Announcement • Jun 29
Brainsway Ltd. Presents Positive Data From Largest Real-World Study Of Deep TMS In Patients With Comorbid PTSD And Major Depressive Disorder Brainsway Ltd. announced the presentation of positive new real-world data demonstrating significant improvements in patients with comorbid post-traumatic stress disorder (PTSD) and Major Depressive Disorder (MDD) treated with Deep Transcranial Magnetic Stimulation (Deep TMS). This real-world data collection study evaluated the efficacy of Deep TMS as a tool to improve both PTSD and MDD symptoms in patients with comorbid disease. All 462 patients in the retrospective study, from 11 clinical sites, were diagnosed with both MDD and PTSD, received at least 20 Deep TMS treatment sessions using BrainsWay's H1 or H7 coils. Outcomes included changes in the PTSD Checklist for DSM-5 (PCL-5) and the Patient Health Questionnaire-9 (PHQ-9) before and after treatment. Of these patients, 83.5% experienced a response (a reduction in PTSD symptoms of 50%), with an average 52% reduction in PCL-5 scores. Patients also experienced substantial improvements in depression symptoms, including a 66.6% response rate (a reduction in depression symptoms of 50%), a 27.3% remission rate, and an average 50% reduction in PHQ-9 scores. Deep TMS is not currently cleared by the FDA for the treatment of PTSD and/or comorbid PTSD and MDD, and the preliminary findings from the real-world study remain subject to peer review analysis. BrainsWay continues to lead the field with its proprietary H-coil technology, robust clinical research, and ongoing collaboration with providers and policymakers to expand access to care and improve the lives of patients. Announcement • Jun 10
BrainsWay Presents First SWIFT Accelerated Deep TMS 12-Month Durability Data at Clinical TMS Society Annual Meeting BrainsWay presented new prospective 12-month durability data demonstrating sustained clinical benefits following accelerated Deep Transcranial Magnetic Stimulation (Deep TMS) for Major Depressive Disorder (MDD). The findings were recently presented in a poster by Colleen Hanlon, PhD, Vice President of Medical Affairs for BrainsWay, at the 14 Annual Clinical TMS Society (CTMSS) Meeting which was held on June 4-6, 2026. The data represented outcomes from the first multisite, randomized, controlled trial evaluating the long-term outcomes of BrainsWay's SWIFT protocol, an FDA-cleared Deep TMS protocol which reduces the number of clinic visits in the acute phase by 70% in comparison to the traditional standard protocol. Over 80% of patients treated with the SWIFT protocol were in remission through the 12-month follow-up period, based on clinician-rated assessments. Among those that received the SWIFT protocol, the percent of patients with severe functional impairment decreased dramatically from 85% at baseline to 0% at 12 months, supporting the real-world impact of Deep TMS on work performance, social engagement, relationships, and overall well-being. Less than 25% of patients had a change in their prescribed medication or another course of TMS within the 12-month period to treat their depression. The durable remission, response, and quality of life changes with the SWIFT protocol were also present in the group that received standard once a day Deep TMS, highlighting the overall durability of the Deep TMS technology for treating depression. The new prospective study followed patients that had enrolled in BrainsWay's original FDA pivotal non-inferiority trial which had compared the SWIFT accelerated protocol (5 sessions per day for 6 half days, followed by 4 weekly follow up visits) with BrainsWay's standard Deep TMS protocol (1 daily session, 5 days per week over 4 weeks, followed by 2 daily sessions per week for 2 weeks). Of the 89 patients that had completed the original pivotal trial (Phase 1), 73% (65 patients) consented to participate in this new one-year durability trial (Phase 2). These participants were evaluated at 3, 6, 9, and 12 months using clinician-rated and patient-reported outcome measures. The durability study outcomes build upon the previously reported pivotal trial results that supported FDA clearance of the BrainsWay SWIFT protocol for the treatment of Major Depressive Disorder in September 2025. Together, the data demonstrates both rapid antidepressant effects and sustained long-term outcomes, without the need for neuronavigation equipment. Announcement • May 15
Brainsway Ltd. Reiterates Earnings Guidance for the Year 2026 BrainsWay Ltd. reiterated earnings guidance for the year 2026. For the year, the company expects full-year 2026 revenue of $66 million to $68 million, which represents growth of 27% to 30% compared with revenue for 2025. The Company anticipates continued profitability and positive cash flow, targeting operating income of 13%-14% of revenue. Announcement • Apr 29
BrainsWay Ltd. to Report Q1, 2026 Results on May 13, 2026 BrainsWay Ltd. announced that they will report Q1, 2026 results Pre-Market on May 13, 2026 Announcement • Mar 11
BrainsWay Ltd. Provides Earnings Guidance for Full Year 2026 BrainsWay Ltd. provided earnings guidance for full year 2026. For the period, the company expects revenue of $66 million to $68 million, which represents growth of 27% to 30% compared with revenue for 2025. The Company anticipates continued profitability and positive cash flow, targeting operating income of 13% to 14%. Announcement • Mar 05
