Personal Exoskeleton cleared by FDA

This revolutionary technology, which allows people with Spinal Cord Injury
to stand & walk, receives clearance for personal use in the U.S.

ReWalk PersonalExoskeleton leader ReWalk Robotics has announced that the FDA cleared the company’s ReWalk Personal System for use at home and in the community.

ReWalk is a wearable robotic exoskeleton that provides powered hip and knee motion to enable people with Spinal Cord Injuries to stand upright and walk. It’s the only exoskeleton with FDA clearance for personal use available in the United States.

Derek Herrera, a Captain in the U.S. Marine Corps, is a paraplegic trained on the ReWalk. He will be one of the first Americans to own the ReWalk and said, “I see this as a milestone for people in my same situation … to experience walking again, and all of the health benefits that come with ReWalking.”

The Marine Special Operations Command Foundation (MARSOC Foundation) will be donating the funds for Herrera’s ReWalk system. Herrera, who works for the Marine Special Operations Command, added, “It will be incredible for me to regain independence, to use the system to walk and stand on my own.”

Brian Flanagan, 26, is featured in the TODAY show video below since he too has learned how to use the ReWalk Personal system. Flanagan was injured in an ATV accident two years ago, which severed his spinal cord. When surgeons told him he would likely never walk again, he considered suicide but now is getting much of his life back.

“It’s great!” he says. “I was 6’4″, so I’m used to looking down on people and staring over the crowd. So, being in a wheel chair is a lot different … looking up to everybody. ”

ReWalk provides user-initiated mobility through the integration of a wearable brace support, a computer-based control system and motion sensors. The system allows independent, controlled walking while mimicking the natural gait patterns of the legs, similar to that of an able-bodied person. In addition to the ability to stand and walk independently, clinical studies of the ReWalk Rehabilitation system show significant health benefits to the user, on both a physiological and psychological level.

Study data of the ReWalk system indicates potential improvements in cardiovascular health, building of lean muscle mass, and improved bowel function. Feedback from ReWalk users supports these potential benefits and others, such as better pain management, fewer medications, and potentially reduced hospitalizations.

ReWalk was tested extensively in the U.S., Europe, and Israel, resulting in the most published data of all exoskeleton systems in the rehabilitation market. It is used by more people worldwide than all other exoskeleton systems combined.

ReWalk was developed by Dr. Amit Goffer, an Israeli inventor who became quadriplegic after an ATV accident in 1997. It was through his own personal experience in utilizing mobility devices for people with spinal cord injury that Dr. Goffer developed the ReWalk.

The company offers two products: ReWalk Personal and the ReWalk Rehabilitation wearable robotic systems. The Rewalk Personal System, designed for everyday use by people at home and in their communities, is custom-fit for each user. The system is designed for daily use in a range of environments such as in the home, at work, at social events, indoors and outdoors, as well as on different surfaces or terrains. This revolutionary technology allows users to stand, turn, walk and sit with independent control of the system.

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 people to be certified, enabling them to buy a Personal system.

“The person walks the system, the system does not walk them,” said ReWalk inventor Dr. Goffer. “The users are in control — when they want to sit, they sit, when then want to stand and walk, they do so”

“ReWalking is much more than walking,” says Jeff Dykan, ReWalk’s Chairman of the Board. “ReWalk provides paralyzed individuals with the ability to stand and walk, to look someone in the eye, to hug and be hugged. These are simple acts which many of our ReWalkers thought they would never be able to do again,” he added. “When you take that into account in addition to the physical health benefits, it underscores just how monumental a day this is for the SCI [spinal cord injury] community here in the U.S.”

According to the National Spinal Cord Injury Statistical Center at the Universit of Alabama, about 273,000 people in the United States live with spinal cord injuries. Over 80% of them are men, with nearly half of the injuries occurring between the ages of 16 and 30. Falls and motor vehicle accidents are the most common causes.

The ReWalk Personal System is available to consumers upon meeting requirements from a medical examination and successful completion of the required training program. The company also offers a comprehensive maintenance and warranty program for the system.

About ReWalk Robotics

ReWalk Robotics (formerly Argo Medical Technologies) develops, manufactures and markets wearable robotic exoskeletons for people with lower limb disabilities, such as paraplegia. ReWalk’s mission is to fundamentally change the health and life experiences of individuals with spinal cord injury. Founded in 2001, ReWalk Robotics is a global company with headquarters in the US, Germany, and Israel. For more videos and other information on ReWalk Robotics and the ReWalk Systems, please visit http://www.rewalk.com.

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