Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 32

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 32
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with investigators, healthcare professionals, consultants, third-party payors, and customers will be subject, directly or indirectly,
to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws, and other healthcare
laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties. We
are exposed to the risk of employee fraud or other illegal activity by our employees, independent contractors, consultants, commercial
partners, vendors, and agents acting on behalf of us or our affiliates. Misconduct by these parties could include intentional, reckless,
and/or negligent conduct that fails to (1) comply with the regulations of the FDA or foreign health authorities; (2) provide true, complete,
and accurate information to the FDA or foreign health authorities; (3) comply with manufacturing standards we have established; (4) comply
with healthcare fraud and abuse laws in the U.S. and similar foreign fraudulent misconduct laws; or (5) report financial information or
data accurately or to disclose unauthorized activities to us.

Our business operations and current and future relationships with investigators, healthcare professionals, consultants, third-party payors, and customers are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, transparency laws, and other healthcare laws and regulations. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

Healthcare providers and others play a primary role
in the recommendation, ordering, and prescription of any diagnostic tests or therapeutic products for which we obtain marketing approval.
Our operations and current and future arrangements with investigators, healthcare professionals, customers, and third-party payors are
subject to various U.S. federal and state healthcare laws and regulations, including, without limitation, U.S. federal Anti-Kickback Statute,
the U.S. federal civil and criminal false claims laws, and the Physician Payments Sunshine Act and regulations. These laws may impact,
among other things, our current business operations, including our clinical research activities, and proposed sales, marketing, and education
programs and constrain the business of financial arrangements and relationships with healthcare providers and other parties through which
we may market, sell, and distribute our diagnostic tests or therapeutic products for which we obtain marketing approval. In addition,
we may be subject to additional healthcare, statutory, and regulatory requirements and enforcement by foreign regulatory authorities in
jurisdictions in which we conduct our business.

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Ensuring that our internal operations and