Company: BIAF
Filing Date: 2025-06-27
Form Type: POS AM
Source: 0001641172-25-016923
Chunk: 99

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-06-27
Form: POS AM
Chunk 99
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 future FDA cleared diagnostic test, we have named the test for which we are seeking FDA clearance “FlowPath Lung.” In December 2024, we met with FDA to discuss our pre-submission and subsequently incorporated the requested protocol changes to improve the trial design. Our revised trial protocol is now under review by an IRB. In the third quarter of 2024, the National Association of Veterans Research and Education Foundation (“NAVREF”) extended a “Call for Interest” to VA systems to solicit participation in the pivotal trial, which resulted in a positive response from 22 VA medical centers. We are in the process of qualifying VA, academic and private medical centers that have asked to participate. Our Clinical Research Organization (“CRO”) is Courante Oncology. Retired Army Col. Michael Morris, MD., of Brooke Army Medical Center has accepted the position as national Principal Investigator for the clinical trials. We anticipate a three-to-four-year clinical trial including an 18-month patient enrollment of approximately 3,400 patients, with the first clinical site expected to open and patient enrollment expected to begin in in the second quarter of 2025.

The pivotal trial will analyze sputum using flow cytometry data and patient data using the algorithm used for our LDT CyPath ®Lung, including (1) the proportion of cells with a high ratio of high TCPP fluorescence intensity over cell size; (2) the proportion of cells with an intermediate ratio of fluorescence intensity caused by the viability dye (FVS510) over cell size; (3) the proportion of cells that were CD206 negative but positive for one or more of the following markers: CD66b (granulocytes), CD3 (T cells), and CD19 (B cells); and (4) patient age. Patient enrollment is scheduled to begin in the second quarter of 2025 at up to 20 collection sites. Assuming the study is successful, we intend to submit a de novo classification request to the FDA within six months of study completion. Phase 4 of our business plan accelerates the market presence of CyPath ®Lung in the U.S. as well as countries in Asia, Eastern Europe, and Australia after obtaining FDA marketing authorization.

We have developed messaging and marketing programs that will continue to grow both in size and scope with each phase of development, including key convention attendance, digital marketing, social media presence, and advertising, to create an “inbound” lead generation mechanism that delivers our message to our target audience. In addition, we will continue to