Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 112

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 112
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 to treat MDD. The clinical trial is anticipated to enroll over 100
patients with MDD who will be split into two groups - one receiving a novel accelerated treatment protocol featuring an acute phase
over several treatment days, and the other receiving the FDA-cleared standard-of-care protocol which entails an acute phase over several
weeks. The design of this non-inferiority trial, which was determined in discussion with the FDA, aims to compare the outcomes achieved
with the accelerated Deep TMS protocol versus the current standard-of-care Deep TMS protocol.

The limitations of anti-depressant medications in
MDD treatment were demonstrated in the STAR*D study, a large clinical trial funded by the NIMH that enrolled more than 4,000 adult MDD
patients at 41 clinical sites to examine the outcomes to a sequenced series of anti-depressant medication attempts that mimicked best
practices. In the study, only 36.8% and 30.6% of patients achieved remission in their first and second medication attempts, respectively.
In addition, 30-40% of MDD patients did not experience a meaningful response to anti-depressant medication. An analysis conducted in 2020
which was based on the STAR*D study further reinforced the limitations of anti-depressant medications in MDD treatment, finding that only
21% of patients achieve remission with medication and that 58% achieved no meaningful benefit with a second step switch to a monoaminergic
antidepressant. This means that there is still a significant number of patients who could benefit from an alternative treatment such as
Deep TMS.

TMS has been used as an antidepressant therapy since
2008. Currently, TMS for MDD is generally recommended for treatment-resistant MDD patients. Until recently payors typically required that
patients fail multiple antidepressant medications prior to receiving TMS; however, there has been a trend which continued in recent years
to reduce the number of required failures to one or two medication failures before qualifying for TMS. Based on research showing that
TMS is effective in treating depressive symptoms in patients earlier within the continuum of care, many payors have now reduced the number
of prior failed medication trials needed to qualify for Deep TMS for MDD. Specifically, about 90 million covered lives in the US with
commercial coverage now qualify for Deep TMS for MDD after two to three failed medication trials, and approximately 42 million lives in
the US with Medicare reimbursement coverage