Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 111

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 111
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 is the recommended initial treatment. TMS is a second line therapy for the treatment
of a patient who has failed to achieve satisfactory improvement from prior pharmacotherapy. For patients with severe depression and later
stage treatment, somatic treatments such as ECT may be an option.

The central group of anti-depressant medicines is
the selective serotonin reuptake inhibitors (SSRI) and selective serotonin and norepinephrine reuptake (SNR).

A significant systematic review of the existing evidence
linking serotonin levels to depression was published in Naturein July of 2022. The review concluded that “[t]he main areas
of serotonin research provide no consistent evidence of there being an association between serotonin and depression, and no support for
the hypothesis that depression is caused by lowered serotonin activity or concentrations.” The review, however, did not refute the
body of evidence showing that randomized clinical trials (RCTs) comparing SSRIs to placebo have consistently demonstrated statistical
significance in reducing depression. As such, there has not been an appreciable change in prescribing patterns. Thus, SSRIs are effective
for some patients in treating depression, but there is a gap in understanding as to why.

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Positive data published in May 2023 in the Journal
of Psychiatric Research demonstrated compelling data with respect to the effectiveness of Deep TMS for MDD, showing a high response rate
from patients in an average period of 16 sessions or 21 days after beginning treatment with Deep TMS.

A publication in October 2023 in the Psychiatry Research
journal published new real-world post-marketing data demonstrating the efficacy of accelerated Deep TMS for the treatment of major depressive
disorder (MDD). The standard FDA-cleared Deep TMS protocol involves one treatment session per day, five days a week for 4 weeks, followed
by a maintenance period. However, there has been recent interest in “accelerated” dosing schedules which involve multiple
sessions each day to allow for quicker overall treatment time. Data collected using this approach to treat depression was compiled from
clinical sites and analyzed in this study. Key findings from this post-marketing study included data demonstrating efficacy of Deep TMS
administered over multiple sessions each day to allow for quicker overall treatment time for depression patients. Following publication
of these post-marketing results, in June 2024 we announced the launch of a prospective, randomized, controlled, multicenter clinical trial
evaluating an accelerated treatment protocol for our Deep TMS system