Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 38

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 38
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 obsolete, or we may be unable to keep pace with technological developments or other market factors. Technological competition
from diagnostic, pharmaceutical and biotechnology companies, universities, governmental entities, and others diversifying into the field
is intense and is expected to increase.

As a company engaged in the development of diagnostic
technology with limited revenue generated to date, our resources are limited, and we may experience technical challenges inherent in such
technologies. Competitors have developed or are in the process of developing technologies that are, or in the future may be, the basis
for competition. Some of these technologies may have an entirely different approach or means of accomplishing similar diagnostic efficacy
compared to our proposed tests or products. Our competitors may develop diagnostic technologies that are more effective or less costly
than our proposed tests or products and therefore present a serious competitive threat.

The potential widespread acceptance of diagnostic
tests or therapies that are alternatives to ours may limit market acceptance of our proposed tests or products, even if commercialized.
Many of our targeted diseases and conditions can also be detected by other tests or treated by other medications. These tests and treatments
may be widely accepted in medical communities and have a longer history of use. The established use of these competitive technologies
may limit the potential for our technologies, formulations, tests, and products to receive widespread acceptance if commercialized.

Healthcare cost containment initiatives and the growth of managed care may limit our returns.

Our ability to commercialize our diagnostic tests
and therapeutic products successfully may be affected by the ongoing efforts of governmental and third-party payors to contain the cost
of healthcare. These entities are challenging prices of healthcare products and services, denying or limiting coverage and reimbursement
amounts for new diagnostic tests and therapeutic products, CAP/CLIA-validated LDTs, and FDA-approved diagnostic tests and therapeutic
products considered experimental or investigational or which are used for disease indications without FDA marketing authorization. Even
if we succeed in bringing any tests or products to the market, they may not be considered cost effective, and governmental or third-party
reimbursement might not be available or sufficient. If adequate governmental or third-party coverage is not available, we may not be able
to maintain price levels sufficient to realize an appropriate return on our investment in research and development for new tests and products.
In addition, legislation and regulations affecting the pricing of diagnostic tests, pharmaceuticals, or healthcare services may change
in ways adverse to us before or after any of our proposed tests and products are approved for marketing.

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