BrainsWay’s strategic investment in Neurolief paved the way for the first and only FDA approved at-home neuromodulation device with Class III Premarket Approval labeling for MDD patients who failed one or more prior antidepressantsBURLINGTON, Mass. and JERUSALEM, Jan. 12, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that the U.S. Food and Drug Administration (FDA) has gran ...

BURLINGTON, Mass. and JERUSALEM, Jan. 12, 2026 (GLOBE NEWSWIRE) -- BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain stimulation technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for Neurolief's Proliv™Rx system, a Class III device, as an adjunctive treatment for adult patients suffering from major depressive disorder (MDD) who have failed to achieve satisfactory improvement fro ...

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 Points - The U.S. National Institutes of Health (NIH) has awarded BrainsWay Ltd. a grant of approximately $2.5 million over five years for a clinical study on the efficacy of an accelerated Deep Transcranial Magnetic Stimulation (Deep TMS™) protocol for treating Alcohol Use Disorder (AUD) [1][2] - The study aims to evaluate the mechanism of action and potential efficacy of the treatment, utilizing BrainsWay's H7 Coil to target brain regions associated with addiction and relapse risk [2][3] - This grant marks the second major NIH funding awarded to the research team in two years, highlighting their leadership in neuromodulation for addiction [3] Research Details - The study will involve 100 adults with AUD in a randomized, double-blind, sham-controlled trial, with participants receiving three Deep TMS treatments per day for 10 consecutive business days, totaling 30 treatment sessions [6] - Neuroimaging assessments will be used to investigate neural activation in targeted brain regions, linking clinical outcomes such as days abstinent and heavy drinking days to observed brain changes [6] Company Background - BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, with a proprietary Deep TMS™ platform technology [5] - The company has received FDA clearance for multiple indications, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction, demonstrating clinically proven efficacy [5] - Recent developments include FDA clearance for the H1 Coil for accelerated treatment of major depressive disorder, indicating ongoing innovation in treatment protocols [4]

Core Insights - BrainsWay Ltd. will report its Q3 2025 financial results and operational highlights on November 11, 2025, before the U.S. market opens [1] - A conference call and webcast will be held at 8:30 AM Eastern Time to discuss the results and provide business updates [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 [3] - The company has received FDA clearance for three indications: major depressive disorder, obsessive-compulsive disorder, and smoking addiction, supported by pivotal clinical studies [3] - Founded in 2003, BrainsWay operates in the U.S. and Israel, focusing on increasing awareness and access to Deep TMS [3]

Core Viewpoint - BrainsWay is strategically investing in minority positions in leading U.S. mental health providers to enhance awareness and access to innovative mental health treatments, particularly Deep TMS Therapy [1][2]. Investment Details - BrainsWay has entered into a strategic equity financing agreement with Axis Management Company, Inc., committing an initial investment of $2.3 million, with a potential additional $1 million based on milestones [1]. - The investment will be in the form of a preferred, annually compounding security, and includes a redemption mechanism for the shares [1]. Strategic Goals - The investment in Axis is part of BrainsWay's broader initiative to accelerate access to innovative mental health treatments while maintaining a focus on advancing scientific and technological capabilities [2]. - The company aims to provide capital injections into high-performing healthcare providers, enabling them to invest in growth and expand their services [2]. Axis Management Company Overview - Axis Integrated Mental Health is a management services organization that operates several mental health clinics in Colorado, focusing on delivering comprehensive and integrative care [4]. - The organization combines modern psychiatry and psychotherapy with advanced treatments, including Deep TMS and Spravato, to provide a holistic therapeutic approach [4]. BrainsWay Overview - BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, particularly known for its proprietary Deep TMS technology [3]. - The company has received FDA clearance for three indications, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction, and is committed to increasing global awareness and access to Deep TMS [3].

Core Viewpoint - BrainsWay Ltd. is set to report its second quarter 2025 financial results and operational highlights on August 13, 2025, before the U.S. markets open, followed by a conference call to discuss the results and business updates [1]. Company Overview - BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, utilizing its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) platform technology [3]. - The company has obtained three FDA-cleared indications for its TMS technology, which include major depressive disorder, obsessive-compulsive disorder, and smoking addiction, supported by pivotal clinical studies [3]. - Founded in 2003, BrainsWay operates in the United States and Israel, focusing on increasing global awareness and access to Deep TMS [3]. Conference Call Details - The conference call is scheduled for August 13, 2025, at 8:30 AM Eastern Time, with dial-in numbers provided for the United States, international participants, and Israel [2]. - The call will be available for live broadcast and replay for 30 days on the company's website [2].

