Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 108

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 108
---
 systems  

We continue to develop innovative enhancements and
features for our Deep TMS systems to expand the applicability of Deep TMS to additional indications and improve the capabilities of the
systems for approved indications. For example, in December 2021 we displayed a future version of the platform that will serve as the basis
for our next generation Deep TMS system, which includes our patented “rotational field” TMS or “ Deep TMS 360°™”
technology, allowing for simultaneous modulation of different areas of the brain and stimulation of neurons in various orientations to
cover a greater number of neurons. Our novel rotational field technology involves the operation of two orthogonal coils to induce a rotating
field in the brain, allowing for stimulation of neurons in various orientations. We have recently begun to test the clinical efficacy
of this next generation technology in 2 new feasibility studies - one for post-stroke rehabilitation, and the other for OCD using
an accelerated protocol. We further believe these enhancements hold the potential to make Deep TMS even more attractive for clinicians,
researchers, and patients, and may serve to better position its use in neurology.

  Increase our international commercial footprint  
 ───────────────────────────────────────────────────

We are working to expand our existing commercial
footprint in Europe, Asia, Latin America, Australia, and the broader Middle East, and to pursue commercialization in additional markets.
We currently have distribution and agent agreements in various territories, including, notably, Canada, Italy, Spain, Czech Republic,
Japan, South Korea, Taiwan, Thailand, Greece, and India. In Israel, we directly distribute to our customers.

We obtained regulatory approval with the Pharmaceuticals
and Medical Devices Agency (PMDA) in Japan, which is a precondition to receiving reimbursement coverage under the Japanese National Health
Insurance Plan. After working extensively with our Japanese distributor with the relevant bodies in Japan, in 2024 we succeeded in updating
the guidelines issued by the Japanese Society of Psychology and Neurology to include coverage for Deep TMS. Commercial sales of our systems
thus commenced in 2024, and our Japanese distributor has initiated a Post Marketing Study (PMS) in Japan to assess the efficacy and safety
of our treatment on the local population, which is a required commercialization criteria for this territory.

Deep TMS for MDD

Disease
Overview

MDD is a common and debilitating mental disorder
characterized by physiological symptoms, such as sleep disturbance and changes in appetite, emotional symptoms, such as sadness, despair,