ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable individuals with spinal-cord injury to stand upright, climb stairs and walk. It was developed by Argo founder Dr. Amit Goffer in 2001 after he was paralyzed in an accident with an all-terrain vehicle. After ISRAEL21c’s first story, the world media have reported extensively about this futuristic bionic suit.
Available in Europe since 2012, the Israeli system stole the spotlight at the Virgin London Marathon when Claire Lomas, a chiropractor who was permanently paralyzed below her chest as the result of a 2007 riding accident, crossed the finish line in the 26.2-mile run thanks to the exoskeleton device.
Now the ReWalk system, which was dubbed by TIME magazine as one of 2013′s best inventions in the world, is back in the headlines thanks to its recent US Food and Drug Administration approval for using its ReWalk device at home and in the community.
ReWalk is the only exoskeleton with FDA clearance via clinical studies and extensive performance testing for personal use.
According to the US Centers for Disease Control and Prevention, there are about 200,000 people in the United States living with a spinal-cord injury, many of whom have complete or partial paraplegia.
“Innovative devices such as ReWalk go a long way towards helping individuals with spinal cord injuries gain some mobility,” said Christy Foreman, director of the Office of Device Evaluation, at the FDA’s Center for Devices and Radiological Health. “Along with physical therapy, training and assistance from a caregiver, these individuals may be able to use these devices to walk again in their homes and in their communities.”
Argo actually offers two products: ReWalk Personal and the ReWalk Rehabilitation wearable robotic systems. The Rewalk Personal System, designed for everyday use by individuals at home and in their communities, is custom-fit for each user. The ReWalk Rehabilitation system is used in the clinical rehabilitation environment, where it provides a valuable means of exercise and therapy as well as a training base for individuals to be certified, enabling them to purchase a Personal system.
“The person walks the system; the system does not walk them. The users are in control — when they want to sit, they sit, when then want to stand and walk, they do so,” says ReWalk inventor Goffer.
Derek Herrera, a captain in the US Marine Corps, is a paraplegic trained on the ReWalk Personal System, and will be one of the first Americans to own the ReWalk. “I see this as a milestone for people in my same situation who will now have access to this technology – to experience walking again, and all of the health benefits that come with ReWalking,” Captain Herrera said.
The Marine Special Operations Command (MARSOC) Foundation will donate the funds for Herrera’s ReWalk system, which carries a price tag of $69,500. “It will be incredible for me to regain independence, to use the system to walk and stand on my own,” he added.
The FDA’s marketing clearance was granted via a rigorous process that involved multiple clinical studies demonstrating safety and effectiveness of the technology.
“This revolutionary product will have an immediate, life-changing impact on individuals with spinal cord injuries,” said Larry Jasinski, CEO of ReWalk Robotics. “For the first time individuals with paraplegia will be able to take home this exoskeleton technology, use it every day and maximize on the physiological and psychological benefits we have observed in clinical trials. This is truly the beginning of ‘ReWalking’ as a daily reality in the US.”
Argo is just one of many Israeli health-related companies hoping to raise money in the US to finance product development and marketing, according to a Bloomberg report.
Bloomberg reports that Argo is backed by investors including SCP Vitalife Partners, Pontifax Venture Capital Fund, OurCrowd, and Technion Research & Development Foundation.