Breath Diagnostics, Inc. (“Breath-Dx” or “the Company”), is a medical-device diagnostics company developing a novel, patented breath analysis system to quantify cancer specific markers in exhaled breath. The Company’s proprietary technology, OneBreath™, offers a unique solution by providing accurate, affordable, and safe lung cancer detection by analyzing a single exhaled breath. The Company’s innovative platform can selectively detect a spectrum of predictive markers and therefore has the potential to expand into other cancer indications as well as a variety of other disease states.
Current lung cancer diagnosis is expensive, inaccurate, and potentially harmful to patients. OneBreath™ offers a solution which is easily administered, readily deployable, non-invasive, and provides better accuracy than current technologies, all within 24 hours. The Company’s technology is ideally suited for application in three lung cancer related indications: (1) as a primary screen for detection of lung cancer; (2) to differentiate benign from malignant pulmonary nodules; and (3) to monitor for recurrence after surgical resection of lung cancer. Breath-Dx has cumulatively studied 800 subjects using the breath analysis technology. The data from these various studies have been disclosed in 10 peer-reviewed publications representing the most of any breath analysis company. In one of pre-clinical study consisting of 204 subjects, OneBreath™ demonstrated a sensitivity of 94% and a specificity of 86% in detecting lung cancer. In another study, Breath-Dx’s technology displayed a 77% specificity in differentiating malignant from benign pulmonary nodules, illustrating twice the specificity of positron emission tomography (PET) scans (39%), a commonly used diagnostic tool for lung cancer. The breath cancer markers normalized after surgical removal of the tumor, thereby validating the markers as indicators for cancer. The Company is preparing for independent clinical trials which it anticipates beginning in Q1/Q2 2020.
Breath Diagnostics, Inc. is a Louisville, Kentucky-based company formed to commercialize its revolutionary OneBreath™ technology. The breath analysis platform was originally conceived, developed, and patented by scientists at the University of Louisville, which continues to support research and development activities. Breath-Dx is currently seeking capital in a Bridge Financing round via Convertible Preferred Notes to support the launch of pivotal clinical trials in collaboration with Mayo Clinic Laboratories and Parexel, development of scalable manufacturing and management infrastructure.