Brainsway Ltd. SEC Filings

BrainsWay Ltd. reported a strong 2025, combining fast growth with higher profitability. Full-year revenue reached $52.2 million, up 27% from 2024, while net income rose 161% to $7.6 million and Adjusted EBITDA increased to about $7.1 million. Q4 revenue grew 27% year-over-year to $14.5 million, with operating income of $1.9 million and net income of $2.9 million.

The company ended 2025 with $68.0 million in cash, cash equivalents and restricted cash and remaining performance obligations of approximately $70 million, up 43% from December 31, 2024. BrainsWay also highlighted regulatory and commercial progress, including FDA label expansion for Deep TMS in adolescent depression, first insurer coverage for its accelerated SWIFT protocol, and FDA approval of Neurolief’s Proliv Rx neuromodulation system.

For 2026, BrainsWay targets revenue of $66 million to $68 million, implying 27% to 30% growth over 2025, and is guiding to operating income of 13% to 14% and Adjusted EBITDA of $12 million to $14 million, while expecting continued profitability and positive cash flow.

BrainsWay Ltd. reported new clinical data on its FDA-cleared SWIFT™ accelerated Deep TMS™ protocol for major depressive disorder. Two peer-reviewed manuscripts in Brain Stimulation show that SWIFT achieves comparable outcomes to the standard Deep TMS protocol while sharply reducing treatment time.

The accelerated protocol shortens the traditional 20-visit acute phase to 6 half days, then weekly maintenance visits for 4 weeks. In a large randomized multisite trial, SWIFT delivered an 87.8% response rate, a 78.0% remission rate, and a median time to remission of 21 days versus 28 days for the standard protocol.

Patient-reported data showed quality-of-life scores improving by about 32 percentage points by 6 weeks, with roughly 70% no longer severely impaired and about 60% reaching normal-range functioning. BrainsWay positions SWIFT as a way to reduce treatment burden and expand access to non-drug depression therapy.

Brainsway Ltd. reports that Harel Insurance Investments & Financial Services Ltd. beneficially owns 1,981,714 Ordinary Shares, representing 5.2% of the outstanding ordinary shares based on June 30, 2025 share count. The filing states 1,974,472 Ordinary Shares are held for public clients by subsidiaries with independent voting and investment decisions and 7,242 Ordinary Shares are held in third‑party client accounts where the manager has investment but not voting power. The CUSIP cited (10501L106) applies to American Depositary Shares, each representing two ordinary shares.

BrainsWay Ltd. has entered into a strategic equity financing agreement to make a minority investment in Canadian mental health provider BrainStim Health Inc.. BrainsWay will invest $1.0 million initially, with the potential for an additional $1.5 million through two milestone-based investments in a preferred, annually compounding security that includes a redemption mechanism.

This is BrainsWay’s fifth minority-stake investment in growth-oriented clinical service platforms and supports its strategy to expand access to and awareness of Deep TMS mental health treatments while the company continues focusing on scientific, clinical, and commercial advancement of its technology.

BrainsWay Ltd. filed a Form 6-K highlighting a policy change by Cigna Group’s Evernorth Behavioral Health, which serves over 18 million covered lives across 12 states. Evernorth will stop requiring prior authorization for transcranial magnetic stimulation (TMS) for contracted providers under Evernorth and Cigna Healthcare plans, effective March 6, 2026.

BrainsWay’s CEO said eliminating prior authorizations should expand timely access to TMS for patients who meet Evernorth’s criteria, including those with major depressive disorder and obsessive-compulsive disorder. The company notes its Deep TMS systems are already widely adopted in the U.S. and that it remains focused on expanding access to its three FDA-cleared indications.

BrainsWay Ltd. is changing the ratio of its American Depositary Shares (ADSs) traded on Nasdaq to match its ordinary shares on the Tel Aviv Stock Exchange. The ratio will shift from 2 ordinary shares per 1 ADS to a new 1-to-1 structure, effective before trading begins on March 3, 2026.

Each existing ADS holder will receive one additional ADS for every ADS currently held, which is economically similar to a 2-for-1 forward split of the ADSs. Because each ADS will represent half as many ordinary shares as before, the trading price of the ADSs is expected to be roughly halved after the change, without altering the underlying economic ownership.

The company’s ADSs will continue to trade on Nasdaq under the symbol BWAY, and its ordinary shares will continue to trade on the Tel Aviv Stock Exchange, with no change to the ordinary shares themselves. Management states that the goal is to simplify capital structure comparisons across exchanges and potentially enhance liquidity and accessibility for U.S. investors.

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 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.