Company: BWAY
Filing Date: 2025-09-30
Form Type: 6-K
Source: 0001171843-25-006185
Chunk: 17

Company: Brainsway Ltd.
Filing Date: 2025-09-30
Form: 6-K
Chunk 17
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 planned.

Our first commercial H1 Coil Deep TMS product received clearance
from the FDA in 2013 for the treatment of MDD in adult patients who have failed to achieve satisfactory improvement from anti-depressant
medication in the current episode. Our Deep TMS system for MDD is currently marketed to and installed at psychiatrists’ offices
and other facilities principally in the United States and in certain other countries throughout the world. In addition, our second Deep
TMS commercial product received FDA marketing authorization in August 2018 as an adjunct therapy for adult patients suffering from OCD,
and we currently market this product to the same general clientele as our MDD systems. Furthermore, our third Deep TMS commercial product
received FDA marketing authorization in August 2020 as a short-term therapy for smoking addiction. Moreover, in August 2021, we received
510(k) clearance from the FDA for our Deep TMS for its use for the reduction of comorbid anxiety symptoms in adult patients with depression.
In August 2022, we received 510(k) clearance from the FDA for the use of our H7 Coil 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
84% of our revenues in the six months ended June 30, 2025.

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.

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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