BrainsWay Ltd Unveils Swift Deep TMS Accelerated Treatment For Depression BrainsWay Ltd. unveiled new clinical data showing a significantly faster, noninvasive way to treat depression without compromising the efficacy of one of psychiatry’s most impactful treatments. Two new peer-reviewed manuscripts in Brain Stimulation found that BrainsWay’s exclusive FDA-cleared SWIFT™ accelerated Deep Transcranial Magnetic Stimulation (Deep TMS™) protocol for the treatment of Major Depressive Disorder (MDD) achieved comparable remission and response rates when compared to the traditional standard protocol. The accelerated protocol reduces the traditional 20-visit acute treatment phase to just 6 half days, followed by weekly maintenance visits for 4 weeks. Widespread adoption of the SWIFT approach, which reduces the number of clinic visits in the acute phase by ~70%, could alter how interventional psychiatry is delivered, improving patient retention and expanding clinical options at a time when demand for non-drug depression therapies is rising. In a large, randomized, multisite non-inferiority trial, patients treated with BrainsWay’s accelerated protocol achieved: · 87.8% response rate · 78.0% remission rates · Median time to remission of 21 days, compared with 28 days under the standard daily protocol. Over 20 million U.S. adults live with MDD, at an estimated USD 333,000 million annual economic burden. Yet logistical barriers – time away from work, caregiving responsibilities, and travel – reduce the number of people who initiate access to this life-saving treatment. SWIFT™ lowers one of the most persistent barriers in interventional psychiatry: Time. The second published manuscript, focusing on the patients’ own ratings of perceived impact of the treatment on their lives, highlights the human impact of that efficiency. Key secondary outcomes in this study include: · ~70% of the participants no longer suffered from severe quality of life impairment · Approximately 60% returned to normal-range functioning after treatment. Patients also reported earlier symptom improvement across a range of measures, consistent with clinician-rated outcomes, suggesting not only statistical success, but lived recovery. As clinical innovation improves access, payers are also reducing administrative barriers, including the previously announced move by Evernorth Behavioral Health to eliminate prior authorization requirements for Deep TMS. Study Design and Results The trial incorporated input from both patients and providers in both urban and rural areas, reflecting a patient-centric approach uncommon in studies of this type. Each manuscript highlights different but complementary findings from the same clinical trial. Manuscript 1: Accelerated TMS with the H1-coil for Depression: A Multisite, Randomized Non-Inferiority Trial In the randomized non-inferiority comparison, the accelerated SWIFT protocol achieved an 87.8% response rate and a 78.0% remission rate on the clinician-rated Hamilton Depression Rating Scale (HDRS-21), establishing efficacy comparable to the standard once-daily protocol while requiring substantially fewer treatment days. The standard protocol consists of an acute phase of 5 daily sessions over 4 weeks, followed by 2 daily sessions per week for 2 weeks. Median time to remission was 21 days for SWIFT versus 28 days for the standard protocol. Outcomes were consistent across diverse patient subgroups, including individuals with moderate-to-severe depression and comorbid anxiety symptoms. Manuscript 2: Patient-Reported Outcomes Following Accelerated vs. Standard Deep TMS with the H1 coil for Major Depression: A Multisite Randomized Trial Clinician-rated measures remain the gold standard in depression trials; however, patient-reported outcomes provide critical insight into real-world experiences. Daily patient assessments confirmed substantial improvements in quality of life, functioning, and symptom burden among patients receiving accelerated treatment. By 6 weeks, quality-of-life scores improved by approximately 32 percentage points from those measured at baseline. The proportion of patients reporting severe functional impairment declined from 85–100% at baseline to 15–17% at the end of treatment, and approximately 60% reached normal-range functioning by the end of treatment. Patients receiving SWIFT also reported earlier perceived symptom improvement across a range of symptoms, consistent with clinician-rated findings. Announcement • Feb 25
BrainsWay Ltd. to Report Q4, 2025 Results on Mar 11, 2026 BrainsWay Ltd. announced that they will report Q4, 2025 results Pre-Market on Mar 11, 2026 Announcement • Jan 13
Brainsway Announces Fda Approval of Neurolief’S Proliv™Rx Neuromodulation System for Major Depressive Disorder (Mdd) BrainsWay Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA) for Neurolief's ProlivTMRx 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 from at least one previous antidepressant medication, for use at home or in the clinic. This approval represents a significant regulatory milestone, making ProlivTMRx the first and only at-home neuromodulation treatment with FDA labeling applicable to treatment refractory MDD patients. The approval expands the clinical landscape beyond traditional in-clinic care and reflects growing regulatory recognition of advanced neuromodulation solutions designed for use in the home setting. Announcement • Nov 18
BrainsWay Ltd. Launches First Clinical Trial of Deep TMS 360™? System for Alcohol Use Disorder BrainsWay Ltd. announced the launch of a multicenter clinical trial investigating the use of its novel Deep TMS 360™? system in individuals with Alcohol Use Disorder (AUD). AUD represents a major economic and health burden, affecting about 29 million Americans (10% of those aged 12+) and, despite available treatments, up to 60% of patients relapse within 3-6 months. This study will mark the first multicenter clinical trial utilizing BrainsWay's next-generation multichannel TMS platform, representing a major milestone in advancing the company's innovation pipeline. The Company's new Deep TMS 360 technology has been designed to provide more comprehensive and uniform stimulation of the neurons in the targeted brain regions. BrainsWay believes that the multichannel architecture of this new system may be better suited for complex clinical populations such as those suffering from chronic AUD, where there may be greater difficulty in achieving desired stimulation levels due to cortical atrophy (i.e. brain shrinkage). The study will be a randomized, double-blind, sham-controlled clinical trial, and will enroll over 200 patients aged 18-86 with moderate to severe AUD as determined using the DSM-5 criteria. Participants will receive either active or sham Deep TMS 360 treatments for approximately six months, including an intensive treatment phase during the first 3-5 weeks, followed by weekly maintenance sessions until the 6-month follow-up visit. Each visit comprises two sessions per day. The trial's primary endpoint is the proportion of participants who experience no heavy drinking days (NHDD) during the initial four-month treatment period - an endpoint recognized by the FDA as clinically meaningful in AUD research. Subjects will also undergo educational and behavioral sessions focused on coping strategies and alcohol use reduction. