Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 188

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 188
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 operations, including our clinical research activities,
and proposed sales, marketing, and education programs and constrain the business of financial arrangements and relationships with healthcare
providers and other parties through which we may market, sell, and distribute our diagnostic tests or therapeutic products for which
we obtain marketing approval. In addition, we may be subject to additional healthcare, statutory, and regulatory requirements and enforcement
by foreign regulatory authorities in jurisdictions in which we conduct our business.

Ensuring
that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations
will involve substantial costs. It is possible that governmental authorities will conclude that our business practices, including certain
arrangements with physicians who receive stock, warrants, or stock options as compensation for services provided to us, do not comply
with current or future statutes, regulations, agency guidance, or case law involving applicable fraud and abuse or other healthcare laws
and regulations. If our operations are found to be in violation of any of the laws described above or any other governmental laws and
regulations that may apply to us, we may be subject to significant penalties, including civil, criminal, and administrative penalties,
damages, fines, exclusion from U.S. government-funded healthcare programs, such as Medicare and Medicaid, or similar programs in other
countries or jurisdictions, disgorgement, imprisonment, contractual damages, reputational harm, diminished profits, additional reporting
requirements, and oversight if we become subject to a corporate integrity agreement or similar agreement to resolve allegations of non-compliance
with these laws, and the delay, reduction, termination, or restructuring of our operations. Further, defending against any such actions
can be costly and time consuming and may require significant financial and personnel resources. Therefore, even if we are successful
in defending against any such actions that may be brought against us, our business may be impaired. If any of the physicians or other
providers or entities with whom we expect to do business are found not to be in compliance with applicable laws, they may be subject
to significant criminal, civil, or administrative sanctions, including exclusions from government-funded healthcare programs and imprisonment.
If any of the above occur, it could adversely affect our ability to operate our business and our results of operations.

We
face intense competition in the biotechnology and pharmaceutical industries.

The
biotechnology and pharmaceutical industries are intensely competitive. We face direct competition from U.S. and foreign companies focusing
on diagnostic tests and pharmaceutical products, which are rapidly evolving. Our competitors include major multinational diagnostic and
pharm