Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 114

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 114
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 TMS, is a therapy
in which patients are administered brief electric currents through the brain. ECT is a noninvasive treatment carried out by a doctor under
full anesthesia and muscle relaxant medicines, and patients often undergo partial hospitalization with recovery time lasting from hours
to even days. While fewer treatment sessions are required (6-12 sessions) compared to TMS (20-30 sessions), each session lasts approximately
an hour compared to the Deep TMS sessions that are typically about 20 minutes each. While ECT has high proven efficacy (70-75%) for patients
with MDD, ECT’s potential for serious side effects, as well as negative stereotypes surrounding the treatment, often cause patients
to be reluctant to undergo ECT. In addition, ECT affects the entire brain, including parts which do not need treatment, and may cause
permanent cognitive damage, including memory loss. ECT may have significant and relatively severe side effects, the most common of which
are cognitive and memory loss, changes in blood pressure, muscle pains, nausea, changes in mood, headaches, and pain or discomfort. ECT
is currently approved for treatment-resistant depression, severe mania, schizophrenia, bipolar disorder, aggression or agitation in patients
with dementia, and catatonia. It is provided usually in cases of severe MDD, where medicinal treatment is ineffective or impossible and
in instances where the depression constitutes a risk to the life of the patient.

VNS and DBS are invasive therapies that can have
serious side effects. Both involve implanted devices, which require surgery. In DBS, two electrodes are surgically implanted in the brain
and a pulse generator is implanted into the patient’s chest. The electrodes produce electrical impulses that can regulate the electrical
activity of the brain. In VNS, a pulse generator is implanted on the upper left side of the chest to stimulate the vagus nerve. VNS and
DBS include surgical related risks, such as infection or local damage to the recurrent laryngeal nerve, which may lead to permanent voice
alteration.

Prescription Digital Therapeutics, or PDTs, are a
new therapeutic class of products designed to directly treat diseases with software. Certain PDTs are prescribed by healthcare providers
after evaluation by the FDA for safety and efficacy testing via randomized clinical trials. Digital therapeutic companies, such as Pear
Therapeutics, Inc., offer and/or are exploring products across a variety of therapeutic areas including substance abuse, insomnia, and
depression. These