NeuroMetrix Up 31.5% on FDA Breakthrough Device Designation
By Sam Boughedda
Investing.com — Medical device company NeuroMetrix Inc (NASDAQ:NURO) saw a 31.5% jump in its share price after it revealed the U.S Food and Drug Administration awarded its Quell technology product Breakthrough Device Designation.
The Breakthrough Device Designation has been granted to reduce moderate to severe symptoms of chemotherapy induced peripheral neuropathy.
The FDA Breakthrough Device Program is in place to help patients receive faster access to technologies that have the possibility of providing more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases. The program means the FDA will give NeuroMetrix priority review and interactive communication regarding development and commercialization.
NeuroMetrix submitted data supporting the designation that included results from a 6-week study evaluating the safety and effectiveness of Quell used at home for treatment of patients diagnosed with chemotherapy induced peripheral neuropathy.
"This Breakthrough Device Designation is an important step in our effort to make Quell technology available to patients suffering from the debilitating effects of CIPN,” said Shai Gozani, CEO of NeuroMetrix. “We are looking forward to completion and subsequent reporting of the results from the ongoing multi-center RCT of Quell in CIPN.
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