Company: BWAY
Filing Date: 2025-05-01
Form Type: 424B3
Source: 0001171843-25-002668
Chunk: 6

Company: Brainsway Ltd.
Filing Date: 2025-05-01
Form: 424B3
Chunk 6
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 to treat MDD (including anxious depression). In 2024,
we received FDA clearance for an expansion of our existing MDD clearance allowing for the treatment of patients within the 69-86 age range
suffering from late life depression. Our sales and marketing efforts are currently focused in the United States, where we generated approximately
81% of our revenues in the year ended December 31, 2024.

We believe that Deep TMS represents a platform technology
that provides for an opportunity to develop additional Deep TMS products for a variety of psychiatric, neurological, and addiction disorders.
We are planning clinical trials for other indications, including neurological and/or addiction disorders.

Our current customers are principally doctors, hospitals,
and medical centers in the field of psychiatry. Treatment with Deep TMS is typically performed as an office-based procedure using our
Deep TMS system, which consists of our proprietary H-Coil helmet, as well as several other components, including a stimulator, cooling
system, positioning arm and an operator interface. A course of treatment for MDD typically requires 20 treatment sessions (five times
a week over a period of four weeks) and thereafter up to 24 additional maintenance-continuation sessions (twice weekly over a period of
up to 12 weeks). The standard Deep TMS treatment protocol for OCD requires 29 treatment sessions over six weeks. A course of treatment
for smoking addiction typically requires 18 treatment sessions, comprised of treatment five times a week over a period of three weeks,
followed by treatment once per week for an additional three weeks. Each standard MDD, OCD or smoking addiction session lasts 20 minutes,
19 minutes, and 18 minutes, respectively. For Deep TMS for MDD, the FDA has also cleared a 3 minute “Theta Burst” treatment
protocol. Patients may experience some discomfort during treatment and must use earplugs to reduce exposure to the loud sounds produced
by the device. The treatment requires no anesthesia, hospitalization or sedation and no systemic side effects are associated with this
therapy.

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In the United States, we sell or lease Deep TMS systems
by one of the following two methods: (i) a fixed-fee lease model in which the Deep TMS system is leased to a customer for a fixed annual
fee, generally with a term of between 48 and 60 months, for unlimited use; and (ii) a sales or purchase model in which the Deep TMS system
is sold to