Eyenuk, Inc. Granted CE Marking For EyeArt™ Automated High-Throughput Diabetic Retinopathy Screening

The new software technology is designed to seamlessly integrate into existing diabetic retinopathy care, while providing a cost-effective, highly scalable and safe solution to address the screening needs of the hundreds of millions of people suffering from diabetes.

News provided by

Eyenuk, Inc.

Apr 14, 2015, 09:00 ET

LOS ANGELES, April 14, 2015 /PRNewswire/ -- Eyenuk, Inc. announced today that it received CE Marking for its pioneering EyeArt software, a suite of advanced image analysis tools for automated high-throughput screening of diabetic retinopathy. The company plans to launch its product in select leading eye care sites across Europe in the next few months.

Diabetic Retinopathy (DR), a common microvascular complication of diabetes, is the leading cause of blindness in the adult working-age population. The total annual economic burden of eye disorders and vision loss associated with diabetes is estimated at over $130 billion in the US alone. Early detection and treatment can reduce the number of people with vision loss caused by DR by up to 90%. But with over 350 million individuals living with diabetes worldwide, and expected to reach 500 million people by 2030, there are simply not enough eye care providers to serve the screening needs of this growing population. Automation of diabetic retinopathy screening is the only realistic method to screen a large proportion of those with diabetes. This screening will also significantly reduce healthcare costs and improve efficiency for ophthalmologists and other eye care specialists.

EyeArt provides a highly-scalable and cost-effective cloud-based DR screening solution that analyzes thousands of patients' eyes in just a few hours. Using color retinal images taken with standard fundus cameras, the software analyzes the high-resolution images of the retina, and uses this information to automate detection of diabetic retinopathy. By automating this process, EyeArt is designed to help healthcare professionals identify patients who need immediate attention in a more effective and efficient manner. Extensive clinical validation studies for EyeArt have shown that the product can achieve better sensitivity than human graders, while cutting the screening workload in half. EyeArt's cloud-based programming interface is expected to be made widely available in Europe and the US (pending FDA clearance), enabling quick and seamless integration into existing electronic medical or health record software.

"Receiving the CE Marking for our flagship screening product, EyeArt, is a significant milestone for Eyenuk," said Dr. Kaushal Solanki, CEO of Eyenuk. "Our exhaustive research and patented image analysis technology behind EyeArt has culminated in a DR screening product that is more sensitive than human graders, while still reducing workloads by more than 50%."

Members of the diabetes care community are also optimistic. Dr. Andrew Boulton, a renowned diabetes expert stated, "I am excited that EyeArt is soon to become available in Europe. Automated eye screening could have a huge impact in improving the lives of individuals with diabetes who still face the risk of losing vision asymptomatically."

Leading retina expert Dr. SriniVas Sadda from the Doheny Eye Institute agrees: "I believe that an automated, reliable DR screening tool such as EyeArt would empower primary care providers to better manage their patients with diabetes. We continue to work with the company in supporting its clinical efforts here in the United States."

About EyeArt™
EyeArt is Eyenuk's first product, a state-of-the-art retinal image analysis software suite intended to efficiently screen for preventable blindness within the growing population with diabetes. Its cloud-based back-end is designed to analyze and screen hundreds of thousands of color retinal fundus images in just a few hours. The software, intended for high diagnostic efficacy, can analyze images taken with a wide-variety of the fundus cameras currently available. EyeArt was granted CE Marking in March 2015, clearing it for sales in the European Union as a Class IIa medical device. In the United States, EyeArt is limited by federal law to investigational use.

About Eyenuk, Inc.
Eyenuk Inc. is headquartered in Los Angeles, CA. The Eyenuk team is a group of passionate PhDs, led by computer vision and image analysis expert Dr. Kaushal Solanki. Eyenuk's mission is to use automated analysis to solve real world problems in the medical domain. Eyenuk's product portfolio includes: 1) EyeArt™ – image analysis tools to expand screening and aid early DR diagnosis; 2) EyeMark™ – an automated image-based biomarker for DR risk assessment and monitoring; and 3) EyeApp™ – automated image analysis tools for DR screening using iPhone-based retinal cameras. Together, these tools are paving the frontier of retinal image analysis, expanding screening capability and aiding in early diagnosis of blinding retinal diseases. With these innovations, Eyenuk hopes to make eye care more accessible and more affordable. The company has received over $3.5 million in NIH grants and is currently raising additional funds in a Series A round.

EyeArt™, EyeMark™ and EyeApp™ are trademarks of Eyenuk, Inc. For more information visit www.eyenuk.com or contact Jeremy Koff at [email protected].

NOTE – EyeArt has been cleared for sales only in the European Union as a Class IIa medical device.

CAUTION – Investigational device. Limited by federal law to investigational use. Not available for sale in the United States.

Media Contact:
Jeremy Koff
[email protected]
21860 Burbank Blvd, Ste. 160
Los Angeles, CA 91367 USA
Ph: +1 818 835 2633
www.eyenuk.com

SOURCE Eyenuk, Inc.