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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.
bioAffinity Technologies (BIAF) reported Q3 2024 revenue of $2.4 million, with CyPath® Lung test orders showing over 1,300% growth in the first nine months of 2024 compared to full-year 2023. The company expanded its physician network by 75% compared to Q2 2024, now receiving orders from 11 states. CyPath® Lung was added to the U.S. Federal Supply Schedule, providing access to 1,380 government healthcare facilities. The company reported a net loss of $2.0 million ($0.16 per share), an improvement from the $2.3 million loss in Q3 2023. Cash position stood at $0.8 million, with an additional $2.7 million raised through an offering in October 2024.
bioAffinity Technologies (Nasdaq: BIAF) has appointed Dr. William Bauta as Chief Science Officer, succeeding Dr. Vivienne Rebel who retired on Oct. 31, 2024. Dr. Bauta, previously Senior VP of Research and Development since 2016, brings experience from Genzyme and Ilex Products. He has contributed to multiple company inventions and patents, particularly in optimizing CyPath® Lung, their noninvasive early-stage lung cancer detection test. His work has improved test performance, reduced costs, and expanded the company's patent portfolio. Dr. Bauta earned his Ph.D. from the University of Chicago and completed post-doctoral studies at the University of Texas at Austin.
bioAffinity Technologies (Nasdaq: BIAF) has been granted a patent in Japan for its CyPath® Lung diagnostic test method, which predicts lung cancer likelihood. This marks the first patent specifically for CyPath® Lung as a standalone flow cytometry test for lung cancer detection. The patent, titled 'System and Method for Determining the State of Health of the Lungs,' adds to the company's portfolio of 17 awarded patents and 30 pending applications across various regions. The company focuses on developing noninvasive tests for early-stage lung cancer and other lung diseases detection.
WallachBeth Capital announced the closing of bioAffinity Technologies' (Nasdaq: BIAF) $2.6 million registered direct offering and concurrent private placement. The offering included 2,048,294 shares of common stock at $1.30 per share and warrants to purchase up to 2,662,782 shares at $1.50 per share. The warrants will be exercisable upon stockholder approval and expire five years from that date. bioAffinity Technologies plans to use the net proceeds for general corporate purposes and working capital. WallachBeth Capital acted as the sole placement agent for the offering, which was conducted under an effective shelf registration statement. The private placement of warrants was made under exemptions from registration requirements.
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW) has closed a $2.6 million registered direct offering and concurrent private placement. The company sold 2,048,294 shares of common stock at $1.30 per share and issued warrants to purchase up to 2,662,782 shares at an exercise price of $1.50 per share. The warrants will be exercisable upon stockholder approval and expire five years from that date. WallachBeth Capital acted as the sole placement agent. The company plans to use the net proceeds for general corporate purposes and working capital. The offering was made pursuant to an effective shelf registration statement, with a prospectus supplement to be filed with the SEC.
WallachBeth Capital announced that bioAffinity Technologies (Nasdaq: BIAF) has entered into a securities purchase agreement for a $2.66 million registered direct offering and concurrent private placement. The offering includes:
1. 2,048,294 shares of common stock at $1.30 per share in a registered direct offering
2. Common warrants to purchase up to 2,662,782 shares at $1.50 per share in a private placement
The warrants will be exercisable upon stockholder approval and expire five years from approval date. The offering is expected to close around Oct. 21, 2024. WallachBeth Capital is acting as the sole placement agent. The common stock will be issued under an effective shelf registration statement, while the warrants will be issued under a Section 4(a)(2) exemption.
bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW) has announced a $2.66 million registered direct offering and concurrent private placement. The company will sell 2,048,294 shares of common stock at $1.30 per share in a registered direct offering. Additionally, in a private placement, it will issue common warrants to purchase up to 2,662,782 shares at an exercise price of $1.50 per share. The warrants will be exercisable upon shareholder approval and expire five years from that date. The offering is expected to close around October 21, 2024, subject to conditions. WallachBeth Capital is acting as the sole placement agent. The common stock will be issued under an effective shelf registration statement, while the warrants will be issued under a Section 4(a)(2) exemption.
bioAffinity Technologies (Nasdaq: BIAF; BIAFW) announced that its VP of Diagnostics, Jennifer Rebeles, Ph.D., contributed to a peer-reviewed paper on flow cytometry guidelines for rare matrix samples. The paper, published in Cytometry Part B: Clinical Cytometry, supports the validation approach used for bioAffinity's CyPath® Lung cancer test.
CyPath® Lung is a noninvasive test for early lung cancer detection, particularly useful for patients with pulmonary nodules. It has shown 92% sensitivity and 87% specificity in detecting lung cancer in nodules 20mm or less. The new guidelines address challenges in validating unique sample types like sputum, which CyPath® Lung uses.
The paper supplements the CLSI Guideline H62 and reflects the increasing use of specialized samples in flow cytometry. It acknowledges the challenges bioAffinity scientists overcame in developing CyPath® Lung, including dealing with high viscosity, inhibitors, and complex cellular mixtures.
bioAffinity Technologies has been awarded a U.S. Federal Supply Schedule contract for its CyPath® Lung test, a noninvasive diagnostic tool for early-stage lung cancer detection. This contract enables the Veterans Health Administration (VHA) and Military Health System to access the test for their patients. The VHA, serving 9.1 million Veterans annually, is the largest integrated healthcare system in the U.S.
Lung cancer is the leading cause of cancer-related death in Veterans, who are 25% more likely to receive a lung cancer diagnosis compared to non-Veterans. The CyPath® Lung test is particularly effective for patients with indeterminate pulmonary nodules detected during low dose computed tomography (LDCT) scans. A recent economic impact study suggests that incorporating CyPath® Lung into the current standard of care could result in significant healthcare cost savings.
A peer-reviewed economic study published in the Journal of Health Economics and Outcomes Research has found that incorporating bioAffinity Technologies' CyPath® Lung test into the standard care for Medicare patients with positive lung cancer screenings could lead to significant healthcare savings. The study, conducted by researchers from Brooke Army Medical Center and South Texas Veterans Health Care Systems, estimates potential savings of $2,773 per patient, totaling $379 million in 2022.
The savings are attributed to reduced follow-up diagnostic assessments, expensive procedures, and related complications. For private-payer patients, the potential savings are even higher at $6,460 per patient, with a total estimated savings of $895 million if all screened individuals in 2022 were privately insured. The study highlights CyPath® Lung's potential to improve early lung cancer diagnosis while reducing unnecessary procedures and medical complications.
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