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BrainsWay Expands Medical Policy Coverage to 70 Million in the U.S.
BrainsWay announced further expansion in the number of medical policies across the U.S. providing coverage for its Swift Accelerated Deep TMS protocol. With this update, there are now over 70M covered lives in the U.S. with access to policies covering Swift. The announcement comes amid continued momentum in favorable policy changes for Deep TMS generally, including for the treatment major depressive disorder and obsessive-compulsive disorder patients.
BrainsWay Publishes Results of Deep Brain Stimulation Study
BrainsWay announced the publication of results from a pilot study evaluating the company's proprietary Deep Transcranial Magnetic Stimulation technology in patients with co-occurring Major Depressive Disorder and early-stage Alzheimer's disease. The results were published in the peer-reviewed Journal of Geriatric Psychiatry and Neurology. The study, conducted by researchers from the Delray Center for Brain Science and the Department of Psychology at Florida Atlantic University, included 12 patients who received 36 Deep TMS sessions using BrainsWay's H1 and H7 Coils. The treatment protocol involved stimulation of the left dorsolateral prefrontal cortex with the H1 Coil, followed by stimulation of the temporal regions with the H7 Coil. The study reported an 83.3% response rate and a 50% remission rate in depressive symptoms following Deep TMS treatment. In addition to the clinical outcomes, researchers observed changes in brain activity using quantitative electroencephalography, a technique that compares electrophysiological brain patterns, before and after treatment. This included a reduction of power in the delta frequency band in the right temporal lobe after treatment, which could suggest reduced cortical slowing - a common biological phenomenon associated with Alzeimer's disease. In addition, an increase in alpha coherence - a measure of synchronization and functional connectivity between different brain regions - was observed between several frontal and temporal sites, suggesting an improvement upon the brain dysconnectivity often implicated in Alzheimer's disease.
BrainsWay Q2 Revenue $12.77M, Raises 2026 Financial Guidance
Reports Q2 revenue $12.77M, consensus $16.54M. "This quarter marked our second consecutive quarter of approximately 35% revenue growth and further expansion in operating leverage. Revenue reached a record $17.1 million, Adjusted EBITDA more than doubled to $3.5 million, and we generated more than $6.0 million of operating cash flow. Record system shipments and RPO of $80.4 million further strengthen our visibility into continued growth," said Hadar Levy, Chief Executive Officer of BrainsWay. "We are seeing strong momentum across the business, which is fueled by expanding reimbursement coverage and increasing utilization throughout our installed base. As a result, we are raising our full-year financial guidance for 2026."
BrainsWay Raises FY26 Financial Guidance to $13M-$14M
Consensus $67.65M. Narrows FY26 adjusted EBITDA view to $13M-$14M from $12M-$14M. "This quarter marked our second consecutive quarter of approximately 35% revenue growth and further expansion in operating leverage. Revenue reached a record $17.1 million, Adjusted EBITDA more than doubled to $3.5 million, and we generated more than $6.0 million of operating cash flow. Record system shipments and RPO of $80.4 million further strengthen our visibility into continued growth," said Hadar Levy, Chief Executive Officer of BrainsWay. "We are seeing strong momentum across the business, which is fueled by expanding reimbursement coverage and increasing utilization throughout our installed base. As a result, we are raising our full-year financial guidance for 2026."
BrainsWay Presents New Data on Deep TMS for PTSD and Depression
BrainsWay announced the presentation of new real-world data demonstrating significant improvements in patients with comorbid post-traumatic stress disorder and Major Depressive Disorder treated with Deep Transcranial Magnetic Stimulation. 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 and the Patient Health Questionnaire-9 before and after treatment. Of these patients, 83.5% experienced a response, with an average 52% reduction in PCL-5 scores. Patients also experienced substantial improvements in depression symptoms, including a 66.6% response rate, a 27.3% remission rate, and an average 50% reduction in PHQ-9 scores.
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