BrainsWay Receives FDA Clearance for Accelerated Deep TMS Protocol for Non-Invasive Treatment of Major Depressive Disorder (MDD)

Core Viewpoint - BrainsWay has received FDA clearance for an accelerated treatment protocol for its Deep TMS system, which is expected to enhance patient access and treatment efficacy for major depressive disorder (MDD) [1][2][3] Group 1: FDA Clearance and Treatment Protocol - The FDA has expanded the treatment protocols for BrainsWay's Deep TMS system to include an accelerated protocol for MDD, which is now commercially available in the U.S. [1] - The new accelerated protocol reduces the treatment duration from 4 weeks to just 6 days of acute treatment, allowing for quicker patient response [2][3] - The accelerated protocol consists of 5 sessions per day for 6 days, followed by 2 sessions per week for 4 weeks, with each session lasting less than 10 minutes [3] Group 2: Clinical Study Results - Clinical data from a multicenter, randomized, controlled study showed that the accelerated protocol resulted in comparable outcomes to the standard protocol, with HDRS-21 depression scores reduced by 19.02 points in the accelerated group and 19.79 points in the standard group [3] - Response and remission rates for the accelerated group were 87.8% and 78.0%, respectively, compared to 87.5% and 87.5% for the standard group [3] - The median time to remission was 21 days for the accelerated group, compared to 28 days for the standard group, indicating a faster therapeutic effect [3] Group 3: Market Context and Company Overview - MDD is a leading cause of disability globally, affecting millions and creating a critical gap in accessible and effective therapies, particularly for patients who do not respond to traditional treatments [4] - BrainsWay is a leader in noninvasive neurostimulation treatments, with its Deep TMS platform being the first to receive three FDA-cleared indications backed by clinical studies [5] - The company is committed to advancing neuroscience and increasing global awareness and access to Deep TMS, with ongoing clinical trials for various psychiatric and neurological disorders [5][6]