2020 06 19 - GTX announces FDA Breakthrough Device Designation

11/06/2020 - 10:05 | Portfolio

Eindhoven, NL and Lausanne, CH: June 9, 2020 - GTX medical (GTX), today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its implantable Go-2 system which was designed to promote the recovery of leg motor functions and neurological control in adults with spinal cord injuries (SCI) and paralysis.

The Go-2 System provides Targeted Epidural Spinal Stimulation (TESS) therapy, promoting the recovery of leg motor functions and neurological control in adults with spinal cord injuries (SCI). Specifically, the device is designed to improve the reconnection of the brain with paralyzed muscles in individuals with traumatic spinal cord injury. The Company anticipates the first clinical trial for the complete Go-2 system in humans to take place in 2021.

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