Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 39

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 39
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 (pre-amendments device), a device that was originally on the U. S. market pursuant to a PMA and later down-classified,
or a 510(k)-exempt device. To be “substantially equivalent,” the proposed device must have the same intended use as the predicate
device, and either have the same technological characteristics as the predicate device or have different technological characteristics
and not raise different questions of safety or effectiveness than the predicate device. Clinical data are sometimes required to support
substantial equivalence.

We received marketing authorization of our MDD and
smoking addiction indications through the 510(k) clearance process and have made various expansions to our MDD indication, including,
in 2021, a clearance for a shortened three-minute depression protocol and a labeling expansion for anxious depression through subsequent
510(k) clearances. In 2022, we extended our FDA clearance for MDD (including anxious depression) to our H7 Coil, also via the 510(k) process.
This does not include our shortened three-minute depression protocol, which continues only to apply for our H1 Coil. In 2024, we expanded
the FDA labeling for our system to treat late-life (ages 69-86) MDD indications. We also received marketing authorization of our OCD indication
through the de novoclassification process. Several competitors have obtained 510(k) clearance for their TMS device for an OCD
indication, using our de novoclassification as a predicate device in their submission, and others may follow suit. The process
of obtaining regulatory authorization to market a medical device can be costly and time consuming, and we may not be able to successfully
obtain authorizations on a timely basis, if at all.

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The FDA can delay, limit or deny clearance or approval
of a device for many reasons, including: we may be unable to demonstrate to the FDA’s satisfaction that the product or modification
is substantially equivalent to the proposed predicate device or is safe and effective for its intended use; the data from our pre-clinical
studies and clinical trials may be insufficient to support authorization, where required; and the manufacturing process or facilities
we use may not meet applicable requirements. The FDA may also, instead of accepting a 510(k) submission, require us to submit a PMA, which
is typically a much more complex, lengthy, and burdensome application than a 510(k) submission. To support a PMA, the FDA would likely