BrainsWay Ltd.'s SEC filings document foreign private issuer current reports for a medical technology company focused on noninvasive neurostimulation for mental health disorders. Recent Form 6-K reports furnish press releases and investor materials covering Deep TMS commercialization, FDA-cleared indications, payer reimbursement policies, clinical data, financial results, operating guidance, and strategic investments in provider networks and related neurostimulation assets.
The filings also identify the company as a Form 20-F filer and reference registration statements on Form S-8 and Form F-3. Exhibits disclose capital-allocation activity, customer and reimbursement developments, risk-factor themes in investor materials, and formal updates on the business model built around leasing and selling Deep TMS systems.
BrainsWay Ltd. reported third-quarter 2026 revenue of $18.1 million, up 34% from $13.5 million a year earlier. Operating income rose to $2.6 million from $1.3 million, net income to $2.2 million from $1.6 million, and Adjusted EBITDA to $3.9 million from $2.0 million. Operating cash flow was $6.2 million, compared with $1.4 million. Operating income margin was 14%, versus 9%, and Adjusted EBITDA margin was 21%, versus 15%.
Remaining performance obligations were approximately $85 million as of September 30, 2026, up 31% year over year. BrainsWay shipped 130 Deep TMS systems, up 44%, bringing its installed base to approximately 2,080 systems. Full-year 2026 revenue, operating income margin and Adjusted EBITDA are expected at the upper end of prior guidance, with potential to modestly exceed it. Subsequent to quarter end, it entered a strategic collaboration with Inland Psychiatric Medical Group, including a multisystem Deep TMS order for planned installation at its clinics and exploration of scientific, clinical and research projects. BrainsWay stated Deep TMS is not FDA-cleared to treat suicidal ideation or comorbid early-stage Alzheimer’s disease, conditions referenced in its cited research.
BrainsWay Ltd. announced a strategic collaboration with Mindful Health Solutions (MHS) to expand patient access to noninvasive mental-health treatments, including Deep TMS™ and the recently FDA-cleared accelerated SWIFT™ treatment protocol, and to explore integrating Neurolief’s Proliv™Rx at-home therapy into broader care pathways. MHS’s managed services organization was acquired by Radial Health in August; the combined management company, operating under the Radial banner, supports 27 brain medicine clinic locations across California, Missouri, New York, South Carolina, Tennessee, Texas and Washington.
The companies intend to develop physician education and clinical awareness through joint initiatives. Separately, BrainsWay made a recent $0.8 million follow-on equity investment in the management services organization servicing the Texas-based Heading Health clinic network. BrainsWay lists three current FDA-cleared indications for Deep TMS: major depressive disorder, obsessive-compulsive disorder and smoking addiction.
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. is seeking approval at its November 25, 2026 annual meeting for four proposals: reappoint Kost Forer Gabbay & Kasierer as auditor for 2026 through the next annual meeting; re-elect directors Ami Boehm, David Zacut, Eti Mitrany, Karen Sarid, Prof. Abraham Zangen, Avner Lushi and Jonathan Shulkin; and approve equity grants to CEO Hadar Levy and six directors.
Levy’s proposed grant is 60,000 RSUs with an aggregate fair market value of approximately $693,000. The proposed director grants are 17,500 RSUs each to David Zacut, Eti Mitrany, Karen Sarid, Prof. Abraham Zangen, Avner Lushi and Jonathan Shulkin, valued at approximately $202,125 per director. The proposed vesting schedules span 3.5 years from shareholder approval and require continuing service.
Brainsway expects 40,252,989 Ordinary Shares outstanding at the close of business on October 26, 2026, each carrying one vote. Proposal 3 requires a majority of votes cast and either majority support from participating non-controlling shareholders without a personal interest, or votes against from that group not exceeding 2% of total voting rights. The Board recommends voting FOR each proposal.
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.