NeuroMetrix, Inc. (NASDAQ: NURO) is a medical device and technology company, which is focused on the research and development of non-invasive medical devices to diagnose and treat pain and neurological disorders. Shares of the medical device company are rallying 31% through afternoon trading on Tuesday, January 18, 2022. Over the past three months, NeuroMetrix has seen average daily volume of 345,110 shares. However, volume of 51.2 million shares or dollar volume of around $335.36 million, has already exchanged hands through late trading Tuesday.
Shares of NeuroMetrix are rallying after the company announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Quell technology and the treatment of reducing symptoms of chronic chemotherapy induced peripheral neuropathy (CIPN).
CIPN can be a disabling complication that occurs in patients that are undergoing chemotherapy with common medications, such as vincristine, paclitaxel and cisplatin. Patients can experience symptoms like shooting or burning pain, tingling, camps, and numbness in extremities. The complication has also shown to impair balance, walking, sleeping and more.
Each year, roughly 650,000 Americans undergo chemotherapy treatment in the United States. Around 30% of those patients experience chronic CIPN, which features prolonged symptoms over a 3-6 month period. There are currently no FDA approved treatments for CIPN.
NeuroMetrix’s Quell is a non-invasive, advanced, neuromodulation technology, which is protected by nineteen U.S. utility patents. Quell’s technology is delivered via a wearable neuromodulator, which is capable of providing power nerve stimulation in a form factor the size of a credit card. Quell also supports Bluetooth low energy (BLE), which allows the device to communicate with smartphone and smartwatch apps for better patient personalization and treatment control.
The company is currently undergoing a multi-center, double-blind, randomized, sham-controlled trial of Quell in CIPN. A total of 150 patients have been enrolled in the trial and will randomly provide patients with an active or sham Quell device for six weeks. The study is estimated to be completed by the end of 2022.
“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,” said Shai N. Gozani, M.D., Ph.D., CEO of NeuroMetrix. “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.”
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