Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 104

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 104
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 TMS for MDD, including our own sales, marketing, and support employees. We estimate that over
90% of total private insurer covered lives in the United States have coverage for reimbursement of MDD treatment with Deep TMS. In addition,
our MDD treatment with Deep TMS is eligible for reimbursement from all Medicare Administrative Contractors (MACs), and our OCD treatment
is currently covered by one of the seven MACs. We are also currently selling Deep TMS for MDD in Canada, Europe, Asia, India, Israel,
and certain other countries. We received reimbursement coverage applicable to Deep TMS in Australia in November 2021 and in Israel in
June 2022. We are also increasing our commercialization efforts for Deep TMS for OCD. Our installed base of Deep TMS systems for MDD facilitates
faster expansion into OCD because clinicians who already have a Deep TMS system only need to lease or purchase an add-on arm and helmet
to the existing system. In 2021, for the first time, several payors issued policies and coverage determinations allowing for reimbursement
coverage applicable to Deep TMS for OCD, with over 90 million covered lives in the U. S. eligible for coverage as of March 2024. Positive
coverage decisions for Deep TMS for OCD have been issued by Centene Corporation (with 26 million covered lives), Health Care Service Corporation
(HCSC) (with 17 million covered lives), TriCare (with 9.6 million covered lives), Cigna Corporation (with 17 million covered lives), Highmark
(with 6.8 million covered lives), Premera (with 2.6 million covered lives) and LifeWise (with 2.2 million covered lives). Additionally,
one of the seven Medicare Administrative Contractors (MACs) in the US, Palmetto GBA, published a final Local Coverage Determination (LCD)
in 2022 extending coverage applicable to Deep TMS for OCD. While the criteria for this emerging Deep TMS for OCD coverage varies with
each payor, generally, coverage requires the failure of between two and four medication trials before qualifying for reimbursement. Our
strategy is to look for ways to facilitate increased coverage for OCD treatment by more payors, including both commercial and governmental.
After the receipt of FDA clearance for our Deep TMS product for smoking addiction, we initiated a clinical data collection effort to facilitate
a long-term commercial plan for this product.

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