Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 103

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 103
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 OCD demonstrated statistically
significant response and partial response rates of 38.1% and 54.8%, respectively, after six weeks of daily active Deep TMS treatment of
19 minutes per session, compared to 11.1% and 26.7%, respectively, after sham treatment. Post-marketing data on Deep TMS for OCD published
in 2021 found that 58.4% of those who completed 29 sessions achieved response, and 73% of patients, including those who did and did not
complete the full course of therapy, demonstrated response at least once prior to the conclusion of treatment. Our pivotal trial for smoking
addiction demonstrated a statistically significant difference in reaching the Continuous Quit Rate (CQR), defined as 4 weeks of continuous
abstinence from smoking at any point during the study. Among the 168 participants in the study who completed three weeks of Deep TMS or
sham treatment, plus the mandatory additional three weeks of follow-up (reaching the six-week endpoint), the CQR was 28.4% in the treatment
group, compared to 11.7% in the sham group (p=0.007). Overall, Deep TMS treatment was safe and well-tolerated by patients in these trials.

With respect to our MDD labeling
expansion which now includes anxious depression, data from 573 patients who had undergone Deep TMS treatment in 11 studies, including
both randomized controlled trials (RCT) and open-label studies, which was submitted by us in support of our application to the FDA, demonstrated
a treatment effect that was consistent, robust, and clinically meaningful for decreasing anxiety symptoms in adult patients suffering
from major depressive disorder. An analysis of our data found favorable outcomes with Deep TMS when compared to sham or medication as
standard of care. For example, using the Cohen’s d statistical method, data from the 3 randomized studies of Deep TMS demonstrated
effect sizes ranging from 0.34 (when compared to sham) to 0.90 (when compared to medication). As a reference, published articles from
approximately 16,000 subjects in over 70 studies of drug-based anxiety treatments - including studies of standard-of-care medications
frequently prescribed for patients suffering from anxious depression and general anxiety disorder - report effect sizes ranging
from 0.2 - 0.37.

  We have a commercial track record for MDD and OCD  

We have an established commercial
footprint in the United States for Deep