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™?) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the failure to realize anticipated synergies and other benefits of the proposed transaction; the failure of investments in management services organizations and/or other clinic-related entities to produce profitable returns; inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; changes in technology andmarket requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company's anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products; unexpected difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company's intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable conditions. Announcement • Nov 13
BrainsWay Ltd. Receives FDA Clearance of Deep TMS as Adjunct Therapy for Major Depressive Disorder in Adolescents Aged 15 to 21 BrainsWay Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted a label expansion for the Deep Transcranial Magnetic Stimulation (Deep TMS™?) system making the treatment available as an adjacent therapy for adolescents aged 15 to 21 years suffering from major depressive disorder (MDD). The Company is boldly advancing neuroscience with its proprietary Deep Transcranial Magneticstimulation (Deep TMS™™?) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with operations in the United States and Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. While the clinical study described in this release found a higher incidence of certain adverse events such as headaches and application site discomfort/pain in the accelerated group when compared to the standard of care group, none of these events was classified as severe, and they were comparable to previous TMS clinical studies. In addition, historical results or conclusions from scientific research and clinical studies - especially preliminary data which remains subject to peer-review - do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ significantly from those described in the forward the forward-looking statements: the failure to realize anticipated synergies and other benefits of the proposed transaction; the failure of investments in management services organizations and/or other clinic-related entities to produce profitable returns; inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company's anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products; unforeseen problems with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company's intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and Medicare; inability to commercialize Deep TMS, including internationally, by the Company or through third-party distributors; product development by competitors; inability to timely develop and introduce new technologies. Announcement • Nov 12
Brainsway Ltd. Raises Earnings Guidance for the Full-Year 2025 BrainsWay Ltd. raised earnings guidance for the Full-Year 2025. For the period, the company announced that With results continuing to trend toward the high end of expectations and improved visibility into the remainder of the year, the Company is raising the midpoint and narrowing its full-year 2025 financial outlook: including: Revenues of $51 million – $52 million, up from the previous guidance of $50 million – $52 million; Operating income of 6% – 7%, up from the previous guidance of 4% – 5%. Announcement • Oct 28
BrainsWay Ltd. to Report Q3, 2025 Results on Nov 11, 2025 BrainsWay Ltd. announced that they will report Q3, 2025 results Pre-Market on Nov 11, 2025 Announcement • Sep 16
BrainsWay Ltd. Announces FDA Clearance of the Cleared Treatment Protocol for the Company's Deep Transcranial Magnetic Stimulation System BrainsWay Ltd. announced that the U.S. Food and Drug Administration (FDA) has granted an expansion of the cleared treatment protocols for the Company's Deep Transcranial Magnetic Stimulation system (Deep TMS™?) to include an accelerated protocol for the treatment of patients with major depressive disorder (MDD) including those with comorbid anxiety symptoms. BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial magnetic Stimulation (Deep TMS™?") platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with operations in the United States and Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. While the clinical study described in this release found a higher incidence of certain adverse events such as headaches and application site discomfort/pain in the accelerated group when compared to the standard of care group, none of these events was classified as severe, and they were comparable to previous TMS clinical studies. In addition, historical results or conclusions from scientific research and clinical studies - especially preliminary data which remains subject to peer-review - do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. The following factors, among others, could cause actual results to differ significantly from those described in the forward the forward-looking statements: the failure to realize anticipated synergies and other benefits of the proposed transaction; the failure of investments in management services organizations and/or other clinic-related entities to produce profitable returns; inadequacy of financial resources to meet future capital requirements; changes in