Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 12

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 12
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| ● | If we cannot convince physicians of the benefits of our diagnostic tests 
 or therapeutic products, market acceptance could be delayed.             |

| ● | We face substantial competition. |

| ● | Our success depends upon our ability to retain key executives and attract 
 and retain qualified personnel.                                           |

| ● | Our lack of operating experience may make it difficult to manage our growth. |

| ● | We will depend on third parties to manufacture and market our diagnostic 
 tests and to design trial protocols and monitor clinical trials.         |

| ● | We are exposed to product liability and pre-clinical and clinical liability 
 risks.                                                                      |

| ● | Our failure to comply with privacy and security regulations could result 
 in liability or reputational harm.                                       |

| ● | Our ability to obtain adequate reimbursement for our diagnostic tests may 
 impact our revenues.                                                      |

| ● | 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.