleton technology has received clearance from the FDA 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 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.
“Our mission at ReWalk has been to achieve widespread access to the health benefits of walking in everyday life for individuals with spinal cord injury,” said Larry Jasinski, CEO of ReWalk. “Today’s announcement demonstrates our commitment from a technical perspective to improve access to a broader range of activities of daily living such as walking up the steps to visit a friend’s home or stepping over a curb during a neighborhood walk. In parallel, our focus continues to be to broaden access to these life changing technologies through expanding payor coverage as we continue to work with Medicare to develop the pathway to reimbursement for medically-eligible individuals.”
“To have the option to sit, stand, walk, and even step over curbs as a paralyzed individual is unimaginably rewarding,” said Simon Kindleysides, a ReWalk user and Guinness World Record holder for the most stairs climbed in an exoskeleton. “I’m in full control of the exoskeleton, and I am able to conquer stairs and other obstacles that may appear in my way. It’s been life-changing for me.”ReWalk looks forward to expanding the possibilities for its users in the United States with this recent FDA clearance.