ARC-EX SCS therapy delivers targeted, programmed electrical stimulation transcutaneously to the spinal cord. The technology uses electrodes placed on the back of the neck for non-invasive therapy without the need for surgery. It enables increased strength, movement and function in the upper limbs after SCI. The company submitted ARC-EX to the FDA for approval in April.
Results from the company’s Up-LIFT study showed that ARC-EX achieved all primary safety and effectiveness endpoints. Additionally, ARC-EX showed significant improvements in upper limb strength, function and sensation. That study looked at subjects with chronic tetraplegia due to cervical spinal cord injury (SCI).