BrainsWay Stock Gains On FDA Expanded Use Approval For Its Stimulation Device

  • The FDA has cleared BrainsWay Ltd's BWAY Deep Transcranial Magnetic Stimulation (Deep TMS) System to reduce comorbid anxiety symptoms in adult patients with depression, also known as anxious depression.
  • BrainsWay submitted data from 573 patients in support of its application to the FDA. 
  • The data demonstrated a treatment effect that was consistent, robust, and clinically meaningful for decreasing anxiety symptoms in adult patients suffering from a major depressive disorder. 
  • An analysis of the BrainsWay data found favorable outcomes with Deep TMS compared to sham or medication as a standard of care. 
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: BWAY Stock is up 18.4% at $9.00 during the premarket session on the last check Wednesday.
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