Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 50

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 50
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 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:

    ●
    the
    results of pre-clinical studies may be inconclusive, or they may not be indicative of results that will be obtained in human clinical
    trials;

    ●
    safety
    and efficacy results attained in early human clinical trials may not be indicative of results that are obtained in