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.

Public Health Relevance

EyeArt, a fully automated, highly accurate, diabetic retinopathy (DR) screening system will help enable exponential expansion of screening of diabetic people who increasingly face the risk of vision loss asymptomatically, making DR the leading cause of blindness in the adult working age population. EyeArt?s integration into existing telescreening/PACS systems (such as EyePACS) and retinal camera software will enable its immediate use in wide range of clinical setups, such as EyePACs network of primary care centers in the US and elsewhere, and Los Angeles County Department of Health Services (LAC-DHS). The increased access to DR screening with high accuracy will help significantly reduce vision loss due to DR through early detection and treatment.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Project #
9SB1EY027241-06
Application #
9203032
Study Section
Special Emphasis Panel (ZRG1-ETTN-C (56))
Program Officer
Wujek, Jerome R
Project Start
2016-09-30
Project End
2019-07-31
Budget Start
2016-09-30
Budget End
2017-07-31
Support Year
6
Fiscal Year
2016
Total Cost
$500,000
Indirect Cost
$133,512
Name
Eyenuk, Inc.
Department
Type
DUNS #
832930569
City
Woodland Hills
State
CA
Country
United States
Zip Code
91367