Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 45

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 45
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of previously unknown problems with our products or manufacturing processes could result in, among other things: warning letters or
untitled letters; fines, injunctions or civil penalties; suspension or withdrawal of approvals or clearances; seizures or recalls of
our products; total or partial suspension of production or distribution; administrative or judicially imposed sanctions; the
FDA’s refusal to grant pending or future clearances or approvals of Deep TMS for additional indications or any other
clearances or approvals we may seek; clinical holds; refusal to permit the import or export of our products; and criminal
prosecution of us or our employees. Any of these actions could significantly and negatively impact supply of our Deep TMS systems.
If any of these events occurs, our reputation could be harmed, we could be exposed to product liability claims, and we could lose
customers and suffer reduced revenues and increased costs.

  26  

If treatment
guidelines for the clinical conditions we are targeting change or the standard of care evolves, we may need to redesign and seek new marketing
authorization from the FDA for one or more of our products.

If treatment guidelines for the clinical conditions
we are targeting or the standard of care for such conditions evolves, we may need to redesign our Deep TMS systems and seek new marketing
authorizations from the FDA. Our existing 510(k) and de novoclearances from the FDA are based on current treatment guidelines.
Additionally, if treatment guidelines change so that different treatments become desirable, the clinical utility of one or more of our
indications could be diminished and our business could suffer.

The misuse
or off-label use of Deep TMS may harm our reputation in the marketplace, result in injuries that lead to product liability suits or result
in costly investigations, fines or sanctions by regulatory bodies, particularly if we are deemed to have engaged in the promotion of these
uses, any of which could be costly to our business.

The Deep TMS system has been authorized for marketing
by the FDA only for MDD (including reduction of comorbid anxiety symptoms, commonly referred to as anxious depression), OCD, and smoking
addiction indications. We train our commercial organization to not promote our products for uses outside of the FDA-authorized indications
for use, known as “off-label uses.” However, we cannot guarantee that all of our employees, representatives, and agents will
abide by our marketing policies. If the FDA determines that our promotional materials, training or other marketing activities constitute
promotion of an off-label or un