Nalu Medical's COMFORT 2 Trial Establishes First Level-1 Evidence for Permanent Peripheral Nerve Stimulation in Chronic Pain
核心洞察
The COMFORT 2 randomized controlled trial demonstrated an 80% responder rate at 3 months with 66% average pain reduction in patients using the Nalu PNS System (搜索), compared to just 4% responder rate in controls.
Results published in Chronic Pain (搜索) & Management represent the first Level-1 confirmatory evidence for a permanently implanted peripheral nerve (搜索) stimulation device for chronic pain treatment.
Pooled data from both COMFORT trials showed 82% of patients achieved at least 50% pain relief at 6 months, with 97% reporting improvement on Patient Global Impression of Change measures.
Nalu Medical (搜索) has achieved a significant milestone in chronic pain (搜索) management with the publication of COMFORT 2 trial results, establishing the first Level-1 confirmatory evidence for a permanently implanted peripheral nerve (搜索) stimulation (PNS) device. The randomized controlled trial results, published July 30, 2025, in the peer-reviewed journal Chronic Pain & Management, demonstrate substantial efficacy improvements across multiple clinical measures.
Trial Results Show Dramatic Pain Relief
The COMFORT 2 trial delivered compelling efficacy data with statistically significant improvements across all measured outcomes. At 3 months, the active treatment arm achieved an 80% responder rate, with responders experiencing at least 50% pain relief and an average pain reduction of 66% (p<0.001). This contrasted sharply with the control arm, which showed only a 4% responder rate and 3% pain reduction.
The therapeutic benefits proved durable, with the responder rate maintaining at 79% at 6 months alongside an average pain relief of 64%. Beyond pain reduction, 75% of active arm subjects demonstrated clinically significant functional improvement as measured by the Oswestry Disability Index (p<0.001), while 73% reported clinically meaningful quality of life improvements (p<0.001).
Pooled Analysis Reinforces Consistent Outcomes
When combined with data from the original COMFORT trial, the pooled analysis at 6 months revealed an 82% responder rate with 66% average pain reduction (p<0.001) in the active arm, compared to 4% in controls. Remarkably, 97% of pooled active arm subjects reported improvement according to the Patient Global Impression of Change scale (p<0.001).
"The outcomes from COMFORT 2 confirm what we have seen clinically — that PNS therapy with the Nalu PNS System (搜索) 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."
Revolutionary Device Technology
The Nalu Neurostimulation System (搜索) represents a technological advancement in neurostimulation therapy, featuring a fully-featured, battery-free, miniaturized implantable pulse generator (IPG) powered wirelessly by an externally worn Therapy Disc. Despite its compact size, the Nalu micro-IPG delivers treatment capabilities comparable to larger IPGs while offering unique advantages including advanced waveforms, extensive programming options, robust software upgradability, and an expected service life of 18 years.
The system's smartphone-based remote control app provides patients with convenient therapy management. The device has received recognition for its innovative technology, including selection 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.
Clinical Indications and Applications
The Nalu PNS System (搜索) is FDA-cleared for pain management in adults with severe chronic intractable pain (搜索) of peripheral nerve (搜索) origin, serving either as the sole treatment or as an adjunct to other therapies in a multidisciplinary approach. The system is not intended for craniofacial pain treatment. Trial devices are used for stimulation periods of 30 days or less to determine efficacy before permanent device implantation.
Additionally, the system holds FDA clearance for spinal cord stimulation (SCS) applications, indicated for chronic intractable pain (搜索) of the trunk and/or limbs, including unilateral or bilateral pain presentations.
Market Impact and Future Implications
Tom West, Nalu CEO and President, emphasized the significance of achieving Level-1 evidence: "This Level-1 confirmatory evidence provides further proof that the Nalu PNS System (搜索) 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 (搜索)."
The Carlsbad, California-based medical technology company focuses on developing minimally invasive solutions for chronic neuropathic pain (搜索). The Nalu system addresses major unmet needs in chronic neuropathic pain treatment by delivering gentle electrical pulses to modulate pain signals before they reach the brain, providing a differentiated value proposition for both patients and physicians in the evolving pain management landscape.