BrainsWay announced that the U.S. Food and Drug Administration has granted a label expansion for its Deep TMS system, authorizing its use as an adjunct therapy for major depressive disorder in adolescents aged 15 to 21. The clearance was supported by a real‑world dataset of 1,120 adolescents treated across 35 U.S. centers, which showed a 66.1% response rate and an average 12.1‑point improvement on the PHQ‑9 after 36 sessions.
The approval makes BrainsWay the first TMS platform with evidence‑based efficacy in this age group, positioning the company to capture a share of an estimated 5 million U.S. adolescents who have experienced a major depressive episode in the past year. By extending its indication to the broadest age range for any TMS system—15 to 86 years—BrainsWay expands its addressable market and strengthens its competitive moat in non‑invasive neurostimulation.
The clearance comes on the heels of strong quarterly results. In Q3 2025, BrainsWay reported revenue of $13.5 million, up 29% year‑over‑year, and operating income of $1.3 million, with adjusted EBITDA of $2.0 million—an 81% increase from the prior year. Management raised its full‑year 2025 revenue guidance to $51 million–$52 million, reflecting confidence that the new adolescent indication will accelerate growth.
CEO Hadar Levy said the approval “will allow us to reach the broadest age range of any TMS system for the treatment of depression,” while VP of Medical Affairs Dr. Colleen Hanlon highlighted that adolescents are often underserved and that the data demonstrate meaningful reductions in comorbid anxiety symptoms.
Investors responded positively to the announcement, with the company’s market capitalization increasing as analysts noted the potential for a new revenue channel and the strengthening of BrainsWay’s leadership position in the TMS market.
BrainsWay has also been pursuing strategic investments in complementary mental‑health companies, such as Neurolief Ltd., to broaden its ecosystem. The FDA clearance, combined with the company’s robust financial performance and strategic expansion plans, positions BrainsWay to capitalize on a growing demand for safe, non‑pharmacologic treatments for depression across a wide age spectrum.
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