Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 119

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 119
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1,351 patients met the inclusion criteria for the analysis. All
patients were treated with our H1 Coil utilizing either a standard protocol (typically 18Hz, 20-minutes long) or a shorter intermittent
theta burst (iTBS) protocol. Outcomes were measured with clinician-based scales (HDRS-21) and/or patient self-administered questionnaires
designed specifically for depression (PHQ-9, BDI-II). This analysis also showed that the average patient achieved sustained response at
16 sessions, or 21 days after beginning treatment. The results found similar efficacy rates among patients undergoing the standard protocol
and those who had been administered an iTBS protocol. Data from questionnaires which are not specific to depression, and thus less relevant
for assessing depression changes, were intentionally excluded.

Use of H7 Coil for treatment of MDD

Our randomized, double-blind, controlled multicenter,
non-inferiority study of our H1 and H7 Coils trial, which included 144 subjects, found overall efficacy rates for the H7 Coil which were
comparable to those achieved with our H1 Coil. Based on this trial, our MDD clearance, which had previously applied to our H1 Coil, was
extended by the FDA to also apply to our H7 Coil, which until this clearance was used only for treatment of OCD.

Furthermore, following receipt of this clearance,
a publication of the study inThe Journal of Clinical Investigation (JCI) Insightincluded a retrospective analysis of the study
results which identify preliminary predictors that could help optimize treatment based on individual patients’ attributes. This
analysis examined clinician rating scales and EEG data revealing intriguing differences between the patient treatment of the two coils.
Categorizing patients according to “clusters” of clinical depressive and anxiety baseline symptoms derived from a subset of
the Hamilton Depression Rating Scale (HDRS-21) resulted in two subject groups: One with higher severity of the cluster, which on average
responded better to the H1 Coil, and another with lower severity of the cluster, which on average responded better to the H7 Coil. This
analysis also showed that brain activity measured during the first treatment session correlated with the clinical outcomes ultimately
achieved after the full course of treatment. This finding suggests that specific brain patterns observed in an individual’s response
to either coil during the early stages of treatment might be predictive of the longer-term outcome of treatment with that coil.

Deep TMS for
OCD

Disease
Overview

O