Company: BIAF
Filing Date: 2025-05-02
Form Type: S-1
Source: 0001641172-25-008170
Chunk: 16

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-02
Form: S-1
Chunk 16
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| ● | If                                                                                              
 PPLS uses hazardous chemicals in a manner that causes injury, PPLS could be liable for damages. |

| ● | If                                                                                       
 PPLS is unable to successfully scale its operations to support demand its business could 
 suffer.                                                                                  |

| ● | PPLS                                                                                    
 must dedicate substantial time and resources to its complex billing process to be paid. |

| ● | Delays                                                                                       
 of third-party billing and collection providers and an in-house billing function to transmit 
 claims to payors could have an adverse effect on PPLS.                                       |

Risks Related to Intellectual Property Rights

| ● | If                                                                                        
 we fail to comply with our obligations imposed by any intellectual property licenses with 
 third parties that we may need in the future, we could lose rights that are important to  
 our business.                                                                             |

| ● | We                                                                                       
 may need to obtain licenses of third-party technology that may not be available to us or 
 available to us on reasonable terms.                                                     |

| ● | Our                                                                      
 competitive position depends on protection of our intellectual property. |

| ● | Diagnostic                                                                         
 tests and therapeutic products we develop could be subject to infringement claims. |

| ● | We                                                                               
 may become involved in lawsuits to protect or enforce our intellectual property. |

| ● | If                                                                                         
 we are unable to protect our trade secrets, our business and competitive position could be 
 harmed.                                                                                    |

| ● | Changes                                                                             
 in patent law could impair our ability to protect our tests and product candidates. |

| ● | Our                                                                                                 
 patent protection could be reduced or eliminated for non-compliance with governmental requirements. |

| ● | Patent                                                                                     
 terms may be inadequate to protect our diagnostic tests or therapeutic product candidates. |

| ● | Issued                                           
 patents could be found invalid or unenforceable. |

| ● | If                                                                  
 we do not obtain patent term extension, our business may be harmed. |

| ● | We                                                                          
 enjoy only limited geographical protection with respect to certain patents. |

| ● | If                                                                                       
 our trademarks and trade names are not adequately protected, we may not be able to build 
 name recognition.                                                                        |

Risks Related to Government Regulations

| ● | Should                                                                                
 the FDA’s regulatory approach to LDTs change, our strategy may be adversely affected. |

| ● | Delay                                                                                     
 by or failure of the FDA to grant our request for de novo classification adversely affect 
 our business.                                                                             |

| ● | Failure                                                                             
 to