In 2018, ReWalk Robotics is slated to launch its soft suit exoskeleton for people who have suffered a stroke. To that end, the company is working with Harvard University’s Wyss Institute to test the device ahead of clinical trials to be run next year.
Rewalk first partnered with Wyss in 2016 when the duo teamed up to develop and test lightweight exoskeleton designs for people with lower limb disabilities. The soft suit exoskeleton works similarly to ReWalk’s rigid exoskeleton for people with spinal cord injuries. It transmits power to major joints in the leg through cables that are connected to fabric-based pieces that attach to the legs and foot.
The partners will now test ReWalk’s exosuit with individuals who have suffered a stroke, the Israel-based company said in a statement.
"Utilization of the technology in an IRB approved research study, ahead of our clinical trials planned for next year, is a key milestone in the larger effort to pursue regulatory approval and eventually offer a commercial product to millions of patients who need ambulatory assistance," said ReWalk CEO Larry Jasinski in a statement.
In a separate announcement, ReWalk said it had cleared internal hurdles to start clinical trials of the soft suit exoskeleton, dubbed Restore, the prototype of which was unveiled in June. While the device is designed to provide stroke patients with real-time, adjustable walking assistance, the company hopes to apply the technology in other indications, including Parkinson’s disease and multiple sclerosis.
After completing clinical and lab testing over the next few months, ReWalk plans to apply for CE and FDA clearances in mid-2018, according to the statement.
ReWalk has already snagged FDA approval for its ReWalk hard exoskeleton but has faced challenges, namely securing reimbursement for a device with a $71,000 price tag. However, a Florida court ruled in June that Blue Cross Blue Shield of Florida must cover the cost of the device for a plan member with a spinal cord injury.