Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 138

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 138
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 the helmet, and the arm of the helmet. In addition, we rely
on the outsourcing company utilized for the manufacture of our newer systems, including our proprietary stimulator and various other components.
We manage our arrangements with our third-party manufacturers and suppliers to adjust delivery schedules and quantities of components
to match our changing manufacturing requirements. We forecast our component needs based on historical trends, current utilization patterns,
and sales forecasts of future demand. We establish our relationships with our third-party manufacturers and suppliers through supplier
contracts and purchase orders. In most cases, these supplier relationships may be terminated by either party upon short notice. The prices
that we pay for sourced components vary depending on various factors, including the cost of the raw materials required for those components,
our required delivery times, and shipping costs.

In order to mitigate the risks related to a single-source
of supply, we qualify alternative suppliers when possible, maximize the use of commercial, off the shelf components and materials, minimize
specialized or proprietary manufacturing processes, and develop contingency plans for responding to disruptions, including maintaining
adequate inventory of any critical components. For further discussion of the risks related to our supply chain, see “ Risk Factors
 - Our operations could be affected in the event of further geopolitical instability, war, supply chain disruptions, unfavorable
market or political conditions, global pandemics or other outbreaks or other negative global trends or disruptions”. To date,
the supply of finished products to our customers and clinicians has not been materially adversely affected as a result of component supply
issues.

We are subject to extensive governmental regulation
in connection with the manufacture of our devices. We must ensure that all of the processes, methods, and equipment are compliant with
the current Quality System Regulations (QSR) for devices on an ongoing basis, mandated by the FDA and other regulatory authorities, and
must conduct extensive audits of vendors, contract laboratories and suppliers. We comply with such regulatory requirements. Certain of
our foreign marketing authorizations require compliance of said manufacturing process with the ISO 13485 standard and with the Medical
Device Single Audit Program (MDSAP), with which we are compliant.

Reimbursement

We estimate that over 90% of the total private insurer
adult covered lives in the United States have coverage for reimbursement of MDD treatment with Deep TMS, available after one to four failed
(inadequate response or intolerable) trials of antidepressant medications. In addition, our MDD treatment with Deep TMS is eligible for
reimbursement from Medicare, and is available