Company: BIAF
Filing Date: 2025-04-11
Form Type: S-1
Source: 0001641172-25-003892
Chunk: 47

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-11
Form: S-1
Chunk 47
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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 negatively affect the quality of test results, or that it will be successful in responding
to the growing complexity of testing operations.

In addition, PPLS’ growth may place a significant
strain on its management, operating and financial systems, and its sales, marketing, and administrative resources. As a result of its
growth, PPLS’ operating costs may escalate even faster than planned, and some of its internal systems may need to be enhanced or
replaced. If we cannot effectively manage PPLS’ expanding operations and its costs, we may not be able to grow effectively or we
may grow at a slower pace, and our business could be adversely affected.

Billing for PPLS’ services is complex, and PPLS must dedicate substantial time and resources to the billing process to be paid.

Billing for clinical laboratory services is complex,
time consuming and expensive. Depending on the billing arrangement and applicable law, PPLS bills various payors, including Medicare,
insurance companies, and patients, all of which have different billing requirements. It generally bills third-party payors for its diagnostic
assays and pursues reimbursement on a