Core Insights - BrainsWay Ltd. (BWAY) has expanded insurance coverage for its Deep TMS therapy in adolescent depression, indicating increased payer confidence in non-drug neurostimulation treatments and enhancing reimbursement visibility for younger patients [1][10]. Company Developments - Optum Behavioral Health has expanded its medical policy to include eligible adolescents, significantly increasing the number of covered lives and reinforcing the clinical acceptance of Deep TMS [2][10]. - The expansion of coverage is expected to strengthen BrainsWay by broadening its reimbursable patient base, improving utilization, and enhancing the lifetime value per system [4]. - BWAY's market capitalization stands at $334.8 million, with projected earnings growth of 100% for the current year [5]. Stock Performance - Following the announcement of the coverage expansion, BWAY shares rose by 10.1% at the market close, with a 53.6% increase over the past six months compared to the industry’s 5.5% growth and the S&P 500's 15.1% gain [3]. Industry Context - The global neuromodulation devices market is projected to grow from $5.80 billion in 2024 to $10.39 billion by 2030, with a CAGR of 8.51% from 2025 to 2030, driven by the rising incidence of chronic pain, neurological disorders, and mental health conditions [13]. - The expansion of Deep TMS coverage is particularly significant given the estimated 5 million adolescents aged 15-21 in the U.S. affected by major depression, a demographic with limited effective treatment options [12]. Future Prospects - BrainsWay is advancing its clinical footprint beyond depression with a new multicenter clinical trial for its next-generation Deep TMS 360 system aimed at treating Alcohol Use Disorder (AUD) [14].

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 is focused on transforming innovative medical technology into scalable business solutions that improve patient outcomes in mental health [2]. Group 1: Company Overview - The CEO of BrainsWay, Hadar Levy, has over 25 years of experience in the med tech industry, emphasizing innovation and scalability [2]. - BrainsWay is collaborating with key partners in the mental health sector, including Dr. Owen Muir, who is instrumental in addressing unmet needs in mental health and has contributed to the development of accelerated treatment protocols in the U.S. [3]. - The company has made a strategic minority investment in Stella, a rapidly growing mental health network, to enhance care delivery [4]. Group 2: Industry Context - The event highlights the increasing focus on mental health and the need for innovative solutions to provide faster relief to patients [3][4]. - The collaboration with leading clinicians and mental health networks indicates a trend towards integrated care models in the mental health industry [4].

Summary of BrainsWay 2025 Investor Day Company Overview - **Company**: BrainsWay (NasdaqGM:BWAY) - **Industry**: Mental Health Technology - **Core Product**: Noninvasive brain stimulation technology, specifically Deep Transcranial Magnetic Stimulation (TMS) for treating major mental health conditions [6][5][3] Key Financial Highlights - **Q3 Revenue**: $13.5 million, up 29% year-over-year [7] - **Gross Margin**: 75% [7] - **Adjusted EBITDA**: $2 million, up 81% [7] - **Net Profit**: $1.6 million, up 137% [7] - **Remaining Performance Obligation**: $65 million, up 37% year-over-year [8] - **Systems Shipped**: 90 systems, up 43% [8] - **Customer Retention Rate**: 93% [12] - **Cash Position**: $71 million, no debts [13] Business Model Transition - Transition from a one-time sale model to a recurring revenue model, with recurring revenue growing 34% year-over-year [13][14] - Shift towards multiyear leases, with 70% of new deals being multiyear [9] - Expected revenue growth from $10 million in 2023 to $18.4 million in 2025 for recurring revenue [14] Clinical and Regulatory Developments - **FDA Clearance**: Accelerated protocol for Major Depressive Disorder (MDD) [9] - **NIH Grant**: $2.5 million grant for Deep TMS for alcohol use disorder [10] - **New Clinical Indications**: Expansion into PTSD, addiction, and cognitive decline [18] Strategic Partnerships and Investments - Four strategic minority investments in mental health clinics to expand access and utilization [11][23] - Partnership with Valo Equity Partners, a $20 billion technology-focused investment fund, to scale operations [20] Market Opportunity and Growth Strategy - **Total Addressable Market (TAM)**: Significant unmet need in mental health, with millions suffering from PTSD, depression, and anxiety [35] - Plans to expand into new care settings, including home use and international markets [24][25] - Development of a connected mental health ecosystem, integrating various treatment modalities [25] Future Milestones - Targeting five enterprise deployments before 2025 [28] - Launch of the Nuuly home-use device for MDD [29] - Continued focus on expanding the neurology portfolio and global presence [30] Competitive Landscape - BrainsWay is positioned as a leader in TMS technology, with a focus on innovative treatment protocols that improve patient outcomes [6][63] - The company aims to differentiate itself through its unique Deep TMS technology and integrated care model [64] Conclusion - BrainsWay is at a pivotal point with strong financial performance, a robust growth strategy, and significant market opportunities in the mental health sector. The company is well-positioned to capitalize on the increasing demand for effective mental health treatments and innovative care delivery models [31][32]

