ReWalk(TM) Personal Exoskeleton System Approved by FDA for Home Use

ReWalk(TM) Personal Exoskeleton System Approved by FDA for Home Use

MARLBOROUGH, Mass., June 27, 2014 /PRNewswire/ -- Exoskeleton leader ReWalk

Robotics announced today that the U.S. Food and Drug Administration has 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 individuals with Spinal Cord Injury (SCI) to stand upright and

walk. ReWalk, the only exoskeleton with FDA clearance via clinical studies and

extensive performance testing for personal use, is now available throughoutthe

United States.

The FDA has issued a marketing clearance for the ReWalk, which was granted

via a rigorous de novo 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," saidLarry 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,"

he added. "This is truly the beginning of 'ReWalking' as a daily reality in the

U.S."

Derek Herrera, a Captain in the U.S. 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 Foundation (MARSOC Foundation) will be donating the

funds for Herrera's ReWalk system; Herrera works for the Marine Special

Operations Command. "It will be incredible for me to regain independence, to

use the system to walk and stand on my own," he added.

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, loss of fat tissue, 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.

"What makes this so exciting is the understanding that, in addition to the

psychological benefits realized by ReWalking, consumers are able to improve

upon the clinical benefits," said Jasinski. "Now, with FDA clearance, users

will continue to experience these benefits on a daily basis at home."

ReWalk has been tested extensively in the U.S., Europe, and Israel. The

ReWalk system is supported by the most published data of all exoskeleton

systems in the rehabilitation market, and 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 individuals 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 as well as outdoors, as

well as on different surfaces or terrains. This revolutionary, cutting-edge

technology allows users to stand, turn and walk 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 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," said ReWalk inventor Dr. Goffer.

"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 health benefits, it

underscores just how monumental a day this is for the SCI community here in the

U.S."

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.

SOURCE ReWalk Robotics

ReWalk Robotics

Web Site: http://www.rewalk.com