BURLINGTON, Mass. and JERUSALEM, Feb. 25, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation technologies, today announced that it will report its fourth quarter and full year 2025 financial results, as well as operational highlights, before the open of the U.S. financial markets on Wednesday, March 11, 2026. The Company will host a conference call and webcast at 8:30 AM Eastern Time to discuss the results an ...

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 - Highmark Blue Cross Blue Shield has released a draft medical policy expanding coverage for adolescent and adult patients with major depressive disorder (MDD) to include BrainsWay's accelerated Deep TMS™ protocol [1][2] - The new policy is expected to take effect in February 2026, following an open comment period, and will cover BrainsWay's accelerated SWIFT™ protocol, which involves a total of 38 treatment sessions [2] - BrainsWay's accelerated depression protocol for Deep TMS received FDA clearance in September 2025, demonstrating an 87.8% response rate and a 78.0% remission rate in clinical trials [4] Company Overview - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, with a proprietary Deep TMS™ platform 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 and access to 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 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].

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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]