LOS ANGELES--(BUSINESS WIRE)--SpineX Inc. is today announcing close to full recruitment -- over 80% -- of the patient cohort for its clinical trial of its proprietary SCONE™ device. 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.
The clinical trial—Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE “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 data from this study will be used in SpineX’s anticipated De Novo FDA Submission in the coming months.
“We truly believe SCONE will transform the treatment of neurogenic bladder, providing non-invasive treatment for millions of people living with neurogenic bladder,” says Parag Gad, SpineX co-founder & CEO. “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 minimize bladder control issues caused by neurogenic bladder. Treatment is simple, requiring 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 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 multi-center pivotal trial for children with Cerebral Palsy in 2024.
Both SCONE™ and SCiP have been granted FDA Breakthrough Devices designation, a process that fast-tracks regulatory review, allows direct access to FDA experts, and streamlines the approvals process.
About SpineX Inc.
SpineX Inc. is a clinical stage bioelectric MedTech company developing noninvasive spinal cord neuromodulation devices as a platform technology. SCONE™ and SCiP™ are two FDA-designated Breakthrough Devices being developed by SpineX for the treatment of adults with Neurogenic Bladder and Children with Cerebral Palsy respectively. SCiP™ and SCONE™ are investigational devices and are limited by Federal (USA) law to investigational use only. FDA has not yet reviewed the safety and effectiveness of SCIP™ or SCONE™. spinex.co
