One-year data from the Nalu COMFORT randomized controlled trial (RCT), published in Regional Anesthesia & Pain Medicine, confirms the long-lasting effectiveness of Nalu’s peripheral nerve stimulation (PNS) technology in providing durable pain relief and significant functional improvement. The findings, which reinforce earlier results at three and six months, demonstrate that Nalu technology is a reliable and suitable option for routine clinical application.
Sustained Pain Reduction
The one-year data (N=61) showed promising results for patients treated with the Nalu Neurostimulation System:
- 87% of patients experienced at least 50% pain relief.
- Patients saw an average pain reduction of 69%.
- 95% reported overall improvement in their condition.
These outcomes help solidify Nalu as a leading solution in PNS and pave the way for broader access, particularly as more commercial payors are expected to offer coverage for PNS, matching the benefits already available through Medicare and Medicare Advantage plans.
Tom West, Nalu’s CEO and President, commented, “These results highlight the significant, long-term improvements in pain, quality of life, and functionality that our patients experience. The data from the COMFORT trial show results far exceeding other PNS RCTs, and align with the positive outcomes we’ve seen in real-world applications of Nalu technology. Our findings showcase the profound clinical impact of Nalu in providing enduring relief to those with chronic pain.”
Functional and Psychological Improvements
In addition to pain relief, patients in the trial also showed substantial improvements in overall health status. Notable outcomes include:
- 78% of patients reported a reduction in depression.
- 73% reported a decrease in disability.
- 70% saw an improvement in quality of life.
Dr. John Hatheway, lead investigator of the COMFORT RCT, emphasized, “Nalu PNS therapy consistently delivered statistically significant improvements in pain, disability, quality of life, and mood. This level of durable, long-term improvement in multiple areas is unparalleled. Beyond pain relief, patients are able to regain a more fulfilling life, which makes a substantial difference in their overall wellbeing.”
About Nalu Medical
Nalu Medical, based in Carlsbad, California, develops innovative, minimally invasive solutions for patients suffering from chronic neuropathic pain. The Nalu Neurostimulation System uses gentle electrical pulses to modulate pain signals before they reach the brain, addressing significant unmet needs in chronic pain treatment.
About the Nalu Neurostimulation System
The Nalu System is a small, fully-featured, battery-free implantable pulse generator (IPG) that is powered wirelessly by an externally worn Therapy Disc. The system is controlled via a smartphone app, providing patients with convenience and ease of use. Despite its small size, the Nalu micro-IPG™ delivers treatment comparable to larger devices, with added benefits such as advanced waveforms, multiple programming options, and an expected service life of 18 years. The Nalu System is FDA-cleared for both Spinal Cord Stimulation (SCS) and Peripheral Nerve Stimulation (PNS).
