Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 132

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 132
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 installed in the territory.

The duration of these agreements varies between distributors
and ranges between three and ten years. In territories in which we use a local distributor, the distributor is generally responsible for
obtaining and maintaining the regulatory approvals required for marketing of Deep TMS systems in the territory and for the installation,
training, and maintenance of the systems in the relevant territory. In Japan, we have obtained PMDA regulatory approval for our Deep TMS
system, which is a precondition to receiving reimbursement coverage under the Japanese National Health Insurance Plan. After working extensively
with our Japanese distributor with the relevant bodies in Japan, in 2024 we succeeded in updating the guidelines issued by the Japanese
Society of Psychology and Neurology to include coverage for Deep TMS. Commercial sales of our systems thus commenced in 2024, and our
Japanese distributor has initiated a Post Marketing Study (PMS) in Japan to assess the efficacy and safety of our treatment on the local
population, which is a required commercialization criteria for this territory.

In October 2024, we received orders for 15 Deep TMS
systems to be used by mental health centers in Taiwan and South Korea. In June 2024, we entered into an exclusive multi-year distribution
agreement with a specialty distributor serving both the acute hospital and non-acute healthcare spaces with minimum quantity orders which
increase successively over several years, starting with 11 Deep TMS systems to be ordered in 2024.

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We aim to increase our marketing and sales outside
the United States by means of cultivating and supporting our existing distributors, and by considering other strategic opportunities in
various markets. Success of penetration in each country is contingent on a variety of factors, including, among others, the strength and
capabilities of the distribution partner, the existence of regulatory approvals, the availability of reimbursement, the support of key
opinion leaders, and the ability of customers to adopt our technology.

Our Clinical
Pipeline

Set forth below is a table presenting the status of our currently planned
clinical pipeline:

Additional Potential
Deep TMS Applications

Our primary focus for additional potential applications
for Deep TMS include neurological and/or addiction disorders. For instance, we announced pilot study results from a randomized, placebo-controlled,
double-blind study on the safety and efficacy of Deep TMS in reducing alcohol consumption and craving in adults with Alcohol Use Disorder
(AUD). Analyzing data from 46 subjects, the study demonstrated that subjects in the active group had an average of