SpineX announced today that its first-in-human study backs the use of its proprietary non-surgical treatment for children with cerebral palsy (CP).
Los Angeles-based SpineX published the study in Nature Communications. Dr. Susan Hastings and Dr. V Reggie Edgerton led the study.
SCiP demonstrated unparalleled functional improvements with SCiP (spinal cord innovation in pediatrics) in children with CP. The study combined non-invasive spinal neuromodulation and activity-based neurorehabilitation therapy, SpineX said in a news release.
SpineX said SCiP delivery during physical therapy improved sensorimotor function in 16 of 16 children. This patient population included a wide range of ages and CP severity. The treatment holds breakthrough device designation from the FDA. The company plans to align with the agency for a proposed clinical trial for 2023. It plans to use the results to pursue FDA clearance for SCiP in the treatment of CP.
The SCiP neuromodulation device provides transcutaneous spinal cord neuro-stimulation. SpineX designed it to potentially treat the underlying neurological dysfunction in pediatric patients with CP. The company said it aims to make SCiP the first medical device in the U.S. for treating CP “by transforming the brain and spinal cord dysfunctional connectivity into highly functional systems.”
“A world of possibilities” with the SpineX SCiP system
“At just three years old and highly affected by CP, our son has shown such exciting progress since he began using SCiP,” Dana, the mother of a young boy diagnosed with CP who was enrolled in a clinical study sponsored by SpineX, said in the news release. “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.”
SpineX also holds FDA breakthrough device designation for its SCONE device for treating neurogenic bladder. The company enrolled the first patient in its trial for the system in June.