Company: BIAF
Filing Date: 2025-05-05
Form Type: S-1/A
Source: 0001641172-25-008629
Chunk: 33

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-05
Form: S-1/A
Chunk 33
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 tests;                                  |
| ● | inability                                                                                                                                  
 of certain types of patients to use our diagnostic tests or take our therapeutic products; and                                             |
| ● | the                                                                                                                                        
 prevalence and severity of side effects from our therapeutic products.                                                                     |

If we are unable to address and overcome these and similar concerns, our business and results of operations could be substantially harmed.

If we are unable to establish effective sales, marketing, and distribution capabilities or enter into agreements with third parties with such capabilities, we may not be successful in commercializing our diagnostic tests or therapeutic products if and when they are approved.

We are building our sales and marketing organizations and have limited experience in the sale, marketing, or distribution of our diagnostic tests and therapeutic products. To achieve commercial success for any diagnostic test or therapeutic product for which we obtain marketing approval, we will need to successfully establish and maintain relationships directly and with third parties to perform sales and marketing functions.

Factors that may inhibit our efforts to commercialize our diagnostic tests or therapeutic products on our own include:

| ● | our                                                                                                                                     
 inability to recruit, train, and retain adequate numbers of effective sales, technical support, and marketing personnel;                |
| ● | the                                                                                                                                     
 inability of sales personnel to obtain access to or educate physicians on the benefits of our diagnostic tests or therapeutic products; |
| ● | the                                                                                                                                     
 lack of complementary diagnostic tests or therapeutic products to be offered by sales personnel, which may put us at a competitive      
 disadvantage relative to companies with more extensive diagnostic tests or therapeutic product lines;                                   |
| ● | unforeseen                                                                                                                              
 costs and expenses associated with creating an independent sales, technical support, and marketing organization; and                    |
| ● | the                                                                                                                                     
 inability to obtain sufficient coverage and reimbursement from third-party payors and governmental agencies.                            |

If we do not establish sales, marketing, and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our diagnostic tests or therapeutic products.

We are currently dependent upon our pathology laboratory PPLS to offer and perform CyPath ®Lung.

PPLS is currently the only commercial laboratory offering CyPath ®Lung and, therefore we are dependent upon our subsidiary PPLS for the generation of our revenue. PPLS performs testing when ordered by physicians for their patients. PPLS also generates revenue related to the use of CyPath ®Lung tests for a DOD observational study titled “Detection of Abnormal Respiratory Cell Populations in Lung Cancer Screening Patients Using the CyPath ®