Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 29

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 29
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-party payors, and others in the medical community necessary for commercial success.

Even if our products receive marketing approval, if
needed, they may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors, and others in the
medical community. If we do not generate significant product revenues, we may not become profitable. The degree of market acceptance of
our products and tests, if approved for commercial sale, will depend on a number of factors, including:

| ● | their efficacy, safety, and other potential advantages compared to alternative tests or products;                                                        |
| ● | our ability to offer them for sale at competitive prices;                                                                                                |
| ● | their convenience and ease of administration compared to alternative diagnostics or treatments;                                                          |
| ● | the willingness of the target patient population to try new diagnostic tests and of physicians to order these tests;                                     |
| ● | the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;                                    |
| ● | the strength of marketing and distribution support;                                                                                                      |
| ● | the availability of governmental agencies and third-party medical insurance and adequate reimbursement for our diagnostic tests or therapeutic products; |
| ● | any restrictions on the use of our diagnostic tests or therapeutic products together with other diagnostic methods or therapeutic treatments;            |
| ● | any restrictions on the use of our diagnostic tests or therapeutic products together with other medications;                                             |
| ● | inability of certain types of patients to produce adequate samples for analysis in the use of our diagnostic 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.

| 13 |

Factors that may inhibit our efforts to commercialize
our diagnostic tests or