Company: BIAF
Filing Date: 2025-05-02
Form Type: S-1
Source: 0001641172-25-008170
Chunk: 113

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-02
Form: S-1
Chunk 113
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3 and subsequent sales persons in 2024 who are experienced and well respected in the pulmonary field; and (3) marketing materials for the newly branded CyPath ®Lung that emphasize our test’s ability to assist physicians with next steps in patient care.

In October 2024, CyPath ®Lung was awarded listing on the U.S. Federal Supply Schedule (FSS), making the test available to U.S. Veterans and active military personnel across government health systems. We view this market opportunity as the next step in expanding sales nationally in the U.S., including strategic expansion into regional markets in 2025. Phase 2 of our business plan anticipates entering the EU market with CyPath ®Lung as a CE-marked IVD test beginning with sales in the Netherlands, followed by a staged EU expansion. Phase 3 of our business plan focuses on the marketing of an FDA-cleared CyPath ®Lung test, beginning with conducting a pivotal clinical trial in the U.S. Toward that end, we have voluntarily sought FDA guidance with the intention of obtaining clearance after completion of the pivotal trial of a Class II IVD medical device for use in the diagnosis of lung cancer in individuals with indeterminate pulmonary nodules between 6 mm to less than 20 mm.

To differentiate our LDT test from the 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 third quarter 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