Technologies for OUD Prevention, Control and Supportive Care - Development of Patient/Caregiver mobile application and Provider Dashboard

ABSTRACT Pain is an important issue for both society and health care. The increasing frequency of individuals with chronic pain as the result of chronic diseases and postoperative pain have directly led, over the past two decades, to the over-prescription and misuse of opioids. In early 2019, an estimated 130 people per day were dying from opioid- related drug overdoses, 2 million people were misusing first-time opioid prescriptions, and almost 33000 deaths were attributed to overdosing with synthetic non-methadone opioids in the USA alone. Even though respiratory depression and complete respiratory arrest are the major causes of mortality with opioid overdose, there is currently a serious knowledge gap in our understanding of the underlying mechanisms of opioid pain relief and respiratory depression by opioids, and how these mechanisms differ from each other. Aidar Health’s ground- breaking technology offers a rapid medical assessment device, MouthLab, which non-invasively measures 10+ vital medical parameters in under 60 seconds, and an enterprise platform that leverages data science, to create a new kind of precision medicine through clinical-grade monitoring, at home. A point-of-care solution such as MouthLab is fundamental in understanding the impact of prescribed opioids and synthetic drugs, its impact on the underlying chronic condition and effectiveness of mitigation strategies. Powered by AI and machine learning, Aidar’s proprietary software would be able to provide deeper, real-time insights of subtle changes in physiology to assist the provider with decisions related to drug titration, treatment changes, adjunct therapies before any adverse event can occur. MouthLab’s ability to combine a wide-ranging spectrum of cardiopulmonary measurements (i.e. SpO2, Heart rate, Heart rate variability, Respiratory Rate, Respiratory Flow Cycle Morphology, Spirometry), would be able to solve the problem of lack of real-time health insights which would have significant relevance to providers in the treatment development process through the collection of multiple biomarker data linked to opioid-induced respiratory depression. This product creates a fundamental shift in the technology employed at home by identifying early warning symptoms through a multiparameter approach and facilitates understanding of the underlying mechanisms linking pain relief with control of breathing to identify pain therapies with minimal or no respiratory side effects. The novelty is affirmed with two approved patents and the freedom to operate analysis that found no prior art of concern. The goal of this project is to develop software infrastructure that would enhance the progressive and holistic monitoring of users experiencing OUD. By the end of this award, the company will test and validate the newly developed software capabilities in a small cohort of patients and controls at TentHouse Health and Wellness. Our solution has a validated business model (through over 100 consumers at Johns Hopkins Hospital and with 6 Pharmaceutical customer interviews) that drive value for patients, physicians, biopharmaceuticals, and payers. A successful development of this product is forecast to create 43 new jobs (2022) with an annual payroll exceeding $11.5M. As a direct result of this award, this innovative product can reach the U.S. market in 2022, with $123M in projected revenue by 2025. Our mission is to empower the uses and improve the quality of life of every individual with OUD. MouthLab will essentially be like a ‘Check Engine’ light for individual with OUD.