The 24-month results of the COMFORT Peripheral Nerve Stimulation (PNS) RCT were published on January 23, 2026 in the peer-reviewed journal Chronic Pain & Management. These results demonstrate that treatment with the Nalu Neurostimulation System resulted in durable, consistent and statistically significant improvements for chronic intractable pain, regardless of the area of the body treated and efficacy metric used.

At 24 months,

• 85% of the Active Arm and Crossover Arm were classified as responders (≥50% pain reduction) with an average pain reduction of 67%, consistent with previously published data.
• 28% were high responders (≥80% pain reduction).
• 74% of subjects experienced clinically significant improvement in functionality (p<0.001) as reported by the ODI.
• 72% of subjects reported a clinically meaningful improvement in quality of life (p<0.001).
• 96% of subjects were satisfied with the therapy.

“The 24-month outcomes of the COMFORT RCT confirm what we have seen clinically — that peripheral nerve stimulation therapy with the Nalu Neurostimulation System results in clinically significant improvement in patient symptoms, quality of life, and general well-being,” said Mitch Engle, MD, PhD, lead author of the paper. “These robust results reinforce the efficacy and safety of the Nalu Neurostimulation System with consistent pain relief across multiple anatomical targets at all timepoints, from 3 to 24 months.”

Tom West, Nalu CEO and President stated, “The 24-month outcomes provide further proof that the Nalu Neurostimulation System delivers clinically meaningful and sustained relief in patients with chronic intractable neuropathic pain. The consistency of results over the last 24 months, and the reproducible outcomes across a range of nerve targets give confidence that the Nalu Neurostimulation System is an effective PNS solution for localized pain.”