Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 94

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 94
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 clearance, which had previously applied
to its H1 Coil, was extended to also apply to its H7 Coil. The Deep TMS H7 Coil had been previously cleared for use in treating obsessive-compulsive
disorder since 2018, and with this new clearance it can be marketed for the treatment of MDD (including anxious depression). The FDA’s
grant of clearance was based on its review of successful results from a randomized, double-blind, controlled multicenter trial completed
by the Company. The study, which included 144 subjects, found overall efficacy rates for the H7 Coil that were comparable to those achieved
with BrainsWay’s H1 Coil.

Following receipt of this clearance, a publication
of the study in The Journal of Clinical Investigation (JCI) Insight included a retrospective analysis of the study results which identifies
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.

In May 2024, the FDA cleared an expansion of our
existing MDD clearance allowing for the treatment of patients with late life depression. The expanded clearance covers MDD patients ages
22 to 86, changing the previous upper age limit of 68. This expanded clearance makes our Deep TMS the first and only form of TMS indicated
for the treatment of patients over the age of 68 suffering from MDD, including those with comorbid anxiety symptoms. Our application to
the FDA included study data showing, for example, that MDD patients over 68 years of age who were treated with our H1 Coil demonstrated
69% and 62% response and remission rates, respectively, using the HDRS-21, and 65% and