BWAY Brainsway Ltd

By Chris Wack

BrainsWay Ltd. shares rose 25% to $9.52 after the company said it received 510(k) clearance from the U.S. Food and Drug Administration, allowing it to market its Deep Transcranial Magnetic Stimulation System for the reduction of comorbid anxiety symptoms in adult patients with depression.

The company said data from 573 patients who had undergone Deep TMS treatment in 11 studies, including both randomized controlled trials and open-label studies, was submitted by BrainsWay in support of its application to the FDA. The data demonstrated a treatment effect that was consistent, robust, and clinically meaningful for decreasing anxiety symptoms in adult patients suffering from major depressive disorder.

An analysis of the BrainsWay data found favorable outcomes with Deep TMS when compared to sham or medication as standard of care.

The expanded FDA labeling now allows BrainsWay to market its Deep TMS System for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from major depressive disorder and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

August 18, 2021 10:30 ET (14:30 GMT)

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