ReWalk ReBoot Soft Exosuit Receives FDA Breakthrough Device Designation

Exoskeletons and other assistive systems face stringent requirements for regulatory approval before they can be widely deployed. ReWalk Robotics Ltd. last week said that the U.S. Food and Drug Administration has desginated its ReBoot device a "breakthrough device."

“Breakthrough device designation from the FDA is a critical milestone for the ReBoot, as it provides a more streamlined review pathway that can get this uniquely innovative device to market faster,” said Larry Jasinski, CEO of ReWalk. “The ReBoot will give stroke survivors a device customizable for each individual user, giving them the opportunity for regular assistance at home and in the community. ”

Founded in 2001, ReWalk develops, manufactures and markets exoskeletons for individuals with lower limb disabilities as a result of spinal cord injury or stroke.

Stock in the company, which has headquarters in the U.S., Israel, and Germany, jumped by 40% last week after the announcement. It closed a $40 million private placement round in February and raised $35.5 million in a direct offering in September.

ReBoot offers walking benefits

ReBoot is a lightweight, battery-powered orthotic exosuit and is a sister product to the ReStore device, which received FDA clearance in 2019 for use in rehabilitation settings. The soft, wearable device works with the muscles of the affected leg to assist, not only with maintaining safe foot positioning, but also with pushing off the ground.

ReWalk said ReBoot can help improve user's gait and offer the following benefits:

• Facilitate muscle re-education, particularly of plantarflexor function
• Prevent or retard disuse atrophy
• Maintain or increase joint range of motion
• Improve walking speed and endurance independent of the device
• Reduce incidence of falls due to poor foot positioning secondary to footdrop

Designation leads to ReWalk clinical studies

The FDA's Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. It is available for devices and device-led combination products which are subject to review under a premarket approval application (PMA), 510(k) premarket notification, or a De Novo classification request.

The program is intended to help patients have more timely access to these medical devices by expediting their development, assessment, and review, said ReWalk. It is also intended to ensure compliance with statutory standards for premarket approval and clearance and De Novo marketing authorization, consistent with the FDA’s mission to protect and promote public health.

The Breakthrough Devices Program offers manufacturers such as ReWalk an opportunity to interact with the FDA's experts through several different program options to efficiently address topics as they arise during the premarket review phase.

The company said the program will enable it to receive feedback from the FDA and identify areas of agreement in a timely way. The program also provides manufacturers such as ReWalk prioritized review of their submissions.

With this designation, ReWalk will now readily pursue the FDA approval pathway for the ReBoot. The company said it is finalizing the ReBoot’s design and development and will proceed to the clinical studies required for FDA clearance application.