SpineX Receives NIH SBIR Phase II Award for SCiP Clinical Trial in Children With CP

LOS ANGELES–(BUSINESS WIRE)–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.

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™.

Contacts

Jennifer Boon, Head of Communications, SpineX

[email protected]

Subscribe on LinkedIn

Get the free newsletter

Subscribe to MedicaEx for top news, trends & analysis

We're committed to your privacy. MedicaEx uses the information you provide to us to contact you about our relevant content, products, and services. You may unsubscribe from these communications at any time. For more information, check out our Privacy Policy.

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Businesswire is solely responsible for the content of the above news submissions. If there are any violations of laws, violations of the membership terms of this website, or the risk of infringing on the rights of third parties, businesswire will be solely responsible for legal and damage compensation. Responsibility has nothing to do with MedicaEx.

Are you in?

Subscribe to receive exclusive content and notifications to your inbox

We're committed to your privacy. MedicaEx uses the information you provide to us to contact you about our relevant content, products, and services. You may unsubscribe from these communications at any time. For more information, check out our Privacy Policy.

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.