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 Insights - BrainsWay Ltd. (BWAY) has received FDA clearance for an accelerated treatment protocol using its Deep Transcranial Magnetic Stimulation (TMS) system for major depressive disorder, enhancing patient access and provider flexibility [1][4] - The new protocol requires fewer visits while showing comparable outcomes to the standard approach, which may facilitate stronger adoption in the mental health market [2][11] - Following the announcement, BWAY's shares increased by 11.9%, with a year-to-date gain of 79.2%, significantly outperforming the industry and S&P 500 [3] Company Developments - The accelerated Deep TMS protocol reduces treatment time to six days with five sessions per day, compared to the traditional four-week regimen, making it more convenient for patients [9] - Clinical trials demonstrated that the accelerated protocol achieved similar depression score reductions and remission rates as the standard method, with no severe adverse events reported [10][11] - BWAY is actively preparing provider training and reimbursement updates to support the wider adoption of the new treatment protocol [2][11] Market Position and Growth Potential - The FDA clearance positions BWAY to capture a larger share of the mental health market by offering a faster treatment option, potentially driving revenue growth and enhancing competitive differentiation [4][11] - BWAY has a market capitalization of $285.3 million and projects an earnings growth of 94.4% for the current year [5] - 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%, indicating favorable industry prospects for BWAY [12]

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 Insights - BrainsWay Ltd. (BWAY) has made a strategic investment of $5 million in Neurolief Ltd., aiming to expand its presence in the mental health market, particularly in at-home treatment solutions [1][9][10] - Neurolief is developing Proliv Rx, a therapy targeting Major Depressive Disorder (MDD), which is a significant area of unmet medical need [2][11] - Following the investment announcement, BWAY's stock increased by 1.5%, and the company has seen a year-to-date stock surge of 59%, outperforming the industry and S&P 500 [3][5] Company Strategy - The investment allows BrainsWay to enter the at-home mental health treatment market, thereby expanding its total addressable market (TAM) beyond its existing Deep TMS platform [4][12] - By utilizing Neurolief's wearable neuromodulation technology, BrainsWay can diversify its revenue streams and enhance its competitive positioning in the treatment of depression [4][13] Financial Projections - BWAY currently has a market capitalization of $279.2 million and is projecting an earnings growth of 88.9% for the current year [5] - The investment includes future milestone-based funding, with potential additional investments contingent on FDA approval and revenue milestones for Neurolief [10] Industry Outlook - The global neuromodulation devices market is projected to grow from $5.80 billion in 2024 to $10.39 billion by 2030, with a compound annual growth rate (CAGR) of 8.51% from 2025 to 2030 [14] - The increasing prevalence of chronic pain, neurological disorders, and mental health conditions is expected to drive demand for innovative treatment solutions [14]

Core Insights - BrainsWay has made a strategic investment of $5 million in Neurolief, which is developing the Proliv™Rx device pending FDA approval for treating Major Depressive Disorder (MDD) outside of clinical settings [1][2][4] - Neurolief's technology aims to address the significant gap in accessible therapies for treatment-resistant MDD patients, who often face prolonged suffering and higher healthcare costs [3][4] - The partnership is expected to enhance both companies' market presence and expand access to innovative mental health treatments [2][4] Company Overview - BrainsWay is a leader in non-invasive neurostimulation treatments for mental health disorders, with its Deep TMS™ platform technology having three FDA-cleared indications [6][7] - Neurolief is a pioneering company focused on developing wearable, non-invasive neuromodulation systems for mental health and neurological disorders, with its Relivion®MG therapy already approved for migraine treatment [8] Financial Aspects - The investment agreement includes potential milestone-based funding, with a second tranche of up to $6 million contingent on FDA approval of Neurolief's Proliv™Rx system, and a third tranche of up to $5 million based on revenue milestones [4] - The strategic investment is seen as a validation of Neurolief's technology and vision, aiming to reshape the treatment landscape for depression [4]

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]

Core Viewpoint - Brainsway Ltd. Sponsored ADR (BWAY) is positioned as a strong investment opportunity due to significant upward revisions in earnings estimates, indicating a positive earnings outlook and potential for continued stock price appreciation [1][2]. Earnings Estimate Revisions - Analysts have shown increasing optimism regarding Brainsway's earnings prospects, leading to higher earnings estimates that are expected to positively influence the stock price [2]. - For the current quarter, Brainsway is projected to earn $0.09 per share, reflecting a substantial increase of +125.0% compared to the same quarter last year [6]. - The Zacks Consensus Estimate for the current quarter has risen by 27.27% over the past 30 days, with two estimates moving higher and no negative revisions [6]. - For the full year, the expected earnings per share is $0.34, which represents a year-over-year increase of +88.9% [7]. Zacks Rank and Performance - Brainsway currently holds a Zacks Rank 2 (Buy), indicating strong agreement among analysts regarding the positive revisions in earnings estimates [9]. - The Zacks Rank system has a proven track record, with Zacks 1 Ranked stocks averaging an annual return of +25% since 2008, suggesting that stocks with favorable rankings tend to outperform the S&P 500 [3][9]. Stock Performance - Over the past four weeks, Brainsway shares have increased by 7.4%, indicating investor confidence in the company's earnings growth potential driven by the positive estimate revisions [10].