ReWalk Robotics, Ltd. (Nasdaq: RWLK) (“ReWalk” or the “Company”), a leading manufacturer of robotic medical devices for individuals with lower limb disabilities, today announced the submission of its 510k application to the U.S. Food and Drug Administration (FDA) for the ReStore™ exo-suit for gait training during stroke rehabilitation. The 510k application submission marks the next step, and a significant milestone in the process of commercialization.
Strokes are a major cause of serious long-term disability, with over 795,000 people suffering a stroke each year in the U.S. alone. Five million people are permanently disabled each year by strokes globally, according to the World Health Organization (WHO) figures.*
Unveiled in 2017, the novel ReStore soft exo-suit is designed to be a versatile, cost-effective gait therapy solution. The soft, garment-like design allows variability of movement in combination with first-of-its-kind active ankle assistance that adaptively synchronizes with the patient’s natural gait, to facilitate functional gait training activities. The device also provides therapists the ability to adjust and optimize a patient’s treatment using real-time analytics.
‘‘This submission marks a significant milestone for robotic rehabilitation technologies and represents a clear, distinct evolution in powered rehabilitation solutions,” said Larry Jasinski, ReWalk CEO. “The ReStore is a versatile device which will provide high-level, reproducible care for a broad range of a clinic’s gait training clients, at a price point accessible to many more clinics than current technologies. The company is proud to continue its work in revolutionizing devices for mobility challenged individuals, and to be at the forefront of next-gen development in medical exoskeletons.”
The 510k submission follows the completion of a nationwide clinical study, with 44 patients enrolled across five leading rehabilitation centers in the United States:
- The Shirley Ryan AbilityLab in Chicago, IL
- Spaulding Rehabilitation Hospital in Boston, MA, in partnership with Boston University College of Health and Rehabilitation Sciences: Sargent College
- MossRehab Stroke and Neurological Disease Center in Elkins Park, PA
- TIRR Memorial Hermann in Houston, TX
- Kessler Foundation in West Orange, NJ
“As part of the multi-site study of the ReStore exo-suit, we applied the device to a broad range of individuals with post-stroke gait dysfunctions. The device allowed the study participants to walk effectively and efficiently, and we are encouraged with the potential of this technology to interact with and enhance everyday clinical care” explained Arun Jayaraman, PT, PhD who is Director of the Max Nader Lab for Rehabilitation Technologies & Outcomes Research at Shirley Ryan AbilityLab and lead investigator for the ReStore clinical study.
Following CE submission in Q4 of 2018, ReWalk anticipates commercializing the ReStore device for use by stroke patients and rehab clinics in Europe in mid-2019. In the United States a potential launch of the product could occur in late Q2 or Q3, pending clearance from the FDA.
How it works: The ReStore promotes an improved gait with coordinated plantarflexion and dorsiflexion assistance to a patient’s impaired foot and ankle. Power is transmitted from waist belt-mounted motors through cables to attachment points on the calf and an insole, which is placed in the patient’s shoe. Sensors clipped to the patient’s shoes detect motion and inform timing of the assistance. Using a handheld smartphone controller, a trained therapist is able to adjust assistance level, monitor key metrics such as session progress and gait symmetry, and record standard gait training assessments.