Israel’s ReWalk Robotics Ltd., the Israeli developer of a robotic exoskeleton system that helps people who are paralyzed to walk, has asked the US Food and Drug Administration for clearance to market another robotic exoskeleton suit, this one aiming to help stroke sufferers regain their ability to walk.
The move is a “significant milestone” toward commercialization of the so-called ReStore suit, the company said in a statement.
Strokes are a major cause of serious long-term disability, with over 795,000 people suffering a stroke each year in the US alone. Five million people are permanently disabled each year by strokes globally, according to the World Health Organization (WHO) figures.
Unveiled in 2017, the ReStore soft suit helps rehabilitate individuals with lower limb disability due to stroke. The ReStore seeks to be a “versatile, cost-effective gait therapy solution” for use in rehabilitation centers, and is meant to allow therapists to deliver treatment with real time analytics, allowing them to adjust the treatment as they get feedback. The ReStore suit transmits power to key joints of the legs via cables, powered with software and mechanics that are similar to the technologies used in the earlier ReWalk exoskeleton system. The cables are connected to fabric-based designs that attach to the patient’s leg and foot, hence the name “soft suit.”
Developed jointly with the robotics institute of Harvard University in Boston, the system operates on one leg, because generally in stroke victims one side is more affected than the other. Its motors and cables are connected to a waist pack that has a computer. Physical therapists can use a tablet to set their patient’s walking plan and determine how much walking assistance the patient requires.
When the patients start walking, the cables monitor and analyze the patients’ gait, both when they raise their feet and when they lower them back onto the ground, and ensure that they walk in the correct way, by flexing or loosening the cables.
‘‘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 FDA submission follows the completion of a nationwide clinical study, with 44 patients enrolled across five rehabilitation centers in the United States.
After applying for European regulatory clearance in the fourth quarter of 2018, ReWalk said it expects to commercialize its 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 the second quarter or third quarter of the year, pending FDA clearance, the company said.
ReStore is the second product developed by ReWalk, allowing the still loss-making firm, whose shares are traded on the Nasdaq exchange, to enlarge its offering to a wider market. The ReWalk product serves paraplegics, helping people with spinal cord injuries to walk. The ReStore suit is lighter and less expensive than a ReWalk suit.
As opposed to the ReWalk exoskeleton, which costs some $80,000 to $85,000, the company estimated last year that the target price for the ReStore is expected to be $20,000 per system.
Earlier this month, ReWalk said total revenues for 2018 came in at $6.5 million, saying it didn’t achieve its anticipated results in the US in the fourth quarter of the year. The company posted an annual loss of some $22 million.
The ReWalk exoskeleton is one of the 15 Israeli technologies mentioned in the book “Thou Shalt Innovate: How Israeli Ingenuity Repairs the World,” which details how Israeli products are having an impact on the world.