Nalu PNS System Achieves Significant and Durable Pain Reduction, Meeting the Primary Endpoint of the COMFORT RCT Study

CARLSBAD, Calif.--(BUSINESS WIRE)--Nalu Medical Inc. (“Nalu”) revealed significant findings from a landmark clinical trial evaluating the Nalu Peripheral Nerve Stimulation (PNS) System utilizing their proprietary micro-implantable pulse generator (micro-IPG™) to treat chronic pain patients.

The Nalu COMFORT study is a post-market, multicenter, randomized, controlled trial (RCT) evaluating pain reduction and functional outcomes across a variety of peripheral pain targets. The primary endpoint was met, showing Nalu PNS outperformed conventional care alone (p < 0.001). Results were published in Regional Anesthesia & Pain Medicine highlighting sustained therapeutic efficacy and safety.¹

88% of patients using Nalu PNS achieved ≥50% pain relief at 6 months (n=46)

• Patients using Nalu PNS showed a 70% average pain reduction.
• Outcomes were consistent across all anatomical areas in the study, including shoulder, low-back, knee, and foot/ankle pain.
• Devices utilized Nalu advanced programming.

Nalu PNS delivered clinically meaningful functional outcome benefits in addition to significant pain relief

• 98% reported overall improvement.
• 70% reported quality of life improvement.
• 80% reported reduction in depression.
• 72% reported reduction in disability.

“For the first time, interventional pain management clinicians can confidently provide SCS-level outcomes with a PNS system that is proven with RCT data,” said Dr. John Hatheway, lead author of the study and interventional pain medicine physician at Northwest Pain Care in Spokane, WA. “In addition to significant pain reduction, the COMFORT study demonstrated meaningful improvements in quality of life, mood, and functionality.”

There were no reports of pocket pain, a common concern with traditional implanted neurostimulation devices.² There were also no serious device-related adverse effects and the vast majority of patients found the external components comfortable to wear.

Nalu Medical is leading the charge in developing Level-1 evidence for PNS

The ongoing COMFORT RCT study will monitor patients over a three-year period. Another study, COMFORT 2, is currently enrolling patients with anticipated completion of enrollment in 2024. Together, COMFORT and COMFORT 2 are designed to enroll the largest cohort to date of randomized controlled trial subjects comparing the responder rate of Nalu PNS combined with conventional care to the responder rate of conventional care alone.

“Our dedication to rigorous research cements our leadership in the field,” stated Tom West, CEO and President of Nalu. “The clinical outcomes unveiled by the COMFORT RCT study demonstrate that our technology yields unparalleled benefits for chronic pain patients, setting a new standard of care for PNS.”

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, the Nalu logo, and micro-IPG are trademarks of Nalu Medical, Inc.

1. Hatheway J, Hersel A, Song J, et al. Clinical study of a micro-implantable pulse generator for the treatment of peripheral neuropathic pain: 3- and 6-month results from the COMFORT randomised controlled trial. Reg Anesth Pain Med. 2024.
2. Burke L, Desai MJ. Pocket pain following spinal cord stimulator generator implantation: A narrative review of this under-reported risk. Pain Pract. Apr 2024;24(4):659-669. doi:10.1111/papr.13336.