Rewalk's Robotic Stroke Therapy System Gets FDA Nod, Shares Soar 175%

Shares of nanocap medical device company Rewalk Robotics Ltd RWLK soared in pre-market trading Wednesday.

What Happened

Israel-based Rewalk said the FDA has cleared its ReStore soft exo-suit system for sale to rehabilitation centers across the United States.

The maker of robotic medical devices for individuals with lower limb disabilities said Restore is the only soft exo-suit approved by the FDA and is intended to treat stroke survivors with mobility challenges.

The system has a launch price of $28,900, as well as leasing options.

Why It's Important

Stroke is the leading cause of disability affecting about 17 million people worldwide each year, with about 80 percent of the people who have had a stroke suffering from gait impairments, Rewalk said.

"The exo-suit achieves our commercial goal to offer a functional and affordable system that can be utilized in the 'Main Street' clinics in every community," said ReWalk CEO Larry Jasinski.

Rewalk expects to publish the results of a multi-center clinical study of the ReStore system conducted across five of its leading rehabilitation later this year.

At time of publication, Realk's stock was trading higher by 175 percent to $5.81 per share. The stock previously closed at $3.32.

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