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. 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.
BrainsWay Ltd. announced a $3 million minority equity investment in Radial Health, Inc. as part of Radial’s Series A financing. Radial operates a management services organization that supports a leading network of Brain Medicine clinics, providing clinical infrastructure, reimbursement tools and an AI-guided decision support platform.
The financing is expected to support Radial’s exploration of M&A opportunities. BrainsWay describes this stake as part of a broader strategy to secure minority positions in high-performing mental health provider networks, expanding awareness of and access to its noninvasive Deep TMS treatments, which currently have three FDA-cleared indications.
BrainsWay Ltd. announced a strategic minority investment in Sound Minds Behavioral, a growth-oriented outpatient behavioral health platform operating multiple locations across Connecticut, Pennsylvania, New Jersey and New York. Under the agreement, BrainsWay will invest $500,000 in Sound Minds through a preferred, annually compounding security as part of an equity financing round.
The partnership aligns with BrainsWay’s strategy of working with mental health providers to expand access to interventional psychiatry solutions based on its Deep Transcranial Magnetic Stimulation platform. Sound Minds offers therapy, medication management, PHP/IOP and interventional psychiatry services across its Mid-Atlantic footprint.
BrainsWay Ltd. reported positive real-world results for its Deep Transcranial Magnetic Stimulation (Deep TMS™) in patients suffering from both post-traumatic stress disorder (PTSD) and major depressive disorder (MDD). In a retrospective study of 462 patients across 11 clinical sites, all received at least 20 Deep TMS sessions using BrainsWay’s H1 or H7 coils.
About 83.5% of patients met the PTSD response threshold, defined as at least a 50% reduction in symptoms, with an average 52% reduction in PTSD Checklist for DSM‑5 (PCL‑5) scores. Depression measures also improved, with a 66.6% response rate, a 27.3% remission rate, and an average 50% reduction in Patient Health Questionnaire‑9 (PHQ‑9) scores.
The company emphasizes that Deep TMS is not currently FDA‑cleared for PTSD or comorbid PTSD and MDD and that these retrospective findings remain preliminary and subject to peer review. BrainsWay highlights this study as the largest real‑world analysis of Deep TMS in this comorbid population to date.
Brainsway Ltd. Chief Technology Officer Moiseyev Gilad reported multiple equity transactions. On May 25, 2026, he exercised stock options for 7,500 Ordinary Shares at an exercise price of NIS 11.17 per share, and the company retained 1,902 shares at NIS 44.04 per share to cover the option exercise.
On June 15, 2026, he sold 5,000 Ordinary Shares in an open-market transaction at a sale price of NIS 42.0397 per share, leaving him with 53,098 Ordinary Shares held directly. Footnotes indicate remaining stock options to purchase 13,125 Ordinary Shares vesting in equal quarterly installments until March 5, 2028, alongside additional unvested RSUs that settle in Ordinary Shares over future dates.
BrainsWay Ltd. reported a major expansion of insurance coverage for its SWIFT™ Accelerated Deep TMS™ protocol in the United States. Following several favorable policy changes, including a newly issued policy covering 2 million members in South Carolina, more payers now reimburse this accelerated treatment approach.
With these updates, eight major payers and the U.S. Department of Veterans Affairs now either cover or include policy language supporting accelerated TMS treatment approaches, representing over 57 million covered lives. Management highlights this as evidence of growing adoption of Deep TMS therapies and broader patient access.
The company positions itself as a leader in noninvasive neurostimulation, with its Deep TMS platform cleared by the FDA for major depressive disorder, obsessive-compulsive disorder, and smoking addiction. BrainsWay emphasizes ongoing clinical research and collaboration with providers and policymakers to further expand access to its treatments.
BrainsWay Ltd. filed a Form 6-K highlighting new 12-month durability data for its FDA-cleared SWIFT™ accelerated Deep Transcranial Magnetic Stimulation (Deep TMS™) protocol for Major Depressive Disorder. In a prospective multisite randomized controlled trial, over 80% of patients treated with the SWIFT protocol remained in remission through 12 months based on clinician-rated assessments.
The share of patients with severe functional impairment fell from 85% at baseline to 0% at 12 months, indicating marked improvement in daily functioning, work, and social life. Fewer than 25% of patients needed a medication change or another TMS course during the year. Similar durable benefits were also seen with BrainsWay’s standard once-daily Deep TMS protocol, supporting the long-term durability of the technology for depression treatment.
Brainsway Ltd. Chief Scientist Dr. Roth Yiftach reported open-market sales of a total of 7,000 Ordinary Shares on June 1–2, 2026. The filing notes sale prices between NIS 42.0035 and NIS 43.64 per share. After these transactions, he directly holds 1,072,305 Ordinary Shares, including shares held jointly with his spouse and 5,000 unvested RSUs that vest in stages through March 10, 2030. The Ordinary Shares may also be represented by American Depositary Shares, each currently equal to one Ordinary Share.