Brainsway Ltd. (NASDAQ:BWAY) saw its stock pop 5% in premarket trading Thursday after securing a key FDA label expansion for its Deep Transcranial Magnetic Stimulation (Deep TMS) system, clearing the treatment for use in adolescents diagnosed with major depressive disorder (MDD).
The updated approval authorizes Deep TMS as an add-on therapy for patients ages 15 to 21, widening its reach and giving Brainsway the broadest approved age range of any TMS-based depression treatment currently available.
Regulators based the decision on real-world clinical evidence from 1,120 teenagers treated at 35 U.S. centers between 2012 and 2024. Patients recorded an average 12.1-point improvement on the PHQ-9 scale, a 66.1% response rate after 36 sessions, and notable reductions in anxiety-related 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.”
With the expanded label, Deep TMS is now indicated both for adults with MDD who have not responded to antidepressant therapy and as an adjunctive option for teens and young adults aged 15 to 21.