BrainsWay Ltd. (NASDAQ: BWAY) stock gained by 17.45% in the current market trading session. BrainsWay is the world’s leading provider of innovative noninvasive neurostimulation therapies for mental health issues.
Significant Development in BWAY Stock
The United States Food and Drug Administration has granted BrainsWay Ltd. 510(k) approval to sell their Deep Transcranial Magnetic Stimulation System for the treatment of comorbid anxiety symptoms in adult patients with depression, commonly known as anxious depression.
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BrainsWay provided data from 573 individuals who had Deep TMS therapy in 11 investigations, including both randomized controlled trials and open-label studies, in support of their FDA application. The findings revealed a treatment benefit for reducing anxiety symptoms in adult patients with a major depressive disorder that was persistent, strong, and clinically significant. In contrast to sham or medicine as standard of care, an examination of the BrainsWay data revealed that Deep TMS had better results. Data from the three RCT investigations of Deep TMS, for example, revealed impact values ranging from 0.34 (when compared to sham) to 0.90 (when compared to medicine), with an overall weighted, pooled effect size of 0.55 using the Cohen’s d statistical technique.
Christopher von Jako, President, and CEO of BWAY Stock stated,
This approval adds to BrainsWay’s depression diagnosis and is the latest in a long line of firsts for the company. Anxiety symptoms are common in people suffering from severe depression. This latest regulatory accomplishment solidifies BrainsWay’s position as a pioneer in developing transformational solutions to improve patient wellness.
BrainsWay may now sell its Deep TMS System for the treatment of depressive episodes owing to the enhanced FDA labeling. It also aids in the reduction of anxiety symptoms in adult patients with the major depressive disorder who may have concomitant anxiety symptoms. In addition, individuals who have not seen adequate results from earlier antidepressant drug therapy in this episode.