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

University Of Texas At San Antonio, San Antonio TX

Investigators

Abstract

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.