Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 46

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 46
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approved use, it could request that we modify our training or promotional materials or subject us to regulatory
or enforcement actions, including the issuance or imposition of an untitled letter, a warning letter, injunction, seizure, civil fine
or criminal penalties. It is also possible that other federal, state or foreign enforcement authorities might take action under other
regulatory authority, such as laws prohibiting false claims for reimbursement.

Moreover, even if we, and all our employees, contractors,
and agents, market our products in compliance with applicable FDA regulations, such regulations do not apply to the practice of medicine,
and we cannot prevent a physician from prescribing and/or using our products off-label when, in the physician’s independent professional
medical judgment, he or she deems it appropriate. Similarly, we cannot prevent patients from using our products off-label. There may be
increased risk of injury to patients if physicians attempt to prescribe, or patients attempt to use, Deep TMS off-label. Furthermore,
the use of Deep TMS for MDD (including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression), OCD or smoking
addiction other than as stated on product labeling, or for indications other than those authorized by the FDA, may not be effective to
treat such conditions, which could harm our reputation in the marketplace among physicians and patients. There are similar risks if Deep
TMS is prescribed or used off-label with respect to non-U. S. regulatory approvals.

Deep TMS may
cause or contribute to adverse medical events that we are required to report to the FDA, and if we fail to do so, we would be subject
to sanctions that could harm our reputation, business, financial condition, and results of operations. The discovery of serious safety
issues with our products, or a recall of our products either voluntarily or at the direction of the FDA or another governmental authority,
could have a negative impact on us.

We are subject to the FDA’s medical device
reporting regulations and similar foreign regulations, which require us to report to the FDA when we receive or become aware of information
that reasonably suggests that one or more of our products may have caused or contributed to a death or serious injury or malfunctioned
in a way that, if the malfunction were to recur, it could cause or contribute to a death or serious injury. The timing of our obligation
to report is triggered by the date we become aware of the adverse event as well as the nature of the event. We may fail to report adverse
events