technology and market requirements; delays or obstacles in launching and/or successfully completing planned studies and clinical trials; failure to obtain approvals by regulatory agencies on the Company's anticipated timeframe, or at all; inability to retain or attract key employees whose knowledge is essential to the development of Deep TMS products; unforeseen difficulties with Deep TMS products and processes, and/or inability to develop necessary enhancements; unexpected costs related to Deep TMS products; failure to obtain and maintain adequate protection of the Company's intellectual property, including intellectual property licensed to the Company; the potential for product liability; changes in legislation and applicable rules and regulations; unfavorable market perception and acceptance of Deep TMS technology; inadequate or delays in reimbursement from third-party payers, including insurance companies and insurance companies and other companies. Announcement • Aug 14
Brainsway Ltd. Raises Earnings Guidance for the Full Year 2025 BrainsWay Ltd. raised earnings guidance for the full year 2025. Based on the strength of its results to date, improved visibility and business momentum, the company raises its full-year 2025 revenue guidance to between $50 million and $52 million with operating income of 4% to 5%. Previous guidance expected 2025 revenues of between $49 million and $51 million, operating income of 3% to 4%. Announcement • Aug 07
BrainsWay Ltd., Annual General Meeting, Sep 11, 2025 BrainsWay Ltd., Annual General Meeting, Sep 11, 2025. Location: 16 hartum street, rad tower, 14th floor, har hahotzvim, jerusalem, Israel Announcement • Jul 30
BrainsWay Ltd. to Report Q2, 2025 Results on Aug 13, 2025 BrainsWay Ltd. announced that they will report Q2, 2025 results Pre-Market on Aug 13, 2025 Announcement • Jun 11
Brainsway Reports Positive Results from Multicenter Randomized Study of Accelerated Deep Tms for Major Depressive Disorder (Mdd) BrainsWay Ltd. announced preliminary results from a multicenter, randomized controlled trial titled, “Accelerated Deep TMS for Depression: Results from a Multisite, Randomized Non-Inferiority Trial.” The results suggest that the accelerated Deep Transcranial Magnetic Stimulation (Deep TMS™) protocol using intermittent theta burst stimulation (iTBS) to treat patients with major depressive disorder (MDD) resulted in outcomes that are comparable to the standard once-daily TMS protocol — while requiring considerably fewer visits to the clinic. The trial, which enrolled 104 adult patients diagnosed with depression across eight sites, is the largest randomized, controlled, blinded, multicenter trial of an accelerated Deep TMS protocol. Patients from the study were divided into two active treatment groups, with one group receiving treatment under the standard Deep TMS protocol and the other group receiving treatment under the accelerated Deep TMS protocol.Patients in the accelerated group completed five sessions per day over six treatment days, followed by a brief continuation phase of eight sessions over the subsequent four weeks. This protocol was designed to significantly reduce treatment burden. The primary endpoint of the study was the change in depressive symptoms as measured using the HDRS-21 scale, and secondary endpoints included response and remission rates.Key Points from the Study:Comparable Efficacy: The accelerated Deep TMS group achieved significant improvement that was comparable to the standard Deep TMS group: HDRS depression scores were reduced by 18.9 and 19.9 points in the accelerated and standard Deep TMS groups, respectively; andResponse and remission rates were 87.8% and 78.0%, respectively, for the accelerated group, compared to response and remission rates of 87.5% and 87.5%, respectively, for the standard group.Shorter Sessions: Accelerated Deep TMS sessions lasted less than 10 minutes, compared to 20 minutes for standard treatment sessions.Time to Remission: Median time to remission was 21 days for the accelerated group v. 28 days for the standard group.Safety and Tolerability: The accelerated protocol was well-tolerated, with no reported serious adverse events. Side effects, such as headache and site discomfort, were mild and consistent with standard TMS treatments.No Reliance on fMRI Imaging: The study was conducted using BrainsWay’s H1 Coil with standard targeting, without reliance on any neuronavigation equipment. The accelerated protocol tested in the study is investigational in nature and not yet FDA-cleared. The preliminary results remain subject to additional analysis and peer-review. Announcement • May 14
BrainsWay Ltd. Reiterates Earnings Guidance for the Full Year 2025 BrainsWay Ltd. reiterated earnings guidance for the full year 2025. For the period, the company Reiterating full-year 2025 financial guidance, including revenue between $49 million to $51 million with an operating profit of 3% to 4%. Announcement • Apr 29
BrainsWay Ltd. to Report Q1, 2025 Results on May 13, 2025 BrainsWay Ltd. announced that they will report Q1, 2025 results Pre-Market on May 13, 2025 Announcement • Mar 12
Brainsway Ltd. Provides Earnings Guidance for Full Year 2025 BrainsWay Ltd. provided earnings guidance for full year 2025. For the period, the company expects revenue guidance of between $49 million to $51 million, which represents 20% to 24% growth over 2024 revenue. Anticipating continued profitability and positive cash flow, targeting operating income of 3% to 4%. Announcement • Feb 24
BrainsWay Ltd. to Report Q4, 2024 Results on Mar 11, 2025 BrainsWay Ltd. announced that they will report Q4, 2024 results Pre-Market on Mar 11, 2025 Announcement • Dec 13
