BrainsWay Completes Additional $6 Million Milestone-Based Investment in Neurolief Ltd. Following FDA Approval of Proliv™Rx System for MDD BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive neurostimulation treatments for mental health disorders, today announced the completion of an additional $6 million

#BWAY BrainsWay Completes Additional $6 Million Milestone-Based Investment in Neurolief Ltd. Following FDA Approval of Proliv™Rx System for MDD

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BrainsWay Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights 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.

#BWAY BrainsWay Reports Fourth Quarter and Full Year 2025 Financial Results and Operational Highlights

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Landmark Data Validate BrainsWay’s SWIFT™ Deep TMS, Beginning a New Era in Depression Treatment 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.

#BWAY Landmark Data Validate BrainsWay’s SWIFT™ Deep TMS, Beginning a New Era in Depression Treatment

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BrainsWay Announces Draft Coverage Policy from Highmark® for Accelerated Deep TMS™ BrainsWay Ltd. (NASDAQ & TASE: BWAY) (“BrainsWay” or the “Company”), a global leader in advanced noninvasive brain

#BWAY BrainsWay Announces Draft Coverage Policy from Highmark® for Accelerated Deep TMS™

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BrainsWay Announces FDA Approval of Neurolief’s Proliv™Rx Neuromodulation System for Major Depressive Disorder (MDD) 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.

#BWAY BrainsWay Announces FDA Approval of Neurolief’s Proliv™Rx Neuromodulation System for Major Depressive Disorder (MDD)

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BrainsWay Announces First Coverage Policy for Accelerated Deep TMS™ 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.

#BWAY BrainsWay Announces First Coverage Policy for Accelerated Deep TMS™

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Major insurer adds non-drug depression treatment option for teens 15 and up Optum Behavioral Health, with 48M covered lives, now covers BrainsWay's Deep TMS for teens with MDD, joining payers representing about 180M people.

#BWAY BrainsWay Reports Expansion of Adolescent Depression Coverage Applicable to Deep TMS™

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BrainsWay Launches First Clinical Trial of Deep TMS 360™ System for Alcohol Use Disorder BrainsWay (NASDAQ: BWAY) launched a multicenter, randomized, double-blind, sham-controlled clinical trial using its next-generation Deep TMS 360 system to treat Alcohol Use Disorder (AUD). The study will enroll >200 adults aged 18–86 with moderate-to-severe AUD, run for approximately six months with an intensive 3–5 week phase and weekly maintenance, and uses the FDA-recognized primary endpoint of no heavy drinking days (NHDD) during the initial four-month treatment period.Sites span multiple US states and select international locations in Israel and Sweden; each visit includes two sessions per day and behavioral education components.

#BWAY BrainsWay Launches First Clinical Trial of Deep TMS 360™ System for Alcohol Use Disorder

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BrainsWay Receives FDA Clearance of Deep TMS™ as Adjunct Therapy for Major Depressive Disorder (MDD) in Adolescents Aged 15 to 21 BrainsWay (NASDAQ: BWAY) announced on Nov 13, 2025 that the FDA has expanded the Deep TMS™ label to permit use as an adjunct therapy for adolescents aged 15–21 with major depressive disorder (MDD). The clearance followed real-world data from 1,120 adolescents treated across 35 U.S. centers (2012–2024), showing a 12.1-point average PHQ-9 improvement after 36 sessions and a 66.1% response rate. The system remains indicated for adults who failed prior antidepressant treatment and now covers the broadest age range for a TMS system.

#BWAY BrainsWay Receives FDA Clearance of Deep TMS™ as Adjunct Therapy for Major Depressive Disorder (MDD) in Adolescents Aged 15 to 21

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BrainsWay Reports Third Quarter 2025 Financial Results and Operational Highlights BrainsWay (NASDAQ: BWAY) reported strong Q3 2025 results: revenue +29% to $13.5M, adjusted EBITDA +81% to $2.0M, operating income $1.3M, and net profit $1.6M. Gross margin was 75% and cash totaled $70.7M as of Sept 30, 2025.The company shipped 90 Deep TMS systems in Q3 (installed base >1,600), holds $65M of remaining performance obligations, and notes ~70% of new engagements are multi-year leases. FDA cleared an accelerated Deep TMS protocol for MDD. Full-year 2025 guidance midpoint was raised to $51M–$52M revenue with higher margin and EBITDA ranges.

#BWAY BrainsWay Reports Third Quarter 2025 Financial Results and Operational Highlights

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BrainsWay Reports National Institutes of Health Grant to Leading U.S. Research Team Investigating Accelerated Deep TMS for Treatment of Alcohol Use Disorder BrainsWay (NASDAQ: BWAY) announced that the U.S. National Institutes of Health awarded a grant of approximately $2.5 million over five years to a Stanford-led team to study an accelerated Deep TMS protocol for Alcohol Use Disorder (AUD). The randomized, double-blind, sham-controlled trial will enroll 100 adults and deliver an accelerated schedule of three Deep TMS sessions per day for 10 business days (30 sessions) using BrainsWay’s H7 Coil.The mechanistic study will use neuroimaging to assess target engagement in regions such as the dorsal anterior cingulate cortex and link brain changes to clinical outcomes including percentage days abstinent and heavy drinking days. This is the second major NIH grant to this team in two years and follows recent FDA clearance for BrainsWay’s H1 Coil for accelerated MDD treatment.

#BWAY BrainsWay Reports National Institutes of Health Grant to Leading U.S. Research Team Investigating Accelerated Deep TMS for Treatment of Alcohol Use Disorder

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THIS JUST IN... that talented actor/writer/director DAN LAURIA will be hosting a Q&A with the Director, Cast and myself following the reading! YOU'RE INVITED!

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THIS JUST IN... that talented actor/writer/director DAN LAURIA will be hosting a Q&A with the Director, Cast and myself following the reading! YOU'RE INVITED!

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6 Days vs 4 Weeks: BrainsWay's Revolutionary FDA-Cleared Depression Treatment Shows 88% Response Rate BrainsWay's accelerated Deep TMS protocol achieves 87.8% response rate in MDD treatment, reducing therapy time from 4 weeks to 6 days. Patients reach remission 7 days faster than standard protocol.

#BWAY BrainsWay Receives FDA Clearance for Accelerated Deep TMS Protocol for Non-Invasive Treatment of Major Depressive Disorder (MDD)

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