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. amended its notice and proxy statement for its November 25, 2026 annual meeting after director Dr. David Zacut notified the company on October 25, 2026, that he would not stand for re-election for personal reasons. Shareholders are asked to reappoint Kost Forer Gabbay & Kasierer as auditor, elect six director nominees—Ami Boehm, Eti Mitrany, Karen Sarid, Professor Abraham Zangen, Avner Lushi and Jonathan Shulkin—and approve equity awards.
The proposed CEO award is 60,000 RSUs, with an aggregate fair market value of approximately $693,000. If approved, vesting begins on the shareholder-approval date: 25% after six months, followed by the remaining 75% in 12 equal quarterly portions through May 25, 2030, subject to continued employment or service. A separate proposal seeks 17,500 RSUs for each of five directors, with an approximate fair market value of $202,125 per director and vesting subject to continued board service. BrainsWay expected to have 40,252,989 ordinary shares outstanding on the October 26, 2026 record date.
BrainsWay Ltd. announced expanded U.S. medical-policy coverage for access to its Deep TMS™ treatment for OCD, with more than 118 million Americans now covered under insurance policies providing that access. The company said this follows a recent coverage increase for its accelerated SWIFT™ protocol for major depressive disorder, as part of broader reimbursement developments.
BrainsWay states that Deep TMS is FDA-indicated as an intended adjunct treatment for adults with OCD. The company also says it is the only TMS company to have published data from a randomized, placebo-controlled multicenter study on its device demonstrating efficacy and safety for OCD.
BrainsWay Ltd. announced a collaboration with Inland Psychiatric Medical Group, a behavioral health provider serving Southern California. The collaboration includes a multisystem order of BrainsWay Deep TMS systems planned for installation at IPMG clinics and exploration of scientific, clinical and research projects related to interventional psychiatry and mental health care.
BrainsWay says its Deep TMS system is currently FDA-cleared to treat major depressive disorder with and without anxiety symptoms, obsessive-compulsive disorder and smoking addiction.
BrainsWay Ltd. reported further expansion in favorable U.S. medical policies covering its SWIFT Accelerated Deep TMS™ protocol, with over 70 million covered lives now having access to policies covering SWIFT. The company also reported favorable policy changes for Deep TMS generally, including treatment of major depressive disorder and obsessive-compulsive disorder. BrainsWay describes three FDA-cleared indications: major depressive disorder, obsessive-compulsive disorder and smoking addiction.
BrainsWay Ltd. reported revenue of $32.6 million for the six months ended June 30, 2026, up 35% from $24.2 million a year earlier. Net profit rose 60% to $5.0 million from $3.1 million, and operating profit was $4.4 million versus $1.2 million. The company attributed higher revenue primarily to increased Deep TMS system sales and leases.
Net cash provided by operating activities was $7.5 million, compared with $17.4 million in the prior-year period. Cash, cash equivalents and restricted cash totaled $62.4 million at June 30, 2026, versus $68.0 million at December 31, 2025. Remaining performance obligations grew 30% year over year to $80.4 million. BrainsWay said its cash resources and anticipated product revenue should fund operating expenses and capital expenditure requirements in the foreseeable future under its current business plan. Its installed base was approximately 1,949 Deep TMS systems at June 30, 2026, including 755 leased and 1,194 sold; it increased by 242 systems during the half. Strategic investment activity included a $6.0 million second-tranche convertible loan investment in Neurolief.
BrainsWay Ltd. (BWAY) reports peer-reviewed pilot data on its proprietary Deep Transcranial Magnetic Stimulation (Deep TMS™) in patients with comorbid Major Depressive Disorder and early-stage Alzheimer’s disease. The study, published in the Journal of Geriatric Psychiatry and Neurology, evaluated 12 patients.
