SpineX Inc. Announces Significant Improvement in Urinary Bladder Function in Paralyzed Individuals with SCONE™ Therapy

SCONE™ Therapy Demonstrates Safety and Efficacy in Global Pivotal Trial

• More than 50% of participants reported clinically significant improvement in neurogenic bladder symptoms
• Positive outcomes observed in individuals with spinal cord injury (SCI), stroke, or multiple sclerosis (MS)
• Additional benefits reported in Bowel and Sexual function

LOS ANGELES--(BUSINESS WIRE)--SpineX Inc., a pioneering medical technology company developing innovative non-surgical spinal cord neuromodulation solutions, today announced the results of its global, multisite pivotal trial, CONTINENCE, evaluating the safety and efficacy of SCONE™ therapy for neurogenic bladder (NB) in individuals with paralysis due to spinal cord injury (SCI), stroke, or multiple sclerosis (MS).

The study demonstrated a statistically significant improvement in NB symptoms in the target patient group who received SCONE™ therapy compared to those who received sham treatment. At the end of the 12-week trial, more than 50% of participants receiving SCONE therapy showed a clinically significant response, as measured by a reduction of 10 points or more on the Neurogenic Bladder Symptom Score (NBSS), a key metric of bladder health.

“The results of the SCONE CONTINENCE trial are highly encouraging,” said Dr. V Reggie Edgerton, PhD, Co-Founder of SpineX Inc. “Participants not only reported fewer episodes of urinary incontinence but also improvements in bladder sensation, urgency control, and reduced nighttime awakenings. Participants also reported needing fewer catheters throughout the day - a groundbreaking outcome.”

“Restoring bladder, bowel, and sexual function is a top priority for individuals with paralysis, who have endured a lack of effective therapies for far too long,” said Parag Gad, Ph.D., Co-Founder and CEO of SpineX Inc. “Unfortunately, effective treatment options have remained elusive—until now. At SpineX, we are dedicated to advancing non-invasive neuromodulation technologies that empower people to regain control and live life on their own terms. SCONE™ therapy marks a transformative step forward in the treatment of neurological conditions—shifting the focus from merely managing symptoms to actively restoring function.”

SCONE™ is a non-invasive spinal cord neuromodulation device designed to target spinal neurons and address the root causes of neurogenic bladder dysfunction. Previously, the U.S. Food and Drug Administration (FDA) granted SCONE™ Breakthrough Device Designation based on promising early clinical data. The clinical data from the CONTINENCE trial will support regulatory submissions to obtain approval for marketing.

The CONTINENCE trial was a prospective, single-blinded, sham-controlled pivotal study evaluating the safety and effectiveness of SCONE™ therapy for neurogenic bladder in individuals living with paralysis due to SCI, stroke or MS. The global study was conducted at 13 leading medical centers across the United States, Canada and India.

SpineX Inc. is a clinical-stage bioelectric MedTech company pioneering non-invasive spinal neuromodulation therapies. The company is developing SCONE™ and SCiP™, two FDA-designated Breakthrough Devices aimed at treating neurogenic bladder in adults and cerebral palsy in children, respectively. All SpineX Inc. devices and therapies, including SCONE™ and SCiP™, are investigational and not yet available for commercial use.

For more information, visit www.spinex.co or follow @spinex_inc on social media.