Shares of medical device manufacturer NeuroMetrix soared Tuesday after the company announced it had received breakthrough designation by the Food and Drug Administration for one of its flagship neurostimulation devices.
Investors jumped on the stock, sending it up 170% as of 12:30 p.m. ET. Shares began trading at $4 Tuesday but were in the $9 range by midday.
The company’s Quell device received the FDA designation to help treat symptoms of fibromyalgia in adults. That chronic pain affects between 5 million and 15 million people in the U.S., typically between the ages of 30 and 50. It often also causes fatigue as well as cognitive and mood disturbances.
Quell is a wearable device that stimulates the nerves, and NeuroMetrix claims it can decrease pain. With the breakthrough designation, the FDA will give the device priority review—and could lead to Medicare reimbursement for Quell buyers.
In a double-blind study of 119 people with fibromyalgia, NeuroMetrix reported 56% of those who used the Quell for three months showed a “clinically meaningful improvement” in health-related quality of life.
The company says it’s moving forward with a regulatory filing that could result in Quell launching specifically for fibromyalgia patients in the second half of the year. (The device is available now, but only as a pain-relief band, without mention of specific health issues.)
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