Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 96

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 96
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 for OCD requires 29 treatment sessions over six weeks. A course of treatment for
smoking addiction typically requires 18 treatment sessions, comprised of treatment five times a week over a period of three weeks, followed
by treatment once per week for an additional three weeks. Each standard MDD, OCD or smoking addiction session lasts 20 minutes, 19 minutes,
and 18 minutes, respectively. For Deep TMS for MDD, the FDA has also cleared a 3 minute “ Theta Burst” treatment protocol.
Patients may experience some discomfort during treatment and must use earplugs to reduce exposure to the loud sounds produced by the device.
The treatment requires no anesthesia, hospitalization or sedation, and no systemic side effects are associated with the therapy.

We estimate that over 90% of the total private insurer
adult covered lives in the United States have coverage for reimbursement of MDD treatment with Deep TMS. In addition, our MDD treatment
(including for reduction of anxiety symptoms, commonly referred to as anxious depression) with Deep TMS is eligible for reimbursement
from Medicare. Deep TMS treatment for MDD reimbursement coverage is generally available after between one and four failed (inadequate
response or intolerable) trials of anti-depressant medications. However, there is an increasing trend to reduce the number of prior failed
medication treatments required to qualify for coverage and thus to place Deep TMS for MDD earlier within the continuum of care. We are
actively engaged in efforts to work with payors to facilitate a continuation of this trend.

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 2023. 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, has published its final Local Coverage