Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 17

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 17
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 is or will be necessary to expand our sales force, including by hiring additional sales representatives or distributors with specific
technical backgrounds that can support our customers’ needs.

As we develop and seek regulatory clearances for
new indications, enhancements, features and treatment protocols and increase our marketing efforts, we will need to expand the reach of
our marketing and sales networks. Our future success will depend largely on our ability to continue to hire, train, retain and motivate
skilled employees, and distributors with significant technical knowledge in various areas. New hires require training and take time to
achieve full productivity. If we fail to train new hires adequately, or if we experience high turnover in our sales force in the future,
new hires may not become as productive as may be necessary to maintain or increase our sales. If we are unable to expand our sales and
marketing capabilities domestically and internationally, we may be unable to effectively commercialize our Deep TMS systems, which could
harm our business.

  11  

Failure to
secure or maintain adequate coverage and reimbursement of our Deep TMS system for the currently authorized indications and other indications
for which we obtain FDA authorization in the future, if any, may make physicians reluctant to use or recommend Deep TMS and have a material
adverse effect on our sales, results of operations, and financial condition.

Patients generally rely on third-party payors to
reimburse all or part of the costs associated with outpatient treatment services. Patients may, thus, be unwilling to undergo, and physicians
may be unwilling to prescribe, a given course of treatment in the absence of adequate coverage and reimbursement. Accordingly, our ability
to successfully commercialize our Deep TMS system depends significantly on the extent to which treatment sessions using Deep TMS are covered
and reimbursed by government healthcare programs, such as Medicare and Medicaid (among others), commercial health insurers, managed care
organizations, and other third-party payors.

Third-party payors are increasingly examining the
medical necessity and cost effectiveness of medical products and services, in addition to safety and efficacy. Significant uncertainty
exists as to the reimbursement status of any newly approved (or cleared) products or therapies, which represent novel approaches to treatment
of a disease, addiction, or condition, such as Deep TMS for smoking addiction. Even if a third-party payor covers a particular treatment
that uses Deep TMS, the resulting reimbursement rate may not be adequate to cover a provider’s cost to purchase or lease the Deep
TMS system or ensure such transaction