Research Project
9203032
Abstract In this Commercialization Readiness Pilot (CRP) Program 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 developing and executing a market access plan, conducting a pilot clinical study, and formulating an intellectual property strategy. With its fully-automated use, real-world applicability (handles variable number of images per patient including poor quality and external eye images), high throughput capability (can analyze thousands of patient cases in just a few hours), scalable cloud-based architecture, and ability to seamlessly integrate into clinical workflows, EyeArt 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 providers. DR is a common microvascular complication of diabetes potentially affecting 80% of all diabetic patients. Even though vision loss due to DR is preventable by early detection and treatment, DR remains to be 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 29 million in the US, 387 million world-wide and expected to grow to 110 million and 592 million respectively by 2030. To help reduce risk of DR related vision loss in the diabetic population, EyeArt uses advanced image analysis algorithms to make DR screening more efficient, cost-effective, and accessible. EyeArt has been validated and shown to have high screening safety (sensitivity) and efficacy (specificity) on multiple large real- world datasets including one with over 30,000 patient cases (and 240,000 images). Eyenuk has received ISO 13485 certification as a medical device manufacturer and EyeArt has received CE Marking and is commercially available in Europe. We will clinically validate EyeArt in formal clinical trials which will pave the way for EyeArt?s availability in the US DR screening market. EyeArt will reduce the burden on clinical resources by improving health care productivity, and 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.
