Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 93

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 93
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addressable market opportunity for smoking addiction in the United States is approximately between $3.9 and $4.1 billion.

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Our first commercial H1 Coil Deep TMS product received
clearance from the FDA in 2013 for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from anti-depressant
medication in the current episode. Our pivotal trial for MDD demonstrated statistically significant response and remission rates of 38.4%
and 32.6%, respectively, in week five of Deep TMS treatment of 20 minutes per session, compared to 21.4% and 14.6%, respectively, after
sham treatment. Our Deep TMS system for MDD is currently marketed to and installed at psychiatrists’ offices and other facilities
principally in the United States and in certain other countries throughout the world.

Additionally, in April 2021, we received FDA clearance
for a shorter 3-minute “ Theta-Burst” protocol for our MDD treatment. In support of our successful application to the FDA for
this protocol, we submitted safety and efficacy data from 146 subjects who had received either the standard Deep TMS protocol or Theta
Burst Deep TMS. Clearance was obtained after it was demonstrated that subjects in both groups experienced a statistically and clinically
meaningful reduction in depression scores, and the results met the equivalence criteria needed for clearance of the shorter treatment.
We believe that certain patients and providers can benefit from these shorter treatment sessions and that this protocol has the potential
to expand access to care by providing patients with added flexibility in selecting courses of treatment that may fit better with their
lifestyle.

In August 2021, the FDA cleared an expansion of our
existing MDD clearance to include the noninvasive treatment of anxiety symptoms among subjects with MDD, commonly referred to as anxious
depression. In support of our application for this labeling expansion, we demonstrated statistically significant results from three randomized
controlled trials and open label studies which found favorable outcomes with Deep TMS when compared to sham or medication as a standard
of care. The data from the three randomized controlled trials studies of Deep TMS demonstrated effect sizes ranging from 0.34 (when compared
to sham) to 0.90 (when compared to medication).

In August 2022, based on a randomized, double-blind,
controlled multicenter, non-inferiority study of our H1 and H7 Coils, the Company’s MDD