The Investment is part of BrainsWay’s ongoing strategy to acquire minority positions in leading U.S. mental health providers to help them raise awareness for and expand access to transformative careBURLINGTON, Mass. and JERUSALEM, Aug. 20, 2025 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced that it has entered into a strategic equity financing agreement w ...

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]

Core Insights - BrainsWay has entered into a strategic equity financing agreement with Stella MSO, LLC to enhance access to mental health care and raise awareness of innovative treatments [1][2] - The investment in Stella is part of a broader strategy to make minority-stake investments in high-performing mental health providers across the U.S. [2] - BrainsWay will invest $5 million in Stella, acquiring a minority position in the company through preferred, annually compounding securities [4] Company Overview - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology [5] - The company has received FDA clearance for three indications: major depressive disorder, obsessive-compulsive disorder, and smoking addiction [5] - BrainsWay aims to increase global awareness and access to Deep TMS through ongoing clinical trials and scientific advancements [5] Stella Overview - Stella is an interventional psychiatry practice focused on effective mental health protocols for conditions such as severe trauma, stress, anxiety, and depression [6] - The organization has a strong reputation for clinical excellence and operational strength, having treated over 30,000 patients across more than 20 clinics [1][6] - Stella's partnership with BrainsWay is expected to accelerate its growth and enhance patient care [3][5]

Core Insights - BrainsWay Ltd. has entered into a strategic equity financing agreement with Stella MSO, LLC to enhance access to innovative mental health treatments [1][2] - The investment of $5 million will provide BrainsWay with a minority position in Stella, aimed at supporting the interventional psychiatry space [4][2] - This partnership is expected to accelerate growth and improve patient care through Stella's established network of mental health clinics [3][5] Company Overview - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep TMS™ technology [5] - The company has received FDA clearance for three indications: major depressive disorder, obsessive-compulsive disorder, and smoking addiction [5] - BrainsWay is focused on advancing neuroscience and increasing global awareness of its treatment options [5] Stella Overview - Stella is an interventional psychiatry practice that addresses severe trauma, stress, anxiety, and depression through a multidisciplinary approach [6] - The organization has a strong reputation for clinical excellence and operational strength, having treated over 30,000 patients [1][6] - Stella aims to expand access to transformative mental health care through its network of clinics [3][5]

Company Overview - BrainsWay Ltd. is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, specifically through its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology [4] - The company has obtained three FDA-cleared indications for Deep TMS, which include Major Depressive Disorder (MDD), Anxious Depression, Obsessive-Compulsive Disorder (OCD), and Smoking Addiction [4] - Founded in 2003, BrainsWay operates in both Israel and the U.S. and is committed to increasing global awareness and access to Deep TMS [4] Industry Participation - BrainsWay will participate in the American Psychiatric Association (APA) Annual Meeting from May 17–21, 2025, in Los Angeles, California, showcasing its role in psychiatric care [1] - The company will host live demonstrations of its Deep TMS system at its exhibit booth, providing hands-on interaction with this innovative treatment modality [3] Educational Initiatives - A master course titled "Clinical Applications for Psychiatric Practice: Ketamine and TMS" will be held on May 18, 2025, focusing on integrating novel treatments into clinical psychiatric practice [2] - The course will feature prominent clinician-researchers, including BrainsWay's Chief Medical Officer Dr. Richard Bermudes and Vice President of Medical Affairs Dr. Colleen Hanlon, discussing innovative therapeutic approaches [2][3]

Core Insights - BrainsWay Ltd. will report its first quarter 2025 financial results and operational highlights on May 13, 2025, before the U.S. market opens [1] - A conference call and webcast will be held at 8:30 AM Eastern Time on the same day to discuss the results and business operations [1][2] Company Overview - BrainsWay is a leader in advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology [3] - The company has obtained three FDA-cleared indications for its TMS technology, which include major depressive disorder, obsessive-compulsive disorder, and smoking addiction, supported by pivotal clinical studies [3] - Founded in 2003, BrainsWay operates in Israel and the U.S. and is focused on increasing global awareness and access to Deep TMS [3]