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 and are available here. 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.”

About Nalu Medical

Nalu is a Carlsbad, California-based medical technology company focused on developing and commercializing innovative and minimally invasive solutions for patients with chronic neuropathic pain. The Nalu Neurostimulation System delivers gentle electrical pulses to the nervous system to modulate pain signals before they get to the brain. The Nalu Neurostimulation System was designed to address major unmet needs in the treatment of chronic neuropathic pain and provide a differentiated value proposition for patients and physicians.

About the Nalu Neurostimulation System

The Nalu Neurostimulation System consists of a fully featured, battery-free, miniaturized implantable pulse generator (IPG) that is powered wirelessly by an externally worn Therapy Disc and controlled through a smartphone-based remote-control app. Despite its small size, the Nalu micro-IPG™ delivers treatment capabilities like larger IPGs as well as unique advantages associated with advanced waveforms, extensive programming options, robust software upgradability, and an expected service life of 18 years. The Nalu System has been repeatedly recognized for its revolutionary technology, including being named as one of the world’s top 100 new products by R&D Magazine in 2021 and ranking number 19 in the 2023 Deloitte Technology Fast 500. It is FDA-cleared for Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS) indications. To learn more, visit https://www.nalumed.com.

Indications for Use

Peripheral Nerve Stimulation — The Nalu PNS System is indicated for pain management in adults who have severe chronic intractable pain of peripheral nerve origin as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Nalu Neurostimulation System for PNS is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (≤ 30 days) to determine efficacy before recommendation for a permanent (long-term) device.

Spinal Cord Stimulation — The Nalu SCS System is indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (≤ 30 days) to determine efficacy before recommendation for a permanent (long-term) device.

Nalu and the Nalu logo, and micro-IPG are trademarks of Nalu Medical, Inc.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260123602966/en/