Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 118

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 118
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 reported side effects within the Deep TMS group are as follows: 26.7% of patients experienced headaches,
5.0% experienced application site pain, and 3.0% experienced application site discomfort. The most common reported side effects within
the sham group are as follows: 18.9% of patients experienced headaches, 3.6% experienced insomnia, and 2.7% of patients experienced back
pain. One subject experienced a seizure, following excessive consumption of alcohol on the night before treatment that was not reported
to the treating physician or operator at the time of treatment. This was considered device-related, albeit with the caveat that withdrawal
from alcohol may have led to a reduction of seizure threshold and consequently to this seizure during Deep TMS.

Longer-Term Remission and Response

As demonstrated by our pivotal multicenter study
for MDD (as described above), and in another third-party study (Harel et al. (2014)), MDD patients who achieved remission or response
after an acute course of Deep TMS treatment of 20 sessions over four weeks were able to sustain the therapeutic effect by continuing to
undergo Deep TMS treatment beyond the treatment course. Additionally, our trial and the Harel study showed that among MDD patients who
did not achieve a response after an acute course of Deep TMS treatment, the longer such patients continued to undergo Deep TMS therapy,
the more likely they were to achieve remission or response. This result was also demonstrated in another study examining the results of
our multicenter trial (Yip et al. (2017)), which found that 72.7% of the patients who did not achieve response after an acute course of
treatment achieved a response within the next 12 weeks (which involved twice weekly Deep TMS treatment), of which 60.6% achieved response
within the first four weeks. These studies suggest that Deep TMS may continue to be effective beyond the standard acute treatment course,
potentially broadening its clinical applicability.

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Real world data further demonstrates the benefits
of Deep TMS for MDD: In a peer-reviewed post-marketing study published in Psychiatry Research in 2023, we demonstrated that patients who
had received 30 or more Deep TMS treatments achieved an 82% response rate and a 65% remission rate. In the study, BrainsWay collected
an aggregate data set from 1,753 patients across 21 clinics, of which