Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 109

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 109
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emptiness, self-hate and critique, and cognitive symptoms, such as difficulty concentrating, memory dysfunction, suicidal thinking, and
faulty judgment of reality. MDD is expressed differently, and in different intensities, among patients, and significantly impacts the
functioning in all aspects of life. Patients are often not diagnosed due to low levels of awareness of the disease and its symptoms by
the patient and the family doctor involved, or due to prejudice related to psychotherapy. In order to be diagnosed with MDD, a patient
must display symptoms that are present most of the day, nearly every day, for at least two weeks. A diagnosis of MDD is established by
clinical interview, and an assessment of whether a patient reports a collection of the relevant symptoms.

MDD is a recurrent disease and follows a fluctuating
course over an individual’s lifetime, with periods of remission and relapse. If an initial episode of MDD is resolved, the return
of depressive symptoms during the first nine months thereafter is referred to as a relapse of the illness and is generally considered
to be part of the same depressive episode. When depressive symptoms return more than twelve months after the initial episode of MDD is
resolved, it is considered to be a recurrence of the illness and is deemed a new and distinct episode. A response to treatment is commonly
measured as a clinically significant decrease in symptoms on a standardized rating scale from baseline scores. When a patient shows no
or nearly no symptoms, the patient is referred to as being in remission. Experiencing one episode of MDD places an individual at an estimated
50% risk of experiencing an additional episode of MDD. Approximately 80% of those individuals who have experienced two episodes of MDD
will experience an additional episode.

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In people with MDD, the complex system of neuronal
communication does not function properly. One of the most important discoveries in neuroscience has been the recognition that improper
regulation of one or more of the three major neurotransmitters, serotonin, norepinephrine, and dopamine, plays a key role in a patient’s
depression. This understanding has guided psychiatric drug development and the treatment of depression for more than three decades by
placing a major focus on targeting chemically-based mechanisms. The relatively recent introduction of TMS as a targeted, circuit-based
treatment option has reintroduced the importance of electrical mechanisms in restoring proper function to neuronal pathways to treat depression.

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According to the WHO,