Nalu Medical is a privately held medical device manufacturer based in Carlsbad, California. During the 2024 North American Neuromodulation Society (NANS) meeting, Nalu Medical announced the positive long-term data from the COMFORT randomized controlled trial (RCT) of its peripheral nerve stimulation (PNS) device for the treatment of chronic pain.

The COMFORT RCT aimed to assess the Nalu neurostimulation system’s efficacy in managing pain in areas such as the shoulder, lower back, knee, ankle, or foot. This system utilizes a battery-free, compact implantable pulse generator (IPG) and incorporates both peripheral nerve stimulation (PNS) and spinal cord stimulation (SCS) capabilities.

Results from the trial revealed promising outcomes, with 98 percent of device users experiencing significant pain relief or improvement at the three-month mark. Furthermore, after 12 months, 87 percent of users reported experiencing over 50 percent pain relief. Speaking at the NANS 2024 meeting, Nalu Medical’s CEO, Tom West, emphasized that the COMFORT RCT aims to provide robust evidence of the device’s sustained effectiveness in addressing chronic pain, particularly for patients with limited treatment options, thereby enhancing their overall quality of life.