Company: BIAF
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001641172-25-001840
Chunk: 69

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1
Chunk 69
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 35 

If
PPLS uses hazardous chemicals in a manner that causes injury, PPLS could be liable for damages.

PPLS’
activities currently require the controlled use of potentially harmful chemicals. PPLS cannot eliminate the risk of accidental contamination
or injury to employees or third parties from the use, storage, handling, or disposal of these materials. In the event of contamination
or injury, PPLS could be held liable for any resulting damages, and any liability could exceed its resources or any applicable insurance
coverage it may have. Additionally, PPLS is subject to, on an ongoing basis, federal, state, and local laws and regulations governing the use, storage, handling,
and disposal of these materials and specified waste products. The cost of compliance with these laws and regulations may become significant
and could have a material adverse effect on its, and therefore our, financial condition, results of operations, and cash flows. In the
event of an accident or if PPLS otherwise fails to comply with applicable regulations, it could lose its permits or approvals or be held
liable for damages or penalized with fines.

If
PPLS is unable to successfully scale its operations to support demand for CyPath® Lung, its business could suffer.

As
test volume of CyPath® Lung grows, PPLS will need to continue to ramp up its testing capacity, implement increases in
scale and related processing, customer service, billing and systems process improvements, and expand its internal quality assurance program
and technology platform to support testing on a larger scale. PPLS will also need additional equipment and certified laboratory personnel
to process higher volumes of our tests. We cannot assure you that any increases in scale, related improvements, and quality assurance
will be successfully implemented by PPLS or that equipment and appropriate personnel will be available. As additional tests are developed,
PPLS may need to bring new equipment on-line, implement new systems, technology, controls and procedures, and hire personnel with different
qualifications.

The
value of CyPath® Lung depends, in large part, on PPLS’ ability to perform the tests accurately and on a timely basis
and on its reputation for such timeliness and accuracy. Failure to implement necessary procedures or to hire the necessary personnel
could impact its ability to meet market demand. There can be no assurance that it will be able to perform tests on a timely basis at
a level consistent with demand, that its efforts to scale its commercial operations will not