Company: BIAF
Filing Date: 2025-05-07
Form Type: 424B4
Source: 0001641172-25-008977
Chunk: 28

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-07
Form: 424B4
Chunk 28
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 will suffer. We may be subject to legal claims arising from such limitations, errors, or inaccuracies.

We may experience difficulties that delay or prevent our development, introduction, or marketing of enhanced or new tests.

Our success may also depend on our ability to effectively introduce enhanced or new tests. The development of enhanced or new tests is complex, costly, and uncertain. Furthermore, enhancing or developing new tests requires us to anticipate patients’, clinicians’, and payors’ needs and emerging technology trends accurately. We may experience research and development, regulatory, marketing, and other difficulties that could delay or prevent our introduction of enhanced or new tests. The research and development process in diagnostics generally takes a significant amount of time from the research and design stage to commercialization. This process is conducted in various stages, and each stage presents the risk that we will not achieve our goals. We may have to abandon a test in which we have invested substantial resources. In order to successfully commercialize tests that we may develop in the future, we may need to conduct lengthy, expensive clinical trials and develop dedicated sales and marketing operations or enter into collaborative agreements to achieve market awareness and demand. Any delay in the research and development, approval, production, marketing, or distribution of enhanced or new tests could adversely affect our competitive position, branding, and results of operations.

We cannot be certain that:

| ● | any                                                                                    
 tests that we may enhance or develop will prove to be effective in clinical trials;    |
| ● | we                                                                                     
 will be able to obtain, in a timely manner or at all, regulatory approvals, if needed; |

| ● | any                                                                                                      
 tests that we may enhance or develop will be ordered and used by healthcare providers;                   |
| ● | any                                                                                                      
 tests that we may enhance or develop can be provided at acceptable cost and with appropriate quality; or |
| ● | any                                                                                                      
 of our tests can be successfully marketed.                                                               |

These factors and other factors beyond our control could delay the launch of enhanced or new tests.

If clinical testing of a particular diagnostic test or therapeutic product candidate does not yield successful results, we will be unable to commercialize that test or product candidate.

We must demonstrate the product safety and efficacy of our candidates for diagnostic tests and therapeutic products in humans through extensive clinical testing. Our research and development programs are at an early stage of development. We may experience numerous unforeseen events during, or as a result of, the testing process that could delay or prevent commercialization of any test or product, including the following