BrainsWay Ltd. Reports Positive Independent Pilot Data on Accelerated Deep TMS Treatment of Alcohol Use Disorder BrainsWay Ltd. announced recent positive pilot data from an independent, third-party study conducted at Stanford University evaluating an accelerated protocol using the Company's Deep Transcranial Magnetic Stimulation (TMS) technology to treat alcohol use disorder (AUD) patients. The outcomes were reported in a publication in the Brain Stimulation journal entitled, "Accelerated deep TMS in alcohol use disorder: A preliminary pilot trial targeting the dorsal anterior cingulate cortex increases neural target engagement and abstinence." The study compared outcomes achieved in a residential treatment program on a group of AUD patients treated with BrainsWay's H7-Coil (n=5) using an "accelerated" protocol of multiple sessions of Deep TMS per day over several days, with those achieved in a previously collected sample of data from patients in the same program (n=39) who had undergone other forms of treatment not involving Deep TMS. In the follow-up period after treatment, subjects receiving accelerated Deep TMS showed notably better improvements when compared to those treated by other means. BrainsWay Deep TMS is not currently cleared by the FDA for the safe or effective treatment of AUD. Announcement • Nov 21
BrainsWay Ltd. Reports Promising Feasibility Data Showing Pain Reduction with Deep Tms Therapy BrainsWay Ltd. announced the publication of positive feasibility clinical data evaluating the analgesic effects of deep transcranial magnetic stimulation (Deep TMS™?) in patients with peripheral neuropathic pain. The results were published in the Neuromodulation journal, in a peer-reviewed article entitled, H-Coil Repetitive Transcranial Magnetic Stimulation Relieves Pain and Symptoms of Anxiety and Depression in patients with Chronic Peripheral Neuropathic pain: A Randomized Sham-Controlled Crossover Study. The double-blind, randomized crossover trial included seventeen (17) patients with chronic neuropathic pain. Secondary outcomes included changes in pain ratings at specific time points in the two arms, as well as changes in comorbid symptoms experienced by the patients, including, for example, anxiety and depression. Results showed that Active deep-TMS therapy significantly reduced " usual pain intensity" in patients with chronic peripheral neuropathic pain compared to sham treatment and improved symptoms of anxiety and depression in the same patient population. BrainsWay Deep TMS is not currently cleared by the FDA for the safe or effective treatment of neuropathic pain. Additional outcomes from research conducted on these and other neuropathic pain patients were recently published, lending additional support to the findings of this study on the potential benefits of Deep TMS. Announcement • Nov 13
BrainsWay Ltd. Raises Earnings Guidance for the Full Year 2024 BrainsWay Ltd. raised earnings guidance for the full year 2024. The company increasing full-year 2024 revenue guidance to between $40 million to $41 million, which represents 25% to 29% growth over 2023 revenue. Operating income of 3% to 4%. Announcement • Oct 31
BrainsWay Ltd. to Report Q3, 2024 Results on Nov 12, 2024 BrainsWay Ltd. announced that they will report Q3, 2024 results at 9:46 AM, Israel Standard Time on Nov 12, 2024 Announcement • Oct 16
BrainsWay Ltd. announced that it has received $20.006615 million in funding from Valor Management LLC On October 15, 2024, BrainsWay Ltd., closed the transaction. The transaction included participation from 1 investor pursuant to regulation D. Announcement • Sep 10
Israel Ministry of Defense Clears BrainsWay Deep TMS™ for PTSD Reimbursement at Israeli BrainsWay Ltd. announced that the Israel Ministry of Defense's Rehabilitation Department has granted approval for the reimbursement of Deep Transcranial Magnetic Stimulation system (Deep TMS™) therapy for qualifying patients with post- traumatic stress disorder (PTSD) at Israeli public hospitals. BrainsWay will continue its work toward expanding the available reimbursement for PTSD within the country, with the goal of potentially including more Israeli medical centers, as well as adding private clinic settings. Announcement • Aug 29
BrainsWay Ltd. Appoints Richard A. Bermudes, M.D. as Chief Medical Officer, Effective September 1, 2024 BrainsWay Ltd. announced the appointment of Richard A. Bermudes, M.D. as Chief Medical Officer (CMO), effective September 1, 2024. Dr. Aron Tendler, M.D., who has served as CMO since 2015, will continue to serve as a collaborator on important strategic research projects. With more than 20 years of experience pioneering new brain stimulation and innovative mental health technologies, Dr. Bermudes is widely considered one of the preeminent clinicians in the TMS field. Having co-founded an innovative behavioral health care network with 24 outpatient clinics, pioneered in the adoption of new therapies across the treatment landscape, and launched successful telehealth programs, he has been at the forefront of improving mental health through innovative care. Dr. Bermudes is also an Associate Physician at the UC Davis Department of Psychiatry and Behavioral Sciences, and his academic contributions include serving as a Diplomat of the Academy of Cognitive Therapy. He is the lead editor of the widely acclaimed book, “Transcranial Magnetic Stimulation: Clinical Applications for Psychiatric Practice,” and holds an M.D. from the University of California, San Diego, School of Medicine. Announcement • Aug 07
BrainsWay Ltd. Updates Revenue Guidance for the Full Year of 2024 BrainsWay Ltd. updates revenue guidance for the full year of 2024. For the period, the company raising the lower end of the revenue guidance to a range of $38.5 million to $40 million, thus representing growth of 21% to 25% over full-year 2023 revenue. Announcement • Jul 23
BrainsWay Ltd. to Report Q2, 2024 Results on Aug 06, 2024 BrainsWay Ltd. announced that they will report Q2, 2024 results Pre-Market on Aug 06, 2024 Announcement • Jun 13
