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

Description

AbstractIn this Commercialization Readiness PilotCRPProgram applicationwe propose to commercialize and bring to market EyeArta fully automatedhigh throughputretinal image analysis based diabetic retinopathyDRscreening toolwhich has been developed and already validated in bench tests on very large real world databy developing and executing a market access planconducting a pilot clinical studyand formulating an intellectual property strategyWith its fully automated usereal world applicabilityhandles variable number of images per patient including poor quality and external eye imageshigh throughput capabilitycan analyze thousands of patient cases in just a few hoursscalable cloud based architectureand ability to seamlessly integrate into clinical workflowsEyeArt will aid the expansion of DR screening and help bridge the fast growing disparity between the number of diabetic patients and the number of eye care providersDR is a common microvascular complication of diabetes potentially affectingof all diabetic patientsEven though vision loss due to DR is preventable by early detection and treatmentDR remains to be one of the leading global causes of preventable blindness primarily due to the lack of easy access to eye care providersAutomated DR screening is the only way to make DR screening more accessible to the large and growing population of diabetic patientscurrentlymillion in the USmillion world wide and expected to grow tomillion andmillion respectively byTo help reduce risk of DR related vision loss in the diabetic populationEyeArt uses advanced image analysis algorithms to make DR screening more efficientcost effectiveand accessibleEyeArt has been validated and shown to have high screening safetysensitivityand efficacyspecificityon multiple large realworld datasets including one with overpatient casesandimagesEyenuk has received ISOcertification as a medical device manufacturer and EyeArt has received CE Marking and is commercially available in EuropeWe will clinically validate EyeArt in formal clinical trials which will pave the way for EyeArt s availability in the US DR screening marketEyeArt will reduce the burden on clinical resources by improving health care productivityand also help increase the DR screening conformance in the diabetic population and thus aid in reducing and ultimately eliminating vision loss due to DR through early detection and treatment Narrative EyeArta fully automatedhighly accuratediabetic retinopathyDRscreening system will help enable exponential expansion of screening of diabetic people who increasingly face the risk of vision loss asymptomaticallymaking DR the leading cause of blindness in the adult working age populationEyeArt s integration into existing telescreening PACS systemssuch as EyePACSand retinal camera software will enable its immediate use in wide range of clinical setupssuch as EyePACs network of primary care centers in the US and elsewhereand Los Angeles County Department of Health ServicesLAC DHSThe increased access to DR screening with high accuracy will help significantly reduce vision loss due to DR through early detection and treatment