NeuroMetrix Stock Skyrockets After Quell® Wearable Neuromodulation Device has Received FDA De Novo Authorization
May 19, 2022 By MarketDepth
NeuroMetrix, Inc. (NASDAQ: NURO) shares up about 50% Thursday after the Company announced U.S. Food and Drug Administration (FDA) De Novo authorization to market the Quell neuromodulation device as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. The Company received FDA Breakthrough Designation for the use of Quell to treat fibromyalgia in July 2021.
Wearable Credit Card Sized Nerve Stimulator
Quell is an advanced, non-invasive, neuromodulation technology that is covered by 23 U.S. utility patents. It is the only wearable neuromodulator that is enabled by a proprietary microchip that provides precise, high-power nerve stimulation in a form factor the size of a credit card. Quell utilizes position and motion sensing to automatically adjust stimulation for an optimal user experience both day and night. The device supports Bluetooth® low energy (BLE) to communicate with mobile apps for multiple smartphone and smartwatch platforms.
“There is an unmet need for effective and safe fibromyalgia treatments. Receiving this De Novo authorization is a key milestone towards the Company’s goal of making Quell available as a prescription treatment option for people living with fibromyalgia. We believe physicians treating patients with fibromyalgia will be interested in Quell’s potential clinical benefits and safety profile. Our initial commercialization efforts will focus on rheumatologists and pain medicine physicians. We anticipate launching in the fourth quarter, with initial prescriptions processed by an online pharmacy partner before the end of this year.”Shai N. Gozani, M.D., Ph.D., Chief Executive Officer, NeuroMetrix
NeuroMetrix is an innovation-driven company with a mission to improve individual and population health through innovative medical devices and technology solutions for neurological disorders and pain syndromes.