BrainsWay Ltd. files as a foreign private issuer on Form 6-K, with reports incorporated by reference into its Form S-8 and Form F-3 registration statements. The filings document company updates on Deep TMS and transcranial magnetic stimulation therapy, U.S. reimbursement and payer coverage policies, and strategic investments related to mental health treatment providers and neurostimulation technologies.
The company's filed exhibits also include investor presentation materials and risk-factor discussion covering reimbursement, third-party payor decisions, healthcare regulation, manufacturing, market adoption, competition, product liability, and regulatory actions. These disclosures frame BrainsWay's registration statements, equity incentive registration, and ongoing current-report updates as an Israel-based issuer reporting on Form 20-F.
BrainsWay Ltd. filed a Form 6-K to share that Highmark Blue Cross Blue Shield, which covers over seven million lives, has issued a draft medical policy to expand coverage for its accelerated Deep TMS™ protocol for major depressive disorder in both adolescents and adults. The draft policy is anticipated to take effect in February 2026 after an open comment period and would cover BrainsWay’s SWIFT™ protocol, a short-course regimen totaling 38 treatment sessions without requiring functional MRI or other costly neuronavigation equipment.
The company notes that this follows adoption of a similar medical policy by another payer and positions accelerated Deep TMS as a more convenient option requiring fewer clinic visits. BrainsWay’s accelerated depression protocol received FDA clearance in September 2025, supported by a multisite randomized trial showing an 87.8% response rate and 78.0% remission rate, with outcomes comparable to standard Deep TMS treatment.
BrainsWay Ltd. submitted a current report for January 2026 that centers on a regulatory milestone related to depression treatment. The report attaches a press release titled “BrainsWay Announces FDA Approval of Neurolief’s Proliv™Rx Neuromodulation System for Major Depressive Disorder (MDD).” This indicates that the U.S. Food and Drug Administration has approved Neurolief’s Proliv™Rx neuromodulation system specifically for treating major depressive disorder. The filing also notes that this report is incorporated by reference into BrainsWay’s existing Form S-8 and Form F-3 registration statements.
BrainsWay Ltd. submitted a Form 6-K as a foreign private issuer, linking it to its existing Form S-8 and Form F-3 registration statements. The filing mainly furnishes an exhibit titled “BrainsWay Announces First Coverage Policy for Accelerated Deep TMS™”, indicating a new coverage policy related to its Accelerated Deep TMS treatment. The report was signed by the company’s Chief Executive Officer, Hadar Levy.
BrainsWay Ltd. submitted a foreign issuer report providing an update related to its Deep TMS technology. The report mainly serves to furnish an exhibit titled “BrainsWay Reports Expansion of Adolescent Depression Coverage Applicable to Deep TMS,” indicating the company is reporting an expansion of coverage for adolescent depression treatment using its Deep TMS system. The 6-K is also incorporated by reference into BrainsWay’s existing Form S-8 and Form F-3 registration statements.
BrainsWay Ltd. (BWAY) submitted a Form 6-K as a foreign private issuer, incorporating this report into its existing Form S-8 and Form F-3 registration statements filed in 2019, 2024, and 2025.
The report includes an exhibit titled “BrainsWay Launches First Clinical Trial of Deep TMS 360™ System for Alcohol Use Disorder.” This indicates that the company has begun its first clinical trial using the Deep TMS 360 system in the area of alcohol use disorder.
BrainsWay Ltd. furnished a Form 6-K reporting that it received FDA clearance for its Deep TMS therapy as an adjunct treatment for major depressive disorder (MDD) in adolescents aged 15 to 21. The update is provided as an exhibit to the report. The company also notes that this Form 6-K is incorporated by reference into its existing U.S. registration statements on Form S-8 and Form F-3.
BrainsWay Ltd. (BWAY) furnished a Form 6-K for November 2025, providing an Investor Deck as Exhibit 99.1. The report notes that the submission is a foreign private issuer filing under the Securities Exchange Act.
The company states that this Form 6-K is incorporated by reference into its existing registration statements: a Form S-8 filed April 22, 2019 and Forms F-3 filed July 22, 2024 and April 22, 2025. The filing itself contains no financial results or transaction details beyond the inclusion of the investor presentation.
BrainsWay Ltd., an Israel-based foreign private issuer, submitted a Form 6-K for November 2025. The report furnishes Exhibit 99.1, a press release titled “BrainsWay Reports Third Quarter 2025 Financial Results and Operational Highlights.” The filing is incorporated by reference into the company’s existing Form S-8 and two Form F-3 registration statements and is signed by Chief Executive Officer Hadar Levy.
BrainsWay Ltd. furnished a Form 6-K. The filing includes an exhibit announcing a National Institutes of Health grant to a leading U.S. research team investigating accelerated Deep TMS for treatment of alcohol use disorder.
The report states this Form 6-K is incorporated by reference into the company’s Form S-8 and two Form F-3 registration statements.