Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 62

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 62
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 or misbranded in violation of the FDCA and to require
a 510(k) clearance for a specimen collection indication as a condition of distributing the device. Any disruption to our ability to distribute
the Acapella Choice Blue could interfere with our ability to collect adequate patient samples necessary for CyPath
Lung.

CyPathLung also relies on a proprietary
algorithm to develop and validate software integrated into the test procedure that generates the quantitative and qualitative diagnostic
results that are included in the laboratory report. Certain types of standalone diagnostics software are subject to FDA regulation as
a medical device (specifically, software as a medical device or “SaMD”).Some types of SaMD are subject to premarket
authorization requirements. If the FDA were to conclude that we are required to obtain premarket authorization for the software, our ability
to offer CyPath Lung as an LDT could be delayed or prevented, which would adversely affect our business.

The third-party licensors of our future therapeutic products, when ready, may be unable to obtain regulatory approval. The denial or delay of any such approval would delay commercialization of our future therapeutic products and have a material adverse effect on our potential to generate revenue, our business, and our results of operations.

We plan to license our therapeutic candidates to third
parties for development, including clinical testing, manufacturing, labeling, packaging, approval, promotion, advertising, storage, recordkeeping,
marketing, distribution, post-approval monitoring and reporting, and export and import. These activities that are to be undertaken by
third-party licensees of our future therapeutic products are subject to extensive regulation by the FDA and by foreign health authorities
in other countries. These regulations differ from country to country. In the U.S., we are not permitted to market our therapeutic product
candidates until we receive regulatory approval from the FDA. The process of obtaining regulatory approval is expensive, often takes many
years following research and development and thereafter the commencement of clinical trials, and can vary substantially based upon the
type, complexity, and novelty of the product candidates involved, as well as the target indications and patient population. Despite the
time and expense invested in clinical development of product candidates, regulatory approval is never guaranteed. For our licensors to
gain approval to market our product candidates, they must provide clinical data that adequately demonstrate the safety and efficacy of
the product for the intended indication. We or any third party has not yet obtained regulatory approval to market any of our product candidates
in the U.S. or any other country. Our