New draft policy from Highmark Blue Cross Blue Shield extends to both adolescent and adult depression patientsBURLINGTON, Mass. and JERUSALEM, Jan. 21, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that Highmark Blue Cross Blue Shield®, a company with over seven million covered lives that primarily serves Pennsylvania, Delaware, West Virginia, and parts of New York, has rel ...

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].

Key Takeaways BWAY benefits as Optum expands Deep TMS coverage to adolescents with major depressive disorder.BWAY sees a wider reimbursable teen patient base, driving earlier treatment adoption and utilization growth.BWAY gains from broader insurer alignment that improves revenue visibility and encourages clinic investment.BrainsWay Ltd. (BWAY) recently announced an expansion of insurance coverage for its Deep TMS therapy in adolescent depression. The update signals growing payer confidence in non-drug neur ...

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].

Summary of BrainsWay 2025 Investor Day Company Overview - **Company**: BrainsWay (NasdaqGM:BWAY) - **Industry**: Mental Health Technology - **Core Product**: Noninvasive brain stimulation technology, specifically Deep Transcranial Magnetic Stimulation (TMS) for treating major mental health conditions [6][5][3] Key Financial Highlights - **Q3 Revenue**: $13.5 million, up 29% year-over-year [7] - **Gross Margin**: 75% [7] - **Adjusted EBITDA**: $2 million, up 81% [7] - **Net Profit**: $1.6 million, up 137% [7] - **Remaining Performance Obligation**: $65 million, up 37% year-over-year [8] - **Systems Shipped**: 90 systems, up 43% [8] - **Customer Retention Rate**: 93% [12] - **Cash Position**: $71 million, no debts [13] Business Model Transition - Transition from a one-time sale model to a recurring revenue model, with recurring revenue growing 34% year-over-year [13][14] - Shift towards multiyear leases, with 70% of new deals being multiyear [9] - Expected revenue growth from $10 million in 2023 to $18.4 million in 2025 for recurring revenue [14] Clinical and Regulatory Developments - **FDA Clearance**: Accelerated protocol for Major Depressive Disorder (MDD) [9] - **NIH Grant**: $2.5 million grant for Deep TMS for alcohol use disorder [10] - **New Clinical Indications**: Expansion into PTSD, addiction, and cognitive decline [18] Strategic Partnerships and Investments - Four strategic minority investments in mental health clinics to expand access and utilization [11][23] - Partnership with Valo Equity Partners, a $20 billion technology-focused investment fund, to scale operations [20] Market Opportunity and Growth Strategy - **Total Addressable Market (TAM)**: Significant unmet need in mental health, with millions suffering from PTSD, depression, and anxiety [35] - Plans to expand into new care settings, including home use and international markets [24][25] - Development of a connected mental health ecosystem, integrating various treatment modalities [25] Future Milestones - Targeting five enterprise deployments before 2025 [28] - Launch of the Nuuly home-use device for MDD [29] - Continued focus on expanding the neurology portfolio and global presence [30] Competitive Landscape - BrainsWay is positioned as a leader in TMS technology, with a focus on innovative treatment protocols that improve patient outcomes [6][63] - The company aims to differentiate itself through its unique Deep TMS technology and integrated care model [64] Conclusion - BrainsWay is at a pivotal point with strong financial performance, a robust growth strategy, and significant market opportunities in the mental health sector. The company is well-positioned to capitalize on the increasing demand for effective mental health treatments and innovative care delivery models [31][32]

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]

Core Insights - BrainsWay Ltd. will host a virtual Analyst & Investor Day on December 1, 2025, to discuss its growth strategy and showcase its patented Deep TMS technology [1][2] Company Overview - BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep TMS™ platform technology [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] Event Details - The event will feature discussions from key figures, including Owen Scott Muir, MD, who will address the unmet needs in mental health and his clinical experience with Deep TMS [1][4] - Michael Gershenzon, CEO of Stella MSO, will share insights on BrainsWay's strategic investment in Stella, which services over 20 mental health clinics in the U.S. and Israel [1] Technology Insights - Deep TMS is a clinically proven, noninvasive treatment that uses magnetic fields to activate neural networks in the brain, aimed at improving symptoms of various mental health conditions [2] - The event will also cover the potential impact of an accelerated protocol for Deep TMS [2]