Shares of ReWalk Robotics Ltd. [NASDAQ: RWLK] surged 24.81% as the firm has gained +0.32 at the time of writing on Friday. The strong performance of the firm’s stock has shown the positive sentiments of the investors after the firm has received Breakthrough Device Designation by the FDA for its ReBoot device.
This Breakthrough device designation from the FDA is an important accomplishment for ReBoot, as it offers a more modernized review pathway that can get this uniquely advanced device to market faster. The ReBoot is a lightweight, battery-powered orthotic exo-suit meant to assist ambulatory functions in individuals with decreased ankle function related to neurological injuries, such as stroke.
Furthermore, the Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that offer more effective cures or diagnoses of life-threatening or irreversibly debilitating diseases or conditions.
The Breakthrough Devices Program offers manufacturers such as ReWalk an opportunity to cooperate with the FDA’s experts through several different program options to resourcefully address topics as they arise during the premarket review phase, which can help the firm receive feedback from the FDA and identify areas of agreement in a timely way.
Moreover, the ReBoot works in combination with the muscles of the affected leg to assist individuals not only with keeping safe foot positioning but also with pushing off the ground, which means it may enhance their gait. It may also maintain or increase joint range of motion, prevent disuse atrophy, etc.