Company: BWAY
Filing Date: 2025-04-22
Form Type: 20-F
Source: 0001171843-25-002347
Chunk: 4

Company: Brainsway Ltd.
Filing Date: 2025-04-22
Form: 20-F
Item: Item 5
Chunk 4
---
────────────────────────────────────────────────────────────────────────────────────────────────────────────

Government Regulatory Risks

  Our products and operations are subject to extensive government regulation and oversight                                                     

  Our products must be manufactured in accordance with any applicable federal, state                                                          

  If treatment guidelines for the clinical conditions we are targeting change or the                                                     
  standard of care evolves, we may need to redesign and seek new marketing authorizations from the FDA for one or more of our products.  
 ─────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────

  The misuse or off-label use of Deep TMS may harm our reputation in the marketplace,                                                                
  result in injuries that lead to product liability suits or result in costly investigations, fines or sanctions by regulatory bodies, particularly  
  if we are deemed to have engaged in the promotion of these uses, any of which could be costly to our business.                                     
 ─────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────

  Deep TMS may cause or contribute to adverse medical events that we are required to                                                           
  report to the FDA, and if we fail to do so, we would be subject to sanctions that could harm our reputation, business, financial condition,  
  and results of operations. The discovery of serious safety issues with our products, or a recall of our products either voluntarily or       
  at the direction of the FDA or another governmental authority, could have a negative impact on us.                                           
 ───────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────────

  If we or our distributors do not obtain and maintain international regulatory registrations                 

  We are subject to certain federal, state, and foreign fraud and abuse laws, health                                                          

  Healthcare policy changes, including legislation reforming the U. S. healthcare system,  

   4  

Intellectual Property Risks

  We depend on our intellectual property, and our future success is dependent on our      

  The duration of our patent rights may not be sufficient to effectively protect our  
  products and business.                                                              
 ──────────────────────────────────────────────────────────────────────────────────────

  Our right to the essential intellectual property upon which the Deep TMS technology                                                     

  The license agreements for our critical patents and related intellectual property impose                                                  
  significant monetary obligations and other requirements on us that may adversely affect our ability to successfully execute our business  
  plan.                                                                                                                                     
 ─────────