Core Viewpoint - Optum Behavioral Health has expanded its medical policy to cover Deep TMS therapy for adolescents aged 15 and older with major depressive disorder, reflecting a growing recognition of this treatment as essential in modern mental health care [1][2]. Group 1: Coverage Expansion - Optum's policy expansion aligns with other insurers such as Evernorth Health Services, CVS/Aetna, and several Blue Cross and Blue Shield companies, collectively covering approximately 180 million lives [2]. - The inclusion of adolescents in the coverage for Deep TMS therapy signifies a commitment to early intervention and innovation in treating major depressive disorder [2]. Group 2: Public Health Challenge - An estimated 5 million adolescents aged 15–21 in the U.S. experience major depression, which disrupts developmental milestones and can lead to higher healthcare costs and comorbid conditions [3]. - The limited treatment options for adolescents who cannot tolerate or do not respond to medication highlight a critical gap in access to effective treatments for this vulnerable population [3]. Group 3: Deep TMS Technology - BrainsWay's Deep TMS is FDA cleared as an adjunct therapy for adolescents with depression, demonstrating meaningful response and remission rates [4]. - The company utilizes proprietary H-coil technology and is committed to expanding access to advanced neurostimulation therapies through ongoing clinical research and collaboration with providers [4][5]. Group 4: Company Overview - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, with FDA-cleared indications for major depressive disorder, obsessive-compulsive disorder, and smoking addiction [5]. - The company was founded in 2003 and operates in the U.S. and Israel, focusing on increasing global awareness and access to Deep TMS technology [5].

Core Insights - BrainsWay Ltd. will host a virtual Analyst & Investor Day on December 1, 2025, to discuss its growth strategy and advancements in noninvasive brain stimulation technologies [1][2] - The event will feature discussions on the unmet needs in mental health treatment and the clinical application of BrainsWay's Deep TMS technology [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™) platform [5] - The company has received FDA clearance for three indications: major depressive disorder, obsessive-compulsive disorder, and smoking addiction, supported by pivotal clinical studies [5] - BrainsWay aims to enhance global awareness and access to Deep TMS, with ongoing clinical trials for various psychiatric, neurological, and addiction disorders [5] Event Details - The Analyst & Investor Day will include presentations from key figures in the field, including Owen Scott Muir, MD, who will address the clinical experience with Deep TMS and its implications for mental health treatment [1][4] - A live Q&A session will follow the formal presentations, allowing for direct engagement with the company's management [3]

Core Insights - BrainsWay Ltd. will host a virtual Analyst & Investor Day on December 1, 2025, to discuss its growth strategy and showcase its patented Deep TMS technology [1][2] Company Overview - BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep TMS™ platform technology [5] - The company has received FDA clearance for three indications: major depressive disorder, obsessive-compulsive disorder, and smoking addiction, supported by pivotal clinical studies [5] Event Details - The event will feature discussions from key figures, including Owen Scott Muir, MD, who will address the unmet needs in mental health and his clinical experience with Deep TMS [1][4] - Michael Gershenzon, CEO of Stella MSO, will share insights on BrainsWay's strategic investment in Stella, which services over 20 mental health clinics in the U.S. and Israel [1] Technology Insights - Deep TMS is a clinically proven, noninvasive treatment that uses magnetic fields to activate neural networks in the brain, aimed at improving symptoms of various mental health conditions [2] - The event will also cover the potential impact of an accelerated protocol for Deep TMS [2]

Core Insights - The FDA has granted a label expansion for BrainsWay's Deep TMS™ system, making it the first and only TMS device cleared for treating patients aged 15 to 86 suffering from major depressive disorder (MDD) [1][2][3] - This clearance allows access to Deep TMS™ for adolescents aged 15 to 21, a demographic often underserved by traditional pharmacological treatments [2][3] - The approval was supported by a substantial dataset from 1,120 adolescents treated across 35 TMS centers in the U.S., demonstrating a 66.1% response rate and an average improvement of 12.1 points on the PHQ-9 scale after 36 treatment sessions [2][3] Company Overview - BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, with a proprietary Deep TMS™ platform technology [4] - The company has obtained three FDA-cleared indications, including MDD, obsessive-compulsive disorder, and smoking addiction, backed by pivotal clinical studies [4] - BrainsWay aims to increase global awareness and access to Deep TMS, with ongoing clinical trials for various psychiatric, neurological, and addiction disorders [4] Market Impact - Approximately 5 million adolescents in the U.S. are estimated to have experienced a major depressive episode in the past year, highlighting the significance of this clearance for addressing an important segment of the MDD patient population [3] - The Deep TMS™ system is now indicated for both adults and adolescents, allowing clinicians to use the same system and established protocols for treatment [3] - MDD is a leading cause of disability globally, with a critical gap in accessible and effective therapies for patients who do not respond to traditional treatments [3]

Core Insights - BrainsWay Ltd. reported record quarterly revenue of $12.6 million in Q2 2025, marking a 26% increase compared to Q2 2024 [1] - The company raised its full-year 2025 revenue guidance to between $50 million and $52 million, up from the previous range of $49 million to $51 million [4] - Remaining performance obligations increased by 25% year-over-year to $62 million, indicating strong future revenue visibility [1][4] Financial Performance - Operating profit for Q2 2025 totaled $0.6 million, consistent with the prior year [5] - Adjusted EBITDA rose 16% to $1.5 million in Q2 2025, compared to $1.3 million in Q2 2024 [5] - Net profit surged 233% to $2.0 million in Q2 2025, up from $0.6 million in Q2 2024 [5] Operational Highlights - The company shipped a net total of 88 Deep TMS™ systems in Q2 2025, a 35% increase from the same period last year, bringing the total installed base to 1,522 systems [5] - Approximately 70% of recent customer engagements are structured as multi-year lease agreements, contributing to stable revenue streams [5] - The company is actively pursuing minority equity investments in high-performing mental health providers to enhance its strategic initiatives [7] Guidance and Future Outlook - The company expects operating income for full-year 2025 to be between 4% and 5%, with Adjusted EBITDA projected at 12% to 13% [4] - BrainsWay's management expressed confidence in the momentum across its core market and the successful execution of its growth strategy [4][6]

Core Insights - BrainsWay is launching two new Continuing Medical Education (CME) courses to enhance clinician knowledge and confidence in Transcranial Magnetic Stimulation (TMS) [1][2] - The courses are designed to clarify the differences between BrainsWay's Deep TMS™ technology and first-generation TMS, while providing practical guidance for clinical integration [1][3] Company Overview - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, focusing on its proprietary Deep TMS™ platform technology [5] - The company has received FDA clearance for three indications, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction, supported by pivotal clinical studies [5] - BrainsWay aims to increase global awareness and access to Deep TMS, with ongoing clinical trials for various psychiatric, neurological, and addiction disorders [5] Educational Initiatives - The CME courses are supported by independent educational grants from BrainsWay and offer up to 0.5 AMA PRA Category 1 Credits™ [2] - The courses are accessible online to a wide range of healthcare professionals, including psychiatrists and nurse practitioners [2] - The first course focuses on evidence-based data supporting TMS and its role in mental health treatment, while the second course emphasizes practical strategies for patient identification and treatment integration [6]