ZANSORS LLC — Department of Health and Human Services STTR Phase II: NIMHD

Description

ABSTRACT Obstructive sleep apnea OSA is the most common type of sleep apnea OSA affects an estimated million adults and of all children in the US OSA results in tiredness depression and fatigue and has several associated common comorbidities It is believed that over of OSA remains undiagnosed The prevalence of OSA increases with age and if untreated increases the risk of cardiac mortality as well as several comorbidities An affordable available FDA approved and easy to use over the counter OSA screening tool will allow greater screening of at risk individuals enabling a greater proportion of such individuals to seek treatment for their condition The widespread availability of this device through drugstores and consumer health outlets will additionally allow underprivileged communities access to a high quality screening tool for sleep apnea Zansors has developed a bioengineered semiconductor device that measures breathing and movement during sleep It is a x x inch wireless package using four key technologies a an adjustable microphone b a axis accelerometer c embedded algorithms to measure sleep events and d acrylic adhesive The product is designed as a FDA approved over the counter device that the patient can wear during sleep and wake up with a color score of red yellow or green depending on their sleep apnea risk status The product features include home based easy to use non invasive wireless disposable and low cost at less than $ with easily understandable test results A Phase I STTR award demonstrated that that this device can successfully screen for OSA in adults with over sensitivity and specificity against gold standard polysomnography data In this Phase II project we will implement Good Manufacturing Practice and quality systems control ISO develop and implement novel algorithms to detect hypopneas from sound and motion data develop a wireless Bluetooth app that takes the wireless data from the wearable sensor and provides data visualizations on mobile devices and validate our data and findings against home sleep testing and polysomnography in a clinical study at the University of Michigan Sleep Disorders Center The worldwide OSA market will reach $ billion by The marketplace currently does not have an affordable easy to use over the counter home based OSA screening device Increasing awareness of OSA and its impact and a strong unmet need in underserved populations favor market penetration Partnerships with larger leading sleep treatment companies will help the sales and distribution of the Zansors product PROJECT NARRATIVE In this Phase II STTR Zansors in collaboration with University of Michigan Sleep Disorders Center will develop a wireless device for the early screening of sleep apnea at home Current methods include diagnostic boxes and polysomnography PSG which are bulky cumbersome and expensive $ $ Widespread availability of our innovative FDA approved over the counter affordable andlt $ easy to use sleep apnea screening device through drugstores online storefront and consumer health outlets allows easier access to consumers and reduces health disparities