Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 141

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 141
---
 their own methods and approval process apart from Medicare
coverage and reimbursement determinations. Private insurance coverage for Deep TMS has traditionally required three to four failures of
antidepressant medications. However, many payors have now reduced the number of prior failed medication trials needed to qualify for Deep
TMS for MDD. Specifically, 194 million covered lives in the U. S. with commercial coverage now qualify for Deep TMS for MDD after two to
three failed medication trials, and all Medicare Administrative Contractors (MACs) have issued Local Coverage Determinations (LCDs) qualifying
approximately 62 million lives in the U. S. for Medicare reimbursement after just one to two failed medication trials.

Coverage and reimbursement for treatments can differ
significantly from payor to payor. Decisions regarding the extent of coverage and amount of reimbursement to be provided for an in-office
treatment are made on a plan-by-plan basis. One payor’s determination to provide coverage for a specific treatment does not assure
that other payors will also provide coverage and adequate reimbursement.

In addition, the U. S. federal government and state
legislatures have continued to implement cost containment programs, including price controls and restrictions on coverage and reimbursement.
Governmental and private insurers are increasingly challenging the price, examining the medical necessity, and reviewing the cost-efficacy
of medical services. Adoption of price controls and cost containment measures by any such payors, and adoption of more restrictive policies
in jurisdictions with existing controls and measures, could limit our market opportunity and reduce our revenues.

Private insurers currently cover treatments using
our Deep TMS system for MDD, and there is now emerging coverage from various payors for Deep TMS therapy for OCD. We are actively engaged
in efforts to facilitate increased coverage for OCD treatment by more payors, including both commercial and governmental. Reimbursement
is not yet available for Deep TMS for smoking addiction or for therapies currently under development for other indications.

Nonetheless, we can provide no assurances that we
will be able to obtain a wide range reimbursement coverage for OCD nor any reimbursement coverage for smoking addiction, and even if obtained,
we can provide no assurance that the coverage will be at the same levels as we have for MDD.

We are also working to include Deep TMS in additional
insurance coverage policies in the United States and in other jurisdictions in which we operate. In regions where we have appointed a
local distributor, where reasonable, it is typically required under our agreements that the distributor utilize