NeuroMetrix Submits FDA De Novo Request For Treatment Of Fibromyalgia Symptoms With Quell

(RTTNews) - NeuroMetrix Inc. (NURO) said that it has submitted a De Novo request to the U.S. Food and Drug Administration for Quell Wearable Neuromodulation Device as a prescription treatment for the symptoms of fibromyalgia in adults. The company received FDA Breakthrough Designation for this indication in July.

NURO closed Wednesday regular trading at $8.62 down $0.76 or 8.10%. But in the after-hours trade, the stock gained $1.23 or 14.27%.

The company hopes to commercially launch Quell for this indication in the second half of 2022.

Fibromyalgia is a chronic pain condition that is accompanied by fatigue, sleep, cognitive and mood disturbances. The cause of fibromyalgia remains unclear, but scientific studies point to abnormalities in the way the brain processes normal sensations and pain. There are currently no medical devices with FDA clearance or approval for treating fibromyalgia.

The De Novo pathway for marketing authorization is available to low-to-moderate risk medical devices that do not have a cleared predicate device, and are therefore not eligible for the pre-market notification process (i.e., 510(k)).