BrainsWay Ltd. Launches Prospective, Randomized, Controlled, Multicenter Trial Evaluating Accelerated Deep TMS for Depression for the Month of June 2024 BrainsWay Ltd. announced the initiation of a prospective, randomized, controlled, multicenter clinical trial evaluating an accelerated treatment protocol for the Company's proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™?) system to treat major depressive disorder (MDD). The clinical trial is anticipated to enroll over 100 patients with major depressive disorder (MDD) who will be split into two groups - one receiving a novel accelerated treatment protocol featuring an acute phase over several treatment days, and the other receiving the FDA-cleared standard-of-care protocol which entails an acute phase over several weeks. The design of this non-inferiority trial, which was determined in discussion with the U.S. Food and Drug Administration (FDA), aims to compare the outcomes achieved with the accelerated Deep TMS protocol versus the current standard-of-care Deep TMS protocol. In the study, the standard-of-care DeepTMS protocol will involve the traditional four week acute treatment phase, with one session per each day of treatment. BrainsWay is a global leader in advanced noninvasive neurostimulation treatments for mental health disorders. The Company is boldly advancing neuroscience with its proprietary Deep Transcranial magnetic Stimulation (Deep TMS) platform technology to improve health and transform lives. BrainsWay is the first and only TMS company to obtain three FDA-cleared indications backed by pivotal clinical studies demonstrating clinically proven efficacy. Current indications include major depressive disorder (including reduction of anxiety symptoms, commonly referred to as anxious depression), obsessive-compulsive disorder, and smoking addiction. The Company is dedicated to leading through superior science and building on its unparalleled body of clinical evidence. Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway. Founded in 2003, with offices in Burlington, MA and Jerusalem, Israel, BrainsWay is committed to increasing global awareness of and broad access to Deep TMS. Announcement • Jun 05
BrainsWay Ltd. Receives Expanded FDA Labeling to Treat Late Life Depression BrainsWay Ltd. announced that the US Food and Drug Administration (FDA) has granted an expanded indication for the Company’s Deep Transcranial Magnetic Stimulation system (Deep TMS) allowing for the treatment of patients with major depressive disorder (MDD) ages 22 to 86, changing the previous upper age limit of 68. This represents the Company’s 10th FDA clearance and makes BrainsWay Deep TMS the first and only form of TMS indicated for the treatment of patients over the age of 68 suffering from MDD, including those with comorbid anxiety symptoms. BrainsWay’s application to the FDA included study data showing, for example, that MDD patients over 68 years of age who were treated with the Company’s H1 Coil demonstrated 69% and 62% response and remission rates, respectively, using the Hamilton Depression Rating Scale-21 (HDRS-21), and 65% and 35% response and remission rates, respectively, using the self-administered Patient Health Questionnaire-9 (PHQ-9). Announcement • May 14
BrainsWay Ltd., Annual General Meeting, Jun 17, 2024 BrainsWay Ltd., Annual General Meeting, Jun 17, 2024. Location: co. offices, Israel Announcement • May 09
BrainsWay Ltd. Reiterates Revenue Guidance for the Year 2024 BrainsWay Ltd. reiterated revenue guidance for the year 2024. The company is reiterating previously provided full-year 2024 revenue guidance of $37 million to $40 million. This would represent growth of 16% to 26% over full-year 2023 revenue. Announcement • Apr 26
BrainsWay Ltd. to Report Q1, 2024 Results on May 08, 2024 BrainsWay Ltd. announced that they will report Q1, 2024 results Pre-Market on May 08, 2024 Announcement • Apr 05
BrainsWay Ltd. Announces Publish Review Results Highlighting Potential of Deep Transcranial Magnetic Stimulation (Deep TMS™) as a Novel Therapeutic Approach for Parkinson's Disease BrainsWay Ltd. announced results published in a review article exploring the potential efficacy of Deep Transcranial Magnetic Stimulation (Deep TMS™) as a novel therapeutic approach for Parkinson's Disease (PD). The paper was published in Frontiers of Human Neuroscience. The review summarizes data from six different studies involving an aggregate total of 220 patients, including a substantial number of patients who were administered a two-stage Deep TMS protocol addressing prefrontal and motor targets. The two-stage H-Coil protocol is an innovative approach to address multiple symptoms of the disease. While further research is needed in this area, possible benefits of Deep TMS for PD patients may include improved cognitive function, reduced side effect burden relative to drugs, and enhanced quality of life. BrainsWay Deep TMS is not cleared by the FDA as a safe and/or effective treatment for Parkinson's Disease. Announcement • Mar 29
Brainsway Announces Positive Results in Late-Life Depression Post-Marketing Analysis BrainsWay Ltd. announced positive results in a recently published post-marketing study of its Deep Transcranial Magnetic Stimulation (Deep TMS™) for the treatment of late-life depression. The data were highlighted in an article entitled, “Never Too Late: Safety and Efficacy of Deep TMS for Late-Life Depression,” that was published in the Journal of Clinical Medicine, an international, peer-reviewed, open access journal. The post-marketing study demonstrated real-world outcomes for older adults (60-91 years of age) suffering from major depressive disorder (MDD). In the study, data was analyzed from 247 depression patients at 16 clinical sites in this age group who had been treated with BrainsWay’s proprietary H1 Coil. The results showed a 79.4% response rate (=50% reduction in symptoms) and a 60.3% remission rate for those patients who had received at least 30 treatment sessions, and were based on the rating scale that was most utilized for each individual patient. The outcomes were comparable to those reported in a post-marketing analysis of over 1,350 patients published in 2023. BrainsWay’s existing FDA depression labeling does not extend to patients aged over 68, and the results of this study are subject to further review by the FDA. Announcement • Mar 06
