BRSYF Brainsway Ltd.

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Executive Summary

BrainsWay presented new 12-month durability data for its SWIFT accelerated Deep TMS protocol at the CTMSS annual meeting, showing over 80% remission rate and a decline in severe functional impairment from 85% to 0% at 12 months. This is the first prospective, randomized controlled trial to demonstrate one-year durability for both accelerated and conventional Deep TMS, building on the FDA clearance received in September 2025. The data strengthens the clinical evidence supporting BrainsWay's platform and could drive adoption among providers and payers.

Actionable Insight

Key Facts

• Over 80% of SWIFT-treated patients remained in remission at 12 months (clinician-rated).
• Severe functional impairment dropped from 85% at baseline to 0% at 12 months in the SWIFT group.
• Less than 25% of patients required medication change or additional TMS within 12 months.
• Data presented at the 14th Annual Clinical TMS Society Meeting (June 4-6, 2026).
• SWIFT protocol reduces acute-phase clinic visits by 70% vs. standard Deep TMS.
• Study followed 65 patients (73% of the original pivotal trial cohort) over 12 months.
• FDA clearance for SWIFT protocol in MDD was granted in September 2025.

Financial Impact

No financial figures provided; clinical data supports potential market adoption and reimbursement expansion.

Risk Factors

• Data is preliminary and from a conference poster, not yet peer-reviewed.
• Small sample size (65 patients) limits statistical power.
• Competing TMS protocols and alternative depression treatments may erode market share.
• Reimbursement and adoption timelines remain uncertain.

Market Snapshot

Documents Analyzed

This report is based on 5 SEC documents filed with EDGAR.

US Market Status