Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 31

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 31
---
 activities of various government agencies and in the number of private privacy-related
lawsuits filed against companies. Concerns about our practices with regard to the collection, use, retention, disclosure, or security
of personal information or other privacy-related matters, even if unfounded and even if we are in compliance with applicable laws, could
damage our reputation and harm our business.

If we are unable to obtain adequate reimbursement from third-party payors or governmental agencies for CyPath ®Lung or other diagnostic tests or therapeutic products under development or if new restrictive legislation is adopted, market acceptance of our tests or products may be limited, and we may not achieve expected revenues.

The continuing efforts of government and insurance
companies, health maintenance organizations (“HMOs”), and other payors of healthcare costs to contain or reduce costs may
affect our future revenues and profitability, as well as the future revenues and profitability of our potential customers, suppliers,
and collaborative partners and the availability of capital. For example, in certain international markets, pricing or profitability of
diagnostic tests and therapeutic products is subject to government control. In the U.S., given recent federal and state government initiatives
directed at lowering the total cost of healthcare, the U.S. Congress and state legislatures will likely continue to focus on healthcare
reform, the cost of medical devices, tests, and prescription pharmaceuticals, and Medicare and Medicaid reforms. While we cannot predict
whether any such legislative or regulatory proposals will be adopted, the announcement or adoption of such proposals could materially
harm our business, financial condition, and results of operations.

Our ability to commercialize our tests or products
will depend in part on the extent to which appropriate reimbursement levels for the cost of our tests or products are obtained by governmental
authorities, private health insurers, and other organizations such as HMOs. Governmental agencies and third-party payors are increasingly
challenging the prices charged for medical tests, drugs, and services. Also, the trend toward managed healthcare in the U.S. and the concurrent
growth of organizations such as HMOs, which could control or significantly influence the purchase of healthcare services, diagnostics,
and drugs, as well as legislative proposals to reform healthcare or reduce government insurance programs, may all result in lower prices
for or rejection of our tests or products.

Our employees, independent contractors, consultants, commercial partners, and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.

Our business operations and current and future relationships