Carl Byrnes

Raghuram Selvaraju

- BrainsWay Ltd. received **FDA clearance** on **September 16, 2025**, for an **accelerated Deep TMS protocol** for the non-invasive treatment of Major Depressive Disorder (MDD), including those with comorbid anxiety symptoms.  **[1505065_0001171843-25-005914_exh_991.htm:0]** 
- This new protocol significantly shortens the acute treatment phase to **6 days** (5 sessions per day over a 14-day period), compared to the previous standard protocol of 4 weeks of daily sessions.  **[1505065_0001171843-25-005914_exh_991.htm:0]** 
- Clinical data demonstrated that the accelerated protocol achieved **comparable efficacy** to the standard Deep TMS, with HDRS-21 depression scores reduced by **19.02 points** in the accelerated group versus **19.79 points** in the standard group, and similar response and remission rates.  **[1505065_0001171843-25-005914_exh_991.htm:0]** 
- The accelerated protocol is now **commercially available in the United States**, and BrainsWay is focusing on provider training and seeking updates to reimbursement policies.  **[1505065_0001171843-25-005914_exh_991.htm:0]**

Brainsway (BWAY)