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

拟议中的设备是一种变革性的但简单的口罩，人们可以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3000多万人受到影响。主要问题是，目前的技术虽然在治疗阻塞性睡眠呼吸暂停综合征方面有效，但程序繁琐且不舒服，导致大约50%的患者停止按指导使用治疗。如果不进行治疗，OSA会增加一个人患高血压、心脏病发作、中风和其他医学并发症的风险。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。拟议的口罩寻求通过提供一种设备来解决依从性问题，该设备旨在使用户在不牺牲临床有效性的情况下更容易和更方便地进行治疗。不带附件的创新设计以更低的价格带来了更高的舒适性、更强的便携性和更好的合规性。提高依从性将改善患者的结局和治疗的成本效益，直接使患者、医生和医疗保险提供商受益。全球40亿美元的呼吸性OSA市场需要一种旨在产生依从性的产品。与传统机器不同，拟议的设备开发时没有软管或电缆，使用户的治疗更容易和更方便，而不会牺牲临床效果。该设备无需使用电机、鼓风机或电力即可产生正气压(PAP)。它的创新设计，零附件，大大降低了价格，增加了舒适性和便携性，使其更易于使用和维护。在美国的商业影响取决于FDA对产品销售和符合现有保险报销代码的监管许可。I-Corps团队将确定市场需求和最佳的第一批客户群。这项技术将被授权给由企业家领袖组建的一家新的初创公司。该公司将寻求赠款和私募股权资金，以进一步商业化努力，包括寻求SBIR第一阶段赠款，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。

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.