LOS ANGELES, Calif., Oct 5, 2022 – SpineX, Inc., a clinical stage medtech company today
announced the groundbreaking results its first in human study in children with cerebral palsy.
The study is published in the esteemed medical journal Nature Communications demonstrating
unparalleled functional improvements with its proprietary non-surgical treatment SCiP TM (Spinal
Cord Innovation in Pediatrics) in children with Cerebral Palsy (CP). "A pilot study combining
noninvasive spinal neuromodulation and activity-based neurorehabilitation therapy in children
with cerebral palsy", led by Dr. Susan Hastings, PT, DPT and Dr. V Reggie Edgerton, PhD is the
result of years of work championed by the two stalwarts of their respective fields. This study
discusses how delivering non-invasive spinal neuromodulation, using SCiP TM , 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 the SCiP TM device for the treatment of CP.
CP is severely debilitating with no current cure. Over 10,000 new cases are diagnosed each
year where CP is the result of damage to the developing brain and describes a group of
movement disorders that affect a person's ability to move and maintain balance and posture.
To date there are no methods or medications to prevent or treat CP. Often children with CP are
left to be treated with invasive surgeries that attempt to decrease spasticity, a common
symptom of the disease.
SCiP TM 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 TM 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 TM 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 TM
represents their second Breakthrough Device Designation following the SCONE TM device which
is in clinical trials for the treatment of Neurogenic Bladder.
About SpineX Inc.
SpineX Inc. is a clinical stage bioelectric medtech company developing noninvasive
neuromodulation devices. SCiP TM by SpineX Inc. is an investigational device being developed to
treat CP and is limited by Federal (USA) law to investigational use only. FDA has not yet
reviewed the safety or effectiveness of SCiP. SpineX is planning to submit a marketing
submission for FDA review and clearance. To learn more about SpineX, visit www.spinex.co or
follow @spinex_inc on social media.
