NeuroMetrix (NSDQ:NURO) announced today that its Quell device has received breakthrough designation from the FDA for the treatment of fibromyalgia symptoms in adults.
The news saw NURO shares nearly triple in value to $ 9.72 apiece by the close of markets. Mass device‘s MedTech 100 Index, which includes shares of the world’s largest medical device companies, rose 1.5%.
Fibromyalgia involves the widespread perception of pain and affects approximately 4 million Americans, According to the CDC. NeuroMetrix officials believe their company’s non-invasive Quell nerve stimulation device may prove to be a useful alternative to drugs approved by the FDA to treat the disease.
The breakthrough designation signifies priority review and interactive communication with the FDA on NeuroMetrix’s application for Quell. The designation could also facilitate reimbursement from Medicare after authorization.
“The revolutionary device designation is an important step in the company’s efforts to make Quell technology available to people living with fibromyalgia,” NeuroMetrix CEO Dr. Shai N. Gozani said in a statement from hurry. “We are moving forward with a regulatory case that could position us to launch Quell for this indication in the second half of next year.”