NeuroMetrix Receives FDA Breakthrough Device Designation for its Wearable Neurostimulation Technology
Jan 18, 2022 By MarketDepth
NeuroMetrix, Inc. (NASDAQ: NURO) stock jumped about 40% after the healthcare company announced that its Quell® technology has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for reducing moderate to severe symptoms of chemotherapy-induced peripheral neuropathy (CIPN) that have persisted for at least 6-months following the end of chemotherapy.
650,000 Cancer Patients Across USA
According to data provided by NeuroMetrix, there are about 650,000 cancer patients who receive chemotherapy annually in the United States.
Side Effects from Treatment
CIPN is a disabling complication that occurs in many patients treated with common chemotherapeutic drugs such as vincristine, paclitaxel and cisplatin. Symptoms include burning/shooting pain, tingling, cramping, and numbness in the hands and feet. CIPN is also associated with impaired balance, walking, and sleep decreased quality of life and increased risk of falls. Approximately 30% of patients experience chronic CIPN, defined as symptoms lasting longer than 3-6 months after the last chemotherapy treatment. There are no FDA-approved treatments for CIPN, and those that are used have limited effectiveness and have side effects.
Shai N. Gozani, M.D., Ph.D., CEO of NeuroMetrix”This Breakthrough Device Designation is an important step in our effort to make Quell technology available to patients suffering from the debilitating effects of CIPN. We are looking forward to completion and subsequent reporting of the results from the ongoing multi-center RCT of Quell in CIPN. Depending on the outcome of the trial, we hope to be positioned for an FDA filing in 2023. Following on our first Breakthrough Designation for fibromyalgia, this new designation for CIPN advances our effort to build a portfolio of Quell-based prescription wearable neurotherapeutics.”Shai N. Gozani, M.D., Ph.D., CEO of NeuroMetrix
According to the Company, Quell is an advanced, non-invasive, neuromodulation technology that is covered by 19 U.S. utility patents. Quell is a wearable device, and as such 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. The device supports Bluetooth® low energy (BLE) to communicate with smartphone and smartwatch apps that help the patient personalize and control their treatment.