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ReWalk Robotics Inc. (RWLK) stock surged during pre-market. Here’s what you should know.

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ReWalk Robotics Inc. (NASDAQ: RWLK) stock declined by 1.53% at the last close whereas the RWLK stock price gains by 63.57% in the pre-market trading session. ReWalk Robotics creates, manufactures, and sells wearable robotic exoskeletons for people who have lost their lower limbs due to a spinal cord injury or stroke. Through the design and growth of market-leading robotic technology, ReWalk’s objective is to profoundly enhance the quality of life for people with lower limb disabilities.

RWLK stock’ Significant Development

The Food and Drug Administration has designated ReWalk Robotics’ ReBoot technology as a Breakthrough Device, according to the company (FDA). The ReBoot is a battery-powered, lightweight exo-suit designed to aid ambulatory functions in those who have lost ankle function due to neurological impairments like stroke. The ReBoot is a personal device that can be customized for usage at home or in the community. It’s a sister product of the ReStore device, which was approved by the FDA for use in the rehabilitation environment in 2019.

Larry Jasinski, CEO of ReWalk stated that,

The FDA’s breakthrough device designation is a major accomplishment for ReBoot, as it opens the door to a more expedited review process, allowing the technology to reach the market sooner. The ReBoot will provide stroke survivors with a gadget that can be customized for each unique user, allowing them to receive frequent help at home and in the community.

Furthermore,

The ReBoot operates in conjunction with the muscles in the damaged leg to help people not only retain proper foot posture but also push off the ground, potentially improving their gait. It could also:

  • Muscle re-education, particularly of plantar flexor function, should be made easier.
  • Disuse atrophy can be avoided or delayed.
  • Maintain or enhance the range of mobility in your joints.
  • Improve your walking speed and endurance without using a gadget.
  • Reduce the number of falls caused by inadequate foot placement as a result of foot drop.

The Breakthrough Devices Program is a voluntary program that recognizes specific medical devices and device-led combination solutions that improve the cure or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

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