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

摘要 疼痛是社会和医疗保健的重要问题。越来越多的慢性病患者 在过去的二十年里，慢性疾病引起的疼痛和术后疼痛直接导致了 过量处方和滥用阿片类药物。2019年初，估计每天有130人死于阿片类药物。 相关药物过量，200万人滥用首次阿片类药物处方，近33000人死亡 仅在美国归因于合成非美沙酮阿片类药物过量。虽然呼吸 抑郁症和完全呼吸骤停是阿片类药物过量死亡的主要原因， 目前，我们对阿片类药物缓解疼痛的潜在机制的理解存在严重的知识缺口， 阿片类药物的呼吸抑制，以及这些机制彼此之间的差异。爱达健康的理由- 突破性的技术提供了一种快速的医疗评估设备，MouthLab，非侵入性测量10 + 在60秒内获得重要的医疗参数，以及利用数据科学的企业平台， 一种新型的精确医疗，通过临床级的监测，在家里。即时护理解决方案，例如 MouthLab是了解处方阿片类药物和合成药物的影响的基础， 潜在的慢性病和缓解战略的有效性。在人工智能和机器学习的支持下， Aidar的专有软件将能够提供更深入，实时的生理学细微变化的见解 协助提供者做出与药物滴定、治疗变化、任何治疗前的辅助治疗相关的决定， 可能发生不良事件。MouthLab能够将广泛的心肺功能联合收割机 测量（即SpO2、心率、心率变异性、呼吸率、呼吸流量周期 形态学、肺活量测定），将能够解决缺乏实时健康洞察力的问题， 在治疗开发过程中，通过收集多个 与阿片类药物诱导的呼吸抑制相关的生物标志物数据。该产品创造了一个根本性的转变， 通过多参数方法识别早期预警症状， 有助于理解将疼痛缓解与呼吸控制联系起来的潜在机制，以识别疼痛 最小或没有呼吸系统副作用的治疗。新颖性得到了两项批准专利的肯定， 自由操作分析，没有发现任何现有技术的问题。这个项目的目标是开发软件 这将加强对用户体验OUD的渐进和全面监控。年底 该公司将在一个小的队列中测试和验证新开发的软件功能， 病人和对照组在帐篷屋健康与健康。我们的解决方案具有经过验证的业务模型（通过 约翰霍普金斯医院的100多名消费者和6次制药客户访谈）， 为患者、医生、生物制药商和付款人提供服务。预测了该产品的成功开发 创造43个新的就业机会（2022年），年薪超过1150万美元。作为该奖项的直接结果， 创新产品可以在2022年进入美国市场，到2025年预计收入为1.23亿美元。我们的使命是 授权使用并改善每个OUD患者的生活质量。MouthLab将基本上是 就像一个'检查引擎'灯为个人与OUD。

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 & 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.