- The stock price of Neurometrix Inc (NASDAQ: NURO) increased by 173% during intraday trading. This is why it happened.
The stock price of Neurometrix Inc (NASDAQ: NURO) increased by 173% during intraday trading. Investors are responding positively to NeuroMetrix announcing that its Quell device has received Breakthrough Designation from the U.S. Food and Drug Administration (FDA) for treating the symptoms of fibromyalgia in adults.
Fibromyalgia is known as a common form of chronic pain that is also accompanied by fatigue, sleep, cognitive and mood disturbances. And it affects an estimated 2% to 6% of the U.S. population (5 to 15 million people) and is most often diagnosed between the ages of 30 and 50. The cause of fibromyalgia is unclear, but scientific studies point to abnormalities in the way the brain processes normal sensations and pain. Even though several drugs are FDA approved for managing fibromyalgia pain, there is an unmet need for safe and effective non-pharmacological treatments.
Quell is an advanced non-invasive nerve stimulation device covered by 18 U.S. utility patents. And it is the only wearable neurostimulator that is enabled by a custom designed microchip that provides flexible, precise, and high-power nerve stimulation in a form factor the size of a credit card. Quell utilizes position and motion sensing for automatically adjusting stimulation for an optimal patient experience both day and night. The device supports Bluetooth low energy (BLE) for communicating with the Quell app — which is available for iOS and Android mobile devices.
The FDA Breakthrough Device Program is intended for helping 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. And under the program, the FDA will provide NeuroMetrix with priority review and interactive communication regarding device development through to commercialization. Plus there are government policies and programs under consideration that, if eventually adopted, may facilitate Medicare reimbursement for FDA Breakthrough Devices following marketing authorization.
The data submitted by NeuroMetrix in support of the designation included results from a double-blind, randomized, sham-controlled trial (NCT03714425). And a total of 119 subjects with fibromyalgia were enrolled and randomized to a standard (active) or modified (sham) Quell device for 3 months of at-home use.
In an intention-to-treat (ITT) analysis of all subjects, 56% of those on active treatment exhibited a clinically meaningful improvement in health-related quality-of-life (Fibromyalgia Impact Questionnaire, FIQR) compared to 35% that received sham treatment (p=0.029). And there were additional positive outcomes in both the ITT population and in a pre-specified subgroup analysis of subjects with elevated pain sensitivity based on Quantitative Sensory Testing (QST).
“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.”
— Shai N. Gozani, M.D., Ph.D., President and CEO of NeuroMetrix
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