NeuroMetrix, Inc. (NASDAQ: NURO) is engaged as a medical technology and device company, which is focused on the research, development, and commercialization of non-invasive medical devices for pain and neurological disorders. Shares of the medical device company is skyrocketing 165% through early trading on Tuesday, July 20, 2021. Over the past three months, NeuroMetrix has seen average daily volume of 114,610 shares. However, volume of 80.24 million shares or dollar volume of $567.3 million, has already exchanged hands through early trading Tuesday.
Shares of NeuroMetrix are soaring after the company announced that its Quell wearable device for the treatment of symptoms of fibromyalgia in adults, has received Breakthrough Designation from the U.S. FDA. Quell is designed to be a non-invasive, nerve stimulation device that can automatically adjust stimulating activity to optimal levels for both day and night use.
Furthermore, Quell is the only wearable neurostimulator that is powered by a customized microchip that provides more optimized and adjusted treatment. Quell’s technology is protected by 18 U.S. utility patents.
The FDA’s Breakthrough Designation was given after NeuroMetrix conducted a clinical trial of Quell that involved 119 patients with fibromyalgia. Patients were broken down into two separate groups: one with the active Quell device and the other with a non-active device.
For a period of three months, the 119 patients conducted in-home use of Quell and the control device. After the testing period, the group that received the active Quell device showed 56% of test subjects saw clinically meaningful improvement, compared to only 35% in the control group.
“The Breakthrough Device Designation is an important milestone in the Company’s effort to make Quell technology available to people living with fibromyalgia,” said Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix. “We are moving forward with a regulatory filing that could position us to launch Quell for this indication in the second half of next year.”
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