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]

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 Points - The U.S. National Institutes of Health (NIH) has awarded BrainsWay Ltd. a grant of approximately $2.5 million over five years for a clinical study on the efficacy of an accelerated Deep Transcranial Magnetic Stimulation (Deep TMS™) protocol for treating Alcohol Use Disorder (AUD) [1][2] - The study aims to evaluate the mechanism of action and potential efficacy of the treatment, utilizing BrainsWay's H7 Coil to target brain regions associated with addiction and relapse risk [2][3] - This grant marks the second major NIH funding awarded to the research team in two years, highlighting their leadership in neuromodulation for addiction [3] Research Details - The study will involve 100 adults with AUD in a randomized, double-blind, sham-controlled trial, with participants receiving three Deep TMS treatments per day for 10 consecutive business days, totaling 30 treatment sessions [6] - Neuroimaging assessments will be used to investigate neural activation in targeted brain regions, linking clinical outcomes such as days abstinent and heavy drinking days to observed brain changes [6] Company Background - BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, with a proprietary Deep TMS™ platform technology [5] - The company has received FDA clearance for multiple indications, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction, demonstrating clinically proven efficacy [5] - Recent developments include FDA clearance for the H1 Coil for accelerated treatment of major depressive disorder, indicating ongoing innovation in treatment protocols [4]

Core Insights - BrainsWay Ltd. will report its Q3 2025 financial results and operational highlights on November 11, 2025, before the U.S. market opens [1] - A conference call and webcast will be held at 8:30 AM Eastern Time to discuss the results and provide business updates [2] Company Overview - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology [3] - The company has received FDA clearance for three indications: major depressive disorder, obsessive-compulsive disorder, and smoking addiction, supported by pivotal clinical studies [3] - Founded in 2003, BrainsWay operates in the U.S. and Israel, focusing on increasing awareness and access to Deep TMS [3]

Core Viewpoint - BrainsWay Ltd. has made two additional strategic minority stake investments in U.S. mental health providers, bringing the total to four in 2025, aiming to enhance patient access to innovative mental health treatments and drive long-term shareholder value [1][2][5] Investment Details - BrainsWay will invest an initial $1.5 million in Heading Health, with the potential for an additional $2.5 million through three milestone-based investments [3] - The investment in Heading Health will provide BrainsWay with a minority position in the form of a preferred, annually compounding security [3] Strategic Intent - The investment strategy is designed to facilitate the growth of commercial partners while allowing BrainsWay to maintain its focus on scientific and technological advancements [4] - The partnership with Heading Health is seen as a unique opportunity to expand treatment options and improve patient lives on a large scale [5] Company Overview - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology [6] - The company has received FDA clearance for three indications, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction [6] Heading Health Overview - Heading Health specializes in interventional psychiatry, focusing on effective mental health protocols for conditions such as severe trauma, stress, anxiety, and depression [7] - The organization employs a team of board-certified psychiatrists and advanced psychiatric nurse practitioners to deliver cutting-edge treatment options [7]

Group 1 - Alkermes (ALKS) is currently outperforming its peers in the Medical sector with a year-to-date return of 7.7%, compared to the sector average of 1.7% [4] - The Zacks Rank for Alkermes is 2 (Buy), indicating a positive outlook based on earnings estimates and revisions, with a 15.4% increase in the consensus estimate for full-year earnings over the past 90 days [3] - Alkermes is part of the Medical - Biomedical and Genetics industry, which has seen a year-to-date gain of 10.6%, indicating that ALKS is slightly underperforming its industry [6] Group 2 - The Medical group consists of 956 companies and is currently ranked 4 in the Zacks Sector Rank, which evaluates 16 different sector groups [2] - Another stock in the Medical sector, Brainsway Ltd. Sponsored ADR (BWAY), has significantly outperformed with a year-to-date increase of 68.4% and also holds a Zacks Rank of 2 (Buy) [4][5] - The Medical - Products industry, which includes Brainsway, has a lower ranking at 95 and has gained 5.3% since the beginning of the year [7]

Core Viewpoint - BrainsWay has received FDA clearance for an accelerated treatment protocol for its Deep TMS system, which is expected to enhance patient access and treatment efficacy for major depressive disorder (MDD) [1][2][3] Group 1: FDA Clearance and Treatment Protocol - The FDA has expanded the treatment protocols for BrainsWay's Deep TMS system to include an accelerated protocol for MDD, which is now commercially available in the U.S. [1] - The new accelerated protocol reduces the treatment duration from 4 weeks to just 6 days of acute treatment, allowing for quicker patient response [2][3] - The accelerated protocol consists of 5 sessions per day for 6 days, followed by 2 sessions per week for 4 weeks, with each session lasting less than 10 minutes [3] Group 2: Clinical Study Results - Clinical data from a multicenter, randomized, controlled study showed that the accelerated protocol resulted in comparable outcomes to the standard protocol, with HDRS-21 depression scores reduced by 19.02 points in the accelerated group and 19.79 points in the standard group [3] - Response and remission rates for the accelerated group were 87.8% and 78.0%, respectively, compared to 87.5% and 87.5% for the standard group [3] - The median time to remission was 21 days for the accelerated group, compared to 28 days for the standard group, indicating a faster therapeutic effect [3] Group 3: Market Context and Company Overview - MDD is a leading cause of disability globally, affecting millions and creating a critical gap in accessible and effective therapies, particularly for patients who do not respond to traditional treatments [4] - BrainsWay is a leader in noninvasive neurostimulation treatments, with its Deep TMS platform being the first to receive three FDA-cleared indications backed by clinical studies [5] - The company is committed to advancing neuroscience and increasing global awareness and access to Deep TMS, with ongoing clinical trials for various psychiatric and neurological disorders [5][6]

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].

Company Overview - Biotricity Inc. (BTCY) is part of the Medical sector, which includes 976 individual stocks and currently holds a Zacks Sector Rank of 6, indicating its relative strength among sector groups [2] - Biotricity Inc. has a Zacks Rank of 2 (Buy), suggesting a favorable outlook based on earnings estimate revisions and improving earnings outlooks [3] Performance Metrics - Over the past three months, the Zacks Consensus Estimate for BTCY's full-year earnings has increased by 17.9%, reflecting improved analyst sentiment and a stronger earnings outlook [4] - Year-to-date, BTCY has gained approximately 115.6%, significantly outperforming the average loss of 3.3% in the Medical group [4] Industry Comparison - Biotricity Inc. belongs to the Medical Info Systems industry, which consists of 44 companies and currently ranks 51 in the Zacks Industry Rank. This industry has seen a year-to-date gain of about 23.6%, indicating BTCY's strong performance relative to its peers [6] - In contrast, another stock in the Medical sector, Brainsway Ltd. Sponsored ADR (BWAY), has a year-to-date return of 57.5% and belongs to the Medical - Products industry, which ranks 96 and has gained 5.5% year to date [5][6] Investment Consideration - Investors interested in the Medical sector may want to monitor Biotricity Inc. and Brainsway Ltd. Sponsored ADR for their continued strong performance [7]