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BURLINGTON, Mass. and JERUSALEM - BrainsWay Ltd. (NASDAQ & TASE:BWAY) announced Thursday that the U.S. Food and Drug Administration has granted a label expansion for its Deep Transcranial Magnetic Stimulation system, approving it as an adjunct therapy for adolescents aged 15 to 21 with major depressive disorder.
The FDA clearance was supported by real-world evidence from 1,120 adolescents treated across 35 TMS centers in the United States between 2012 and 2024. The data showed that following 36 treatment sessions, patients experienced an average improvement of 12.1 points on the Patient Health Questionnaire-9 scale, with a 66.1% response rate. The treatment also demonstrated 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, according to the company’s press release.
The expanded indication enables clinicians to treat both adults and adolescents using the same Deep TMS system and established stimulation protocols. The company noted that approximately 5 million adolescents in the U.S. are estimated to have experienced a major depressive episode within the past year. This market expansion comes as BrainsWay demonstrates strong revenue growth of 27.08% over the last twelve months, though InvestingPro analysis indicates the stock is currently trading above its Fair Value with high earnings multiples.
BrainsWay’s Deep TMS System is now indicated for treating depressive episodes and decreasing comorbid anxiety symptoms in adults with major depressive disorder who have failed to achieve improvement from previous antidepressant medication, as well as an adjunct therapy for adolescent patients aged 15-21.
The company, founded in 2003 with operations in the United States and Israel, specializes in noninvasive neurostimulation treatments for mental health disorders.
In other recent news, BrainsWay Ltd. has made notable progress with several strategic investments and regulatory advancements. The company has secured two additional minority stake investments with U.S. mental health providers, including a $1.5 million investment in Tangient ATX Inc., with the potential for an additional $2.5 million. Additionally, BrainsWay has invested $5 million in Neurolief Ltd., supporting the development of wearable neuromodulation technology for mental health disorders, and has an option to acquire Neurolief. In a significant regulatory development, the U.S. Food and Drug Administration has granted clearance for BrainsWay’s accelerated treatment protocol using its Deep Transcranial Magnetic Stimulation system for major depressive disorder, reducing the treatment timeline significantly.
Furthermore, BrainsWay has entered into a strategic equity financing agreement with Axis Management Company, involving an initial $2.3 million investment. H.C. Wainwright has reiterated a Buy rating for BrainsWay, maintaining a $17.00 price target following these strategic investments. These developments highlight BrainsWay’s ongoing efforts to expand its presence in the mental health sector and enhance treatment options.
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