Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 29

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 29
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 systems
and controls. If we are unable to do so, our business and financial condition would be materially harmed. If rapid growth occurs, it may
strain our operational, managerial, and financial resources.

We will depend on third parties to manufacture our kits, reagents and supplies and help in marketing our diagnostic tests and to design trial protocols, arrange for and monitor the clinical trials, and collect and analyze data.

We do not have, and do not now intend to develop,
facilities for the manufacture of the contents of our collection kits needed for clinical or commercial production. In addition, we are
not a party to any long-term agreement with any of our suppliers such as the reagents used in processing sputum samples, and accordingly,
we have the products used in our diagnostic tests manufactured on a purchase-order basis from primary suppliers. We have entered into
relationships with manufacturers on a contract basis but will need to expand those relationships. We expect to depend on such collaborators
to supply us with reagents and other materials manufactured in compliance with standards imposed by the CMS, FDA, and foreign regulators.

Moreover, as we develop our diagnostic tests or therapeutic
products eligible for clinical trials, we intend to contract with independent parties to design the trial protocols, arrange for and monitor
the clinical trials, and collect and analyze the data. In addition, certain clinical trials for our products may be conducted by government-sponsored
agencies and will be dependent on governmental participation and funding. Our dependence on independent parties and clinical sites involves
risks, including reduced control over the timing and other aspects of our clinical trials.

We are exposed to product liability and pre-clinical and clinical liability risks which could place a substantial financial burden upon us should we be sued.

Our business exposes us to potential product liability
and other liability risks that are inherent in the testing, manufacturing, and marketing of diagnostic tests and therapeutic products.
Such claims may be asserted against us. In addition, using diagnostic tests and therapeutic products that may be developed with potential
collaborators in our clinical trials and the subsequent sale of these tests and products by bioAffinity or our potential collaborators
may cause us to bear a portion of or all product liability risks. A successful liability claim, or series of claims, brought against us
could have a material adverse effect on our business, financial condition, and results of operations.

While we have obtained product liability insurance
covering CyPath Lung as a commercialized LDT to be sold by our CAP-accredited, CLIA-certified clinical pathology laboratory