FDA IDE Approval for SetPoint Medical MS Neuromod

Image credit: SetPoint Medical via BusinessWire

SetPoint Medical has this month received Investigational Device Exemption (IDE) approval from the US Food and Drug Administration (FDA) to launch a study into its groundbreaking neuromodulation technology, in people with relapsing-remitting multiple sclerosis (RRMS).

Due to take place from 2025, the study will look to enrol up to 60 patients with RRMS across multiple sites in the US.

The SetPoint System is comprised of an implanted rechargeable neurostimulation device, which stimulates the vagus nerve once each day to trigger the body’s natural anti-inflammatory and immune-restoration processes.

“We look forward to initiating this pilot study to advance SetPoint’s platform in another therapeutic area,” said SetPoint Medical’s Chief Executive Officer, Dr David Chernoff, in a statement.

“The results from our studies in validated preclinical models of MS suggest that the SetPoint System has the potential to address the urgent unmet medical need for novel therapies that reduce demyelination and promote remyelination – providing new hope for people living with MS.”

This year also saw the device receive FDA Breakthrough Device Designation in the treatment of RRMS, as well as being accepted into the FDA’s Total Product Life Cycle Advisory Program (TAP) Pilot.

In Australia alone, latest data suggests 33,335 people are currently living with MS – an increase of 30 percent in the previous four years.

Refer to the SetPoint Medical website for further information.