NeuroMetrix (NSDQ:NURO) today announced that its Quell device has received FDA breakthrough designation for treating fibromyalgia symptoms in adults.
The news saw NURO shares nearly triple in value to $9.72 apiece near the close of trading. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up 1.5%.
Fibromyalgia involves the widespread perception of pain and affects roughly 4 million Americans, according to the CDC. NeuroMetrix officials think their company’s Quell non-invasive nerve stimulation device could prove a useful alternative to the drugs FDA has approved to treat the condition.
The breakthrough designation means priority review and interactive communication with FDA over NeuroMetrix’s application for Quell. The designation could also facilitate Medicare reimbursement after authorization.
“The breakthrough device designation is an important milestone in the Company’s effort to make Quell technology available to people living with fibromyalgia,” NeuroMetrix CEO Dr. Shai N. Gozani said in a news release. “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.”