SpineX has closed recruitment for the CONTINENCE clinical trial of its proprietary Scone device. The study began back in May 2022 and is evaluating the company’s spinal cord stimulation (SCS) technology in the treatment of neurogenic bladder patients.
Scone is described by SpineX as 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”.
In a press release, the company further claims that its scientists and researchers anticipate that patients included in the CONTINENCE study will experience a statistically significant improvement in symptoms of neurogenic bladder, as assessed by the neurogenic bladder symptom score (NBSS).
“Scone has the power to transform the lives of millions of patients with neurogenic bladder,” said SpineX co-founder and chief executive officer Parag Gad. “The data from this study will be used in SpineX’s anticipated de novo FDA [Food and Drug Administration] 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 minimise bladder control issues caused by neurogenic bladder. This treatment is simple, requiring just two one-hour sessions per week, according to SpineX.
Neuromodulation is at the heart of SpineX’s other flagship product, Spinal Cord Innovation in Pediatrics (SCiP)—a new treatment intended to help 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, as per its recent release.
Both Scone and SCiP have been granted US FDA Breakthrough Device designations.
