NeuroMetrix Inc. (NASDAQ: NURO) stock declined by 8.1% at last close whereas the NURO stock price surges by 14.73% in the after-hours trading session. NeuroMetrix is a technology-driven business that develops and markets non-invasive medical equipment for the assessment and treatment of pain and neurological diseases throughout the world.
NURO stock’ Significant Development
NeuroMetrix revealed that the company has sent a De Novo request to FDA for Quell. Quell is basically a mode of treatment for the symptoms of fibromyalgia in adults. However, In July, the FDA granted the company Breakthrough Designation for this purpose.
Fibromyalgia is a chronic pain disorder characterized by tiredness, sleep, cognitive, and emotional problems. It affects between 2% and 6% of the population in the United States (5 to 15 million people). Although the exact aetiology of fibromyalgia is unknown, scientific investigations suggest that it is caused by changes in the way the brain interprets normal feelings and pain. Although numerous medicines have been authorized by the FDA to treat fibromyalgia pain, there is still a need for non-pharmacological therapies that are both safe and effective. There are presently no FDA-approved medicinal devices for the treatment of fibromyalgia.
Low-to-moderate risk medical equipment that doesn’t have a cleared predicate device and isn’t qualified for the pre-market notification procedure (510(k)) can use the De Novo pathway for marketing approval. Unlike typical TENS devices, which are only approved for pain treatment, NeuroMetrix is looking for better use for Quell to treat fibromyalgia symptoms.
Shai N. Gozani, President and CEO of NeuroMetrix stated,
The Company’s endeavor to make Quell technology accessible as a prescribed therapy for patients with fibromyalgia has reached a major breakthrough with the submission of this De Novo request. They are excited to collaborate with the FDA as they complete their evaluation, which they believe will be aided by the device’s breakthrough designation. They plan to commercialize Quell for this purpose in the second half of 2022, assuming a timely and efficient procedure.
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