Core Viewpoint - BrainsWay Ltd. has launched a multicenter clinical trial to evaluate its next-generation Deep TMS 360™ technology for treating Alcohol Use Disorder (AUD), which affects approximately 29 million Americans and has a high relapse rate among patients [1][3]. Group 1: Clinical Trial Details - The trial will be randomized, double-blind, and sham-controlled, enrolling over 200 patients aged 18–86 with moderate to severe AUD based on DSM-5 criteria [3]. - Participants will receive either active or sham treatments for about six months, with an intensive treatment phase in the first 3–5 weeks, followed by weekly maintenance sessions [3]. - The primary endpoint is the proportion of participants with no heavy drinking days during the initial four-month treatment period, a measure recognized by the FDA as clinically meaningful [3]. Group 2: Technology Overview - The new Deep TMS 360 technology is designed for more comprehensive and uniform stimulation of targeted brain regions, potentially addressing challenges in treating complex clinical populations like those with chronic AUD [2]. - The multichannel architecture of the system may enhance stimulation levels, particularly in patients with cortical atrophy [2][4]. Group 3: Company Perspective - The CEO of BrainsWay emphasized the significance of this trial in addressing a major public health challenge and the potential of the new technology to aid patients in overcoming alcohol dependence [3]. - The Vice President of Medical Affairs highlighted the study's potential to advance understanding of noninvasive neuromodulation in reducing alcohol cravings and promoting long-term recovery [4]. Group 4: Research Locations - The study will be conducted at multiple research sites across the US, including states like Alabama, California, Florida, Illinois, New York, and West Virginia, as well as select international sites in Israel and Sweden [4].

Core Insights - BrainsWay Ltd. reported a 29% increase in revenue to $13.5 million for Q3 2025 compared to Q3 2024, with significant growth in operating income and adjusted EBITDA [1][5][18] - The company received FDA clearance for an accelerated protocol for Deep TMS treatment of major depressive disorder, enhancing its market position [1][5] - BrainsWay raised its full-year 2025 revenue and EBITDA guidance, reflecting strong operational performance and market dynamics [1][5][6] Financial Performance - Revenue for Q3 2025 was $13.5 million, a 29% increase from $10.5 million in Q3 2024 [1][5][18] - Operating income reached $1.3 million, up from $0.3 million in the prior year [1][5][18] - Adjusted EBITDA rose approximately 81% to $2.0 million compared to $1.1 million in Q3 2024 [1][5][18] - Net profit increased 137% to $1.6 million from $0.7 million in Q3 2024 [1][5][18] - Gross margin improved to 75% from 74% year-over-year [1][5] Operational Highlights - Remaining performance obligations increased to $65 million, with approximately 70% of recent customer engagements structured as multi-year lease agreements [1][5] - The company shipped 90 Deep TMS systems in Q3 2025, a 43% increase from the same period last year, bringing the total installed base to over 1,600 systems [1][5] - BrainsWay announced four new minority equity investments in 2025, expanding its strategic presence in the mental health treatment ecosystem [1][5][6] Guidance and Future Outlook - The company raised its full-year 2025 revenue guidance to $51 million – $52 million, up from the previous range of $50 million – $52 million [1][5] - Operating income guidance was increased to 6% – 7%, up from 4% – 5% [1][5] - Adjusted EBITDA guidance was raised to 13% – 14%, up from 12% – 13% [1][5] - CEO Hadar Levy highlighted significant opportunities for growth through new therapeutic indications and strategic collaborations [1][6][7]

Core Viewpoint - BrainsWay Ltd. announced preliminary results from a multicenter, randomized controlled trial indicating that the accelerated Deep TMS protocol for treating major depressive disorder is comparable in efficacy to the standard protocol while requiring fewer clinic visits [1][2]. Group 1: Study Overview - The trial involved 104 adult patients diagnosed with depression across eight sites, making it the largest randomized, controlled, blinded, multicenter trial of an accelerated Deep TMS protocol [2]. - Patients were divided into two groups: one receiving standard Deep TMS treatment and the other receiving the accelerated protocol [2]. Group 2: Treatment Protocol - The accelerated group underwent five sessions per day over six treatment days, followed by eight sessions over the next four weeks, significantly reducing the treatment burden [3]. - The primary endpoint was the change in depressive symptoms measured by the HDRS-21 scale, with secondary endpoints including response and remission rates [3]. Group 3: Key Findings - The accelerated Deep TMS group showed comparable efficacy with HDRS depression scores reduced by 18.9 points, while the standard group saw a reduction of 19.9 points [7]. - Response and remission rates were 87.8% and 78.0% for the accelerated group, compared to 87.5% and 87.5% for the standard group [7]. - Sessions for the accelerated protocol lasted less than 10 minutes, compared to 20 minutes for standard sessions [7]. - The median time to remission was 21 days for the accelerated group versus 28 days for the standard group [7]. - The accelerated protocol was well-tolerated with no serious adverse events reported, and side effects were mild [7]. Group 4: Company Commitment - BrainsWay emphasizes that innovation in mental health care involves not only new technology but also improving care delivery methods [5]. - The company is dedicated to expanding access to Deep TMS and advancing the field through scientific research [5]. - The accelerated protocol is investigational and not yet FDA-cleared, with preliminary results subject to further analysis and peer review [5]. Group 5: Company Background - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, with a proprietary Deep TMS platform technology [8]. - The company has obtained three FDA-cleared indications for major depressive disorder, obsessive-compulsive disorder, and smoking addiction [8]. - Founded in 2003, BrainsWay operates in the United States and Israel, focusing on increasing global awareness and access to Deep TMS [8].

Core Insights - BrainsWay Ltd. is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, showcasing its Deep TMS technology at the Clinical TMS Society's 2025 Annual Meeting [1][4] - The company will present preliminary results from a multicenter randomized non-inferiority trial comparing its standard Deep TMS protocol to a novel accelerated protocol [2] - BrainsWay is the first and only TMS company to obtain three FDA-cleared indications, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction [4] Company Overview - BrainsWay was founded in 2003 and operates in the United States and Israel, focusing on improving health through its proprietary Deep TMS platform technology [4] - The company is dedicated to advancing neuroscience and increasing global awareness and access to Deep TMS treatments [4] Clinical Research Highlights - The latest Deep TMS research will be featured in poster presentations at the conference, emphasizing the technology's advantages over first-generation TMS systems [3] - A Phase IV Registry Study demonstrated that 49% of patients successfully quit smoking after 15 treatment sessions using the Deep TMS H4 Coil [5] - A post-marketing surveillance study involving over 1,200 adolescent patients showed the efficacy and safety of Deep TMS for adolescent depression [5]