An unobtrusive monitoring device used for tracking asthma symptoms and lungfunction variability

同品种器械执行摘要（1页） 第一阶段具体目标概述 具体目标1：训练和评估用于检测儿童哮喘症状（咳嗽和哮喘）的算法。 喘息）在低功率、小形状因数的可穿戴设备上。规格：90%灵敏度;误报 发生率：1次咳嗽发作/天或1次喘息发作/天。根据医学专家评估算法 使用两种最佳哮喘评分工具（AS：哮喘评分; PRAM：儿科）进行（医生）评分 呼吸评估测量）。 具体目标2：设计和评价在低功率、小功率和高功率下检测肺功能变异的算法 形状因子可穿戴设备。规格：使用来自传感器贴片的呼吸信号，检测 1秒用力呼气量与用力肺活量（FEV 1/FVC）的变化≥ 10%。评价 与肺量测定金标准进行比较。 实现具体目标的进展 截至2020年1月21日，实质等同NIH STTR奖的工作尚未开始。工作 与此NIH STTR相关的研究预计将于2020年4月开始。在提交我们的NIH STTR申请之前， 完成了重要的工作，以测试使用我们的可穿戴设备收集肺功能的可行性 技术.我们对医院里的20多名病人进行了测试，在这项研究中，我们发现了一个阳性的 我们的测量结果和肺量测定结果之间的相关性。我们的NIH STTR工作将建立在 这个 技术、管理或商业挑战以及如何解决这些挑战 到目前为止，在我们的客户发现过程中，我们已经了解了实现 即使我们已经确定了适用的CPT代码，也可以报销。认识到这一挑战，我们选择了一个 不需要报销的初始客户。我们最初的客户将是呼吸临床 审判从我们的采访中，我们了解到，他们有一个强烈的未满足的需求，他们愿意支付 数量大，我们将能够比其他客户类型更早地为他们服务。我们希望 在这个NIH I-Corps项目中进一步探索这一点。 团队成员简介 首席研究员：Justice Amoh博士，Clairways首席技术官- Justice是嵌入式系统的先驱 用于生理信号的随机建模。他的重点是深度神经网络模型， 检测呼吸道疾病的症状发作。 C级企业官：Jeff Bemowski，MBA，Clairways首席执行官- Jeff在产品方面经验丰富 管理，市场研究和客户发现的新型生物医学设备。他此前 我曾在Endotronix（一家C轮融资的医疗器械公司）从事产品管理工作。 行业专家：Bob Gatewood，Portal Instruments数字健康副总裁- Bob Gatewood是一位 经验丰富的医疗保健和数字健康企业家。鲍勃是一个创始成员， Athenahealth现在的价值超过55亿美元。他已经完成了许多 Clairways必须克服的挑战，所以他的观点对我们的团队非常有价值。 此外，鲍勃在行业内有很好的联系，将有助于与100个潜在的 在很短的时间轴内找到客户。

Executive Summary of Predicate (One Page) Summary of Specific Aims of Phase I Specific Aim 1: Train and evaluate an algorithm to detect pediatric asthma symptoms (cough and wheeze) on a low power, small form factor wearable device. Specifications: 90% sensitivity; false alarm rate: 1 cough episode/day or 1 wheeze episode/day. Evaluate algorithm against medical expert (physician) scoring using the two best available asthma scoring tools (AS: asthma score; PRAM: Pediatric Respiratory Assessment Measure). Specific Aim 2: Design and evaluate algorithm to detect lung function variability on a low power, small form factor wearable device. Specifications: Using respiratory signals from sensor patch, detect variations ≥ 10% in forced expiratory volume in 1 second to forced vital capacity (FEV1/FVC). Evaluate algorithm against spirometry gold standard. Progress towards Specific Aims As of today, January 21, 2020, the work on the predicate NIH STTR award has not yet begun. The work related to this NIH STTR is anticipated to begin April 2020. Prior to submitting our NIH STTR application, significant work was completed to test the viability of collecting lung function using our wearable technology. We tested on over 20 patients in the hospital, and in this study we found a positive correlation between our measurements and those of spirometry. Our NIH STTR work will build upon this. Technical, administrative, or commercial challenges and how they’ve been addressed During our customer discovery so far, we have learned about the complexities of achieving reimbursement, even if we have identified applicable CPT codes. Realizing this challenge, we selected an initial customer that will not require reimbursement. Our initial customer will be respiratory clinical trials. From our interviews, we have learned that they have a strong unmet need, they are willing to pay a large amount, and we will be able to serve them earlier than other customer types. We hope to explore this further during this NIH I-Corps program. Brief intro to team members Principal Investigator: Justice Amoh, PhD, CTO of Clairways - Justice is a pioneer in embedded systems for stochastic modelling of physiological signals. His focus is on deep neural network models for detecting the onset of symptoms in respiratory diseases. C-Level Corporate Officer: Jeff Bemowski, MBA, CEO of Clairways - Jeff is experienced in product management, market research, and customer discovery for novel biomedical devices. He previously worked in product management for Endotronix, a Series C funded medical device company. Industry Expert: Bob Gatewood, VP Digital Health at Portal Instruments - Bob Gatewood is an experienced healthcare and digital health entrepreneur. Bob was one of the founding members of Athenahealth, which is now valued at over $5.5 billion. He has already worked through many of the challenges Clairways will have to overcome, so his perspective will be very valuable to our team. Additionally, Bob is well connected within the industry and will aid in connecting with 100 potential customers within the short timeline.