Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 91

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 91
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 and debilitating mental disorder
characterized by physiological symptoms, such as sleep disturbance and changes in appetite, emotional symptoms, such as sadness, despair,
emptiness, self-hate, and critique, and cognitive symptoms, such as difficulty concentrating, memory dysfunction, suicidal thinking, and
faulty judgment of reality. According to a 2018 study cited by the World Health Organization (WHO), depression affects approximately 300
million people worldwide, with the rate of depression increasing in developed countries. The U. S. National Institute of Mental Health
(NIMH) estimates that 21.0 million adults in the United States suffer from a major depressive episode in 2021. Based on 2006-2007 data
from the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study, we estimate that approximately 7 million adult MDD patients
in the United States are considered treatment-resistant (i. e., do not achieve remission after four trials of anti-depressant medication),
of which we estimate that approximately 6.3 million or more are currently eligible to receive reimbursement for Deep TMS from either governmental
or private insurers. Assuming a course of treatment per patient of 33 treatment sessions and a price paid to us per treatment session
of $70 (which has historically served as our benchmark price per treatment session), we believe our total annual addressable market opportunity
for MDD in the United States is approximately $14.6 billion.

Comorbid anxiety symptoms are common in patients
with major depressive disorder. Between sixty and ninety percent of patients with depression have moderate to severe anxiety. As noted
above, in the United States, an estimated 21.0 million adults experienced at least one major depressive episode in 2021. Therefore, considering
the rate of comorbidity, we estimate that 12.6 to 18.9 million adults experience moderate to severe anxiety in addition to their primary
diagnosis of depression. Common anxiety symptoms include nervousness, feelings of panic, increased heart rate, rapid breathing, sweating,
insomnia, trembling, and difficulty focusing or thinking clearly. The economic burden in the United States for major depressive disorder
totaled $333 billion per year between 2010 and 2018.

OCD is a common, chronic, and long-lasting disorder
in which a person has uncontrollable, reoccurring thoughts (obsessions) and behaviors (compulsions) that he or she feels the urge to repeat
over and over in a manner that can