Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 106

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 106
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 Coil to include the treatment of MDD (including anxious depression). Our shortened three-minute
depression protocol, however, continues only to apply for our H1 Coil. 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.

Beyond our existing indications, we are also considering
further clinical trials in other neurological and/or addiction areas.

  59  

Our Strategy

We are currently focused on expanding the commercialization
of Deep TMS with respect to MDD, OCD and smoking addiction. In September 2021, we received a 510(k) clearance from the FDA for expansion
of our Deep TMS MDD treatment also to include treatment for reduction of anxiety symptoms, commonly referred to as anxious depression.
In August 2022, we received FDA clearance for treating anxious depression with our H7 Coil, which had been previously cleared for treating
OCD. In May 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. In addition, we are actively engaged in research for other potential applications
for Deep TMS for patients suffering from neurological conditions and addictions. For each potential indication, we assess and evaluate
our technology’s efficacy, safety, patent status, market potential, and development and regulatory pathways. Our systematic approach
to evaluating and developing applications for Deep TMS allows us to continually build upon our clinical pipeline, and advance those applications
with the greatest clinical effect and revenue potential. We also plan to advance other technological innovations in the neuromodulation
space for the improvement of our products. For example, we are currently developing and initiated clinical testing of our next generation
multichannel device, which includes our patented “rotational field” TMS or “ Deep TMS 360°™” technology,
allowing for simultaneous modulation of different areas of the brain and stimulation of neurons in various orientations to cover a greater
number of neurons.

Specific elements of our strategy include the following:

  Increase the full-scale commercialization of Deep TMS for MDD, OCD and smoking  
  addiction                                                                       
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We are continuing to scale up our commercialization
of Deep TMS for MDD as we seek to further penetrate the MDD market, including based on the FDA-cleared