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

CARLSBAD, Calif.--(BUSINESS WIRE)--The results of COMFORT 2, the second Nalu Medical Peripheral Nerve Stimulation (PNS) RCT, were published on July 30^th, 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. “The fact that the results of COMFORT 2 are consistent with those from COMFORT further reinforces the clinical value of this important therapy in helping patients return to a satisfying life.”

Tom West, Nalu CEO and President stated, “This Level-1 confirmatory evidence provides further proof that the Nalu PNS System provides clinically meaningful improvement in the patient’s condition. The consistent and reproducible outcomes across a range of nerve targets give confidence that the use of Nalu PNS therapy, regardless of the area of the body treated, will result in significant relief in patients with chronic intractable 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 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 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 similar to 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, http://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.

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