SpineX has announced that it is close to full recruitment of the patient cohort for a clinical trial of its proprietary SCONE device, recently passing the 80% mark. SCONE is an innovative device that treats urinary incontinence, allowing people living with neurogenic bladder due to spinal cord injury, multiple sclerosis or stroke to “live life on their own terms”, as stated in a press release.
The CONTINENCE clinical study began in May 2022 and is expected to complete in early 2024. SpineX scientists and researchers anticipate participants will experience a statistically significant improvement in symptoms of neurogenic bladder, as assessed by the Neurogenic bladder symptom score (NBSS). Recruitment is proceeding “apace”, with 95 subjects currently enrolled, the company also claims.
Data from this study will be used in SpineX’s anticipated de novo US Food and Drug Administration (FDA) submission “in the coming months” too.
“We truly believe SCONE will transform the treatment of neurogenic bladder, providing non-invasive treatment for millions of people living with [the condition],” said Parag Gad, SpineX co-founder and chief executive officer. “The underlying science of neuromodulation is the key to treating a huge variety of neurological conditions and we are already exploring applications for a broad group of indications.”
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 minimise bladder control issues caused by neurogenic bladder. Treatment is simple, requiring just two one-hour sessions a week, according to SpineX.
Neuromodulation is also at the heart of SpineX’s other flagship product, Spinal Cord Innovation in Pediatrics (SCiP)—a “bold” 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 multicentre pivotal trial for children with cerebral palsy in 2024.
Spine X notes in its recent release that both SCONE and SCiP have been granted FDA Breakthrough Device designations.
