Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 10

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 10
---
 on our ability to further commercialize
and increase market penetration of Deep TMS for MDD (including reduction of comorbid anxiety symptoms, commonly referred to as anxious
depression), OCD, and smoking addiction, develop and seek regulatory approvals of Deep TMS for new indications or for expanded labeling
of current authorized indications, and add new enhancements or features for the Deep TMS system. These goals are also designed to respond
to changing customer demands, competitive pressures, and technologies. Our industry is characterized by intense competition, including
from other existing treatment options, a growing number of Traditional TMS competitors, rapid technological changes, new product and treatment
protocol introductions and enhancements, price competition, and evolving industry standards. It is important that we anticipate changes
in technology and market demand, as well as physician practices to successfully develop, obtain clearance or approval, if required, and
successfully introduce new, enhanced, and competitive technologies and treatment protocols to meet our prospective customers’ needs
on a timely and cost-effective basis.

   7  

We might be unable to further commercialize Deep
TMS for approved indications or develop, obtain or maintain regulatory clearances or approvals to market Deep TMS for new indications,
different treatment protocols or expanded labeling for current indications, or to develop and obtain regulatory approvals for enhancements
or new features for the Deep TMS system. Furthermore, our clearances on existing indications could be jeopardized by increased regulatory
requirements in different territories. Additionally, Deep TMS for MDD (including reduction of comorbid anxiety symptoms, commonly referred
to as anxious depression), OCD, smoking addiction, and any future indications, even if cleared, might not be sufficiently accepted by
physicians or the third-party payors who reimburse for the procedures performed with our products. Potential customers may not qualify
for credit arrangements with us and/or our third party financing vendors. Likewise, we may be unable to devise pricing strategies that
are attractive to customers, and even when we do, our customers may not always have the financial resources to meet their contractual
commitments, which can negatively impact our ability to collect on open debts accrued by customers, especially in cases of default by
larger customers and/or multi-system orders. The success of any new or expanded indications, enhancements, features or treatment protocols
for the Deep TMS system will depend on numerous additional factors, including but not limited to, our ability to properly identify and
anticipate clinician and patient needs; demonstrate the benefits associated with the use of Deep