Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 53

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 53
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 to investigations can be time and resource consuming and can divert management’s
attention from the business. Any such investigation or settlement could increase our costs or otherwise have an adverse effect on our
business. Even an unsuccessful challenge or investigation into our practices could cause adverse publicity, and be costly to respond to.

If our operations are found to be in violation of
any of the healthcare laws or regulations described above or any other healthcare regulations that apply to us, we may be subject to administrative,
civil and criminal penalties, damages, fines, disgorgement, substantial monetary penalties, exclusion from participation in government
healthcare programs, such as Medicare and Medicaid, imprisonment, additional reporting obligations, and oversight if we become subject
to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, reputational harm, and
the curtailment or restructuring of our operations.

Healthcare
policy changes, including legislation reforming the U. S. healthcare system, could harm our cash flows, financial condition, and results
of operations.

From time to time, legislation is drafted and introduced
in Congress that could significantly change the statutory provisions governing the regulation of medical devices. In addition, FDA regulations
and guidance are often revised or reinterpreted by the FDA in ways that may significantly affect our business and our products. Any new
statutes, regulations, revisions, or reinterpretations of existing regulations may impose additional costs, lengthen review times of any
future products, or make it more difficult to manufacture, market or distribute our products. We cannot determine what effect changes
in regulations, statutes, legal interpretation or policies, when and if promulgated, enacted or adopted may have on our business in the
future.

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For example, in March 2010, the PPACA was enacted
in the United States, which made a number of substantial changes in the way healthcare is financed by both governmental and private insurers.
Among other ways in which it may impact our business, the PPACA establishes a new Patient-Centered Outcomes Research Institute to oversee
and identify priorities in comparative clinical effectiveness research in an effort to coordinate and develop such research; implements
payment system reforms including a national pilot program on payment bundling to encourage hospitals, physicians, and other providers
to improve the coordination, quality, and efficiency of certain healthcare services through bundled payment models; and expands the eligibility
criteria for Medicaid programs.

Some of the provisions of the PPACA have yet to be
implemented, and there have been judicial and Congressional