Core Viewpoint - BrainsWay Ltd. announced preliminary results from a multicenter, randomized controlled trial indicating that the accelerated Deep TMS protocol for treating major depressive disorder is comparable in efficacy to the standard protocol while requiring fewer clinic visits [1][2]. Group 1: Study Overview - The trial involved 104 adult patients diagnosed with depression across eight sites, making it the largest randomized, controlled, blinded, multicenter trial of an accelerated Deep TMS protocol [2]. - Patients were divided into two groups: one receiving standard Deep TMS treatment and the other receiving the accelerated protocol [2]. Group 2: Treatment Protocol - The accelerated group underwent five sessions per day over six treatment days, followed by eight sessions over the next four weeks, significantly reducing the treatment burden [3]. - The primary endpoint was the change in depressive symptoms measured by the HDRS-21 scale, with secondary endpoints including response and remission rates [3]. Group 3: Key Findings - The accelerated Deep TMS group showed comparable efficacy with HDRS depression scores reduced by 18.9 points, while the standard group saw a reduction of 19.9 points [7]. - Response and remission rates were 87.8% and 78.0% for the accelerated group, compared to 87.5% and 87.5% for the standard group [7]. - Sessions for the accelerated protocol lasted less than 10 minutes, compared to 20 minutes for standard sessions [7]. - The median time to remission was 21 days for the accelerated group versus 28 days for the standard group [7]. - The accelerated protocol was well-tolerated with no serious adverse events reported, and side effects were mild [7]. Group 4: Company Commitment - BrainsWay emphasizes that innovation in mental health care involves not only new technology but also improving care delivery methods [5]. - The company is dedicated to expanding access to Deep TMS and advancing the field through scientific research [5]. - The accelerated protocol is investigational and not yet FDA-cleared, with preliminary results subject to further analysis and peer review [5]. Group 5: Company Background - BrainsWay is a leader in noninvasive neurostimulation treatments for mental health disorders, with a proprietary Deep TMS platform technology [8]. - The company has obtained three FDA-cleared indications for major depressive disorder, obsessive-compulsive disorder, and smoking addiction [8]. - Founded in 2003, BrainsWay operates in the United States and Israel, focusing on increasing global awareness and access to Deep TMS [8].

Core Insights - BrainsWay Ltd. is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, showcasing its Deep TMS technology at the Clinical TMS Society's 2025 Annual Meeting [1][4] - The company will present preliminary results from a multicenter randomized non-inferiority trial comparing its standard Deep TMS protocol to a novel accelerated protocol [2] - BrainsWay is the first and only TMS company to obtain three FDA-cleared indications, including major depressive disorder, obsessive-compulsive disorder, and smoking addiction [4] Company Overview - BrainsWay was founded in 2003 and operates in the United States and Israel, focusing on improving health through its proprietary Deep TMS platform technology [4] - The company is dedicated to advancing neuroscience and increasing global awareness and access to Deep TMS treatments [4] Clinical Research Highlights - The latest Deep TMS research will be featured in poster presentations at the conference, emphasizing the technology's advantages over first-generation TMS systems [3] - A Phase IV Registry Study demonstrated that 49% of patients successfully quit smoking after 15 treatment sessions using the Deep TMS H4 Coil [5] - A post-marketing surveillance study involving over 1,200 adolescent patients showed the efficacy and safety of Deep TMS for adolescent depression [5]

Core Insights - BrainsWay has entered into a strategic equity financing agreement with Stella MSO, LLC to enhance access to mental health care and raise awareness of innovative treatments [1][2] - The investment in Stella is part of a broader strategy to make minority-stake investments in high-performing mental health providers across the U.S. [2] - BrainsWay will invest $5 million in Stella, acquiring a minority position in the company through preferred, annually compounding securities [4] 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 and scientific advancements [5] Stella Overview - Stella is an interventional psychiatry practice focused on effective mental health protocols for conditions such as severe trauma, stress, anxiety, and depression [6] - The organization has a strong reputation for clinical excellence and operational strength, having treated over 30,000 patients across more than 20 clinics [1][6] - Stella's partnership with BrainsWay is expected to accelerate its growth and enhance patient care [3][5]