Participants received 36 Deep TMS sessions using BrainsWay’s H1 and H7 coils, targeting the left dorsolateral prefrontal cortex and temporal regions. Investigators reported an 83.3% response rate (≥50% PHQ-9 reduction) and a 50% remission rate (PHQ-9 ≤4) for depressive symptoms, along with QEEG-based evidence of reduced delta power in the right temporal lobe and increased alpha coherence between frontal and temporal regions. BrainsWay notes that Deep TMS is not FDA‑cleared for Alzheimer’s disease and characterizes the results as preliminary, requiring additional controlled clinical research.
BrainsWay Ltd. (BWAY) reported new peer-reviewed data on its Deep Transcranial Magnetic Stimulation (Deep TMS™) technology showing reduced suicidal ideation in patients with Major Depressive Disorder. A secondary analysis of a multisite randomized non-inferiority trial, comparing the SWIFT™ accelerated protocol to standard once-daily Deep TMS, found that patients with suicidal ideation by the Scale for Suicide Ideation (SSI>0) fell from 22.5% (20/89) at baseline to 6.7% (6/89) after 6 weeks, a 70% relative reduction. Median time to improvement, defined as at least a one-point SSI reduction, was 10 days with SWIFT and 13 days with standard Deep TMS, a statistically significant difference. The company notes that Deep TMS is FDA-cleared for Major Depressive Disorder, but not for treatment or prevention of suicidal ideation or behavior.
BrainsWay Ltd. provides an August 2026 business update highlighting its Deep TMS interventional psychiatry platform and recent financial performance. The company reports 1,950 systems installed across 48 U.S. states and 6 continents, with more than 8+ million Deep TMS sessions delivered and over 300M covered lives for reimbursed depression treatment.
The addressable global interventional psychiatry market is presented as $15B+ TAM, with BrainsWay estimating current penetration at less than 2%. The model emphasizes multi-year leases and pay-per-use, with 4–5 year contracts, 90%+ customer retention and a 1.3x book-to-bill ratio, supporting growing recurring revenue and backlog.
For Q2 2026, BrainsWay reports 125 systems shipped (+42% year over year), +35% revenue growth, 75% gross margin, +314% operating income, +141% Adjusted EBITDA, +34% net income, RPO above $80M (+30% year over year) and a $62 cash balance. For the full year 2026, management illustrates revenue growth of +30–34%, targeted operating expense growth below 15% and $13–14M Adjusted EBITDA, indicating operating leverage as shipments and installed base expand.
BrainsWay Ltd. reported a strong second quarter for 2026, with revenue up 35% to $17.1 million from $12.6 million a year earlier. Gross profit reached $12.8 million, while operating income rose to $2.4 million, expanding operating margin to 14% from 5% in the prior-year quarter. Adjusted EBITDA increased 141% to $3.5 million, with margin improving to 20% from 11%. Net income grew 34% to $2.7 million, or $0.07 per basic share.
Remaining performance obligations climbed 30% year-over-year to $80.4 million, and the company shipped a record 125 Deep TMS systems in the quarter, bringing the installed base to about 1,949. Cash, cash equivalents and restricted cash totaled $62.4 million as of June 30, 2026, after generating $6.3 million of operating cash flow in the quarter. Reflecting this momentum, BrainsWay raised its full-year 2026 outlook to revenue of $68–$70 million, operating income of 13.5%–14% of revenue, and Adjusted EBITDA of $13–$14 million, implying anticipated revenue growth of approximately 30%–34% and Adjusted EBITDA growth of approximately 90%–100% versus 2025.
Harel Insurance Investments & Financial Services Ltd. reports beneficial ownership of 3,265,397 Ordinary Shares of Brainsway Ltd., representing 8.3% of the ordinary shares outstanding, based on 39,165,806 Ordinary Shares issued and outstanding as of December 31, 2025.
Most shares are held for public investors through funds and insurance products managed by Harel subsidiaries: 2,900,521 shares via various funds and policies, 359,581 shares in third-party client accounts, and 5,295 shares for Harel’s own account. The filing states that each subsidiary operates under independent management and makes independent voting and investment decisions, and that Harel does not admit beneficial ownership of more than the 5,295 shares held for its own account. Harel reports shared voting power over 2,905,816 shares and shared dispositive power over 3,265,397 shares, with no sole voting or dispositive power.