Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 125

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 125
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mean YBOCS score from baseline over the ten-week period.

  71  

Figure 4. Total YBOCS Score Change
from Baseline over 10-Weeks for Deep TMS and Sham Treatment Groups

Real world data further demonstrates the benefits
of Deep TMS for OCD: In a post-marketing study, published as a peer-reviewed paper, the overall first and sustained response rates were
72.6% and 52.4%, respectively. The response rate was 57.9% in patients who had YBOCS scores after the FDA-cleared protocol of 29 Deep
TMS sessions. First response was achieved in average after 18.5 sessions (SD = 9.4) or 31.6 days (SD = 25.2). Onset of sustained one-month
response was achieved in average after 20 sessions (SD = 9.8) or 32.1 days (SD = 20.5). Average YBOCS scores demonstrated continuous reduction
with increasing numbers of sessions. The results indicate that in real-world clinical practice, the majority of OCD patients benefitted
from our therapy, and the onset of improvement usually occurs within 20 sessions. Extending the treatment course beyond 29 sessions resulted
in continued reduction of OCD symptoms, raising the prospect of value for extended treatment protocols in non-responders.

A study published in November 2021 in the Brain Stimulation
journal demonstrates the durability of Deep TMS for OCD and the significant reduction in functional disability experienced by those who
have undergone our therapy for this disorder. To evaluate durability, clinical sites from our pivotal trial, as well as other clinical
sites contributing post-marketing data, conducted follow up assessments with patients that had met response criteria following treatment
with our H1 Coil. Durability was defined as the elapsed time from the end of the Deep TMS treatment course until there was a change in
ongoing treatment. Data revealed that of the 60 subjects evaluated from seven clinical sites, 52 demonstrated durability of one year or
more (86.7%), 26 of which showed two or more years of durability. The data also showed that patients exhibited a significant reduction
in disability, with self-reported unproductive days per week dropping from 5.5 days (±0.4) to 1.8 days (±0.4), and self-reported
lost days per week dropping from 1.9 (±0.6) to 0.