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

摘要 疼痛对社会和医疗都是一个重要的问题。慢性病患者的频率越来越高 在过去的二十年里，慢性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，200万人首次滥用阿片类药物处方，近33000人死亡 仅在美国就被归因于过量使用合成的非美沙酮阿片类药物。即使是呼吸道 抑郁和完全呼吸停止是阿片类药物过量死亡的主要原因，有 目前，我们对阿片类止痛的潜在机制的了解存在严重的知识差距 阿片类药物对呼吸的抑制，以及这些机制之间的差异。Aidar Health的基础- Breaking Technology提供了一种快速医疗评估设备MouthLab，它可以非侵入性地测量10+ 不到60秒的重要医疗参数，以及利用数据科学创建的企业平台 一种新型的通过临床级监测的精准医学，在国内。医疗点解决方案，例如 MouthLab是了解处方阿片类药物和合成药物的影响的基础，它对 缓解战略的基本慢性病和有效性。在人工智能和机器学习的支持下， Aidar的专有软件将能够对生理上的细微变化提供更深层次的实时洞察 在药物滴定、治疗变更、辅助治疗之前，协助供应商作出决定 可能会发生不良事件。MouthLab将多种心肺疾病相结合的能力 测量(即SpO2、心率、心率变异性、呼吸频率、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的问题，这将 在治疗开发过程中通过收集多个 与阿片类药物引起的呼吸抑制有关的生物标记物数据。这款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并在家中使用的技术 有助于理解将止痛与控制呼吸联系起来以识别疼痛的潜在机制 呼吸道副作用最小或没有的治疗方法。这一新颖性通过两项获得批准的专利和 自由操作分析，发现没有发现关注的现有技术。这个项目的目标是开发软件 基础设施将加强对用户体验的循序渐进和全面监测。到了最后 在该奖项中，该公司将在一小群人中测试和验证新开发的软件功能 TenTower Health&Wellness的患者和对照组。我们的解决方案具有经过验证的业务模式(通过 约翰·霍普金斯医院的100多名消费者和6次制药公司的客户访谈)推动了价值 适用于患者、医生、生物制药和付款人。展望了该产品的成功开发。 创造43个新工作岗位(2022年)，年薪超过1150万美元。作为这个奖项的直接结果，这 创新产品可以在2022年进入美国市场，到2025年预计收入将达到1.23亿美元。我们的任务是 赋予每个人使用OUD的权力，并提高其生活质量。MouthLab基本上将是 就像是OUD的个人检查引擎灯一样。

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.