NeuroMetrix Shares Rise 10% After Submitting De Novo Request for Quell

By Chris Wack

NeuroMetrix Inc. shares were up 10% to $9.46 after the company said it has submitted a De Novo request to the U.S. Food and Drug Administration for Quell as a prescription treatment for the symptoms of fibromyalgia in adults.

The company received FDA Breakthrough Designation for this indication in July.

NeuroMetrix said the De Novo pathway for marketing authorization is available to low-to-moderate risk medical devices that don't have a cleared predicate device, and are therefore not eligible for the premarket notification process. NeuroMetrix is seeking a novel intended use for Quell to treat fibromyalgia symptoms.

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

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

10-07-21 1047ET