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 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 - 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]

Financial Performance - Revenue increased 29% to $13.5 million in Q3 2025 compared to Q3 2024[5] - Operating income totaled $1.3 million in Q3 2025, up from $0.3 million in the prior year period[5] - Adjusted EBITDA rose approximately 81% to $2.0 million in Q3 2025, compared to $1.1 million for Q3 2024[5] - Net profit for Q3 2025 increased 137% to $1.6 million, compared to $0.7 million for Q3 2024[5] - Revenues for Q3 2025 reached $13,512 thousand, a 28.6% increase from $10,502 thousand in Q3 2024[23] - Operating profit for Q3 2025 was $1,253 thousand, compared to $281 thousand in Q3 2024, marking a significant increase of 345.5%[23] - Net profit for the nine months ended September 30, 2025, was $4,700 thousand, a 242.5% increase from $1,373 thousand in the same period of 2024[23] - Adjusted EBITDA for Q3 2025 was $2,021 thousand, up 80.9% from $1,117 thousand in Q3 2024[28] - Basic net income per share for Q3 2025 was $0.04, doubling from $0.02 in Q3 2024[23] Operational Highlights - Remaining performance obligations increased to $65 million from customers under multi-year contracts[5] - Gross margin for Q3 2025 was 75%, compared to 74% in the prior year period[5] - Shipped a net total of 90 Deep TMS™ systems in Q3 2025, a 43% increase compared to the same period last year[5] Guidance and Investments - Full-year 2025 revenue guidance raised to $51 million – $52 million, up from previous guidance of $50 million – $52 million[5] - Announced four new minority equity investments in 2025 to expand strategic presence across the mental health treatment ecosystem[5] Cash and Expenses - Cash and cash equivalents at the end of Q3 2025 were $70,458 thousand, compared to $48,127 thousand at the end of Q3 2024, reflecting a 46.4% increase[26] - Total operating expenses for the nine months ended September 30, 2025, were $25,861 thousand, up 22.5% from $21,110 thousand in 2024[23] - Research and development expenses for the nine months ended September 30, 2025, totaled $7,072 thousand, an increase of 37.4% from $5,146 thousand in 2024[23] - Finance income for the nine months ended September 30, 2025, was $4,540 thousand, compared to $1,945 thousand in the same period of 2024, representing a 133.5% increase[23]

Core Insights - SoftBank Group has sold $5.8 billion worth of Nvidia stock to invest in OpenAI, indicating a strategic shift rather than a retreat from AI investments [1][4] - Nvidia has become a key player in the AI boom, with its stock price increasing over 10 times since the launch of ChatGPT [3] - SoftBank's decision reflects a belief that the potential value of OpenAI's developments will surpass the value of Nvidia's hardware [5][11] Company Actions - SoftBank has already invested $7.5 billion in OpenAI and plans to invest an additional $22.5 billion soon [4] - The sale of Nvidia shares has led to a nearly 3% decline in Nvidia's stock price [4] Market Context - The relationship between OpenAI and Nvidia has been significant, with Nvidia's chips being essential for AI development [2][3] - The move by SoftBank is seen as part of a broader trend where major investors are willing to divest from established stocks to pursue emerging opportunities [11] Historical Perspective - SoftBank's founder, Masayoshi Son, has a history of making bold investment decisions, including a previous investment in Nvidia that he later regretted missing out on [9][10]