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BrainsWay (BWAY) Stock Pops 10% on FDA Clearance News


  • The Food and Drug Administration has cleared BrainsWay’s (BWAY) treatment for depression and anxiety.
  • This novel treatment is based on magnetic stimulation technology.
  • BWAY stock gapped up 10% after the opening bell rang today.
BWAY stock - BrainsWay (BWAY) Stock Pops 10% on FDA Clearance News

Source: Andrus Ciprian / Shutterstock.com

Today, there’s big news for BrainsWay (NASDAQ:BWAY) and the company’s stakeholders. Reportedly, the U.S. Food and Drug Administration (FDA) granted BrainsWay 510(k) clearance for a unique platform to treat major depressive disorder and depression. As we’ll discover, this platform uses an unusual proprietary technology. Due to the FDA clearance, BWAY stock promptly moved higher at the start of today’s trading session.

Based in Israel, BrainsWay develops and commercializes noninvasive neurostimulation treatments for mental health disorders. It’s a potentially lucrative business to be involved with in the 2020s.

The World Health Organization (WHO) reports depression affects roughly 264 million people worldwide. Furthermore, the U.S. National Institute of Mental Health (NIMH) estimates 21 million U.S. adults suffer from a major depressive disorder episode within a given year.

To address these problems, BrainsWay developed a platform called the Deep TMS H7 Coil. The FDA approved this product for the treatment of “major depressive disorder and depression including those with comorbid anxiety symptoms commonly known as anxious depression.” Furthermore, this regulatory clearance occurred after the FDA reviewed a multi-center trial involving 144 subjects.

What’s Happening With BWAY Stock?

BWAY stock gapped up 10% this morning, breaking above the crucial $5 level. After half an hour, however, it settled back below $5 but was still up around 6%.

Clearly, today’s traders are optimistic about the future commercialization prospects of the Deep TMS H7 Coil. Granted, some casual observers might think this is an unusual product. It uses BrainsWay’s proprietary Deep Transcranial Magnetic Stimulation (Deep TMS) platform technology.

It’s safe to say BrainsWay is an emerging leader in advancing this type of medical technology. According to the company, BrainsWay “is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy.”

So, if you believe Deep TMS technology has a promising future, BWAY stock could be a worthy investment to “stimulate” your portfolio in 2022.

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On the date of publication, David Moadel 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.

David Moadel has provided compelling content – and crossed the occasional line – on behalf of Motley Fool, Crush the Street, Market Realist, TalkMarkets, TipRanks, Benzinga, and (of course) InvestorPlace.com. He also serves as the chief analyst and market researcher for Portfolio Wealth Global and hosts the popular financial YouTube channel Looking at the Markets.

Article printed from InvestorPlace Media, https://investorplace.com/2022/08/brainsway-bway-stock-pops-10-on-fda-clearance-news/.

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