ReWalk Robotics Ltd. (NASDAQ: RWLK) shares absolutely exploded on Wednesday on news that the U.S. Food and Drug Administration (FDA) has cleared the firm’s ReStore soft exo-suit system for sale to rehabilitation centers across the United States.

While many of us would like to think of exo-suits as a step away from Iron Man, they’re really a step toward recovery and mobility for many of those who are disabled.

Currently, ReWalk’s ReStore is the only soft exo-suit with FDA clearance, and it is intended for use in the treatment of stroke survivors with mobility challenges. With no other real competitors, this exo-suit is easily considered “superior tech.”

Note that stroke is a leading cause of disability and affects approximately 17 million people worldwide each year. Some 80% of people who have had a stroke will suffer from gait impairments.

Last year, ReWalk launched a clinical study of the ReStore system across five of the country’s leading rehabilitation centers. The data was submitted to the FDA, and ReWalk expects to publish the results of the clinical study later this year.

Larry Jasinski, ReWalk CEO, commented:

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. With a launch price of $28,900 as well as leasing options, ReStore offers cutting edge innovation with features that redefine therapy at a price that is accessable for a broader range of clinics than existing robotic technologies. The current gait training reimbursement codes enable immediate penetration and sales growth as part of our pathway to become a break even and profitable company.

Shares of ReWalk traded up 163% to $8.75 on Wednesday, in a 52-week range of $2.46 to $33.75. The consensus price target is $4.00.

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