NeuroMetrix, Inc. (NURO) stock prices skyrocketed by 145.51% some time after market trading commenced on July 20th, 2021, bringing the price per share up to USD$8.00 early on in the trading day.
Breakthrough Designation Granted
July 20th, 2021 saw the company announce that the United States Food and Drug Administration granted Breakthrough Designation for NURO’s Quell device, which is designed to treat symptoms of fibromyalgia in adults. With the company reporting moving forward with regulatory filing, it hopes to launch Quell for fibromyalgia indication by the second half of 2021.
Fibromyalgia is a form of chronic pain that is associated with fatigue, sleep, cognitive, and mood disturbances. With nearly 2 to 6% of the population of the U.S being affected, diagnoses are most often made between the ages of 30 and 50. While the cause of the illness is unclear, studies have indicated abnormalities in the way the brain processes normal sensations and pain. Despite the FDA having approved several drugs for the management of fibromyalgia pain, there is still a significant unmet need for safe and effective non-pharmacological treatments.
Quell is an innovative, non-invasive, nerve stimulation device that is designed to mitigate the effects of fibromyalgia. Covered by 18 U.S utility patents, it sets itself apart as the only wearable neurostimulator that functions with the use of a custom designed microchip. The device provides flexible, accurate, high-power nerve stimulation in a form factor not bigger than a credit card. The device uses position and motion sensing to automatically adjust stimulation output for an optimal patient experience over the course of the entire day. Bluetooth low energy is supported by the device in communication with its app, which is available on both Android and Apple mobile devices.
Breakthrough Device Designation
The FDA Breakthrough Device Program is designed to facilitate the accessibility of breakthrough technologies for the patients that need them urgently. As per the program, the FDA will provide a priority review for NeuroMetrix, as well as interactive communication regarding its development. Furthermore, government policies and programs currently in the works have the potential to facilitate Medicare reimbursement for FDA Breakthrough Devices after they have been granted marketing authorization.
Future Outlook for NURO
Armed with the support of the FDA, NURO is poised to capitalize on the massive market space it finds at its disposal. Current and potential investors are hopeful for the accelerated development and commercialization of Quell so as to maximize gains in shareholder value.