Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 116

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 116
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 as a reduction of at least 50% from baseline HDRS score.
Remission was defined as a total HDRS score of less than 10. Tertiary efficacy endpoints included a change in HDRS score from baseline
to week 16 and the response and remission rates at week 16. Safety was assessed at every treatment and additional safety evaluations included
auditory threshold tests and cognitive evaluations.

Inclusion and exclusion criteria required patients
to meet the following criteria:

  Antidepressant medication-free (following washout period)  

  Failure to respond to one to four antidepressant trials or not tolerant of at least two antidepressant treatments  

  Diagnosed with MDD with a single or recurrent episode  

  Duration of current episode must be at least one month but less than seven years  
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  Score of at least four on the Clinical Global Impression Severity of Illness (CGI-S)  

  Score of at least 20 on the HDRS  

  No current (or within past year) diagnosis of other Diagnostic and Statistical Manual                                                         

  No history or increased risk of seizures  
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During analysis, the study results were analyzed
in two separate groups: the intention-to-treat (ITT) and per-protocol (PP) analysis sets. The ITT group included all subjects who met
the eligibility criteria and received at least one Deep TMS treatment. Some of these patients, however, were not administered the treatment
at the specified stimulation intensity of 120%. The PP patients included all subjects from the ITT group who received the protocol-specified
treatment and stimulation intensity. Baseline demographic, clinical and safety assessments were performed on the ITT analysis set. Primary
efficacy analysis was performed only on the PP group.

  65  

  (b)      Trial Results  

The primary efficacy endpoint
was a change in the HDRS total score from baseline through week five. The change was measured as the slope of a graph of time point versus
HDRS score. The estimated slope for the Deep TMS treatment group was −6.39 while the estimated slope for the sham treatment group
was −3.28. The difference between groups was statistically significant (p = 0.008) for the PP group.

The secondary efficacy endpoints were response and
remission rates through week five. As shown in Figure 1, response rates were 38.4% at