SBIR Phase I: A novel, active acoustic wearable for real-time deterioration assessment in Chronic Obstructive Pulmonary Disease (COPD)

这项小企业创新研究（SBIR）第一阶段项目的更广泛影响/商业潜力将源于下一代产品的开发，该产品将通过赋予患者、提供者和护理人员监测疾病、预防呼吸系统发作和及时在家接受护理的能力，彻底改变COPD的管理。目前，每四分钟就有一名美国人死于慢性阻塞性肺病，每年造成近720亿美元的损失，其中近一半的成本可归因于急诊室就诊和住院。预计的好处包括早期发现肺部恶化，这将有助于在家中进行预防性干预，从而减少每年在急诊室和医院就诊上花费的360亿美元。最近CMS法规变更（CMS-1689- fc）允许对慢性阻塞性肺病患者的远程监测进行报销，通过承认远程监测在减少住院率和长期急性护理使用方面的成功，表明市场准备就绪。我们的解决方案具有经过验证的商业模式（通过220多个I-Corps客户访谈），可为患者、医生、供应商网络和付款人带来价值。该产品的成功开发预计将创造42个新工作岗位（2024年），年工资超过650万美元。该奖项的直接结果是，该创新产品将于2023年进入美国市场，到2027年预计收入将达到1亿美元。这个小企业创新研究（SBIR）第一阶段项目旨在开发一种新的检测COPD恶化的黄金标准。该产品基于智能手机平台上的低成本音频传感器和人工智能算法，可以跟踪肺部共振并标记肺容量的任何变化。目前在家追踪肺功能的方法还不够理想。家用肺活量计很难使用，而且不能报销。脉搏血氧仪非常不准确，只能提供离散点的数据，导致诊断较晚。这种缺乏及时信息的情况表现为住院人数过多，因为发现往往太晚，无法预防疾病发作。该产品通过识别空气捕获（一种更敏感的肺部恶化生物标志物），为家庭使用的技术带来了根本性的转变。新颖性得到了两项正在申请的专利和自由操作分析的肯定，这些分析没有发现有关的现有技术。目前肺共振测量还未应用于其他呼吸监测设备，这为公司提供了强大的差异化竞争优势。该项目的目标是创建一个可用于人体测试的最小可行产品。到合同结束时，该公司将在一小群患者和对照组中测试和验证这一概念。该奖项反映了美国国家科学基金会的法定使命，并通过使用基金会的知识价值和更广泛的影响审查标准进行评估，被认为值得支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project will result from the development of a next-generation product that will revolutionize COPD management by empowering patients, providers and caregivers to monitor the disease, prevent respiratory attacks, and receive timely care at home. Currently, COPD kills one American every four minutes and costs nearly $72B a year - almost half of that cost is attributable to ER visits and hospitalization. Projected benefits include early detection of lung deterioration, which will facilitate preventive interventions at home and thereby reduce the $36B/year spent on ER and hospital visits. A recent CMS regulatory change (CMS-1689-FC) permits reimbursements for remote monitoring of COPD patients, indicating market readiness by recognizing the success of remote monitoring in reducing admissions and long-term acute care use. Our solution has a validated business model (through over 220 I-Corps customer interviews) that drives value for patients, physicians, provider networks and payers. Successful development of this product is forecast to create 42 new jobs (2024) with an annual payroll exceeding $6.5M. As a direct result of this award, this innovative product can reach the U.S. market in 2023, with $100M in projected revenue by 2027. This Small Business Innovation Research (SBIR) Phase I project aims to develop a new gold-standard for detecting COPD deterioration. The product is based on low-cost audio sensors paired with AI algorithms on a Smartphone platform that track lung resonance and flag any changes in lung volume. Current methods for tracking lung function at home are sub-optimal. Home spirometers are difficult to use, and not reimbursable. Pulse-oximeters are highly inaccurate and only provide data at discrete points, leading to late diagnosis. This lack of timely information manifests in excess hospitalizations because detection often occurs too late to prevent an attack. This product creates a fundamental shift in the technology employed at home by identifying air trapping, a more sensitive biomarker for lung deterioration. The novelty is affirmed with two pending patent applications and a freedom to operate analysis that found no prior art of concern. Currently lung resonance measurement is not used in other respiratory monitoring devices, providing the company with a strong competitive differentiation. The goal of this project is to create a Minimum Viable Product that can be used for human testing. By the end of this award the company will test and validate the concept in a small cohort of patients and controls.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.