- Biotech rallies further after announcing FDA Breakthrough Designation for its fibromyalgia treatment…
- Designation speeds up FDA approval process…
- Device would be a first of its kind treatment…
NeuroMetrix Inc (NASDAQ: NURO) stock is flying high for the second day in a row.
NURO stock rose as much as 239% in today’s session and was still up 155% at writing.
That’s on top of the more than 200% rally for the stock on Tuesday.
The two-day rally comes after the company announced Tuesday that its fibromyalgia treatment device Quell had received a “Breakthrough Designation” from the FDA.
NeuroMetrrix says, “Quell is an advanced, non-invasive, nerve stimulation device.”
The company adds, “It is the only wearable neurostimulator that is enabled by a custom designed microchip that provides flexible, precise, high-power nerve stimulation in a form factor the size of a credit card. Quell utilizes position and motion sensing to automatically adjust stimulation for an optimal patient experience both day and night.”
The FDA designation speeds up the approval process for the treatment.
NeuroMetrix says that 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.”
NeuroMetrix submitted results from a double-blind, randomized, sham-controlled trial to the FDA to receive the designation.
The company says those studies included 119 subjects with fibromyalgia who were enrolled and randomized to a standard (active) or modified (sham) Quell device for 3-months of at-home use.
The results showed 56% of those on active treatment exhibited a clinically meaningful improvement in health-related quality-of-life compared to 35% who received the sham treatment.
The President and CEO of NeuroMetrix, Shai N. Gozani, said, “The Breakthrough Device Designation is an important milestone in the Company’s effort to make Quell technology available to people living with fibromyalgia. 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.”
Fibromyalgia is a chronic pain condition that is also accompanied by fatigue, sleep, cognitive and mood disturbances.
The condition impacts an estimated 2 to 6% of the U.S. population (5 to 15 million people) and is most common between 30 and 50-years-old.
There is no known cause of fibromyalgia but studies show abnormalities in the way the brain processes normal sensations and pain.
If approved by the FDA, Quell would be the first safe and effective non-pharmacological treatment for fibromyalgia.
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