Company: BIAF
Filing Date: 2025-05-05
Form Type: S-1/A
Source: 0001641172-25-008629
Chunk: 15

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-05
Form: S-1/A
Chunk 15
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 | Our                                                                                      
 employees, consultants, partners, and vendors may engage in misconduct or other improper 
 activities.                                                                              |

| ● | Failure                                                                               
 to comply with healthcare laws and regulations could result in substantial penalties. |

| ● | We                                                                           
 face intense competition in the biotechnology and pharmaceutical industries. |

| ● | The                                                                             
 market for our proposed tests and products is competitive and rapidly changing. |

| ● | Healthcare                                                                         
 cost containment initiatives and the growth of managed care may limit our returns. |

| ● | Disruption                                                                     
 of internal information technology systems will adversely affect our business. |

| ● | Declining                                                                           
 general economic or business conditions may have a negative impact on our business. |

| ● | Global                                                                       
 climate change and related regulations could negatively affect our business. |

Risks Related to the Operation of a CAP/CLIA Laboratory

| ● | PPLS’                                                                                           
 operations depend upon the relationship of certain of our pathologists with existing customers. |

| ● | PPLS                                                                                           
 may be unable to maintain equipment or generate revenue when its equipment is not operational. |

| ● | If                                                                                         
 our sole laboratory facility becomes damaged or inoperable, loses its accreditation, or is 
 required to vacate the facility, PPLS’ ability to sell its products or provide diagnostic  
 assays and pursue its research and development efforts may be jeopardized.                 |

| ● | Disruption                                                                                 
 in the commercial courier delivery services used by PPLS to transport sputum samples could 
 harm its business.                                                                         |

| ● | Security                                                                                   
 breaches, data loss, and other disruptions could compromise sensitive information of PPLS’ 
 business.                                                                                  |

| 3 |

| ● | 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