Company: BIAF
Filing Date: 2025-05-07
Form Type: 424B4
Source: 0001641172-25-008977
Chunk: 47

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-07
Form: 424B4
Chunk 47
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 that PPLS may be required to return some portion of prior payments it has received. These billing complexities and the related uncertainty in obtaining payment for its assays could negatively affect its revenue and cash flow, its ability to achieve profitability, and the consistency and comparability of its, and therefore our, results of operations.

PPLS relies on a third-party billing provider and an in-house billing function to transmit claims to payors, and any delay in transmitting claims could have an adverse effect on its revenue.

While PPLS manages the overall processing of claims, it relies on a third-party billing provider to transmit the actual claims to payors based on the specific payor billing format. Claims processing could be delayed if its third-party provider makes changes to its invoicing system. Additionally, coding for diagnostic assays may change, and such changes may cause short-term billing errors that may take significant time to resolve. If claims are not submitted to payors on a timely basis or are erroneously submitted, or if PPLS is required to switch to a different provider to handle claim submissions, it may experience delays in its ability to process these claims and receipt of payments from payors, or possibly denial of claims for lack of timely submission, which would have an adverse effect on its, and therefore our, revenue and business.

Risks Related to Intellectual Property Rights

Intellectual property rights do not necessarily address all potential threats to our competitive advantage.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

| ● | others                                                                                                                           
 may be able to make diagnostic tests and therapeutic product candidates that are the same as or similar to ours but that are not 
 covered by the claims of the patents that we own or have exclusively licensed;                                                   |

| 22 |

| ● | we                                                                                                                                         
 or our licensors or future collaborators might not have been the first to make the inventions covered by the issued patent or pending      
 patent application that we own or have exclusively licensed;                                                                               |
| ● | we                                                                                                                                         
 or our licensors or future collaborators might not have been the first to file patent applications covering certain of our inventions;     |
| ● | others                                                                                                                                     
 may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual     
 property rights;                                                                                                                           |
| ● | it                                                                                                                                         
 is possible that noncompliance with the U.S. Patent and Trademark Office (“USPTO”) and foreign governmental