Researchers Study Improvement in Patient Compliance and Screening Efficacy by Using the EyeArt AI Eye Screening System for Detecting Diabetic Retinopathy

Eyenuk Inc., a global artificial intelligence (AI) medical technology and services company and the leader in real-world applications for AI Eye Screeningtm, announced today that data from scientific studies related to the screening efficacy of the EyeArt® AI Eye Screening System and the impact of using the EyeArt AI System in improving compliance with follow-up ophthalmic care for diabetic retinopathy (DR) will be presented during the American Diabetes Association (ADA) 79^th Scientific Sessions from June 7 to 11 in San Francisco.

The EyeArt AI Eye Screening System is the most extensively validated AI technology for autonomous detection of DR, tested in the real world on more than a half-million patient visits globally with over 2 million images collected in real-world clinical environments. In a prospective, multicenter, pivotal clinical trial, the EyeArt System demonstrated exceptional performance with 95.5% sensitivity, 86.5% specificity and 97.4% imageability against the rigorous ETDRS clinical reference standard while meeting all primary endpoints with p<0.0001.¹

Currently, physicians treating patients with diabetes must refer them annually to an eye specialist for DR screening. While DR screening is recommended for all diabetic patients, less than half get screened annually. In contrast, the EyeArt AI Eye Screening System is designed to make in-clinic, real-time DR screening possible for any physician, enabling quick and accurate on-site identification of patients with DR during a diabetic patient's regular exam, removing the biggest obstacles to annual DR screening and diagnosis: screening access and patient compliance. AI Eye Screening technology allows diabetes care providers to identify patients with referable DR in clinic, in real time, without needing eye care expertise on site, and immediately refer at-risk patients to ophthalmologists for further evaluation and treatment.

The ADA scientific program will feature multiple scientific presentations related to the EyeArt AI Eye Screening System:

• A late-breaking abstract presented by Bruce Bode, M.D., past president of the American Diabetes Association Georgia Affiliate: Diabetic Retinopathy (DR) Screening Performance of an Artificial Intelligence (AI) System: Analysis from a Pivotal Multicenter Prospective Clinical Trial. The abstract will be presented from 12?1 p.m. on Sunday, June 9. Dr. Bode is a diabetes specialist with Atlanta Diabetes Associates in Atlanta and is currently on the faculty of Emory University as a clinical associate professor in the Department of Medicine.
• In addition, Eli Ipp, M.D., will present Diabetic Retinopathy (DR) Screening Performance of General Ophthalmologists, Retina Specialists, and Artificial Intelligence (AI): Analysis from a Pivotal Multicenter Prospective Clinical Trial. The abstract will be presented from 12?1 p.m. on Monday, June 10. Dr. Ipp is professor of medicine at the UCLA School of Medicine, and head of the Section of Diabetes and Metabolism at Harbor-UCLA Medical Center.
• Washington University School of Medicine in St. Louis and the Department of Ophthalmology will present Automated Diabetic Retinopathy Screening in the Primary Care Setting Improves Compliance with Follow-Up Ophthalmic Care. The abstract will be presented on Monday, June 10, from 12?1 p.m.
• Finally, Eyenuk will present Explaining an Artificial Intelligence (AI) System for Diabetic Retinopathy (DR) Screening in Primary Care on Monday, June 10, from 12?1 p.m.

"By giving clinicians who treat diabetes the right tools, we can help them identify DR sooner and get patients treated faster," said Kaushal Solanki, Ph.D., founder and CEO of Eyenuk. "The EyeArt AI Eye Screening System is the solution they need to ensure patient compliance, screen regularly and save vision. We're pleased to be a part of this meeting and share our successful implementation in a number of countries spanning five continents across the globe."

Eyenuk will showcase its EyeArt AI Eye Screening System at Booth #2007 in the ADA Exhibit Hall at the Moscone Center in San Francisco. The company's management team will be available to meet with clinical and business partners.

About the EyeArt® AI Eye Screening System

The EyeArt Eye Screening System provides fully automated DR screening, including imaging, grading for DR in accordance with internationally recognized standards, and reporting, in a single office visit, enabling quick and accurate identification of patients with referable DR during a diabetic patient's regular exam. Once the patient's fundus images have been captured and submitted to the EyeArt System, the DR screening results are available to view and export to a PDF report in less than 60 seconds. The EyeArt System was developed with funding from the U.S. National Institutes of Health (NIH) and is validated by the U.K. National Health Service (NHS).

The EyeArt System has CE marking as a class 2a medical device in the European Union and a Health Canada license. In the U.S., the EyeArt System is limited by federal law to investigational use. EyeArt is designed to be General Data Protection Regulation (GDPR) and HIPAA (Health Insurance Portability and Accountability Act of 1996) compliant.

VIDEO: Learn more about the EyeArt AI Eye Screening System for Diabetic Retinopathy

About Diabetic Retinopathy (DR)

DR is a complication of diabetes caused by damage to the blood vessels of the light-sensitive tissue at the back of the eye (retina). It is a silently progressing disease that at first may cause no symptoms or only mild vision problems. Eventually, it can cause blindness. The condition can develop in anyone who has type 1 or type 2 diabetes.² It is estimated that one-third of all patients with diabetes will develop DR,³ making it the leading cause of vision loss in working-age adults.⁴

While DR screening is recommended for all diabetic patients, less than half get screened annually⁵ even in the developed world. Since diabetic patients outnumber ophthalmologists by 1,600 to 1 in the U.S.,⁶ there are just not enough eye care specialists to meet the DR screening needs of the growing diabetic population. Even for those receiving their annual screening, ophthalmology appointment wait times for DR screening can be weeks or even months.

About Eyenuk Inc.

Eyenuk Inc. is a global artificial intelligence (AI) medical technology and services company and the leader in real-world AI Eye Screeningtm for autonomous disease detection and AI Predictive Biomarkerstm for risk assessment and disease surveillance. Eyenuk is on a mission to screen every eye in the world to ensure timely diagnosis of life- and vision-threatening diseases, including diabetic retinopathy, glaucoma, age-related macular degeneration, stroke risk, cardiovascular risk and Alzheimer's disease.

EyeArt is a registered trademark of Eyenuk Inc.

www.eyenuk.com

1. Lim, J, et al. Artificial intelligence screening for diabetic retinopathy: analysis from a pivotal multi-center prospective clinical trial. ARVO Imaging in the Eye Conference 2019. Vancouver, BC, Canada.
2. https://www.mayoclinic.org/diseases-conditions/diabetic-retinopathy/symptoms-causes/syc-20371611
3. Yau JW, Rogers SL, Kawasaki R, et al. Global prevalence and major risk factors of diabetic retinopathy. Diabetes Care. 2012;35:556-64. doi: 10.2337/dc11-1909.
4. Prokofyeva E, Zrenner E. Epidemiology of major eye diseases leading to blindness in Europe: a literature review. Ophthalmic Res. 2012;47:171-188. doi: 10.1159/000329603.
5. Fitch, K et al. Longitudinal commercial claims?based cost analysis of diabetic retinopathy screening patterns. Am Health Drug Benefits. 2015 Sep;8(6):300-8.
6. http://www.icoph.org/ophthalmologists-worldwide.html and https://www.cdc.gov/diabetes/pdfs/data/statistics/national-diabetes-statistics-report.pdf