Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 13

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 13
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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.    |

| 3 |

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 comply with laws pertaining to LDTs or in vitro devices (“IVDs”) 
 could adversely affect our business.