Core Insights - BrainsWay has completed a $1 million milestone-based investment in Axis Management Company, Inc. to enhance access to mental health care [1] - The investment follows Axis's achievement of a revenue performance milestone as part of a strategic equity financing agreement established in August 2025 [1][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 [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 in various psychiatric and neurological disorders [5] Axis Management Company - Axis Integrated Mental Health provides management services to mental health clinics in Colorado, focusing on a comprehensive and integrative model of care [6] - The organization combines modern psychiatry and psychotherapy with advanced treatments, including Deep TMS™ and Spravato®, to deliver holistic therapeutic approaches [6]

Core Insights - BrainsWay Ltd. has introduced new clinical data demonstrating a significantly faster, noninvasive treatment for depression, reducing the acute treatment phase by 70% without compromising efficacy [1][2][3] Group 1: Clinical Efficacy - The SWIFT™ accelerated Deep TMS™ protocol achieved an 87.8% response rate and a 78.0% remission rate, comparable to traditional protocols while requiring fewer treatment days [11] - Median time to remission was reduced to 21 days with SWIFT compared to 28 days under the standard protocol [11] - Approximately 60% of patients returned to normal-range functioning after treatment, and 70% no longer suffered from severe quality of life impairment [9][12] Group 2: Patient Impact - Patients reported earlier symptom improvement and substantial enhancements in quality of life, with scores improving by approximately 32 percentage points from baseline by week six [12] - The proportion of patients experiencing severe functional impairment decreased from 85-100% at baseline to 15-17% by the end of treatment [12] - Patients are reconnecting with work, relationships, and routines, highlighting the human impact of the treatment [6] Group 3: Market Implications - The SWIFT approach could transform interventional psychiatry by improving patient retention and expanding clinical options, especially as demand for non-drug therapies rises [3][4] - The economic burden of Major Depressive Disorder (MDD) in the U.S. is estimated at $333 billion annually, with time constraints being a significant barrier to treatment access [4] - Payers are reducing administrative barriers, such as eliminating prior authorization requirements for Deep TMS, which may enhance accessibility [6]

Core Viewpoint - BrainsWay Ltd. will report its fourth quarter and full year 2025 financial results on March 11, 2026, and will host a conference call to discuss these results and provide updates on business operations [1]. Group 1: Financial Reporting - The financial results will be announced before the U.S. financial markets open on March 11, 2026 [1]. - A conference call and webcast will take place at 8:30 AM Eastern Time to discuss the results [1]. Group 2: Conference Call Details - The conference call can be accessed in the U.S. at 1-877-300-8521 and internationally at 1-412-317-6026 [2]. - The conference ID for the call is 10206784, and it will be available for replay for 30 days on the Company's website [2]. Group 3: 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 obtained three FDA-cleared indications for its treatments, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction [3]. - Founded in 2003, BrainsWay operates in the U.S. and Israel and is focused on increasing awareness and access to Deep TMS [3].

Core Viewpoint - BrainsWay Ltd. is a leader in noninvasive brain stimulation technologies, focusing on advancing neuroscience through its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform, which has received FDA clearance for multiple mental health disorders [2]. Group 1: Company Overview - BrainsWay is recognized for its advanced neurostimulation treatments aimed at mental health disorders, with a commitment to improving health and transforming lives [2]. - The company has achieved FDA clearance for three indications: major depressive disorder, obsessive-compulsive disorder, and smoking addiction, supported by pivotal clinical studies [2]. - Founded in 2003, BrainsWay operates in the United States and Israel, with ongoing clinical trials for Deep TMS in various psychiatric, neurological, and addiction disorders [2]. Group 2: Upcoming Events - Management from BrainsWay will participate in one-on-one meetings at the Citi 2026 Unplugged MedTech and Life Sciences Access Day on February 26, 2026, in New York [1].

Core Viewpoint - BrainsWay has entered into a strategic equity financing agreement with BrainStim Health Inc. to enhance access to mental health care through investments in innovative clinical service platforms [1][2] Group 1: Investment Details - BrainsWay will initially invest $1.0 million in BrainStim, with the potential for an additional $1.5 million based on milestones, acquiring a minority position through preferred, annually compounding securities [1] - This investment marks BrainsWay's fifth minority-stake investment in growth-oriented clinical service platforms, aligning with its strategic initiative to expand access to advanced mental health interventions [2] Group 2: Company Background - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology [4] - The company has received FDA clearance for three indications: major depressive disorder, obsessive-compulsive disorder, and smoking addiction, and is committed to advancing its clinical applications [4] Group 3: BrainStim Overview - BrainStim focuses on delivering effective mental health protocols for conditions such as severe trauma, stress, anxiety, and depression, particularly for veterans and first responders [5] - The practice employs a team of board-certified psychiatrists and advanced psychiatric nurse practitioners to provide cutting-edge treatment options [5]

