Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 91

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 91
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 or payor authorities outside the U.S. on a timely basis, if at all.

We
may also submit marketing applications in other countries, such as countries in Europe or Asia. We may not be able to file for regulatory
approvals and may not receive necessary approvals to commercialize our diagnostic tests or therapeutic products in any jurisdiction.
Regulatory authorities in jurisdictions outside of the U.S. have requirements for approval of diagnostic tests or therapeutic product
candidates with which we must comply prior to marketing in those jurisdictions. Obtaining foreign regulatory approvals and compliance
with foreign regulatory requirements could result in significant delays, difficulties, and costs for us and could delay or prevent the
introduction of our diagnostic tests or therapeutic products in certain countries. We do not have any diagnostic tests or therapeutic
product candidates approved for sale in any foreign jurisdiction, including international markets, and we do not have experience in obtaining
regulatory approval in international markets. If we are unable to obtain approval of any of our diagnostic tests or therapeutic product
candidates by regulatory or payor authorities in the EU, Asia, or elsewhere, or if we fail to comply with the regulatory requirements
in foreign jurisdictions, the commercial prospects of that diagnostic test or therapeutic product candidate may be significantly diminished,
and our target market will be reduced and our ability to realize the full market potential of our diagnostic tests or therapeutic product
candidates will be harmed.

 44 

Even
if we obtain FDA clearance of any of our diagnostic tests or therapeutic product candidates, we may never obtain approval or commercialize
such products outside of the United States, which would limit our ability to realize their full market potential.

In
order to market any diagnostic test or therapeutic product outside of the U.S., 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,