Core Viewpoint - BrainsWay is strategically investing in minority positions in leading U.S. mental health providers to enhance awareness and access to innovative mental health treatments, particularly Deep TMS Therapy [1][2]. Investment Details - BrainsWay has entered into a strategic equity financing agreement with Axis Management Company, Inc., committing an initial investment of $2.3 million, with a potential additional $1 million based on milestones [1]. - The investment will be in the form of a preferred, annually compounding security, and includes a redemption mechanism for the shares [1]. Strategic Goals - The investment in Axis is part of BrainsWay's broader initiative to accelerate access to innovative mental health treatments while maintaining a focus on advancing scientific and technological capabilities [2]. - The company aims to provide capital injections into high-performing healthcare providers, enabling them to invest in growth and expand their services [2]. Axis Management Company Overview - Axis Integrated Mental Health is a management services organization that operates several mental health clinics in Colorado, focusing on delivering comprehensive and integrative care [4]. - The organization combines modern psychiatry and psychotherapy with advanced treatments, including Deep TMS and Spravato, to provide a holistic therapeutic approach [4]. BrainsWay Overview - BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, particularly known for its proprietary Deep TMS technology [3]. - The company has received FDA clearance for three indications, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction, and is committed to increasing global awareness and access to Deep TMS [3].

Core Viewpoint - BrainsWay Ltd. is set to report its second quarter 2025 financial results and operational highlights on August 13, 2025, before the U.S. markets open, followed by a conference call to discuss the results and business updates [1]. Company Overview - BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform 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 the United States and Israel, focusing on increasing global awareness and access to Deep TMS [3]. Conference Call Details - The conference call is scheduled for August 13, 2025, at 8:30 AM Eastern Time, with dial-in numbers provided for the United States, international participants, and Israel [2]. - The call will be available for live broadcast and replay for 30 days on the company's website [2].

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]