Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 64

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 64
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 products in the EU, many Asian countries, and other jurisdictions, we must obtain separate
regulatory approvals and comply with numerous and varying regulatory requirements, both from a clinical and manufacturing perspective.
Clearance by the FDA does not ensure approval by regulatory or payor authorities in other countries or jurisdictions, and approval by
one regulatory or payor authority outside the U.S. does not ensure approval by regulatory authorities in other countries or jurisdictions
or by the FDA. However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory
approval process in others. For example, even if the FDA grants marketing authorization of a diagnostic test or therapeutic product candidate,
comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing, and promotion of the diagnostic
test or therapeutic product candidate in those countries. Approval procedures vary among jurisdictions and can involve requirements and
administrative review periods different from, and greater than, those in the U.S., including additional preclinical studies or clinical
trials as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many
jurisdictions outside the U.S., a diagnostic test or therapeutic product candidate must be approved for reimbursement before it can be
approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our diagnostic tests or therapeutic products
is also subject to approval. A diagnostic test or therapeutic product candidate that has been approved for sale in a particular country
may not receive reimbursement approval in that country. We may not be able to obtain approvals from regulatory authorities 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