Research Project
9142236
? 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 80% 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 29 million in the US and 387 million world-wide and expected to grow to 110 million and 592 million respectively by 2030. 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 54,000 patient cases (and 434,000 images) obtained from EyePACS, a DR telescreening system with over 360 sites in the US and elsewhere. Eyenuk has received ISO 13485 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 EyeArt's seamless incorporation into existing clinical workflows. This will pave the way for EyeArt'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.
