SpineX Inc announces results from its first in-human study in children with cerebral palsy. The study, published in Nature Communications, demonstrates functional improvements with its proprietary non-surgical treatment SCiP (Spinal Cord Innovation in Pediatrics) in children with Cerebral Palsy (CP).
Led by Dr. Susan Hastings, PT, DPT and Dr. V Reggie Edgerton, PhD, the study discusses how delivering non-invasive spinal neuromodulation, using SCiP, during physical therapy improved voluntary sensorimotor function in 16 out of 16 children over a wide range of ages and severities of CP.
SpineX was awarded the Breakthrough Device Designation (BDD) from US FDA for SCiP and the proposed treatment of CP. In addition, SpineX has engaged with FDA to gain alignment on a proposed clinical trial to be conducted in 2023; the results of which are anticipated to lead to FDA clearance of theSCiP device for the treatment of CP.
SCiP is a non-invasive spinal electrical neuromodulation device which provides transcutaneous spinal cord neuro-stimulation to potentially treat the underlying neurological dysfunction in pediatric patients with CP. SCiP aims to be the first medical device in the U.S. to treat CP by transforming the brain and spinal cord dysfunctional connectivity into highly functional systems.
“At just three years old and highly affected by CP, our son has shown such exciting progress since he began using SCiP,” said Dana, the mother of a young boy diagnosed with CP who was enrolled in a clinical study sponsored by SpineX. “We’re so grateful that our son was included in the clinical study with SCiP as it has opened up a world of possibilities for our son, and we hope others will be able to witness it soon.”
Spinal Neuromodulation is being developed as a platform technology by SpineX, and SCiP represents their second Breakthrough Device Designation following the SCONE device, which is in clinical trials for the treatment of Neurogenic Bladder.
[Source(s): SpineX Inc, Business Wire]