I-Corps: A Novel Design for the Treatment of Obstructive Sleep Apnea (OSA)

I-Corps：治疗阻塞性睡眠呼吸暂停 (OSA) 的新颖设计

• 批准号: 1622726
• 负责人: Arturo Ayon
• 金额: $ 5万
• 依托单位: University of Texas at San Antonio
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-02-15 至 2016-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1622726&HistoricalAwards=false
• 关键词: Corps; Novel; Design; Treatment; Obstructive

The proposed device is a transformational but simple mask that a person wears while sleeping to treat obstructive sleep apnea (OSA), a serious sleep disorder that affects over 30 million people in the U.S. alone. The main problem is that the current technology, while effective at treating OSA, is cumbersome and uncomfortable, causing roughly 50% of patients to stop using treatment as directed. Left untreated, OSA increases a person's risk of high blood pressure, heart attack, stroke, and other medical complications. The economic problem is that non-compliance negatively impacts the cost effectiveness of treatment. The proposed mask seeks to solve the compliance problem by providing a device that was designed to make treatment easier and more convenient for the user without sacrificing clinical effectiveness. The innovative design with no ancillary attachments leads to increased comfort, enhanced portability, and improved compliance, all at a lower price point. Increasing compliance will improve patient outcomes and the cost effectiveness of treatment, directly benefiting the patient, doctor, and health insurance provider.The $4 billion worldwide respiratory OSA market is in need of a product designed to yield compliance. Unlike traditional machines, the proposed device was developed with no hoses or cables, making treatment easier and more convenient for the user without sacrificing clinical effectiveness. This device is capable of generating positive air pressure (PAP) without using motors, blowers, or needing electricity. Its innovative design with zero ancillary attachments leads to a dramatically lower price point, increased comfort, and portability, making it much easier to use and maintain. Commercial impact in the US relies on regulatory clearance by the FDA for product sale and fitting within existing insurance reimbursement codes. The market need and best first customer segment will be identified by the I-Corps team. The technology will be licensed to a new startup company formed by the Entrepreneurial Lead. The company will pursue grant and private equity funding to further commercialization efforts, including pursuit of an SBIR Phase I grant to support continued prototype development, initial clinical validation, and initiation of the FDA regulatory approval process.

这个被提议的设备是一种转换但简单的面具，人们在睡觉时戴上它来治疗阻塞性睡眠呼吸暂停（OSA），这是一种严重的睡眠障碍，仅在美国就有超过3000万人受到影响。主要问题是，目前的技术虽然能有效治疗阻塞性睡眠呼吸暂停，但操作繁琐且不舒服，导致大约50%的患者停止使用指导的治疗方法。如果不及时治疗，阻塞性睡眠呼吸暂停会增加一个人患高血压、心脏病、中风和其他并发症的风险。经济问题是，不遵守规定会对治疗的成本效益产生负面影响。提出的口罩旨在通过提供一种设备，在不牺牲临床效果的情况下，使用户更容易、更方便地治疗，从而解决依从性问题。无辅助附件的创新设计增加了舒适性，增强了便携性，并改善了合规性，所有这些都以更低的价格实现。提高依从性将改善患者的治疗结果和治疗的成本效益，直接使患者、医生和健康保险提供商受益。价值40亿美元的全球呼吸性阻塞性睡眠呼吸暂停（OSA）市场需要一种符合要求的产品。与传统机器不同，该设备没有软管或电缆，在不牺牲临床效果的情况下，使用户更容易、更方便地进行治疗。该装置能够产生正气压（PAP），而无需使用马达、鼓风机或电力。它的创新设计，零辅助附件，导致价格大幅降低，增加了舒适性和便携性，使其更容易使用和维护。在美国，商业影响依赖于FDA对产品销售的监管许可，并符合现有的保险报销代码。I-Corps团队将确定市场需求和最佳的第一批客户。这项技术将被授权给一家由创业领袖成立的新公司。该公司将寻求拨款和私募股权资金，以进一步商业化努力，包括寻求SBIR I期拨款，以支持持续的原型开发、初步临床验证和启动FDA监管批准程序。