SBIR-STTR Award

This Small Business Innovation Research Phase I project proposes to develop a non-invasive pH sensor to determine the pH of exhaled breath vapor to help diagnose and treat gastroesophageal reflux disease (GERD). The commercial application of this project will be on the diagnosis and treatment of respiratory diseases. Acid reflux has been associated with asthma and other inflammatory airway diseases. Current detection methods, such as catheters, are invasive and require hospital visits. A simple non-invasive detector would allow for broader screening and could be used to evaluate the effectiveness of treatment modalities

This Small Business Innovation Research (SBIR) Phase II project aims to develop and market the trademarked Dx-1 pH Measurement System. This medical device integrates the breath pH sensor studied in the Phase I research with an ambulatory, telemetry based data recorder, and data analysis software to provide a non-invasive pH diagnostic tool required by physicians. This pH sensor actively condenses a moisture film on the sensor surface, creating a conduction path across its sensing electrodes. During Phase II, the company plans to complete all technical and regulatory activities in order to gain FDA clearance for product introduction. The commercial application of this project is in the area of medical devices. The proposed sensor technology will offer a new tool for clinicians to more effectively diagnose and treat respiratory diseases, particularly for children and infants who cannot readily undergo alternative diagnostic procedures.