Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 13

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 13
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 given the unavailability of reimbursement for
this indication.

Our competitors may also develop and patent processes
or products earlier than we can or obtain domestic or international regulatory clearances or approvals for competing products or processes,
including treatment protocols, more rapidly than we can, which could impair our ability to develop and commercialize similar products.
Furthermore, our educational efforts to distinguish between Deep TMS and traditional TMS may not be sufficiently effective, and our competitors
may therefore succeed in obtaining regulatory pathways for their products based on our clinical data without having to invest in clinical
trials themselves. In addition, we compete with our competitors to engage the services of independent distributors outside the United
States, both those presently working with us and those with whom we hope to work as we expand.

Furthermore, our competitors may be seeking predicate
FDA approvals in various psychiatric and neurological indications, and TMS products of various companies are frequently used off-label,
and in certain circumstances, are marketed outside of the United States for other indications. Additionally, if either TMS competitors
or other medical device or pharmaceutical companies introduce new and disruptive products or forms of therapy, our market share may be
reduced and our financial performance and ability to compete may be significantly impacted. These competitors may have obtained or seek
to obtain expansions of existing clearances and indications before we do. For example, in March 2024, one of our competitors received
clearance from the FDA effectively expanding its existing MDD clearance to cover adolescent patients aged 15-21 and allowing it to treat
these patients with its device as an adjunct form of therapy.

Moreover, our relationships with large clinic networks,
which we rely on, can be jeopardized (and thus impact on our installed base and future assumed revenue streams) depending on developments
with these networks and/or by the deepening of relationships between these networks and our competitors, thus leading to potential financial
difficulties that may negatively affect our revenues. For example, we had to remove devices and pursue collections from a clinic network
with whom we have had a relationship after the network had accrued an outstanding debt. Moreover, any exclusivity or other commercial
arrangements between our competitors and large clinic networks we also work with may hinder the deployment of our Deep TMS systems in
such networks. We are further exposed to the risk that our competitors, some of whom have more financial resources than us, may enter
into exclusive relationships, acquire or merge with clinic networks, thereby strengthening the relationship between them and the clinic
network and making it