Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 68

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 68
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., we must establish and comply with numerous and varying regulatory requirements of other countries regarding
safety and efficacy. Clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory
approval in one country does not mean that regulatory approval will be obtained in any other country. Approval procedures vary among countries
and can involve additional diagnostic and therapeutic product testing and validation and additional administrative review periods. Seeking
foreign regulatory approvals could result in significant delays, difficulties, and costs 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