NeuroMetrix, Inc. (NURO) announced yesterday that its wearable neurostimulation technology device Quell has received Breakthrough Designation from the U.S. FDA for treating fibromyalgia in adults. Shares skyrocketed 208% on the news, closing at $10.04 on July 20. (See NeuroMetrix stock charts on TipRanks)
Fibromyalgia causes widespread body pain, sleep problems, fatigue, and often emotional and mental distress. Scientific studies point to abnormalities in the way the brain processes normal sensations and pain. About 2% – 6% of the U.S. population aged 30 – 50 suffer from this condition.
Although there are existing FDA-approved drugs to treat the condition, Quell is an advanced, non-invasive technology that utilizes position and motion sensing to automatically adjust stimulation for an optimal patient experience both day and night.
The device is Bluetooth low energy compatible and connects with the Quell app to offer health tracking metrics that can be personalized and used to discretely manage therapy.
In a study, 56% of the 119 people with fibromyalgia who used Quell for three months showed a clinically meaningful improvement in health-related quality of life.
Shai N. Gozani, M.D., Ph.D., President and CEO of the company, said, “The Breakthrough Device Designation is an important milestone in the Company’s effort to make Quell technology available to people living with fibromyalgia…We are moving forward with a regulatory filing that could position us to launch Quell for this indication in the second half of next year.”
A Breakthrough Designation means NURO will receive priority review and will get access to the FDA’s experts to address different issues until the product becomes commercialized.
TipRanks’ Stock Investors tool shows that investors currently have a Very Positive stance on NeuroMetrix, with 12.7% of portfolios tracked by TipRanks increasing their exposure to NURO stock over the past 30 days.