GTX Medical’s implantable Go-2 system has hit a major milestone. The Dutch-Swiss company, formerly known as G-Therapeutics (link in Dutch), was awarded the Breakthrough Device Designation from the US Food and Drug Administration (FDA), paving the way for its use in the treatment of adults with spinal cord injuries (SCI) and paralysis. Having received the approval, the company anticipates the first clinical trial for the complete Go-2 system in humans to take place in 2021.
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 SCI. Specifically, the device is designed to improve the reconnection of the brain with paralyzed muscles in individuals with traumatic spinal cord injury. In 2017, the FDA awarded the medtech company the same approval for its Lift system, a transcutaneous approach that delivers non-invasive electrical spinal Stimulation (NESS) therapy to treat SCI.
“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,” comments Jan Öhrström, chairman of the GTX board of directors. “With Breakthrough Device Designation for the implantable Go-2 system and for the non-invasive Lift technology, we’re 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.”