LOS ANGELES--(BUSINESS WIRE)--Sep 26, 2023--
SpineX Inc., a clinical stage bioelectric medtech company, is pleased to announce receipt of funding from the National Institutes of Health (NIH) through the Small Business Innovation Research Awards (SBIR). These funds will go towards completing a pivotal clinical trial to test the efficacy and safety of our proprietary SCiP™ device in children living with Cerebral Palsy (CP).
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Cerebral Palsy is the most common movement disorder in childhood. In investigational studies, SCiP technology has demonstrated the ability to treat the root cause of CP through spinal cord neuromodulation. (Photo: Business Wire)
The clinical trial will support efforts to seek approval to market from the US Food and Drug Administration (FDA), and subsequently the development of the commercial SCiP device. SCiP therapy targets the abnormal connectivity between brain and spinal cord, thereby treating the root causes of CP. “We are honored to receive Phase II funding through the SBIR program,” says Kara Allanach, Director of Product at SpineX. “Not only is it a nod to our commercial viability, it provides us with the funding to complete our trial and move quickly to market.”
To date, SCiP therapy has demonstrated durable functional improvements that are significantly greater than standard of care treatments in children with CP. “The gains my daughter made with SCiP therapy were huge compared to anything else we had tried previously,” says Jessica Oldham, mother of a young girl living with CP. “We can't wait for SCiP to be on the market.”
SCiP has been awarded the Breakthrough Device Designation based on pilot clinical data, providing an expedited pathway for regulatory clearance. SpineX plans to begin recruiting participants for the SCiP pivotal trial in the first half of 2024 and is aiming to launch SCiP therapy in the US market in 2026.
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. To learn more about SpineX, visit http://www.spinex.co or follow @spinex_inc on social media. 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™.
View source version on businesswire.com:https://www.businesswire.com/news/home/20230926401403/en/
CONTACT: Jennifer Boon, Head of Communications, SpineX
media@spinex.co
KEYWORD: CALIFORNIA UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: RESEARCH MEDICAL DEVICES CHILDREN NEUROLOGY CLINICAL TRIALS HEALTH TECHNOLOGY BIOTECHNOLOGY CONSUMER HEALTH SCIENCE
SOURCE: SpineX Inc.
Copyright Business Wire 2023.
PUB: 09/26/2023 09:30 AM/DISC: 09/26/2023 09:33 AM
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