Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 107

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 107
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 treatment to anxious depression
(received in September 2021) and the H7 Coil cleared by the FDA in August 2022 for such treatment. We continue to focus our principal
commercial activity on the U. S. market in light of the market size and wide range of insurance coverage. In addition, we continue our
full-scale commercialization of Deep TMS for OCD, which is the first noninvasive medical device FDA-authorized for the treatment of OCD,
with reimbursement coverage for this indication obtained since 2021 from payors covering over 90 million covered lives in the United States.
After the receipt of FDA clearance for our products for smoking addiction, we initiated a clinical data collection effort to facilitate
and support the long-term viability of the commercial plan for this product.

  Pursue additional indications and technological innovations for Deep TMS  

We are considering expanding the application of Deep
TMS to other areas including neurological and/or addiction disorders. We intend to progress these plans ourselves and through our relationships
with third-party researchers and clinical institutions in conducting clinical trials for additional psychiatric, neurological, and addiction
disorders. With this approach, we address psychiatric, neurological, and addiction disorders that we believe present some of the most
promising market opportunities for Deep TMS.

  Expand reimbursement coverage for Deep TMS for OCD, smoking addiction and other  

A key prerequisite to the successful market acceptance
of Deep TMS is securing sufficient insurance/third-party payor coverage. The scope and level of coverage are also key factors in our ability
to penetrate the market and to expand further use of our Deep TMS system by healthcare providers and facilities for the benefit of the
larger patient population. Our MDD treatment with Deep TMS is widely eligible for reimbursement, including from Medicare, subject to the
satisfaction of certain clinical criteria. We aim to achieve similar levels of reimbursement for Deep TMS for OCD. We also aim to secure
coverage in various jurisdictions outside of the United States, For example in 2021 and in 2022, favorable coverage decisions applicable
to TMS for MDD were issued in Australia and Israel, respectively. Although there is not currently any reimbursement for smoking addiction,
in October 2023 the Clinical TMS Society, an influential peer group, published the first coverage recommendations for smoking. We believe
that our ability to secure coverage from payors will be a key factor in the long-term success of this indication.

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  Develop innovative enhancements and features for our Deep TMS