Neurometrix Inc (NASDAQ:NURO) rose Wednesday, the company announced that its Quell device has received Breakthrough Designation from the U.S. Food and Drug Administration for treating the symptoms of fibromyalgia in adults.
Fibromyalgia is a common form of chronic pain that is also accompanied by fatigue, sleep, cognitive and mood disturbances. It affects an estimated 2 to 6 percent of the U.S. population (five to 15 million people) and is most often diagnosed between the ages of 30 and 50.
The cause of fibromyalgia remains unclear, but scientific studies point to abnormalities in the way the brain processes normal sensations and pain. Although several drugs are FDA approved for managing fibromyalgia pain, there is an unmet need for safe and effective non-pharmacological treatments.
Quell is an advanced, non-invasive, nerve stimulation device that is covered by 18 U.S. utility patents. It is the only wearable neurostimulator that is enabled by a custom designed microchip that provides flexible, precise, high-power nerve stimulation in a form factor the size of a credit card.
The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
Under the program, the FDA will provide NeuroMetrix with priority review and interactive communication regarding device development, through to commercialization. In addition, there are government policies and programs under consideration that, if eventually adopted, may facilitate Medicare reimbursement for FDA Breakthrough Devices following marketing authorization.
NURO shares rocketed $8.75, or 87.9%, to $18.86.
