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bioAffinity Technologies, Inc. (NASDAQ: BIAF) is a pioneering biotechnology company dedicated to addressing the critical need for the early detection and targeted treatment of cancer and lung diseases. The company develops proprietary, noninvasive diagnostic tests and cancer therapeutics that focus on the cellular level, which has the potential to significantly improve patient outcomes.
One of the company’s leading innovations is the CyPath® Lung test, a noninvasive diagnostic tool designed to detect early-stage lung cancer. This test employs flow cytometry technology to analyze sputum samples, which can dramatically increase diagnostic accuracy, reduce the need for invasive procedures, and lower medical costs while enhancing patient comfort and survival rates. CyPath® Lung has been licensed by Precision Pathology Services for further development and commercial sale as a laboratory-developed test.
Recent company milestones include a securities purchase agreement with institutional investors, announced on March 6, 2024, by WallachBeth Capital LLC. This agreement involves a registered direct offering and a concurrent private placement, expected to raise approximately $2.5 million. The proceeds will support the company's ongoing research, development activities, and potential commercialization efforts.
Financially, bioAffinity Technologies is actively engaging with institutional investors to secure funding necessary for its ambitious projects. The company’s efforts are supported by an effective shelf registration statement filed with the U.S. Securities and Exchange Commission (SEC) and the strategic guidance of WallachBeth Capital, which provides comprehensive capital market and investment banking services tailored to the healthcare sector.
Through its innovative approach and strong industry partnerships, bioAffinity Technologies aims to revolutionize cancer diagnosis and treatment, ultimately improving survival rates and quality of life for patients worldwide.
BioVie (Nasdaq:BIVI) and bioAffinity Technologies (Nasdaq:BIAF) will appear on the RedChip Small Stocks, Big Money show on Bloomberg TV on July 6 at 7 p.m. ET. Cuong Do, President and CEO of BioVie, will discuss their late-stage clinical programs for neurodegeneration and liver disease. BioVie's lead asset, bezisterim, has shown promise in treating Parkinson's and Alzheimer's diseases by reducing inflammation, improving motor control, cognition, and brain imaging. BioVie plans to launch a Phase 2b trial for Parkinson's in Fall 2024 and a Phase 3 trial for Alzheimer's in mid-2025.
Maria Zannes, President and CEO of bioAffinity Technologies, will provide a corporate update, highlighting CyPath Lung's success in early-stage lung cancer detection. The test has demonstrated high sensitivity and specificity, with commercialization already underway. The lung cancer screening market is projected to hit $5.7 billion by 2030. bioAffinity's AI-enhanced flow cytometry platform is also being developed for COPD and asthma diagnosis. The company holds extensive patents and is backed by strong insider ownership (39%).
BioAffinity Technologies (Nasdaq: BIAF; BIAFW) has reported a significant 139% growth in the number of pulmonology practices offering its noninvasive CyPath® Lung test for early-stage lung cancer detection since January 1, 2024. Sales outpaced Q1 2024 targets, leading to expansion beyond Texas to eight additional states. The company increased its 2023 sales forecast by 35% in May. This growth is attributed to positive physician-to-physician word of mouth and effective marketing strategies. CyPath® Lung's high sensitivity, specificity, and accuracy have been well-received by the medical community. The lung cancer diagnostics market is projected to reach $4.7 billion by 2030.
BioAffinity Technologies (Nasdaq: BIAF; BIAFW) reports record Q1 2024 revenue of $2.4 million, driven by CyPath® Lung sales and increased lab volumes. CyPath® Lung orders surged by 547% annualized in the first four months of 2024 over 2023, leading to a 35% increase in the 2024 sales forecast. The number of physician offices ordering the test doubled since January 2024, expanding beyond Texas to states like Pennsylvania and New Jersey. Medicare reimbursement for CyPath® Lung began on January 1, 2024. Precision Pathology Laboratory Services forecasts $9.2-$9.6 million in 2024 revenues, up 23% from 2023. The company reported an increase in R&D and SG&A expenses, resulting in a net loss of $2.1 million for Q1 2024, compared to a net loss of $1.5 million in Q1 2023. BioAffinity closed a $2.5 million funding round to support growth and continued product development in collaboration with the DoD.
bioAffinity Technologies, Inc. (Nasdaq: BIAF) reports an increase in sales of CyPath® Lung, their noninvasive diagnostic test for lung cancer detection. April sales were up 21% from March, with new orders from physicians in various states. The company also welcomed new team members to support the CyPath® Lung product launch. Additionally, bioAffinity will present research at the American Thoracic Society's Annual Conference.
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