Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 117

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 117
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 week five for the Deep TMS group and 21.4% at the
same time point for the sham group. Remission rates were 32.6% for the Deep TMS group and 14.6% for the sham group. The difference between
groups was statistically significant for both response and remission rates (p = 0.0138 and p = 0.0051, respectively).

The tertiary efficacy endpoints were changes in HDRS
scores, response, and remission rates at week 16 compared to baseline (see Figure 1 below). The difference in slope between Deep TMS and
sham groups was 2.47, which was statistically significant (p = 0.0259). Additionally, the response rates at week 16 were 44.3% for the
Deep TMS group and 25.6% for the sham group, which demonstrated a statistically significant difference between the groups (p = 0.0086).
Remission rates at week 16 were 31.8% for the Deep TMS group and 22.2% for the sham group, which was a nonsignificant difference between
groups (p = 0.1492).

Figure 1. Response and Remission
Rates for Deep TMS and Sham Groups at Week 5 and Week 16

Source: Levkovitz et al., 2015

For the group of patients who failed one to two medications,
remission rates were 36.6% in the Deep TMS group and 16.7% in the sham group. This was a statistically significant difference (p = 0.032).
For the group of patients who failed three or more medications, remission rates were 28.9% for the Deep TMS group and 12.2% for the sham
group. This difference was just outside of significance (p = 0.057). The data suggest that Deep TMS treatment can achieve high rates of
remission even in patients who have been more resistant to medications.

  66  

Figure 2. HDRS Score Change (Slope)
and Remission Rates for Deep TMS and Sham Groups in Subpopulations of Patients Who Failed 1 to 2 Medications versus Patients Who Failed
3+ Medications

Source: Levkovitz et al., 2015

  (c)      Safety Results  

Overall, Deep TMS treatment was safe and well-tolerated
by patients. The most common