Company: BIAF
Filing Date: 2025-05-07
Form Type: 424B4
Source: 0001641172-25-008977
Chunk: 83

Company: bioAffinity Technologies, Inc.
Filing Date: 2025-05-07
Form: 424B4
Chunk 83
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Business

We develop noninvasive diagnostics to detect early-stage lung cancer and other diseases of the lung using flow cytometry and automated analysis developed by machine learning, a form of artificial intelligence (“AI”). Our diagnostic tests, including our commercial test CyPath ®Lung and those tests in our pipeline for development, analyzes cell populations that are indicative of a specific diseased state.

Our diagnostic test, CyPath ®Lung, addresses the need for noninvasive detection of early-stage lung cancer. Lung cancer is the leading cause of cancer-related deaths worldwide. Physicians order CyPath ®Lung to assist in their assessment of patients who are at high risk for lung cancer. The CyPath ®Lung test enables physicians to more confidently identify patients who will likely benefit from timely intervention and more invasive follow-up procedures and those who are likely without lung cancer and should continue routine screening. CyPath ®Lung has the potential to increase overall diagnostic accuracy of lung cancer, which could lead to increased survival, fewer unnecessary invasive procedures, reduced patient anxiety, and lower medical costs.

Commercial laboratory services, including CyPath ®Lung, are performed at our wholly owned subsidiary PPLS which we acquired by purchasing the assets of Village Oaks Pathology Services, P.A., a Texas professional association d/b/a Precision Pathology Services, that included the CAP-accredited and CLIA-certified commercial laboratory it owned. We now own and operate the clinical anatomic and clinical pathology laboratory. CyPath ®Lung is offered for sale to physicians by PPLS.

Through our wholly owned subsidiary, OncoSelect ®Therapeutics, LLC, we have conducted research that has led to discoveries and advancement of novel cancer therapeutic approaches that specifically and selectively target cancer cells. We expect to present our findings at conferences and publish our research in the near future. We intend to seek strategic partners to develop our therapeutic discoveries which could result in broad-spectrum cancer treatments in the future.

Research and optimization of our platform technologies are conducted in laboratories at our wholly owned subsidiary, PPLS and leased laboratory space at The University of Texas at San Antonio.

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Current Year Financial Highlights

Key financial results for the year ended December 31, 2024 include:

| ● | Consolidated                                                                                                                     
 revenue increased approximately 270% to $9.4 million as compared to $2.5 million for the year ended December 31, 2023, primarily 
 as a result of the acquisition of PPLS in September 2023.                                                                        |
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