SpineX Receives FDA Breakthrough Device Designation for SCiP

SpineX Receives FDA Breakthrough Device Designation for SCiP




SpineX Receives FDA Breakthrough Device Designation for SCiP

SpineX’s Proprietary non-surgical Device SCiP Offers New Hope for children with Cerebral Palsy

LOS ANGELES, Calif., May 02, 2022 (GLOBE NEWSWIRE) — SpineX, Inc., an early stage medtech company today announced FDA Breakthrough Device Designation for SCiP (Spinal Cord Innovation in Pediatrics) and the proposed treatment of cerebral palsy (CP) in children. CP is the most common childhood motor disorders in the U.S., affecting an estimated 1 in 345 children. CP is debilitating with no cure. Over 10,000 new cases are diagnosed each year where CP is the result of damage to the developing brain, and describes a group of movement disorders that affect a person’s ability to move and maintain balance and posture. To date there are no methods or medications to prevent or treat CP. Often children with CP are left to be treated with permanent invasive surgeries that attempt to decrease spasticity, a common symptom of the illness.

SCiP is a non-invasive spinal electrical neuromodulation device which provides transcutaneous spinal cord stimulation to potentially treat the underlying neurological dysfunction in pediatric patients with CP. SCiP aims to be the first medical device in the U.S. to treat CP by transforming the brain and spinal cord dysfunctional connectivity into highly functional systems, having shown great promise in early clinical feasibility studies.

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“We are delighted to achieve Breakthrough Device Designation for SCiP. Our initial clinical studies with SCiP have shown impressive results compared to current standard of care and we hope to be the new standard of care for CP in the near future,” commented Dr. Parag Gad, PhD, CEO of SpineX. “This Breakthrough Device Designation will expedite our progress and make this therapy available to children addressing an unmet medical need”.

“At just three years old and highly affected, our son has shown such exciting progress since he began using SCiP,” said Dana Harmon, mother of a young boy diagnosed with CP who was enrolled a in clinical study sponsored by SpineX. “We’re so grateful that our son was included in the clinical study with SCiP as it has opened up a world of possibilities for our son, and we hope others will be able to witness it soon!”

“In just three weeks, SCiP helped Ben and William gain so many new skills,” said Sharon Rosuck, mother of twin boys diagnosed with CP who were enrolled in a clinical study sponsored by SpineX. “SCiP will change the lives of so many families in ways that you wouldn’t even believe possible. SCiP makes the impossible possible and opens so many more doors of opportunity for the Cerebral Palsy community”.

Spinal Neuromodulation is being developed as a platform technology by SpineX and SCiP represents their 2nd Breakthrough Device Designation following the SCONETM device which was recognized for Neurogenic Bladder.

About SpineX Inc.
SpineX Inc. is an early stage bioelectric medtech company developing Noninvasive Neuromodulation devices that leverages cutting-edge research from the lab of Dr. V Reggie Edgerton, PhD at UCLA. SCiP by SpineX Inc. is an investigational device being developed to treat cerebral palsy and is limited by Federal (USA) law to investigational use only. FDA has not reviewed the safety or effectiveness of SCiP. To learn more about SpineX, visit www.spinex.co or follow @spinex_inc on social media.

Media Inquiries: Parag Gad, CEO, (408) 203 5061 email: parag@spinex.co