Brainsway Ltd. Provides Earnings Guidance for Full Year 2024 BrainsWay Ltd. provided earnings guidance for full year 2024. For the year, company expect that annual revenues in 2024 will be in the range of $37 Million to $40 Million, representing growth of between 16% and 26% over 2023. Announcement • Feb 22
BrainsWay Ltd. to Report Q4, 2023 Results on Mar 06, 2024 BrainsWay Ltd. announced that they will report Q4, 2023 results Pre-Market on Mar 06, 2024 Announcement • Jan 10
BrainsWay Ltd. Announces New Rotational Field Technology in Two New Feasibility Studies BrainsWay Ltd. announced that it will be clinically evaluating an innovative stimulation technology in two new feasibility trials. The studies both involve BrainsWay's exclusive, patented "Rotational Field" TMS (or "Deep TMS 360deg™?), which employs a method of stimulation that enables activation of a greater number of neurons in the brain. In all currently available forms of TMS, those neurons which are aligned parallel to the coil's electric field are much more likely to be stimulated than other neurons. Thus, only a fraction of the neurons in the targeted brain region are actually impacted. With the new Rotational Field system now being evaluated, two orthogonal TMS coils are placed perpendicular to each other and are operated with a time lag in order to induce a circularly rotating electric field. This results in uniform stimulation of neurons oriented along a wide variety of directions in the targeted brain region - all within less than a millisecond. The Company now aims to assess the potential clinical impact of this technology on patients in two newly launched feasibility studies. One study will test the safety and efficacy of this technology in the field of rehabilitation following stroke, a devastating neurological condition. Another study will test the technology in the field of obsessive-compulsive disorder (OCD) utilizing an accelerated protocol. BrainsWay's existing Deep Transcranial Magnetic Stimulation (Deep TMStm) system is already FDA-cleared to treat OCD using the standard daily protocol via its H7 Coil, and this new study will test the ability to further improve outcomes using Rotational Field stimulation while also reducing the length of the standard treatment. BrainsWay's Rotational Field technology is not commercially available and has not yet been cleared for safety and/or efficacy by the FDA. Announcement • Nov 04
BrainsWay Ltd. Announces Publishes the First Coverage Recommendations for Smoking Addiction Treatment Using TMS BrainsWay Ltd. announced that the Clinical TMS Society, an influential medical society dedicated to supporting clinical practice, research, and access to transcranial magnetic stimulation (TMS), has published the first coverage recommendations for smoking addiction treatment using TMS. BrainsWay Deep TMS™ is the only TMS technology to have received FDA clearance for the treatment of smoking addiction. The leading specialty society advocating for the clinical benefits of noninvasive brain stimulation, CTMSS has been instrumental in helping expand TMS insurance coverage globally across multiple indications. The group’s previously-issued policy guidance helped shape the current TMS treatment reimbursement landscape in the U.S., which is now characterized by near-universal coverage for depression and increasingly expanding coverage for obsessive-compulsive disorder. With this new coverage guidance for insurers, CTMSS now recommends TMS coverage for individuals with a confirmed diagnosis of Tobacco Use Disorder (TUD) who failed two alternative treatment methods, cannot tolerate drugs, or have other comorbid medical conditions (secondary to TUD) such as COPD, artery disease and lung cancer. Results from BrainsWay’s pivotal randomized controlled trial published in 2021 demonstrated that over one in four highly addicted cigarette smokers receiving Deep TMS treatment quit during the course of the study, two in three quitters maintained their abstinence during the follow up period, and the average number of cigarettes smoked per week among the overall active patient group was significantly reduced by 75%. Announcement • Nov 02
BrainsWay Ltd. to Report Q3, 2023 Results on Nov 15, 2023 BrainsWay Ltd. announced that they will report Q3, 2023 results Pre-Market on Nov 15, 2023 Announcement • Oct 17
BrainsWay Announces Publication of Study Data on Accelerated Deep Transcranial Magnetic Stimulation (Deep TMS) for Depression BrainsWay Ltd. announced the publication of new real-world post-marketing data demonstrating the efficacy of accelerated Deep Transcranial Magnetic Stimulation (Deep TMS) for the treatment of major depressive disorder (MDD). The compelling results were published in the peer-reviewed journal, Psychiatry Research, in an article titled, "Real-World Efficacy and Safety of Various Accelerated Deep TMS Protocols for Major Depression." Deep TMS utilizes specially designed H–Coils to stimulate deep and broad cortical regions associated with depression. The standard FDA-cleared Deep TMS protocol involves one treatment session per day, five days a week for 4 weeks, followed by a maintenance period. However, there has been recent interest in “accelerated” dosing schedules which involve multiple sessions each day to allow for quicker overall treatment time. Data collected using this approach to treat depression was compiled from clinical sites and analyzed in this study. Key findings from this post-marketing study included: Accelerated Deep TMS led to an 80% response rate and a 51% remission rate across all dosing schedules, using the most rated scale (HDRS, MADRS, PHQ-9, BDI-II). There was no statistical difference in outcomes seen between the various accelerated dosing schedules, which varied between 2, 3, 5 or 10 Deep TMS sessions per day. Subjects undergoing protocols involving more than 2 sessions per day responded and/or remitted typically within 3-5 days, and the durability of treatment was substantial. BrainsWay Deep TMS is not currently FDA-cleared for accelerated depression treatments. However, these preliminary results could be leveraged to support efforts to expand current labeling for Deep TMS. Major depressive disorder (MDD) is a common and debilitating form of depression characterized by physiological, emotional, and cognitive symptoms. According to the World Health Organization (WHO), depression affects approximately 264 million people worldwide, and the U.S. National Institute of Mental Health (NIMH) estimates that 21 million adults in the United States suffer from an MDD episode within a given year. Common symptoms of MDD include loss of interest, depressed mood, reduced energy, disturbed sleep, and changes in appetite. 