Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 100

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 100
---
 her head, the helmet - and thus
the H-Coil - moves along with it, eliminating the need for features which prevent the patient from moving his or her head during therapy.
In contrast, all other currently available TMS products, which we refer to as Traditional TMS, generally utilize a variation of a figure
8 coil that is placed adjacent to the scalp of the patient and needs to be specifically positioned and attached to the head in order to
deliver focal stimulation of the desired area of the brain. Whereas some figure 8 coils are handheld by the operator, others are attached
to an apparatus designed to minimize the ability of the patient to move the head away from the relevant portion of the coil during therapy,
which would prevent the patient from achieving the required stimulation. These features either alert the operator in the event of a shift
of the patient’s head away from the coil, or actually fasten the coil next to the patient’s head. In either case, only a small
surface area on the patient’s head is likely to come into contact with the figure 8 coil. Traditional TMS is limited to stimulating
relatively narrower and shallower areas of the brain, and the manual positioning of the figure 8 coil in Traditional TMS may cause inaccuracies
in the region treated. Studies suggest that the figure 8 coil misses the target in a substantial number of patients.

  56  

A course of treatment for MDD typically requires
20 treatment sessions five times a week over a period of four weeks, and thereafter up to 24 additional maintenance-continuation sessions
twice weekly over a period of up to 12 weeks. The standard Deep TMS treatment protocol for OCD requires 29 treatment sessions over six
weeks. The clearance for this indication is categorized as an adjunct therapy, which means that it should be administered in conjunction
with other first-line therapies and/or medications, as determined in the independent medical judgment of the treating healthcare professional
on a case-by-case basis. 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. A standard MDD, OCD
or smoking addiction session lasts 20, 19 and 18 minutes, respectively. For Deep TMS for MDD, the FDA has also cleared a 3 minute “ Theta
Burst” treatment protocol. The protocols for OCD and smoking addiction also require a short provocation procedure (i