Nalu Medical Begins Enrollment in Peripheral Nerve Stimulation Trial

Nalu Medical Inc. has enrolled its first patient in the COMFORT-2 peripheral nerve stimulation randomized controlled study.
 
Together with COMFORT-1, COMFORT-2 (Clinical Study Of A Micro-Implantable Pulse Generator For the Treatment of Peripheral Neuropathic Pain) aims to enroll the largest cohort of randomized controlled trial subjects comparing the responder rate of PNS combined with conventional medical management versus the responder rate of conventional medical management alone.
 
Up to 8 million people in the United States suffer from peripheral neuropathic pain.¹ The Nalu Neurostimulation System for PNS (Nalu PNS system) is cleared by the U.S. Food and Drug Administration (FDA) for spinal cord stimulation and peripheral nerve stimulation indications.. It offers long-term pain relief with an FDA-cleared 18-year serviceable life.
 
The Nalu PNS system incorporates a battery-free, micro implantable pulse generator (micro-IPG), powered by an externally worn device (Therapy Disc) housing the battery and controller. The system utilizes mild electrical pulses to create an energy field that acts to modulate the transmission of pain signals to the brain. 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, upgradability, and an expected service life of 18 years.  
 
Dr. John Hatheway, interventional pain physician at Northwest Pain Care in Spokane, Wash., enrolled the first COMFORT-2 trial patient. “I am thrilled to have enrolled the first patient in this clinical trial. This is a significant milestone for our team and many clinicians who await empirical data to guide PNS treatment decisions,” he said. “I am confident this trial will provide insights into the safety and efficacy of this therapy, and I look forward to continuing to work with Nalu Medical to advance this program and build Level 1 clinical evidence in the field of PNS.”
 
The COMFORT-2 randomized controlled trial will enroll up to 200 patients in up to 20 U.S. study centers. Subjects diagnosed with peripheral neuralgia, mononeuropathy, neuropathic pain, or osteoarthritis pain in the low back, shoulder, knee, or foot (including ankle) will be randomized to PNS combined with conventional treatments or conventional treatments alone. The primary endpoints are responder rate at three months and the rate of serious and non-serious adverse events. Secondary endpoints include responder rates and the rate of serious and non-serious adverse events at six and 12 months, as well as patient-reported functional outcomes.
 
“This milestone marks an important step in clinically validating the efficacy of the Nalu PNS system for the long-term treatment of chronic intractable peripheral neuralgia of post-traumatic or post-surgical origin,” Nalu Medical President/CEO Tom West stated. “We are proud to lead the charge in building scientific evidence for PNS while growing our portfolio of Nalu PNS clinical outcomes.”
 
This is the second PNS randomized controlled trial sponsored by Nalu Medical. An interim analysis of the COMFORT-1 study was presented at the American Society of Interventional Pain Physicians in March. Preliminary data demonstrated 81% of patients in the treatment arm experienced ≥ 50% pain relief vs. 0% in the control arm.² Additional COMFORT-1 interim analysis was presented at the 5th Annual American Society of Pain and Neuroscience conference in mid-July.
 
Nalu is a Carlsbad, Calif.-based medical technology company developing and commercializing minimally invasive solutions for 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.
 
References 
¹ van Hecke O, Austin SK, Khan RA, Smith BH, Torrance N. Neuropathic pain in the general population: a systematic review of epidemiological studies. Pain. Apr 2014;155(4):654-662. doi: 10.1016/j.pain.2013.11.013.
² Huynh, J., Martin, P., Kottalgi, S., Desai, M.J., et al. Early outcomes from a randomized control trial for the treatment of peripheral neuralgia. Presented at: American Society of Interventional Pain Physicians (ASIPP) Annual Meeting, March 16-18, 2023, National Harbor, MD.