Summation
- 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.
- 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.
- “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.
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).
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.
