Welcome to our dedicated page for Brainsway Ltd. news (Ticker: BWAY), a resource for investors and traders seeking the latest updates and insights on Brainsway Ltd. stock.
BrainsWay Ltd. (BWAY) generates a steady flow of news centered on its Deep TMS™ neurostimulation technology, regulatory developments, clinical research, and financial performance. As a company focused on noninvasive brain stimulation for mental health disorders, BrainsWay frequently announces updates related to major depressive disorder, obsessive-compulsive disorder, smoking addiction, and emerging indications such as Alcohol Use Disorder.
News items for BrainsWay often cover FDA clearances and label expansions, including accelerated Deep TMS protocols for MDD and indications that extend treatment to adolescent patients aged 15 to 21. The company also reports on payer coverage decisions, such as new or expanded medical policies from insurers that reimburse Deep TMS depression therapy for adults and adolescents, and coverage of its SWIFT™ accelerated protocol. These updates provide insight into how access to Deep TMS is evolving across different patient populations and geographies.
Investors following BWAY can also expect clinical research and grant-related announcements, including NIH-funded studies evaluating accelerated Deep TMS protocols for Alcohol Use Disorder and stimulant use disorders, as well as company-sponsored trials using the Deep TMS 360™ multichannel system. In addition, BrainsWay issues news on strategic investments, such as its minority-stake investment in Neurolief and stakes in mental health providers, and on financial results that highlight revenue trends, installed base growth, and multi-year customer agreements.
The BrainsWay news page on Stock Titan aggregates these updates so readers can track regulatory milestones, payer coverage changes, clinical trial progress, strategic partnerships, and quarterly financial disclosures related to BWAY stock. This makes it a useful reference for monitoring how the company’s Deep TMS platform and broader neuromodulation strategy are developing over time.
BrainsWay (NASDAQ: BWAY) reported strong Q4 and full‑year 2025 results, with Q4 revenue $14.5M (+27% YoY) and full‑year revenue of $52.2M (+27% YoY). Q4 adjusted EBITDA rose 53% to $2.3M; full‑year adjusted EBITDA was ~$7.0M. Remaining performance obligations grew 43% to ~$70M. The company issued 2026 guidance of $66–68M revenue (27%–30% growth), operating income target of 13%–14%, and adjusted EBITDA of $12–14M. Key operational milestones include FDA label expansion for adolescent MDD, insurer coverage for accelerated SWIFT protocol, a multicenter AUD trial for Deep TMS 360™, and Neurolief ProlivRx approval.
BrainsWay (NASDAQ: BWAY) published two peer-reviewed manuscripts showing its FDA-cleared SWIFT™ accelerated Deep TMS reduced the acute depression treatment phase by ~70%, delivering an 87.8% response rate, 78.0% remission rate, and median remission in 21 days versus 28 for standard treatment.
Patient-reported quality of life rose ~32 percentage points and ~60% regained normal-range functioning, improving access and retention for non-drug depression therapy.
BrainsWay (NASDAQ: BWAY) will report its fourth quarter and full year 2025 financial results on Wednesday, March 11, 2026 before U.S. markets open. A conference call and webcast will be held at 8:30 AM ET to discuss results and operational highlights.
Dial-in numbers, a webcast link, and a Conference ID are provided; the live broadcast will be available for replay for 30 days on the company investor website.
BrainsWay (NASDAQ: BWAY) announced management will hold one-on-one meetings at the Citi 2026 Unplugged MedTech and Life Sciences Access Day on Thursday, February 26, 2026, in New York. Investors or analysts should contact their Citi representative to request a meeting.
BrainsWay (NASDAQ & TASE: BWAY) announced a strategic minority-stake equity financing in Canadian provider BrainStim Health on Feb 19, 2026.
BrainsWay will invest an initial $1.0 million, with up to an additional $1.5 million via two milestone-based investments, in a preferred, annually compounding security; the deal includes a redemption mechanism and marks BrainsWay's fifth minority-stake clinical investment.
BrainsWay (NASDAQ: BWAY) commented on Evernorth Behavioral Health's decision to remove prior authorization for transcranial magnetic stimulation (TMS) for contracted providers, effective March 6, 2026. Evernorth serves over 18 million covered lives across 12 states and covers TMS for major depressive disorder and OCD. BrainsWay said the change should reduce administrative barriers and accelerate patient access to its Deep TMS systems.
BrainsWay (NASDAQ: BWAY) will change its ADS-to-ordinary share ratio from 2-to-1 to 1-to-1, effective prior to trading on March 3, 2026. Each ADS holder will receive one additional ADS per ADS held, equivalent to a 2-for-1 forward split of ADSs.
The ADSs will continue trading under the symbol BWAY; ordinary shares on the Tel Aviv Stock Exchange are unaffected. Because each ADS will represent half the ordinary shares after the change, the ADS trading price is expected to be roughly divided in half.
BrainsWay (NASDAQ: BWAY) said Highmark Blue Cross Blue Shield released a draft medical policy expanding coverage to adolescent and adult major depressive disorder (MDD) patients for the company’s accelerated Deep TMS SWIFT protocol.
The policy covers an acute course of five 10-minute sessions/day for six days, then two sessions/day weekly for four weeks (38 sessions total), and is expected to take effect in February 2026 after an open comment period. Highmark serves over 7 million covered lives in Pennsylvania, Delaware, West Virginia and parts of New York.
The company noted FDA clearance for the accelerated protocol in September 2025 and cited a multisite randomized non-inferiority trial reporting an 87.8% response rate and 78.0% remission rate.
BrainsWay (NASDAQ: BWAY) announced that the U.S. FDA granted Premarket Approval (PMA) to Neurolief's Proliv™Rx neuromodulation system on January 12, 2026, as a Class III adjunctive treatment for adults with major depressive disorder (MDD) who failed to improve after at least one antidepressant.
The approval makes Proliv™Rx the first and only FDA‑labeled at‑home neuromodulation therapy for treatment‑refractory MDD and follows BrainsWay's strategic investment in Neurolief, which includes an option to acquire the company and plans for commercial and research synergies.
BrainsWay (NASDAQ: BWAY) announced that Premera Blue Cross Blue Shield has adopted a final medical policy expanding coverage for BrainsWay’s accelerated SWIFT Deep TMS protocol to patients ages 15 and older with moderate to severe major depressive disorder. Premera covers about 2.8 million lives across Alaska and Washington.
The SWIFT protocol features an acute phase of five 10-minute sessions per day for six days, then two sessions per day once weekly for four weeks, totaling 38 sessions. The protocol requires no functional MRI or expensive neuronavigation. Company statements referenced clinical trial and real-world evidence showing comparable response and remission versus standard Deep TMS.