Recruitment Ends for SCONE Clinical Trial

After two years, SpineX Inc. has closed recruitment for the clinical trial of its proprietary SCONE device. Enrollment in the Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr – SCONE “CONTINENCE” Clinical Study began in May 2022.
 
SpineX’s SCONE device treats urinary incontinence for those with a neurogenic bladder due to spinal cord injury, multiple sclerosis, or stroke. SpineX scientists and researchers expect participants to experience a statistically significant improvement in neurogenic bladder symptoms as assessed by the Neurogenic Bladder Symptom Score (NBSS).
 
“SCONE has the power to transform the lives of millions of patients with neurogenic bladder,” SpineX Co-Founder/CEO Parag Gad said. “The data from this study will be used in SpineX’s anticipated De Novo FDA Submission in the coming months and we anticipate access to market later this year.”
 
SCONE therapy is delivered through comfortable hydrogel electrode pads placed on the skin over specific regions of the spinal column and trains the spinal cord and brain to minimize bladder control issues caused by neurogenic bladder. Treatment requires just two one-hour sessions a week.
 
Neuromodulation is at the heart of SpineX’s other flagship product, Spinal Cord Innovation in Pediatrics (SCiP), a new treatment helping children suffering from cerebral palsy. As with SCONE, SCiP uses non-invasive, transcutaneous spinal neuromodulation to help children gain voluntary mobility and improve overall function. SpineX anticipates beginning a multi-center pivotal trial for pediatric cerebral palsy patients this year.
 
Both SCONE™ and SCiP have been granted U.S. Food and Drug Administration (FDA) Breakthrough Devices designation, a process that fast-tracks regulatory review, allows direct access to FDA experts, and streamlines the approvals process.
 
SpineX Inc. is a clinical stage bioelectric medtech company developing noninvasive spinal cord neuromodulation devices as a platform technology. SCiP and SCONE are investigational devices and are limited by U.S. law to investigational use only. The FDA has not yet reviewed the safety and effectiveness of either product.