Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 128

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 128
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 smoking addiction. It was conducted at 14 sites, primarily in the U. S., and enrolled 262 eligible subjects randomized into
two groups: an active treatment group treated with our proprietary H4 Coil targeting addiction-related brain circuits, and a sham control
group. The primary endpoint of the study was a comparison between the two groups of the four-week continuous quit rate (CQR), representing
abstinence during a consecutive four-week period. Weekly abstinence was defined as a subject’s self-report (in a diary) of no smoking,
confirmed by urine tests indicating abstinence from smoking. The participants in the study were highly addicted to smoking, with a history
of smoking on average for over 26 years and multiple failed attempts to quit. All of the subjects in the study had at least one prior
unsuccessful attempt to quit smoking before being enrolled in the trial. Over 68% of the subjects had undertaken at least three prior
unsuccessful attempts, and over 25% had undertaken at least five prior unsuccessful attempts.

Participants received three weeks of daily Deep TMS
(or sham) treatment followed by one session per week for three more weeks (for a total of 18 treatments over six weeks). Assessment visits,
including questionnaires and the collection of urine samples, were performed weekly from week two until week six. In addition, subjects
were asked to keep a record of their smoking behavior on a diary card. Patients reporting abstinence at 6 weeks were invited for a long
follow-up (L-UP) visit at 4 months.

Of the 169 participants in the study who
actually 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 28.0% in the treatment group compared to 11.7% in the sham group (p=0.007). The primary endpoint was
defined based on the CQR among those subjects who received at least one Deep TMS (or sham) treatment session and had at least one
post-baseline assessment, even if not completing the treatment period. Within this cohort (ITT-E, which consisted of 234
participants and included dropouts) the CQR was 19.4% in the treatment group and 8.7% in the sham group (p= 0.0174).

The Overall 4-week continuous quit rate (CQR) is
shown in the figure below for the active Deep TMS and sham groups,