Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 113

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 113
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 qualify after just one to two failed medication trials.

Drug side effects play a decisive role in treatment
selection and modification, as each class of drugs is associated with a host of side effects, some more severe or more common than others.
For many patients, the side effects associated with pharmacological treatments for depression are a primary reason underlying low compliance
and, subsequently, low efficacy of treatment. The most common side effects include gastrointestinal symptoms, sedation, insomnia, weight
changes, sexual dysfunction, nervousness, sleep disruption, nausea, headaches, and cardiovascular or neurological effects. Side effects
may also cause patients not to adhere to the treatment or to abandon it. On initiation of anti-depressant pharmacotherapy, close monitoring
for response to treatment and development of side effects is essential. In addition, correlation was discovered between consumption of
SSRI medications and actualization of suicidal thoughts in youth, and some SSRI group medicines require strict diets and medical supervision.
In August 2022, the FDA has approved AUVELITY (dextromethorphan HBr -bupropion HCl) extended-release tablets for the treatment of MDD
in adults. AUVELITY is the first and only oral N-methyl D-aspartate (NMDA) receptor antagonist approved for the treatment of MDD. The
most common side effects of the recently approved NMDA treatment include dizziness, headache, diarrhea, somnolence, dry mouth, sexual
dysfunction, and hyperhidrosis.

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For TMS, however, no significant side effects have
been observed, other than mild headaches for a short period of up to a few hours after the treatment, and rare instances of short seizures.
The few side effects associated with TMS treatment is considered one of its main advantages. The most common side effect of Deep TMS treatment
is short-lasting mild pain or discomfort around the site of coil application. This side effect usually only lasts during the first week
of treatment. Other adverse reactions such as jaw and face pain, muscle pain, spasm or twitching, and neck pain were reported as mild
or moderate and were also resolved shortly after treatment, as well as seizures in certain patients. The less severe side effects associated
with Deep TMS make it an attractive option for patients.

Alternatives to pharmacological and TMS-based treatments
include ECT, vagal nerve stimulation (VNS), and deep brain stimulation (DBS). ECT, the main psychotherapy alternative to