Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 134

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 134
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 new feasibility studies utilizing our next generation “ Rotational Field” TMS (or “ Deep TMS 360°™”)
system. Factors that contribute to how we prioritize the pursuit of certain clinical studies include, but are not limited to, the strength
of our feasibility clinical data, market potential, required budget, and ease of conduct of the trial. However, there is no guarantee
that we will ultimately be successful in obtaining marketing clearance for the indications prioritized for further study or any other
new indications.

Competition

The industry for the treatment of mental health diseases,
disorders, and other conditions is intensely competitive. Our currently marketed Deep TMS system is, and any future indications, expansions
or new treatment methods we develop and commercialize will be, subject to intense competition. Our Deep TMS system for MDD competes with
existing antidepressant drugs, other TMS therapies and to a lesser degree, more invasive treatments such as ECT, VNS, and DBS. Our Deep
TMS system for OCD also competes with existing medications and other available treatments. 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.
Certain competitors may be larger and have greater resources than us, and may develop treatment options that receive faster regulatory
approvals and/or are more rapidly adopted by clinicians and patients or may expand their operations by partnering with, or acquiring,
healthcare providers, mental health clinic chains or other mental health service providers. Our competitors compete with us on the basis
of efficacy and safety, regulatory approvals, price and availability of reimbursement from third-party payors, ease of use/administration
of the treatment option, reputation, and market trends. Key competitive factors affecting the commercial success of the Deep TMS system
are likely to be efficacy, safety and tolerability, reliability, convenience and time frame of administration, market acceptance of our
products relative to alternative treatments, and availability and scope of reimbursement.

Competitors that sell other forms of TMS therapy
for MDD include Neuronetics, MagVenture, Magstim, Neurocare (MAG & More), Cloud TMS, Nexstim, Yingchi Medical, Sebers, Magnus Medical,
NeuroQuore, and BTL that compete directly with us. Their systems are typically based on traditional TMS utilizing a figure-8 coil and
are generally FDA-cleared for MDD. MagVenture and Neuronetics have also