Nalu Announces Publication of Results from COMFORT 2 Randomized Control Trial (RCT) Making Nalu the First Permanent PNS Device to Demonstrate Level-1 Clinical Evidence
Excerpt from the Press Release:
CARLSBAD, Calif.–(BUSINESS WIRE)–The results of COMFORT 2, the second Nalu Medical Peripheral Nerve Stimulation (PNS) RCT, were published on July 30th, 2025, in the peer-reviewed journal Chronic Pain & Management and are available here. These results confirm the positive clinical outcomes from the COMFORT trial, the first Nalu PNS RCT, and provide the first Level-1 confirmatory evidence for a permanently implanted PNS device for treating chronic pain.
COMFORT 2 results showed improved net health outcomes with statistically significant gains across all efficacy metrics:
- At 3 months, in the COMFORT 2 Active Arm, there was an 80% responder rate where responders achieved at least 50% pain relief, and there was an average pain reduction of 66% (p<0.001) compared to a 4% responder rate and 3% pain reduction for the Control Arm. At 6 months, the responder rate held at 79% with an average pain relief of 64%.
- 75% of COMFORT 2 Active Arm subjects had clinically significant improvement in functionality (p<0.001) as measured by the Oswestry Disability Index.
- 73% of COMFORT 2 Active Arm patients reported a clinically meaningful improvement in quality of life (p<0.001).
- At 6 months, the pooled data from both COMFORT and COMFORT 2 showed an 82% responder rate with an average pain reduction of 66% (p<0.001) in the Active Arm compared to 4% in the Control Arm.
- 97% of the pooled Active Arm subjects were responders as reported in the Patient Global Impression of Change (p<0.001).
“The outcomes from COMFORT 2 confirm what we have seen clinically — that PNS therapy with the Nalu PNS 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.
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