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 ...

Stock Split: BrainsWay Ltd. (NASDAQ:BWAY) is set to undergo a stock split on March 3, 2026, aiming to make shares more accessible to a wider range of investors.Strategic Equity Financing: BWAY has entered into a strategic equity financing agreement with BrainStim Health Inc., investing up to $2.5 million to expand its presence in the North American mental health sector.Improved TMS Therapy Access: Evernorth Behavioral Health, part of the Cigna Group, will enhance patient access to TMS therapy by eliminating ...

BURLINGTON, Mass. and JERUSALEM, Feb. 23, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that management will participate in one-on-one meetings at the Citi 2026 Unplugged MedTech and Life Sciences Access Day on Thursday, February 26, 2026, in New York, NY. Please contact your Citi representative to request a meeting at the conference. About BrainsWayBrainsWay is a global le ...

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]

Change in ADS ratio aimed at simplifying comparisons to ordinary shares traded on the Tel Aviv Stock Exchange, while boosting liquidity and access for U.S. investorsBURLINGTON, Mass. and JERUSALEM, Feb. 17, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that its Board of Directors approved a plan to change to the ratio of its American Depositary Shares (ADSs) listed on the N ...

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 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].