NeuroMetrix plots limited launch of neuromodulation device to treat fibromyalgia pain

NeuroMetrix made headlines—and history—earlier this year as it secured the FDA’s first clearance for a non-drug fibromyalgia treatment and laid out a plan to begin rolling out the wearable neuromodulation device toward the end of the year.

Right on schedule, the Quell Fibromyalgia system is now set to begin its initial U.S. launch. The rollout will begin with distribution through just a smattering of doctors across the country, NeuroMetrix announced Thursday, in what it has coined the Pathfinder Program.

The program will make the device available through 25 physicians, who CEO Shai Gozani, M.D., Ph.D., described in the announcement as “some of the most forward-thinking clinicians on the front lines of fibromyalgia.” NeuroMetrix will use their feedback throughout the pilot program to fine-tune its “messaging and distribution process” before expanding the device’s availability, Gozani said in the company's press release.

The limited rollout is slated to kick off on Dec. 1, and its findings will feed into the full commercial launch of the Quell device, which NeuroMetrix is aiming to begin in the second quarter of 2023.

Quell offers symptom relief to people with fibromyalgia through its transcutaneous electrical nerve stimulation. The technology is housed in a sleeve that’s worn around the upper calf, where electrodes help trigger the body’s natural pain relief mechanisms.

The system is designed to be used for at least three one-hour sessions per day but can provide its neurostimulation therapy as often as every other hour. It can be used while sleeping or awake, and its embedded algorithms are trained to automatically adjust the stimulation’s intensity based on a user’s body position and sleep patterns, the time of day and other factors.

Users can also control that intensity themselves, using a Bluetooth-connected app downloaded to their smartphone or an Apple Watch.

A clinical study of the device—the results of which were presented last year—found that after three months of regular Quell treatments, more than 55% of fibromyalgia patients reported clinically meaningful improvements in their quality of life, compared to just 35% in the control group.

The FDA initially cleared the device in 2014 as an over-the-counter treatment for general cases of chronic pain. In July 2021, however, the agency doled out a breakthrough device designation recognizing the Quell system’s potential as a fibromyalgia-specific treatment, which paved the way for its May 2021 de novo clearance as a prescription-only device in that indication.

Following in those footsteps is another potential indication for the technology. In January of this year, the FDA handed down another breakthrough device label for the Quell system’s potential to treat nerve damage caused by long-term chemotherapy treatments. If that indication does indeed go the way of Quell Fibromyalgia, it’ll be the first-ever FDA-cleared treatment for chemotherapy-induced peripheral neuropathy.