Nalu's Implant Shows Durable Pain Relief in 2-Year Landmark Trial

CARLSBAD, CA – January 23, 2026 – By Carol Moore

For millions suffering from chronic intractable pain, long-term relief can feel like an unattainable goal. Today, new data offers a significant beacon of hope. Nalu Medical announced the publication of 24-month results from its COMFORT randomized controlled trial (RCT), providing powerful evidence that its miniaturized neurostimulation system delivers durable and life-altering relief. The study, published in the peer-reviewed journal Chronic Pain & Management, demonstrates that patients using the Nalu Neurostimulation System experienced sustained, statistically significant reductions in pain and major improvements in physical function and quality of life two years after implantation.

The long-term findings are a critical milestone for a field constantly seeking non-opioid solutions that are not only effective but also lasting. The data shows that an impressive 85% of patients were classified as responders, meaning they achieved at least a 50% reduction in pain. The average pain reduction across this group was a substantial 67%, with over a quarter of patients (28%) being classified as “high responders” with 80% or more pain relief. These results underscore the system's potential to fundamentally change the treatment paradigm for chronic neuropathic pain originating from peripheral nerves.

A New Benchmark in Clinical Evidence

The significance of the COMFORT trial extends beyond its positive outcomes; it lies in the rigor and duration of the study. While many device trials focus on short-term endpoints, the 24-month data provides a rare and crucial look at long-term efficacy. This Level-I evidence, stemming from a prospective, multicenter, randomized controlled trial, is considered the gold standard in clinical research.

“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,” stated Dr. Mitch Engle, the paper's lead author. “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.”

Beyond just pain scores, the study measured the real-world impact on patients' lives. Nearly three-quarters of subjects (74%) experienced clinically significant improvements in functionality, as measured by the Oswestry Disability Index (ODI), a tool that assesses how pain impacts daily activities like sitting, standing, and walking. Furthermore, 72% of subjects reported a meaningful improvement in their overall quality of life. The patient experience was overwhelmingly positive, with 96% of subjects reporting satisfaction with the therapy.

Innovative Technology Drives Patient-Centric Care

At the heart of these results is Nalu Medical's unique technology. The Nalu Neurostimulation System was designed to address key limitations of traditional neurostimulators. The implantable pulse generator (IPG), the component that delivers gentle electrical pulses to modulate pain signals, is miniaturized and completely battery-free. This eliminates the need for a bulky internal battery, which in older systems can cause discomfort or require periodic replacement surgeries.

Instead, the Nalu micro-IPG™ is powered wirelessly by an external, wearable Therapy Disc. This disc is controlled by a smartphone app, giving patients direct control over their therapy. This design innovation not only allows for a minimally invasive implantation procedure but also contributes to the device's remarkable longevity. The system has an expected service life of 18 years, a significant advantage over devices that may require replacement every five to ten years. This combination of a smaller implant, external power, and long-term durability has earned the system numerous accolades, including being named one of the world's top 100 new products by R&D Magazine in 2021.

Reshaping a Competitive Medtech Landscape

The robust 24-month data positions Nalu to make significant inroads in the highly competitive neurostimulation market, which is currently dominated by giants like Medtronic, Abbott, and Boston Scientific. The global market for peripheral nerve stimulators (PNS) is projected to grow to nearly $1 billion by 2034, fueled by an aging population and a desperate need for alternatives to opioid-based pain management.

Nalu's strong clinical evidence provides a key competitive differentiator. While other PNS systems exist, the COMFORT trial provides the kind of long-term, Level-I evidence that clinicians and, crucially, insurance payers look for when evaluating new technologies. The results stand in favorable comparison to data from older-generation devices, potentially establishing a new performance benchmark for the industry.

“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,” said Tom West, CEO and President of Nalu. “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.”

From Trial Data to Patient Access

For a medical device to succeed, it must not only be effective but also accessible. The path from FDA clearance, which the Nalu system has for both Peripheral Nerve Stimulation (PNS) and Spinal Cord Stimulation (SCS), to widespread patient use is paved with reimbursement hurdles. Insurance providers, including Medicare, have rigorous criteria for covering such therapies. They typically require documentation of chronic pain that has failed to respond to more conservative treatments, as well as a successful trial stimulation period where the patient experiences at least 50% pain relief.

The publication of these strong, long-term results is a powerful tool for Nalu in its discussions with payers. Demonstrating sustained efficacy, functional improvement, and high patient satisfaction over two years helps build a compelling case for the therapy's value and cost-effectiveness. By potentially reducing the need for other costly interventions, including revision surgeries or long-term medication, the system presents a strong economic argument for healthcare systems. As the medical community continues to pivot away from opioids, technologies like Nalu’s, backed by irrefutable long-term data, are poised to become a central part of the future of chronic pain management.