BrainsWay Ltd. announced the publication of new real-world post-marketing data demonstrating the efficacy of accelerated Deep Transcranial Magnetic Stimulation (Deep TMS) for the treatment of major depressive disorder (MDD). The compelling results were published in the peer-reviewed journal, Psychiatry Research, in an article titled, "Real-World Efficacy and Safety of Various Accelerated Deep TMS Protocols for Major Depression." Deep TMS utilizes specially designed H?Coils to stimulate deep and broad cortical regions associated with depression. The standard FDA-cleared Deep TMS protocol involves one treatment session per day, five days a week for 4 weeks, followed by a maintenance period.

However, there has been recent interest in ?accelerated? dosing schedules which involve multiple sessions each day to allow for quicker overall treatment time. Data collected using this approach to treat depression was compiled from clinical sites and analyzed in this study.

Key findings from this post-marketing study included: Accelerated Deep TMS led to an 80% response rate and a 51% remission rate across all dosing schedules, using the most rated scale (HDRS, MADRS, PHQ-9, BDI-II). There was no statistical difference in outcomes seen between the various accelerated dosing schedules, which varied between 2, 3, 5 or 10 Deep TMS sessions per day. Subjects undergoing protocols involving more than 2 sessions per day responded and/or remitted typically within 3-5 days, and the durability of treatment was substantial.

BrainsWay Deep TMS is not currently FDA-cleared for accelerated depression treatments. However, these preliminary results could be leveraged to support efforts to expand current labeling for Deep TMS. Major depressive disorder (MDD) is a common and debilitating form of depression characterized by physiological, emotional, and cognitive symptoms. According to the World Health Organization (WHO), depression affects approximately 264 million people worldwide, and the U.S. National Institute of Mental Health (NIMH) estimates that 21 million adults in the United States suffer from an MDD episode within a given year. Common symptoms of MDD include loss of interest, depressed mood, reduced energy, disturbed sleep, and changes in appetite.

60-90% of depression patients also exhibit comorbid moderate to severe anxiety, a condition commonly referred to as anxious depression. These anxiety symptoms include nervousness, feelings of panic, increased heart rate, rapid breathing, sweating, insomnia, trembling, and difficulty focusing or thinking clearly. The economic burden in the United States for major depressive disorder totaled $326 billion prior to the recent COVID pandemic.