60-90% of depression patients also exhibit comorbid moderate to severe anxiety, a condition commonly referred to as anxious depression. These anxiety symptoms include nervousness, feelings of panic, increased heart rate, rapid breathing, sweating, insomnia, trembling, and difficulty focusing or thinking clearly. The economic burden in the United States for major depressive disorder totaled $326 billion prior to the recent COVID pandemic. Announcement • Jul 28
BrainsWay Ltd. to Report Q2, 2023 Results on Aug 09, 2023 BrainsWay Ltd. announced that they will report Q2, 2023 results Pre-Market on Aug 09, 2023 Announcement • May 24
Brainsway Ltd. Announces CFO Changes BrainsWay Ltd. announced the appointment of Ido Marom, an experienced senior financial leader in global industries, including medical technology, as Chief Financial Officer (CFO). Mr. Marom will succeed Scott Areglado, who will be stepping down from the Company to pursue other opportunities. Most recently, Mr. Marom served as CFO of Surgical Theater Inc., a start-up medical technology company, since 2019. In this role, he oversaw all financial and legal matters, including responsibility for budgets and financial statements. Prior to this, Mr. Marom served as Finance Director Commercial Finance Business Officer at Amdocs, a global market leader in the communication and media industry with $4.6 billion in revenue. In this role, he led business teams interacting with the company's largest customers and formulated revenue generating strategies. Previously, Mr. Marom served as CFO and Chief Operating Officer of The Jewish Agency in North America, and as Vice President of Finance of Ness Technologies, a global provider of IT services with approximately $600 million of revenues. Earlier in his career, Mr. Marom held senior finance and accounting roles with Motorola and Intel, and served as a Senior Auditor at EY. Mr. Marom is a Certified Public Accountant and received his Bachelor of Arts degree in Accounting and Finance from Haifa University. Announcement • May 04
BrainsWay Ltd. to Report Q1, 2023 Results on May 17, 2023 BrainsWay Ltd. announced that they will report Q1, 2023 results Pre-Market on May 17, 2023 Announcement • Jan 13
BrainsWay Ltd. Appoints Ami Boehm as an Independent Director BrainsWay Ltd. reported that it has appointed Ami Boehm to serve as an independent director on the Company’s Board of Directors. Mr. Boehm has deep expertise in providing strategic advice for companies operating in multiple global industries. Since 2004, he has been a partner at FIMI Opportunity Funds, Israel’s leading private equity firm. As a partner at FIMI, Mr. Boehm has sourced and led dozens of control equity investments, and led improvement processes of FIMI’s portfolio companies and strategic activities of the portfolio companies in Israel, China, Europe and the U.S. He has served as Chairman of the Board or Director of numerous public and private companies, including Ormat Technologies Inc. (NYSE and TASE listed), Gilat Satellite Networks Ltd. (NASDAQ and TASE listed), TAT Industries Ltd. (NASDAQ and TASE listed), Kamada Ltd. (NASDAQ and TASE listed), Rekah Pharmaceutical Industries Ltd. (TASE listed), Novolog Ltd. (TASE listed), Hamlet Ltd. (TASE listed), Galam Ltd., and Greenstream Ltd., and has worked closely with management teams across the continuum of business and corporate development activities. Mr. Boehm received a Master of Business Administration from Northwestern University and Tel-Aviv University, a Bachelor of Law from Tel-Aviv University, and a Bachelor of Economics from Tel-Aviv University. Announcement • Jan 12
BrainsWay Announces Extended Private Insurance Coverage in Washington State for the Treatment of OCD and Depression Utilizing Deep TMS™ BrainsWay Ltd. announced that a major private insurance company in Washington state will extend positive coverage applicable to Deep Transcranial Magnetic Stimulation (Deep TMS™) for the treatment of obsessive-compulsive disorder (OCD) as of February 3, 2023. This policy extension provides coverage of Deep TMS for OCD to approximately 2.2 million members. The policy change also reduces major depressive disorder (MDD) TMS coverage criteria from four failed medication trials to only three. OCD coverage criteria is also three failed medication trials. BrainsWay continues to focus on informing and providing payers with its growing body of published clinical and real-world evidence to facilitate up-to-date evidence-based coverage determinations. In 2021, only 52.6 million U.S. lives were covered for OCD treatment with TMS. Last year, insurers such as Cigna, Highmark BCBS, and Palmetto GBA Medicare extended coverage, increasing the total covered lives to 90.5 million. Announcement • Jan 11
Neuronetics Settles Litigation Against BrainsWay Ltd. and BrainsWay USA Inc Neuronetics Inc. announced that it has settled the litigation filed in the District of Delaware against BrainsWay Ltd. and BrainsWay USA Inc. for unfair competition under the Lanham Act and state law. Under the terms of the settlement, BrainsWay agreed to stop the use of the efficacy data for the treatment of anxious depression with NeuroStar® Advanced Therapy for Mental Health that was at issue in the Complaint filed by Neuronetics.