Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 97

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 97
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 Determination (LCD) in 2022 extending coverage applicable to Deep
TMS treatment for OCD. While the criteria for Deep TMS for OCD coverage varies with each payor, generally, coverage requires the failure
of between two and four medication trials before qualifying for reimbursement. Our strategy is to look for ways to facilitate increased
coverage for OCD treatment by more payors, including both commercial and governmental.

Reimbursement is not yet available for Deep TMS for
smoking addiction. In October 2023, the Clinical TMS Society (CTMSS), an influential peer group, published the first coverage recommendations
for TMS for smoking addiction.

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In Israel, in June 2022, for the first time the Israeli
Ministry of Health has approved coverage applicable to our Deep TMS system for the treatment of MDD. The inclusion of the treatment within
Israel’s health basket of essential medical services means that the country’s health funds must now make the treatment available
to qualifying patients free of charge. Qualifying patients include adults over the age of 21 with depression who either have not responded
to two prior antidepressants or are intolerant to other treatment alternatives. Coverage may be provided for up to 40 treatment sessions,
which are to be administered in hospitals. Moreover, in Australia, in November 2021, for the first time, coverage applicable to Deep TMS
for MDD was granted for adults over the age of 18. Coverage in Australia is available for 35 treatment sessions.

The United States is our primary and most strategic
market, representing approximately 81% of our revenues for the year ended December 31, 2024 and approximately 75% of our revenues for
each of the years ended December 31, 2023 and 2022. We operate in the United States through our wholly owned subsidiary, BrainsWay USA
Inc, as a direct marketing and sales channel, where we currently have existing sales, marketing, and support infrastructure. We generate
revenue from various flexible pricing models that are designed to maximize market penetration. For the year ended December 31, 2024, we
generated revenues in the United States of $33.2 million, an increase of 38.9% as compared to $23.9 million for the year ended December
31, 2023.

On a consolidated basis, we generated revenue from
leasing, one of our two main categories of activity, of $14.5 million, $8