BrainsWay Ltd BWAY shares are trading higher Monday after the company announced it received FDA clearance for its Deep TMS H7 Coil for use in treating adults suffering from major depressive disorder and depression.
The FDA's grant of clearance was based on its review of successful results from a randomized, double-blind, controlled multicenter trial, designed to better understand the H7 Coil's efficacy in addressing treatment-resistant depression. The study included 144 subjects and found overall efficacy rates for the H7 Coil which that were comparable to those achieved with BrainsWay's H1 Coil.
The Deep TMS H7 Coil has been cleared to treat obsessive-compulsive disorder since 2018. As a result of the FDA clearance, it can now be put to use against depression.
The company will be implementing a training program in the coming months to educate customers on using the Deep TMS H7 Coil to treat depression within the new FDA clearance.
BrainsWay focuses on developing advanced noninvasive neurostimulation treatments for mental health disorders.
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BWAY Price Action: BrainsWay has a 52-week high of $9.18 and a 52-week low of $4.35.
The stock was up 1.56% at $4.57 at press time, according to Benzinga Pro.
Photo: Gerd Altmann from Pixabay.
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