Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 30

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 30
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 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 Lung Assay,” and when performed for DOD research and development on using bronchoalveolar lavage fluid
as a biological sample to assess cardiopulmonary function and exercise performance in military personnel post COVID-19 infection.

If we are unable to convince physicians of the benefits of our proposed diagnostic tests or therapeutic products, we may incur delays or additional expense in our attempt to establish market acceptance.

Broad use of our proposed diagnostic tests and products
may require pathology laboratories and physicians to be informed regarding our proposed diagnostic tests and products and their intended
benefits. Inability to carry out this physician education process may adversely affect market acceptance of our proposed diagnostic tests
or therapeutic products. We may be unable to timely educate physicians regarding our proposed diagnostic tests or therapeutic products
in sufficient numbers to achieve our marketing plans or to achieve acceptance of our diagnostic tests or therapeutic products. Any delay
in physician education may materially delay or reduce demand for our diagnostic tests or therapeutic products. In addition, we may expend
significant funds