Company: BWAY
Filing Date: 2025-04-22
Form Type: F-3
Source: 0001171843-25-002378
Chunk: 7

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: F-3
Chunk 7
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 pivotal randomized placebo-controlled
studies. Current indications include major depressive disorder (MDD), including reduction of comorbid anxiety symptoms, commonly referred
to as anxious depression, obsessive-compulsive disorder (OCD), and smoking addiction. We have also received CE Mark for a variety of psychiatric
and neurological indications. We are focused on increasing global awareness of, and broad access to, Deep TMS. Deep TMS uses magnetic
pulses to stimulate neurons and consequently modulates the physiological activity of the brain. Our technology can either increase brain
activity in neuronal networks which are hypoactive, or alternatively decrease brain activity in neuronal networks which are hypoactive.
Our proprietary electromagnetic coils, which we refer to as H-Coils, are designed to safely stimulate deep and broad brain regions, which
we believe provides an advantage over other available TMS products, which we refer to collectively as Traditional TMS, that generally
use a “figure 8” design. In the United States, we sell our Deep TMS system for the treatment of MDD (including reduction of
comorbid anxiety symptoms, commonly referred to as anxious depression), OCD and smoking addictions. We believe that our Deep TMS technology
has the potential to be safe and effective for the treatment of a wide range of additional psychiatric, neurological, and addiction disorders.
Additional clinical trials of Deep TMS in various psychiatric, neurological, and addiction disorders are underway or 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