NeuroMetrix (NASDAQ:NURO) has submitted a De Novo request to the FDA for Quell as a prescription treatment for the symptoms of fibromyalgia in adults.
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Fibromyalgia is a chronic pain condition that is accompanied by fatigue, sleep, cognitive and mood disturbances.
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)).
The data submitted in support of the De Novo request includes results from a double-blind, randomized trial, with 119 subjects enrolled with Quell device for 3-months of at-home use.
The company hopes to commercially launch Quell for this indication in H2 2022.
Quell is an advanced, non-invasive, neuromodulation device, enabled by a proprietary microchip that provides precise, high-power nerve stimulation in a form factor the size of a credit card.