Daily Newsletter

27 September 2023

Daily Newsletter

27 September 2023

SpineX receives funds to complete trial of SCiP device for cerebral palsy

The company plans to initiate recruitment of patients for the trial in the first half of next year.

September 27 2023

SpineX has received funds to complete a pivotal clinical trial of the SCiP device in children with cerebral palsy (CP), a movement disorder in childhood.

The National Institutes of Health, through the Small Business Innovation Research Awards, has provided the funding.

In the pivotal trial, the company will test the safety and efficacy of the SCiP device.

The data obtained from the trial will be used by the company to seek approval from the US Food and Drug Administration (FDA) for marketing and further development of the commercial device.

SCiP therapy targets the abnormal connectivity between the brain and spinal cord to treat the root causes of CP.

To date, the therapy has shown durable functional improvements that are significantly greater compared to the existing treatments in children with CP.

SCiP technology demonstrated its ability to treat the root cause of CP through spinal cord neuromodulation in investigational studies.

The company plans to initiate patient recruitment for the trial in the first half of next year and launch SCiP therapy in the US in 2026.

SpineX product director Kara Allanach said: “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.”

SCiP has previously received the breakthrough device designation based on pilot clinical results, which enabled the company to accelerate its pathway for regulatory clearance.

Generative AI set to transform the medical devices industry

Generative AI can improve personalized healthcare by collecting data from patients via wearable devices, which can provide continuous, real-time data that can complement traditional data sources such as imaging, patient records, and more. It can also enhance existing imaging techniques by generating high-quality images of organs using data from low-resolution images (such as ultrasounds). However, the collection and use of patient healthcare data through AI medical products could conflict with regulations around the globe.

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