NeuroMetrix, Inc. (Nasdaq: NURO) today 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 that have persisted for at least 6-months following the end of chemotherapy.
About 650,000 cancer patients receive chemotherapy annually in the United States. 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.
Quell is an advanced, non-invasive, neuromodulation technology that is covered by 19 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. The Quell device utilizes position and motion sensing to automatically adjust stimulation for an optimal patient experience both day and night. The device supports Bluetooth® low energy (BLE) to communicate with smartphone and smartwatch apps that help the patient personalize and control their treatment.
https://finance.yahoo.com/news/neurometrix-receives-fda-breakthrough-device-140000796.html
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