NeuroMetrix (NURO) Stock Continues Skyward | Here’s Why

NeuroMetrix, Inc. (Nasdaq: NURO) is screaming for the top in the premarket hours, following up on the massive gains seen in the stock yesterday. The gains started when the company announced that it has received FDA Breakthrough Designation for its Quell device. Here’s what’s happening, and why this news is so significant: 

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NURO Continues Up On Breakthrough Designation

As mentioned above, NeuroMetrix flew in the market yesterday after news broke that the company received Breakthrough Designation from the FDA for its Quell device, a non-drug experimental option for the treatment of fibromyalgia symptoms in adults. 

In the release, NURO reminded investors that Quell is an advanced, non-invasive, nerve stimulation device that’s covered by 18 United States utility patents. In fact, it’s the only wearable neurostimulator that is enabled by a custom designed microchip that provides flexible, precise, high-power nerve stimulation in the form factor the size of a credit card. 

Using position and motion sensing, the Quell device automatically adjusts stimulation for an optimal patient experience both day and night. Moreover, the device is connected to the Quell app through the use of Bluetooth low energy communication and the app is available for iOS and Android mobile devices. 

Management Commentary

In a statement, Shai N. Gozani, M.D., Ph.D., President and CEO at NURO, had the following to offer:

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.

This News Is Massive

First and foremost, let’s address the Breakthrough Designation in and of itself. The Designation was created to help patients receive more timely access to breakthrough technologies that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating disease or conditions. 

As part of the program, NeuroMetrix will enjoy priority review and interactive communication surrounding the development of the device all the way through to commercialization. Not to mention that government policies and programs are under consideration that, if adopted, will likely facilitate Medicare reimbursement for FDA Breakthrough Devices following marketing authorization. 

So, the designation will likely speed up the time to approval and could result in immediate coverage once the device is approved. 

Moreover, the fibromyalgia market represents a massive opportunity. The condition results in chronic pain that’s accompanied by fatigue, sleep, cognitive, and mood disturbances. It currently affects between 2 and 6 percent of the United States population and is most often diagnosed between ages 30 and 50. While the cause of the condition is unclear, studies point to abnormalities in the way the brain processes normal sensations and pain. 

While several drugs have been approved for managing the pain associated with the condition, there is an unmet need for safe and effective non-pharmacological treatments. 

Not to mention, the market is a huge one. 

According to Coherent Market Insights, by 2026, the market will grow to be worth more than $3.6 billion. While I’m not saying that the company will take the entire market, there’s a strong chance that should Quell be approved, it will take a large chunk of it. 

Why?

Well, currently approved therapeutics for fibromyalgia are essentially narcotic pain medications. These are the medications that are quickly being phased out in the United States as a result of the opioid epidemic. 

As these opioids are phased out, patients will need a fall back option, and the Quell device seems to perform as well as, if not better than, its pharmacological counterparts. Considering this, should the therapy be approved, it will likely quickly become the leading option among this patient population, representing a significant opportunity. 

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Final Thoughts

The bottom line here is simple. NeuroMetrix is onto something big with Quell, and the US FDA is taking note. Should things continue going in the positive direction, the therapeutic option has the potential to become a blockbuster, generating significant revenues and profits for NURO and making the stock one that’s hard to ignore. 

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