Company: BIAF
Filing Date: 2025-04-22
Form Type: 424B3
Source: 0001641172-25-005598
Chunk: 118

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-04-22
Form: 424B3
Chunk 118
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 than 600 tests delivered in 2024. We attribute the growth in sales to three 2023 initiatives that came to fruition in 2024: (1) CMS’ inclusion of reimbursement for CyPath ®Lung on its 2024 clinical laboratory fee schedule and subsequent reimbursement by Medicare and private insurance carriers; (2) the hiring of our new National Director of Sales in late 2023 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