SpineX closes recruitment for SCONE™ clinical trial
April 8, 2024—Los Angeles, CA – SpineX Inc. has closed recruitment for its clinical trial of its proprietary SCONE™ device. The clinical trial—Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr – SCONE “CONTINENCE” Clinical Study—began in May 2022.
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. 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).
“SCONE has the power to transform the lives of millions of patients with neurogenic bladder,” says Parag Gad, SpineX co-founder & CEO. “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 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.
SCONE™ and SCiP™ are investigational devices and are limited by Federal (USA) law to investigational use only. FDA has not yet reviewed the safety and effectiveness of SCONE™ and SCiP™. Visit www.spinex.co to learn more about SpineX Inc.
Contact:
Jennifer Boon, Head of Communications, SpineX
media@spinex.co