Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 11

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 11
---
 TMS when compared to the products and
devices of our competitors; demonstrate the safety and efficacy of new or expanded indications and treatment protocols, and develop and
obtain regulatory approvals or clearances of Deep TMS for such indications, enhancements, features or treatment protocols, to the extent
required; and to adequately protect our intellectual property and avoid infringing upon the intellectual property rights of third parties.

If we do not develop and obtain regulatory clearances
or approvals for new or expanded indications, enhancements, features or treatment protocols in time to meet market demand, or if there
is insufficient demand for these indications, enhancements, features or treatment protocols, our results of operations will suffer. Our
research and development efforts may require a substantial investment of time and resources before we are adequately able to determine
the commercial viability of a new indication for Deep TMS, any enhancements to the Deep TMS system or any other innovation. In addition,
even if we are able to develop enhancements or new features for Deep TMS, these enhancements or features may not produce sales in excess
of the costs of development and they may be quickly rendered obsolete by changing customer preferences or the introduction by our competitors
of products embodying new technologies or enhancements or features.

Furthermore, we must carefully manage our introduction
of new indications. If potential customers believe such indications will be subject to additional future enhancements or features or may
become available at a more attractive price, they may delay purchases until such indications are available. We may also have excess or
obsolete inventory as we upgrade to newer models of our products and/or transition to new indications, and we have limited experience
in managing product transitions.

We operate
in a very competitive environment and if we are unable to compete successfully against our existing or potential competitors, our revenues
and operating results may be negatively affected.

Our Deep TMS systems for MDD (including reduction
of comorbid anxiety symptoms, commonly referred to as anxious depression), OCD, smoking addiction, and any future indications are or will
be subject to intense competition. The industry in which we operate is subject to rapid change and is highly sensitive to the introduction
of new products or other market activities of current or new industry participants. Our ability to compete successfully will depend on
our ability to develop and obtain regulatory clearances or approvals of Deep TMS for indications that reach the market in a timely manner,
to receive adequate coverage and reimbursement from third-party payors, and to successfully demonstrate to physicians and patients the
merits of Deep TMS compared to