Company: BWAY
Filing Date: 2025-09-30
Form Type: 6-K
Source: 0001171843-25-006185
Chunk: 18

Company: Brainsway Ltd.
Filing Date: 2025-09-30
Form: 6-K
Chunk 18
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 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 this
therapy.

In the United States, we sell or lease Deep TMS systems by
one of the following two methods: (i) a fixed-fee lease model in which the Deep TMS system is leased to a customer for a fixed annual
fee, generally with a term of between 48 and 60 months, for unlimited use; and (ii) a sales or purchase model in which the Deep TMS system
is sold to the customer for a fixed purchase price. Additional potential revenues may be derived from extended warranty fees paid for
the system for service coverage beyond the standard included warranty period, and from variable or usage fees based on the number of treatments
performed with the system. We are also able to leverage our platform technology, which includes the ability to treat multiple indications
using different H-Coil helmets, to facilitate transactions utilizing combined pricing models often involving a single system with one
or more add-on helmets. These flexible offerings are designed to facilitate market penetration by addressing the differing clinical needs
and risk tolerance among our customer base. We commercialize Deep TMS for OCD based generally on either the sale model, or as part of
a fixed-fee lease model together with our MDD system. Following our receipt of FDA clearance for smoking addiction, we completed controlled
and limited market releases of our system for this indication, and are currently in the process of a clinical data collection effort to
facilitate a long term commercial plan for this product.

As of June 30, 2025, we had an installed base of approximately
1,522 Deep TMS systems, whereby 636 systems were leased from us, and an additional 886 systems were sold by us prior to June 30, 2025.
Our installed base increased by 169 systems during the six months ended June 30,