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

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 20
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 limited payments in a given period and therefore result in extended payment periods.

If adequate levels of reimbursement from third-party
payors outside of the United States are not obtained, international sales and lease transactions for the Deep TMS system may not materialize
or grow significantly.

The marketability of Deep TMS may suffer if the government
and third-party payors fail to provide adequate coverage and reimbursement. Even if favorable coverage and reimbursement status is attained,
less favorable coverage policies and reimbursement rates may be implemented in the future.

Clinical trials
involve a lengthy and expensive process with an uncertain outcome, which may delay or cause us to abandon the development of Deep TMS
for additional indications.

We are currently at various stages of completed,
ongoing or planned clinical trials of Deep TMS for new indications and/or seeking expanded labeling for existing indications. Development
of medical devices includes pre-clinical studies and sometimes clinical trials, and is a long, expensive, and uncertain process, subject
to delays and failure at any stage. Clinical trials for Deep TMS involve certain specific risks, including factors related to trial design
and patient enrollment. Additionally, if we are unable to recruit a sufficient number of patients for our clinical trials, we may be unable
to generate sufficient data to support marketing authorization. Moreover, our research and development, pre-clinical and clinical trial
activities are subject to extensive regulation and review by numerous governmental authorities. We cannot predict whether we will encounter
problems with any of our completed, ongoing or planned clinical trials, which would cause us or regulatory authorities to delay or suspend
clinical trials, or delay the analysis of data from completed or ongoing clinical trials. We estimate that clinical trials involving various
indications of Deep TMS will continue for several years; however, such trials may also take significantly longer to complete and may cost
more money than we have expected.

Furthermore, the data obtained from the studies and
trials may be inadequate to support regulatory authorizations or to enable market acceptance of certain indications of Deep TMS. Failure
can occur at any stage of testing, and we may experience numerous unforeseen events during, or as a result of, the clinical trial process
that could delay or prevent commercialization of the current, or a future, version of Deep TMS for any particular indication, including
but not limited to delays in securing clinical investigators or trial sites for the clinical trial and in obtaining institutional review
board and other regulatory approvals to commence a clinical trial; slower than anticipated patient recruitment and enrollment; negative