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Investing.com -- Brainsway Ltd (NASDAQ:BWAY) stock surged 5% in premarket trading Thursday after the U.S. Food and Drug Administration (FDA) granted a label expansion for the company’s Deep Transcranial Magnetic Stimulation system to treat adolescents with major depressive disorder (MDD).
The expanded approval allows Brainsway’s Deep TMS therapy to be used as an adjunct treatment for patients aged 15 to 21 years suffering from depression. This makes Brainsway’s system available to the broadest age range of any TMS system for depression treatment in the market.
The FDA clearance was supported by real-world evidence from 1,120 adolescents treated across 35 TMS centers in the U.S. between 2012 and 2024. The data showed an average improvement of 12.1 points on the PHQ-9 depression scale and a 66.1% response rate after 36 treatment sessions, along with meaningful reductions in anxiety symptoms.
"This clearance will allow us to reach the broadest age range of any TMS system for the treatment of depression," said Hadar Levy, Brainsway’s Chief Executive Officer. "With approximately 5 million adolescents in the U.S. estimated to have experienced a major depressive episode within the past year, this represents a significant milestone."
The company’s Deep TMS system is now indicated for treating depressive episodes and decreasing comorbid anxiety symptoms in adults with MDD who haven’t responded adequately to previous antidepressant medications, as well as an adjunct therapy for adolescent patients aged 15-21.
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