$2.37 -0.04 ( -1.66% ) 94.8K
NASDAQ: BIAF
Company Overview
“bioAffinity Technologies addresses the urgent need for noninvasive, accurate early-stage cancer diagnosis and broad-spectrum cancer treatments. Lung cancer is the leading cause of cancer-related deaths. The Company’s first product, CyPath® Lung, improves early-stage detection of lung cancer, leading to increased survival, fewer unnecessary invasive procedures, reduced patient anxiety, and lower medical costs. CyPath® Lung, a laboratory developed test (LTD), is patient-friendly and physician focused. Physicians order CyPath® Lung for their patients after lung cancer screening reveals a suspicious finding.
Patients collect their sample at home and ship overnight in a pre-paid envelope to the Company’s commercial laboratory, Precision Pathology Laboratory Services, where data is collected using flow cytometry. Proprietary automated data analysis, developed using artificial intelligence (AI), detects lung cancer by analyzing the lung microenvironment to identify cell populations that indicate malignancy. CyPath® Lung has shown high sensitivity (92%), high specificity (87%) and high accuracy (88%) in detecting early-stage lung cancer in patients with small pulmonary nodules less than 20 millimeters. Research and optimization of the Company’s platform technologies are conducted in its laboratories at Precision Pathology and The University of Texas at San Antonio.”
Value Proposition
bioAffinity Technologies is an emerging player in early-stage cancer diagnosis and treatment. Its flagship product, CyPath® Lung, improves detection of early-stage lung cancer by analyzing the lung microenvironment. The noninvasive test has shown high sensitivity, specificity and accuracy. Lung cancer often goes undetected until it reaches late-stage when treatment options are less effective. Early detection increases survival and reduces medical costs. With commercialization underway, including a pilot program in Texas and the US Department of Defense’s purchase of tests for ongoing research, the Company is well-poised for growth. The lung cancer screening market is projected to reach $5.7 billion by 2030. The Company’s flow cytometry platform, enhanced by AI-driven automated data analysis, is being developed to aid in noninvasive diagnosis of COPD and asthma, which have a combined global market expected to reach $8.2 billion by 2027. The Company holds extensive U.S. and international patents. Insiders show strong support for the Company with ownership at 39% and increasing. With a highly experienced leadership team, bioAffinity Technologies is well-positioned to drive innovation in early-stage cancer diagnosis and treatment.
Recent & Anticipated Milestones
Leadership Team: Innovative, Experienced, Dedicated
Market Data
Investment Highlights
- Commercialization of CyPath® Lung test underway
- Pilot marketing and sales program launched for CyPath® Lung in Texas
- US Department of Defense purchased CyPath® Lung for an observational study and research into the test’s use for screening
- AMA issued a CPT code for CyPath® Lung, paving the way for reimbursement by both private payors and public health insurance programs; CMS approved payment effective January 1, 2024
- Q2 2023 revenue: $298k
- Lung cancer is the leading cause of cancer-related deaths worldwide
- Lung cancer is frequently detected in advanced stages, resulting in limited treatment options
- Global lung cancer screening market is forecast to reach $5.7 billion in 2030, up from $2.8 billion in 2021
- Company holds strong international patent portfolio supporting worldwide commercialization
- Company’s newly acquired CAP/CLIA laboratory showed $6.9 million revenues in 2022, with 12.5% growth in first half, 2023
- Company captures 100% of CyPath Lung revenues
- Precision Pathology Laboratory Services adds capacity for nationwide expansion under one structure
- Accretive in 2023; 100% return on cash investment expected in 24 months
- Experienced leadership team
- Team includes CEO Maria Zannes (30+ years executive-level experience); Chief Science & Medical Officer Dr. Vivienne Rebel (20+ years of scientific research experience); and CFO Michael Dougherty (20+ years financial management/business strategy experience, including CFO of Amazon’s Alexa division)
Archived Webinar
RedChip Investor Group Call with bioAffinity Technologies (NASDAQ: BIAF)
Tuesday, January 9, 2024