Core Insights - BrainsWay Ltd. comments on Evernorth Behavioral Health's decision to eliminate prior authorization for transcranial magnetic stimulation (TMS), effective March 6, 2026, which will enhance patient access to TMS therapy [1][2] Group 1: Company Overview - BrainsWay is a global leader in advanced noninvasive brain stimulation technologies, particularly known for its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform [5] - The company has obtained three FDA-cleared indications for Deep TMS, which include major depressive disorder, obsessive-compulsive disorder, and smoking addiction, supported by pivotal clinical studies [5] Group 2: Industry Impact - Evernorth's policy change is expected to reduce administrative hurdles, allowing providers to focus on patient care and improving treatment access for individuals with major depressive disorder and obsessive-compulsive disorder [2][3] - The change is anticipated to provide timely access to evidence-based treatment for eligible patients, many of whom have not found relief through traditional therapies [3] Group 3: Future Directions - BrainsWay continues to lead in neurostimulation therapies through ongoing clinical research and collaborations aimed at expanding access to these treatments [4]

Core Viewpoint - BrainsWay Ltd. is changing the ratio of its American Depositary Shares (ADSs) to ordinary shares to simplify comparisons and enhance liquidity for U.S. investors [1][4]. Group 1: ADS Ratio Change - The current 2-to-1 ordinary share-to-ADS ratio will be adjusted to a 1-to-1 structure, effective March 3, 2026 [2]. - Each existing ADS holder will receive one additional ADS for each ADS held, effectively acting as a 2-for-1 forward split [2][3]. - The trading price of the ADSs is expected to be halved following the ratio change [3]. Group 2: Company Background - BrainsWay is a leader in advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) technology [5]. - The company has obtained three FDA-cleared indications for its treatments, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction [5]. - BrainsWay is committed to advancing neuroscience and increasing global awareness of Deep TMS [5].

Core Insights - BrainsWay's strategic investment in Neurolief has led to the FDA granting Premarket Approval for the Proliv™Rx system, the first at-home neuromodulation device for major depressive disorder (MDD) patients who have not responded to previous antidepressants [1][2][3] Company Overview - BrainsWay is a leader in noninvasive brain stimulation technologies, focusing on advanced treatments for mental health disorders [5] - The company utilizes its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform to provide effective treatments for various mental health conditions, including MDD, obsessive-compulsive disorder, and smoking addiction [5] Neurolief Overview - Neurolief is a pioneering company in neuromodulation, known for developing the first wearable, non-invasive, multi-channel brain neuromodulation system designed for home use [4] - The Proliv™Rx device is indicated for adults with MDD who have not achieved satisfactory improvement from at least one prior antidepressant [4] Regulatory Milestone - The FDA's approval of Proliv™Rx marks a significant advancement in the treatment landscape for refractory MDD, allowing for treatment in both home and clinical settings [2][3] Strategic Positioning - BrainsWay's investment in Neurolief, which includes an option to acquire the company, aims to enhance its market value and expand its addressable market by providing access to patients who may struggle to visit clinics [3]

Core Insights - The FDA has granted Premarket Approval for Neurolief's Proliv™Rx system, making it the first at-home neuromodulation treatment for patients with major depressive disorder (MDD) who have not responded to previous antidepressant medications [1][2] Group 1: FDA Approval and Market Impact - The approval signifies a major regulatory milestone, expanding treatment options for refractory MDD patients beyond traditional in-clinic care [2] - Proliv™Rx is now recognized as an adjunctive treatment for MDD, indicating its potential to improve patient access to care [4] Group 2: Strategic Positioning of BrainsWay - BrainsWay's investment in Neurolief, which includes an option to acquire the company, aims to enhance its market value and expand its total addressable market [3] - The FDA approval validates BrainsWay's investment strategy and reinforces its commitment to data-driven mental health care [3] Group 3: Company Backgrounds - Neurolief is focused on developing innovative therapies for mental health and neurological disorders, with its Proliv™Rx device designed for home use [4] - BrainsWay is a leader in noninvasive neurostimulation treatments, with a proprietary Deep TMS™ platform and multiple FDA-cleared indications for mental health disorders [5]

Core Viewpoint - BrainsWay Ltd. has announced that Premera Blue Cross Blue Shield has adopted a new medical policy expanding coverage for patients aged 15 and older with moderate to severe major depressive disorder treated with BrainsWay's SWIFT Deep TMS protocol, marking a significant development in insurance coverage for this treatment [1][2]. Group 1: Company Developments - The SWIFT depression protocol consists of five treatment sessions per day for six days, followed by two sessions per day once a week for four weeks, totaling 38 sessions, and does not require expensive neuronavigational equipment [3]. - BrainsWay's clinical trials and real-world evidence show comparable response and remission outcomes for the SWIFT protocol compared to the standard Deep TMS protocol, indicating its effectiveness [4]. - The company continues to lead in the field with its proprietary H-coil technology and is focused on expanding access to advanced neurostimulation therapies through collaboration with providers and policymakers [5]. Group 2: Company Background - BrainsWay is a global leader in noninvasive neurostimulation treatments for mental health disorders, with a proprietary Deep TMS platform that has received FDA clearance for multiple indications, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction [6]. - The company was founded in 2003 and operates in the United States and Israel, with ongoing clinical trials for various psychiatric, neurological, and addiction disorders [6].