BrainsWay Receives Expanded FDA Labeling to Treat Late Life Depression

Core Insights - BrainsWay Ltd. has received FDA approval for an expanded indication of its Deep Transcranial Magnetic Stimulation (Deep TMS™) system, now allowing treatment for major depressive disorder (MDD) in patients aged 22 to 86, up from the previous limit of 68 years [1][2]. Company Developments - This marks the 10th FDA clearance for BrainsWay, making its Deep TMS the first and only TMS treatment approved for patients over 68 with MDD, including those with comorbid anxiety symptoms [2]. - Clinical data presented to the FDA showed that MDD patients over 68 treated with the H1 Coil had response and remission rates of 69% and 62% respectively, based on the Hamilton Depression Rating Scale-21 (HDRS-21), and 65% and 35% respectively using the Patient Health Questionnaire-9 (PHQ-9) [4]. Market Opportunity - The CEO of BrainsWay highlighted the significant business opportunity presented by this development, noting the increasing life expectancy and the demand for effective therapeutic solutions for the elderly suffering from depression [5]. - The economic burden of major depressive disorder in the U.S. was estimated at $326 billion prior to the COVID pandemic, indicating a substantial market for effective treatments [6]. Company Background - BrainsWay is recognized as a leader in noninvasive neurostimulation treatments for mental health disorders, with a focus on advancing neuroscience through its proprietary Deep TMS™ technology [7]. - The company has multiple FDA-cleared indications, including MDD, obsessive-compulsive disorder, and smoking addiction, and is committed to expanding clinical trials for various psychiatric and neurological disorders [7].