Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 57

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 57
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. Recently,
there has been an increase in public awareness of privacy issues in the wake of revelations about the data collection 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