Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 176

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 176
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ven and our business model is continually evolving. We are subject to the risks
inherent to the operation of a new business enterprise and cannot assure you that we will be able to successfully address these risks.

Risks
Related to our Diagnostic Product

Until
we secure FDA clearance for CyPath® Lung as a Class II in vitro diagnostic, we may encounter physicians who will not
order an LDT.

In
order to market our CyPath® Lung as an IVD medical device, we must receive de novo classification from the FDA
as a Class II in vitro diagnostic. Subject to obtaining necessary financing, we intend to launch a pivotal trial later this year in an
effort to attain such classification; however, there can be no assurance that the trial will have favorable results or that it will generate
the results necessary to obtain such classification. Until such time as we receive de novo classification, which we may never
receive, our marketing efforts are limited to the marketing and sale of CyPath® Lung as an LDT. Without clearance of CyPath®
Lung by the FDA, some physicians may not order the test.

 24 

If
we experience delays or difficulties in the enrollment of patients in clinical trials, our receipt of necessary regulatory approvals
could be delayed or prevented.

We
may not be able to initiate or continue clinical trials if we are unable to locate and enroll a sufficient number of eligible patients
to participate in these trials as required by the FDA or similar regulatory authorities outside the U.S., such as the European Medicines
Agency.

Patient
enrollment is affected by many other factors, including:

    ●
    the
    severity of the disease under investigation;

    ●
    the
    patient eligibility criteria for the study in question;

    ●
    the
    efforts to facilitate timely enrollment in clinical trials;

    ●
    our
    payments for conducting clinical trials;

    ●
    the
    patient referral practices of physicians;

    ●
    the
    ability to monitor patients adequately during the trial period; and

    ●
    the
    proximity and availability of clinical trial sites for prospective patients.

We
are unable to forecast with precision our ability to enroll patients. Our inability to enroll a sufficient number of patients for our
clinical trials would result in significant delays and could require us to abandon one or more clinical trials altogether. Enrollment
delays in our clinical trials may result in increased development costs, which would cause the value of our Company to decline and limit