- NeuroMetrix (NASDAQ:NURO) announced a special U.S. Food and Drug Administration designation for its Quell device
- This wearable technology is aimed at patients with fibromyalgia
- NURO stock has surged 70% on anticipation of this product hitting the market in short order
NeuroMetrix (NASDAQ:NURO) stock has accelerated 70% higher as the result of an announcement today that the FDA has authorized NeuroMetrix to market the Quell wearable neuromodulation device. Wearables are a growing market segment in the healthcare sector many investors are watching closely. Notably, this authorization marks the first non-pharmacological treatment for fibromyalgia on the market right now.
As an innovative company focused on medical devices and technological solutions, there’s a lot to like about NeuroMetrix. Undoubtedly, this move by the FDA to grant a special designation for the Quell device is a big step in the right direction. Today, the market appears to be pricing in serious adoption of these devices. However, a risk of uncertainty always surrounds such announcements, and time will tell if this bullish move was ultimately right or not.
That said, let’s dive a bit more into this announcement and what it means for investors.
Why Is NURO Stock Surging Today?
The official term for this FDA authorization is a De Novo authorization. According to officials, this allows companies a unique way to market devices that may be first of their kind. It balances risk and safety data with the need to get new devices onto the market. Previously, NeuroMetrix received breakthrough designation, a status which speeds up the review process.
For smaller-cap companies like NeuroMetrix, these FDA designation announcements are extremely positive. Why?
Well, from a financial perspective, NURO stock should benefit from revenue streams sooner than later. Given the cash burn involved with developing such products, much of the valuations of smaller-cap biotech stocks relies on the timeline of when their products will hit the market. NeuroMetrix says it anticipates launching Quell in the fourth quarter with prescriptions available by the end of the year.
This could be a big breakthrough, and investors will want to pay close attention to the ability of NeuroMetrix to pick up market share.
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On the date of publication, Chris MacDonald did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
