GTX Medical this week said it received FDA breakthrough device designation for its Go-2 targeted epidural spinal stimulation system.
The system is designed to promote the recovery of leg motor functions and neurological control in adults that have spinal cord injuries and paralysis. It improves the reconnection of the brain with paralyzed muscles and individuals with dramatic spinal cord injury.
“The FDA Breakthrough Device Designation is an important regulatory milestone and underscores the transformative potential of the Go-2 system and the unmet medical need it addresses,” chairperson of the board Jan Öhrström said in a news release. “With Breakthrough Device Designation for the implantable Go-2 system and for the non-invasive LIFT technology, we are now on an accelerated pathway. Both designations support our aim to expeditiously bring GTX’ innovative therapies for improving functional recovery, enhancing quality of life and independence of people with spinal cord injury.”
GTX Medical anticipates the first clinical trial for the complete system in humans to take place in 2021.