Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 180

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 180
---
:

    ●
    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 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.

 26 

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