Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 25

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 25
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 trials;                                                             |
| ● | safety and efficacy results attained in early human clinical trials may not be indicative of results that are obtained in later clinical trials;                                                              |
| ● | after reviewing test results, we may abandon projects that we might previously have believed to be promising;                                                                                                 |
| ● | we or our regulators may suspend or terminate clinical trials because the participating subjects or patients are being exposed to unacceptable health risks; and                                              |
| ● | our test or product candidates may not have the desired effects or may include undesirable side effects or other characteristics that preclude regulatory approval or limit their commercial use if approved. |

Even if our diagnostic tests or therapeutic products receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-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