ReWalk pushes forward on soft suit exoskeleton for stroke survivors

walk sign
ReWalk has gotten a rigid exoskeleton for people with spinal cord injury past the FDA and plans to submit its soft suit device for CE and FDA clearances in 2018.

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.

FREE DAILY NEWSLETTER

Like this story? Subscribe to FierceBiotech!

Biopharma is a fast-growing world where big ideas come along every day. Our subscribers rely on FierceBiotech as their must-read source for the latest news, analysis and data in the world of biotech and pharma R&D. Sign up today to get biotech news and updates delivered to your inbox and read on the go.

RELATED: ReWalk Robotics marches to market with $58M IPO

"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.

RELATED: ReWalk Robotics stumbles 6 months after IPO

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.

Suggested Articles

Following an FBI raid and the replacement of its leadership, it’s come to light that the data behind uBiome’s microbiome test may contain flaws.

The purchase comes as AstraZeneca enters a 12-month period in which it plans to file for approval of about 10 assets.

Dr. Ian Hudson is stepping down after six years in charge of the Medicines and Healthcare products Regulatory Agency next month.