A breakthrough mobile phone technology that aids in early detection of COPD - TABA fund supplement

Project Summary / Abstract: This application is for TABA funds as a supplement to the following phase I project. COPD is the fourth leading global killer, in part, because of the failure of frontline medicine to detect the disease. Poor early detection leads to unfavorable outcomes and high healthcare costs. Tele-stethoscope* or “TS” is novel technology that allows acoustic data captured from ordinary mobile phones to perform robust analysis of hemodynamics and pneumodynamics. TS is intended to be used in primary care particularly in Tele-health and before scheduled physical examination. Its purpose is to alert primary care physicians to the need for physical examination and possibly referral. In these situations, there are no other comparable testing options. TS has three important innovations. First, is a clinical use innovation which brings remote, impromptu patient evaluation to anyone with a smartphone. Customer discovery has validated both a workflow and reimbursement strategy consistent with commercial success. Further, FDA guidance suggests viability of agency clearance. Second is TS’s novel approach to making AI algorithms. TS uses acoustic data, captured by OEM phone microphones, into rigorous, physics-based features that describe organ hemodynamics and pneumodynamics. The features or independent variables are then used to create binary classification models with logistic regression. By relying on physics, TS never has to use neural networks or overfitting strategies that have raised concerns about data intensity, model stability, regulatory transparency and unknown reliability. The third innovation is that, by relying on passive acoustic data, TS classifies organ function by observing organ dynamics directly rather than from forced air capacity. TS uses many ideas from physics that were not available until fairly recently. By relying on dynamics, TS offers a novel approach to forced air that may eventually be additive to our understanding of respiratory conditions even in PFT labs. This will be the third large scale human study that demonstrates classification of cardio - pulmonary functionality. It follows a published study on COVID detection as well as soon to be published study on the ability of TS to reproduce echocardiogram estimates of ejection fraction. Analysis of stethoscope recordings suggests that the COPD diagnostic will rely on a combination of right heart side hemodynamics and low frequency lung pneumodynamics. A significant body of research is presented which validates the use of mobile phones as an auscultation device with the ability to detect and diagnosis COPD. The Aim of this study is to develop, evaluate, and test an algorithm that allows ordinary mobile phones to detect COPD. Our hypothesis is that TS technology can detect COPD by matching phone acoustic recordings to diagnosis. Diagnosis will be determined by a physician after considering gold standard testing. Performance of the models will be evaluated by using common statistical approaches such as area under the receiver operating curve AUC, sensitivity, specificity, accuracy. The research will have 3 milestones based on recruitment of 30, 60 and 100 patients respectively. Our approach is based on recruitment from patients assigned to a hospital PFT lab so that recordings and gold standard testing are done concurrently. Our team consists of a broad range of talent including the inventor of TS, pulmonology expertise, the research director of emergency medicine for the hospital running the tests, statistical expertise, and project management. * Tele-stethoscope or "TS" is patent pending technology developed by Fleming Scientific.