ReWalk’s Momentum Continues with New Nod from FDAReWalk’s Momentum Continues with New Nod from FDA

ReWalk Robotics has secured a clearance from FDA for the ReStore soft exo-suit system. The Marlborough, MA and Yokneam Ilit, Israel-based company said exo-suit is intended for use in the treatment of stroke survivors with mobility challenges.

The ReStore system is comprised of a soft, garment-like design which connects to a lightweight waist pack and mechanical cables that help lift the patient's affected leg in synchronized timing with their natural walking pattern.

The patient wears the device in a waist pack, which holds two motors, each with a cable that goes down to the foot and ankle. The cables then extend to a foot plate under the shoe. Sensors clipped to the patient’s shoes detect motion and communicate to a smart phone controller when the user needs assistance in moving the foot. Using data analytics displayed on the smart phone, a therapist can adjust the assistance level, monitor key metrics, and record standard gait-training assessments.

"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," ReWalk CEO Larry Jasinski, said in a release. "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 accessible 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."

ReWalk’s technology has generated significant mainstream attention, which includes being featured on an episode of the now-cancelled Glee, and being brought to the attention of former President Barack Obama back in 2013.

ReWalk won its first FDA nod back in 2014 for an exosuit aimed at providing mobility for spinal cord injury patients. Shortly after the approval, ReWalk filed for an IPO.