Publish date:

NeuroMetrix Soars on FDA 'Breakthrough Status' for Fibromyalgia Device

NeuroMetrix gets the FDA's 'Breakthrough Designation' for its fibromyalgia treatment device.

NeuroMetrix  (NURO) - Get Report skyrocketed Tuesday after the U.S. Food and Drug Administration gave a "Breakthrough Designation" to the biopharma's Quell device for treating fibromyalgia in adults.

Shares of the Woburn, Mass. company ended up $6.78, or 208%, at $10.04.

Under the FDA Breakthrough Device Program, the administration will provide NeuroMetrix with priority review and interactive communication regarding device development, through to commercialization.

Quell is an advanced, non-invasive, nerve stimulation device that is covered by 18 U.S. utility patents, the company said.  

The device is the only wearable neurostimulator that uses a custom designed microchip to provides high-power nerve stimulation in a form factor the size of a credit card, the company said.

Quell uses position and motion sensing to automatically adjust stimulation for an optimal patient experience both day and night.

NeuroMetrix submitted data to support the breakthrough designation, including results from a double-blind, randomized, sham-controlled trial. 

A total of 119 subjects with fibromyalgia were enrolled and randomized to an active or sham Quell device for 3-months of at-home use. 

TST Recommends

Analysis found that 56% of those on active treatment exhibited a clinically meaningful improvement in health-related quality-of-life", the company said, compared with 35% that received sham treatment 

NeorMetrix CEO and President Shai Gozani said the company was "moving forward with a regulatory filing that could position us to launch Quell for this indication in the second half of next year."

Fibromyalgia is a common form of chronic pain that is also accompanied by fatigue, sleep, cognitive and mood disturbances. 

NeuroMetrix said it affects an estimated 2% to 6% of the U.S. population, roughly 5 to 15 million people, and is most often diagnosed between the ages of 30 and 50 years old.

The cause of fibromyalgia is unclear, but scientific studies point to abnormalities in the way the brain processes normal sensations and pain, NeuroMetrix said.

The company said the use of Quell for fibromyalgia is investigational and has not been cleared or approved by the FDA. The safety and effectiveness for this purpose have not been reviewed by the FDA.

While  several drugs are FDA approved for managing fibromyalgia pain, the company said there is an unmet need for safe and effective non-pharmacological treatments.

Last month, the FDA awarded its breakthrough device designation to Aethlon Medical's  (AEMD) - Get Report Hemopurifier cartridge, which is designed to filter viruses and exosomes from the blood.

In September, Virios Therapeutics VIRI was founded to develop its IMC-1 candidate designed to inhibit HSV-1 (Herpes Simplex Virus) activation which may play a role in fibromyalgia symptoms.