LKC Technologies' RETeval™ Undergoing Rigorous Clinical Trials
GAITHERSBURG, Md., Jan. 21, 2014
GAITHERSBURG, Md., Jan. 21, 2014 /PRNewswire/ -- RETeval™ is a handheld DR screening device that enables virtually any health care provider to screen for sight-threatening DR in less than three minutes per patient with no dilation regardless of pupil size or the presence of a cataract. The device is undergoing a multi-center clinical trial to compare its results to the generally accepted gold standard for diabetic retinopathy (DR) diagnosis.
In speaking about the trials, LKC Technologies President James J. Datovech said that Stephen R. Fransen, Associate Professor at the Dean McGee Eye Institute, University of Oklahoma, Oklahoma City, Oklahoma, is the primary investigator for the trials. Dr. Fransen is also the co-founder of Inoveon, a company focusing on solutions to detect, stage, and monitor diseases affecting the eye, including diabetic retinopathy, macular degeneration and glaucoma.
"We are honored to have Dr. Fransen as the overall primary investigator to help ensure rigorous study conditions," Datovech said. "He is a true leader and has been intimately involved with diabetic screening for more than 15 years. He is well known and well respected in this field and is very well suited in leading this very important scientific aspect of the study."
Dr. Fransen explains, "We are very excited LKC chose us to validate their RETeval™ device. Diabetic retinopathy remains the leading cause of preventable blindness in working age Americans. Most patients with diabetes still don't get adequate screening for diabetic retinopathy despite years of work by ophthalmologists, optometrists, and primary care physicians to find a solution. RETeval has the potential to solve this problem."
In commenting on the significance of the trials and the methodology behind them, Dr. Fransen said, "This problem is very important to patients with diabetes and those of us here at Inoveon. Our diabetic retinopathy screening service uses the NIH gold-standard method to screen patients for diabetic retinopathy. All major research trials use this method and the FDA requires pharmaceutical companies to use this method when seeking approval for new drugs."
"We are very pleased LKC chose this standard to validate RETeval™," Dr. Fransen said. "By comparing RETeval™ results to the gold-standard we have great confidence our evaluation of the RETeval™ device will be rock solid and provide results everyone can trust."
RETeval™ is CE marked and is already approved in Canada and Japan. Additionally, it is being used in a number of other countries including the U.K., India, Canada, Indonesia and Malaysia. Furthermore, Mr. Datovech notes that, "People in Japan and the UK are exploring the possibility for pediatric and neo-natal utilization of RETeval™ for prevalent retinal conditions effecting those populations".
In India, the RETeval™ is being used by the Eye Foundation of America (EFA) in its 100,000 Lives Campaign, which the Foundation officially launched this month. The campaign will be reaching more than 100,000 people in rural India with diabetes who are at risk for, or may already be suffering from diabetic retinopathy.
RETeval™ received significant interest from physicians throughout the world at recent ophthalmology and diabetes conferences in the United States and Australia. Mr. Datovech, reflecting upon the conferences, was , "Most impressed about the high level of interest from physicians from various countries from all around the world that expressed a true need for a cost effective, portable, world class device that would enable testing capabilities to exist wherever the need arises". RETeval™ will again be in front of industry professionals at the Association for Research in Vision and Ophthalmology (ARVO) meeting in May, 2014.
LKC knows that diabetic retinopathy screening is important around the world and they are pleased that RETeval™ is being used for this purpose. Mr. Datovech suggests that, "LKC is also exploring potential new uses for the device such as with CRVO, retinitis pigmentosis and various acquired/inherited retinal diseases where a functional assessment of the retina is important to guide diagnostics and impact decisions of the medical community".
This news release contains forward-looking statements related to product growth drivers, product performance, market position, strategies for growth, and LKC's future results of operations, which are subject to risks and uncertainties, such as competitive factors, difficulties and delays inherent in the development, manufacturing, marketing and sale of medical products, government regulation and general economic conditions. Actual results may differ materially from anticipated results. LKC does not undertake to update its forward-looking statements.
SOURCE LKC Technologies, Inc.