Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 221

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 221
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 for us and may require additional preclinical studies or clinical trials, which would be costly and time-consuming.
Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our diagnostic tests or
therapeutic products in those countries. Satisfying these and other regulatory requirements is costly, time consuming, uncertain, and
subject to unanticipated delays. In addition, our failure to obtain regulatory approval in any country may delay or have negative effects
on the process for regulatory approval in other countries. We do not have any diagnostic test or therapeutic product candidate approved
for sale in any jurisdiction, including international markets, and we do not have experience in obtaining regulatory approval in international
markets. If we fail to comply with regulatory requirements in international markets or fail to obtain and maintain required approvals,
our ability to realize the full market potential of our diagnostic tests or therapeutic products will be harmed.

The impact of changes to healthcare law and guidance, as well as other changes in the healthcare industry, and changes
in healthcare spending is currently unknown and may adversely affect our business model.

Our
revenue prospects could be affected by changes in healthcare spending and policy in the U.S. and abroad. We operate in a highly regulated
industry, and new laws, regulations, judicial decisions, or new interpretations of existing laws, regulations, or decisions related to
healthcare availability, the method of delivery, or payment for healthcare tests, products, and services could negatively impact our
business, operations, and financial condition.

There
have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal, and state levels directed at
broadening the availability of healthcare and containing or lowering the cost of healthcare, including proposals aimed at lowering prescription
drug prices and increasing competition for prescription drugs, as well as additional regulation on pharmaceutical transparency and reporting
requirements, any of which could negatively impact our future profitability and increase our compliance burden. We cannot predict the
initiatives that may be adopted in the future, including future challenges or significant revisions to the Affordable Care Act. The continuing
efforts of the government, insurance companies, managed care organizations, and other payors to contain or reduce costs of healthcare
and/or impose price controls may adversely affect:

    ●
    the
    demand for our diagnostic tests or therapeutic product candidates, if we or our licensors obtain regulatory approval;

    ●
    the
    ability to set a price that we believe is fair for our diagnostic tests and therapeutic products;

    ●