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BrainsWay Ltd. reports developments in noninvasive neurostimulation treatments for mental health disorders. The company markets its proprietary Deep TMS platform, with FDA-cleared indications that include major depressive disorder, obsessive-compulsive disorder, and smoking addiction, and derives revenue from leases and sales of Deep TMS systems.
Recurring updates include financial results, operating guidance, system placements, reimbursement and payer coverage for TMS therapy, clinical data for Deep TMS protocols such as SWIFT, and additional regulatory clearances. Company news also covers strategic minority-stake and milestone-based investments in mental health providers and related neurostimulation technologies, along with investor conference participation and operational updates across its U.S. and Israel-based business.
BrainsWay (NASDAQ: BWAY) highlighted expanding U.S. payer policies permitting psychiatric mental health nurse practitioners (PMHNPs) to order, supervise, and administer Transcranial Magnetic Stimulation, including Deep TMS™, where state scope-of-practice allows.
Optum Behavioral Health updated its policy in late 2025, covering ~34.8 million lives; several MACs, VA, and TRICARE West have adopted similar approaches. BrainsWay notes this could expand access amid psychiatrist shortages and cites FDA clearance for Deep TMS for multiple indications.
BrainsWay (NASDAQ: BWAY) will present at the 25th Annual Needham Virtual Healthcare Conference on Wednesday, April 15, 2026 at 8:45 AM ET.
The presentation offers an investor-facing update; investors and analysts should contact their Needham & Co. representative to request meetings.
BrainsWay (NASDAQ: BWAY) completed a $6 million milestone-based convertible loan to Neurolief after the FDA granted Premarket Approval for Neurolief's Proliv™Rx system for treatment-resistant major depressive disorder (MDD).
BrainsWay has invested $11 million to date and may provide further funding, including up to $5 million in a third tranche tied to revenue milestones; BrainsWay also holds a call option to acquire Neurolief equity under defined pricing formulas.
Neurolief reported commercial scaling, including inclusion on the Veterans Affairs Federal Supply Schedule with FSS pricing for Proliv™Rx and Relivion®MG.
BrainsWay (NASDAQ/TASE: BWAY) completed a $1.0 million milestone-based investment in Axis Integrated Mental Health after Axis achieved a predefined revenue milestone under an August 2025 strategic equity financing agreement.
The transaction follows BrainsWay's original $2.3 million equity investment and takes the form of a minority, annually compounding preferred security with a redemption mechanism. BrainsWay said the investment aligns with its strategy to partner with U.S. mental health providers and increase access to care; Axis operates several mental health clinics in Colorado.
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.