CARLSBAD, Calif.--(BUSINESS WIRE)--One-year data from the Nalu COMFORT randomized control trial (RCT) published in the peer-reviewed Regional Anesthesia & Pain Medicine journal confirm the consistent performance of Nalu peripheral nerve stimulation (PNS) technology in delivering pain relief that lasts and functional improvement that is truly meaningful.1 Results at 1 year reinforce earlier 3- and 6-month findings, demonstrating that Nalu technology is clearly appropriate for confident, routine application.
Durable Reduction of Pain
1-year results include the following highlights (N=61)1:
- 87% of patients experienced 50% or more pain relief.
- 69% average pain reduction.
- 95% of patients reported overall improvement.
The publication of robust 1-year data helps position the Nalu Neurostimulation System as the standard of care in PNS and furthers the efforts of Nalu to achieve unencumbered access to PNS. It is anticipated that broadening coverage to include commercial payors will provide access to PNS for patients who do not have the full coverage enjoyed by Medicare and Medicare Advantage plan participants.
According to Tom West, Nalu CEO and President, “These results confirm that Nalu patients achieve significant and durable improvement in pain, quality of life, and functionality. The COMFORT 1-year outcomes are significantly better than results for other permanent PNS RCTs, and the data are consistent with the impressive results reported in Nalu real world experience. These results underscore the undeniable value and clinical impact of our technology in providing lasting relief for those suffering from chronic, intractable pain.”
Significant Improvement in Overall Health Status
In addition to significant reduction in pain levels, the majority of patients achieved the minimal clinically important difference (MCID) at 1 year for the various patient-reported outcomes (N=61)1:
- 78% of patients reported a reduction in depression.
- 73% of patients reported a reduction in disability.
- 70% of patients reported an improvement in quality of life.
John Hatheway, MD, lead investigator for the COMFORT RCT trial, adds specific details: “This study demonstrated that Nalu PNS therapy provided robust, consistent, and durable statistically significant improvement in pain, disability, quality of life, and mood. This level of long-term improvement from PNS across a spectrum of anatomic areas has not been previously reported. It is also important to note that beyond significant, long-term reduction in pain, patients with the Nalu PNS System are typically able to get back to a more satisfying experience of life.”
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, exceptional 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 www.nalumed.com.
Indications for Use
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.
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.
Nalu and the Nalu logo are trademarks of Nalu Medical, Inc.
- Hatheway J, Hersel A, Engle M, et al. Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 12-month results from the COMFORT-randomized controlled trial. Regional Anesthesia & Pain Medicine. Published Online First: 20 November 2024. doi: 10.1136/rapm-2024-106099
