Presidio Medical Receives IDE Approval for Back Pain Neuromodulation Trial

Presidio Medical has secured FDA investigational device exemption (IDE) approval to launch a pivotal trial of its ultra-low frequency (ULF) neuromodulation platform for treating chronic nociceptive low back pain (LBP). Affecting 619 million people globally, LBP often stems from tissue damage like muscle strain or trauma. Presidio’s spinal cord stimulation (SCS) device delivers ULF currents to block pain signals in the lower back.

The randomized FULFILL trial will begin in the US and Australia. Early human trials showed 53% of patients experienced 80–100% pain relief. Results were presented at the 2025 NANS meeting.

Neuromodulation is an evolving field, with companies like Mainstay Medical also making strides. Their ReActiv8 device showed significant disability improvement in a one-year study. WHO estimates LBP cases will rise to 843 million by 2050 due to aging, inactivity, obesity, and muscle weakness.

23-06-2025