BrainsWay continues to actively evaluate similar investments in leading North American mental health providers to raise awareness and expand access to transformative care BURLINGTON, Mass. and JERUSALEM, Feb. 19, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced it has entered into a strategic equity financing agreement with BrainStim Health Inc. (“Brai ...

BURLINGTON, Mass. and JERUSALEM, Feb. 18, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today commented on the recent news issued by Evernorth® Behavioral Health, Inc., a division of the Cigna Group, which serves over 18 million covered lives across 12 states, that it will no longer require prior authorization for transcranial magnetic stimulation (TMS) for contracted providers whose patie ...

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].

Core Insights - BrainsWay Ltd. (BWAY) has expanded insurance coverage for its Deep TMS therapy in adolescent depression, indicating increased payer confidence in non-drug neurostimulation treatments and enhancing reimbursement visibility for younger patients [1][10]. Company Developments - Optum Behavioral Health has expanded its medical policy to include eligible adolescents, significantly increasing the number of covered lives and reinforcing the clinical acceptance of Deep TMS [2][10]. - The expansion of coverage is expected to strengthen BrainsWay by broadening its reimbursable patient base, improving utilization, and enhancing the lifetime value per system [4]. - BWAY's market capitalization stands at $334.8 million, with projected earnings growth of 100% for the current year [5]. Stock Performance - Following the announcement of the coverage expansion, BWAY shares rose by 10.1% at the market close, with a 53.6% increase over the past six months compared to the industry’s 5.5% growth and the S&P 500's 15.1% gain [3]. Industry Context - 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% from 2025 to 2030, driven by the rising incidence of chronic pain, neurological disorders, and mental health conditions [13]. - The expansion of Deep TMS coverage is particularly significant given the estimated 5 million adolescents aged 15-21 in the U.S. affected by major depression, a demographic with limited effective treatment options [12]. Future Prospects - BrainsWay is advancing its clinical footprint beyond depression with a new multicenter clinical trial for its next-generation Deep TMS 360 system aimed at treating Alcohol Use Disorder (AUD) [14].

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].

Core Insights - BrainsWay is focused on transforming innovative medical technology into scalable business solutions that improve patient outcomes in mental health [2]. Group 1: Company Overview - The CEO of BrainsWay, Hadar Levy, has over 25 years of experience in the med tech industry, emphasizing innovation and scalability [2]. - BrainsWay is collaborating with key partners in the mental health sector, including Dr. Owen Muir, who is instrumental in addressing unmet needs in mental health and has contributed to the development of accelerated treatment protocols in the U.S. [3]. - The company has made a strategic minority investment in Stella, a rapidly growing mental health network, to enhance care delivery [4]. Group 2: Industry Context - The event highlights the increasing focus on mental health and the need for innovative solutions to provide faster relief to patients [3][4]. - The collaboration with leading clinicians and mental health networks indicates a trend towards integrated care models in the mental health industry [4].