Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 124

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 124
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 During the
first five weeks of the treatment phase, patients received five consecutive sessions per week, followed by one week with four sessions
(29 total treatment sessions). The third phase was the follow-up, in which patients were assessed in week six after their final treatment.

  70  

The primary endpoint measure was the Yale-Brown Obsessive
Compulsive Scale (YBOCS), which is a score ranging from 0 to 40, with higher scores indicating greater severity of OCD symptoms. The secondary
efficacy endpoint measures were response rate at weeks 6 and 10, partial response rate at weeks 6 and 10, and remission rates at week
6. Secondary safety endpoint measures included the number of adverse events, physical and cognitive evaluations, and vital signs.

Inclusion and exclusion criteria required patients
to be diagnosed with OCD, have a YBOCS score of greater than 20, and not be diagnosed with any severe personality disorders.

  (b)      Trial Results  

After six weeks of treatment, the Deep TMS treatment
group had statistically significant improvement in YBOCS score compared to the sham treatment group. The adjusted mean YBOCS score decreased
by 6.04 points in the Deep TMS group and by 3.27 points in the sham control group. The difference between the slopes of 2.78 points across
six weeks between the treatment arms was statistically significant (p-value: 0.0127), and the effect size at week six assessment was 0.69.
As shown in Figure 3, 38.1% of the Deep TMS treatment group achieved a response compared to 11.1% of the sham treatment group. Furthermore,
54.8% of the Deep TMS treatment group achieved a partial response, compared to 26.7% of the sham treatment group. The differences between
groups were statistically significant for both response rate (p = 0.0033) and partial response rate (p = 0.0076).

Figure 3. Response and Partial
Response Rates for Deep TMS and Sham Treatment Groups

One month after the end of treatment (10 weeks after
baseline), patients retained clinical improvement of symptoms, and these measures (YBOCS change and response rate) were significantly
better in the Deep TMS group compared to the sham group (p=0.03 for YBOCS change and p=0.0057 for response rate).

Figure 4 highlights the continued decrease in unadjusted