Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 59

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 59
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 to third parties, such as distributors. Although these license
agreements may provide guidelines for how our trademarks and tradenames may be used, a breach of these agreements or misuse of our trademarks
and tradenames by our licensees may jeopardize our rights in or diminish the goodwill associated with our trademarks and trade names.

Moreover, any name we have proposed to use with our
therapeutic product candidate in the U.S. must be approved by the FDA, regardless of whether we have registered it, or applied to register
it, as a trademark. The FDA typically conducts a review of proposed product names, including an evaluation of potential for confusion
with other product names. If the FDA, or an equivalent administrative body in a foreign jurisdiction, objects to any of our proposed proprietary
product names, we may be required to expend significant additional resources in an effort to identify a suitable substitute name that
would qualify under applicable trademark laws, not infringe the existing rights of third parties, and be acceptable to the FDA. Furthermore,
in many countries, owning and maintaining a trademark registration may not provide an adequate defense against a subsequent infringement
claim asserted by the owner of a senior trademark. At times, competitors or other third parties may adopt trade names or trademarks similar
to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential
trade name or trademark infringement claims brought by owners of other registered trademarks or trademarks that incorporate variations
of our registered or unregistered trademarks or trade names. If we assert trademark infringement claims, a court may determine that the
marks we have asserted are invalid or unenforceable, or that the party against whom we have asserted trademark infringement has superior
rights to the marks in question. In this case, we could ultimately be forced to cease use of such trademarks.

Risks Related to Government Regulations

CyPath ®Lung is currently being offered as an LDT by PPLS. Should the FDA disagree that CyPath ®Lung is an LDT, or if the FDA’s regulatory approach to LDTs should change in the future, our commercialization strategy may be adversely affected, which would negatively affect our results of operations and financial condition.

The FDA considers an LDT to be a test that is developed,
validated, and performed within a single laboratory. The FDA has historically asserted its authority to regulate LDTs as medical devices
under the FDCA, but it has generally exercised enforcement discretion with regard to LDTs. This means that