Company: BIAF
Filing Date: 2025-10-09
Form Type: 424B5
Source: 0001493152-25-017591
Chunk: 58

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-10-09
Form: 424B5
Chunk 58
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PLS 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.

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The value of CyPath ®Lung depends, in large part, on PPLS’ ability to perform the tests on a timely basis and at high-quality, and on its reputation for such timeliness and quality. 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.

PPLS has executed an agreement for third-party billing services with a national firm specializing in pathology, laboratory and radiology billing services to provide billing services for its business. Nonetheless, PPLS is responsible for billing for clinical laboratory services that can be complex, time-consuming and expensive. Depending on the billing arrangement with insurance carriers and clients, and applicable law, PPLS bills various payors, including Medicare, insurance