EYENUK, INC. — Department of Health and Human Services SBIR Phase II: N

Description

DESCRIPTION provided by applicant In this Phase IIB application we propose to commercialize and bring to market EyeArt a fully automated high throughput retinal image analysis based diabetic retinopathy DR screening tool which has been developed and already validated in bench tests on very large real world data by conducting formal clinical trials and integrating it into several clinical information systems With its fully automated use high throughput capability can analyze several thousands of patient cases in just a few hours scalable architecture and ability to seamlessly integrate into clinical workflows EyeArt will aid the expansion of DR screening and help bridge the exponentially growing disparity between the number of diabetic patients and the number of eye care providers DR is a common microvascular complication of diabetes affecting of all diabetic patients Even though vision loss due to DR is preventable by early detection and treatment it is the one of the leading global causes of preventable blindness primarily due to the lack of easy access to eye care providers Automated DR screening is the only way to make DR screening more accessible to the large and growing population of diabetic patients currently million in the US and million world wide and expected to grow to million and million respectively by To help reduce risk of DR vision loss in the diabetic population EyeArt uses advanced image analysis algorithms to make DR screening more efficient cost effective and more accessible EyeArt has been validated and shown to have high screening sensitivity safety and efficacy on multiple large real world datasets including one with over patient cases and images obtained from EyePACS a DR telescreening system with over sites in the US and elsewhere Eyenuk has received ISO certification as a medical device manufacturer and EyeArt has received CE Marking and is commercially available in Europe Going forward we will clinically validate EyeArt in formal clinical trials and integrate it into clinical informatio systems to enable EyeArtandapos s seamless incorporation into existing clinical workflows This will pave the way for EyeArtandapos s availability to the US DR screening market and reduce the burden on clinical resources by improving health care productivity This will help increase the DR screening conformance in the diabetic population and thus help in reducing and ultimately eliminating vision loss due to DR through early detection and treatment PUBLIC HEALTH RELEVANCE EyeArt a fully automated high throughput retinal image analysis based diabetic retinopathy DR screening system will help in screening patients in need of expert care thus making DR screening more efficient cost effective and accessible EyeArtandapos s integration into EyePACS a DR telescreening system will facilitate an expansion of DR screening within the large and expanding EyePACs network of primary care centers in the US and elsewhere We are also collaborating with Los Angeles County Department of Health Services LAC DHS which already uses the EyePACS to deploy our system following clinical validation in their under resourced safety net teleretinal screening setup which caters to large disparity populations of LA County The increased access to DR screening will help reduce and ultimately eliminate vision loss due to DR through early detection and treatment