Cerebral Palsy is very painful and there is no cure for it right now. Every year, around 10,000 new instances of CP are diagnosed. CP is caused by injury to the developing brain and represents a collection of movement disorders that impact a person’s ability to move and maintain balance and posture.

The outcomes of the first human research using a novel, non-invasive, non-surgical SCiP device to treat children with cerebral palsy.

SpineX, Inc., a clinical-stage MedTech startup, reported today the revolutionary results of its first in-person trial in children with cerebral palsy.

The research, which was published in the prestigious medical journal Nature Communications, shows that infants with cerebral palsy who get the company’s patented non-surgical treatment SCiP TM (Spinal Cord Innovation in Pediatrics) have remarkable functional improvements (CP).

This study talks about how giving non-invasive spinal neuromodulation using SCiP TM during Physical Therapy improved voluntary sensorimotor function in 16 of 16 children with different ages and levels of CP.

For treating CP and SCiP, SpineX received the Breakthrough Device Designation (BDD) from the US FDA.

Additionally, SpineX and the FDA are working together to develop a clinical trial that will be carried out in 2023, the results of which are expected to result in FDA approval of the SCiP TM device for the treatment of CP.

Cerebral Palsy is very painful and there is no cure for it right now. Every year, around 10,000 new instances of CP are diagnosed. CP is caused by injury to the developing brain and represents a collection of movement disorders that impact a person’s ability to move and maintain balance and posture.

There are currently no treatments or preventative measures for CP. Children with CP are frequently left to undergo invasive procedures in an effort to minimize stiffness, which is a common complication of the condition.

SCiPTM is a non-invasive spinal electrical neuromodulation device that uses transcutaneous spinal cord neuro-stimulation to treat the underlying neurological dysfunction in children with CP.

By converting the defective communication between the brain and spinal cord into highly functional systems, SCiP TM seeks to be the first medical device in the United States to treat cerebral palsy (CP).

“At just three years old and highly affected by CP, our son has shown such exciting progress since he began using SCiP,” comments 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.”

SpineX is working on Spinal Neuromodulation as a platform technology, and SCiPTM is their second Breakthrough Device Designation after SCONETM, which is in clinical trials to treat Neurogenic Bladder.

Source: 10.1038/s41467-022-33208-w

Image Credit: Getty

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