Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 24

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 24
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U.S. patents covering each of our therapeutic product candidates may be entitled to patent term extensions. If our product candidates
receive FDA approval, we intend to apply for patent term extensions, if available, to extend the term of patents that cover the approved
product candidates. We also intend to seek patent term extensions in any jurisdictions where they are available; however, there is no
guarantee that the applicable authorities, including the FDA, will agree with our assessment of whether such extensions should be granted
and, if granted, the length of such extensions.

In
addition to patent protection, we also rely on know-how and trade secret protection for our proprietary information that is not amenable
to, or that we do not consider appropriate for, patent protection, to develop and maintain our proprietary position. However, trade secrets
can be difficult to protect. Although we take steps to protect our proprietary information, including restricting access to our premises
and our confidential information, as well as entering into agreements with our employees, consultants, advisors, and potential collaborators,
third parties may independently develop the same or similar proprietary information or may otherwise gain access to our proprietary information.
As a result, we may be unable to meaningfully protect our know-how, trade secrets, and other proprietary information.

In
addition, we plan to rely on regulatory protection based on orphan drug exclusivities, data exclusivities, and market exclusivities.

 15 

Government
Regulation

United
States

Diagnostic
Products (including Medical Devices and Tests)

In
the U.S., medical devices, including IVDs are subject to extensive regulation by the FDA, under the federal Food, Drug and Cosmetic Act
(“FDCA”) and its implementing regulations, and certain other federal and state statutes and regulations. The laws and regulations
govern, among other things, the design, manufacture, storage, recordkeeping, approval, labeling, promotion, post-approval monitoring
and reporting, distribution, and import and export of medical devices, including IVDs. IVDs are a category of medical device that can
be purchased by clinical laboratories and used to perform laboratory testing. IVDs include reagents and instruments used to detect the
presence of certain chemicals or other biomarkers in human specimens for the purpose of diagnosis or detection of diseases or conditions.
IVDs can also be used to perform predictive, prognostic, and screening testing. Like other medical devices, IVDs may require premarket
review and clearance, authorization, or approval by