Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 158

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 158
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 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.

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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