By Chris Wack
NeuroMetrix Inc. shares continued to move up, doubling to $22.05 after saying Tuesday that its Quell device received Breakthrough Designation from the U.S. Food and Drug Administration for treating fibromyalgia in adults.
Volume for the stock was 28 million shares at 10 a.m. EDT, compared to its 65-day average volume of 4.4 million shares. The stock closed Tuesday's session up 208%.
The company said Quell is an advanced, non-invasive, nerve stimulation device that is covered by 18 U.S. utility patents, using position and motion sensing to automatically adjust stimulation for an optimal patient experience both day and night.
The FDA Breakthrough Device Program is intended to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.
Under the program, the FDA will provide NeuroMetrix with priority review and interactive communication regarding device development, through to commercialization. In addition, there are government policies and programs under consideration that, if eventually adopted, may facilitate Medicare reimbursement for FDA Breakthrough Devices following marketing authorization.
Write to Chris Wack at email@example.com
(END) Dow Jones Newswires