Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 52

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 52
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 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.

Factors
that may inhibit our efforts to commercialize our diagnostic tests or therapeutic products on our own include:

    ●
    our
    inability to recruit, train, and retain adequate numbers of effective sales, technical support, and marketing personnel;

    ●
    the
    inability of sales personnel to obtain access to or educate physicians on the benefits of our diagnostic tests or therapeutic products;

    ●
    the
    lack of complementary diagnostic tests or therapeutic products to be offered by sales personnel, which may put us at a competitive
    disadvantage relative to companies with more extensive diagnostic tests or therapeutic product lines;

    ●
    unforeseen
    costs and expenses associated with creating an independent sales, technical support, and marketing organization; and

    ●
    the
    inability to obtain sufficient coverage and reimbursement from third-party payors and governmental agencies.

If
we do not establish sales, marketing, and distribution capabilities successfully, either on our own or in collaboration with third parties,
we will not be successful in commercializing our diagnostic tests or therapeutic products.

We
are currently dependent upon our pathology laboratory PPLS to offer and perform CyPath® Lung.

PPLS
is currently the only commercial laboratory offering CyPath® Lung and, therefore we are dependent upon our subsidiary
PPLS for the generation of our revenue. PPLS performs testing when ordered by physicians for their patients. PPLS also generates revenue
related to the use of CyPath® Lung tests for a DOD observational study titled “Detection of Abnormal Respiratory
Cell Populations in Lung Cancer Screening Patients Using the CyPath® Lung Assay,” and when performed for DOD research
and development on using bronchoalveolar lavage fluid as a biological sample to assess cardiopulmonary function and exercise performance
in military personnel post COVID