BETHESDA, Md.--(BUSINESS WIRE)--Freedom Meditech, Inc., the developer of non-invasive, ophthalmic-based products to detect and manage diabetes, today announced results of a clinical study that showed a high correlation between low to high blood glucose levels and non-invasive glucose measurements in the eye in a live animal model.
Results of the study of Freedom Meditech’s I-SugarX™, non-invasive glucose monitoring system were presented at the Diabetes Technology Meeting in Bethesda, Maryland.
The study showed that the I-SugarX™ non-invasive polarimetric based measurements of glucose in the aqueous humor of eye tracked glucose measurements in the blood with 93 percent of readings in the A zone and the remaining seven percent in the B zone of the Clarke Error Grid (CEG). The CEG is a “gold standard” for determining the accuracy of glucose measurements – with zones A and B designated as acceptable for therapy decisions. No data fell outside the acceptable zones. The reference glucose sensors used in the study were the Johnson and Johnson LifeScan One Touch Ultra glucose meter and the Yellow Springs Instrument glucose analyzer. Seven New Zealand White rabbits were tested in the study with 41 data points collected over average study durations of 60 minutes. The average time delay between blood glucose readings and ocular readings was less than four minutes.
“The eye can be thought of as an optical window into to body for the painless measurement of glucose in the ocular fluid as opposed to the blood, and is well suited for our proprietary optical polarimetric based measurements,” said John F. Burd, Ph.D., Chief Science Officer of Freedom Meditech. “Based on the results of this, and other studies, we plan to begin human clinical studies as we continue our product development.”
The I-SugarX™ is a non-invasive, handheld, ocular glucose measurement device that is intended to provide people with diabetes a convenient, pain-free, and bloodless way to monitor daily glycemic control. The I-SugarX™ aims to become a superior alternative to the current “finger prick” glucose monitoring test. The global market for diabetes glucose monitoring is estimated to be $12 billion annually.
About Freedom Meditech
Freedom Meditech, Inc. is a private, growth-stage medical device company focused on the development and commercialization of first-to-market, non-invasive, ophthalmic medical devices for unmet clinical needs associated with disease detection and the management of diabetes. Freedom Meditech’s proprietary technology platforms are based on the scientific rationale that glucose, which is the hallmark of diabetes when present or elevated in the blood, presents rapidly within the fluid and blood of the eye.
In addition to the I-SugarX™ glucose monitor, the company is also developing the ClearPath DS-120™, a proprietary, non-invasive ophthalmic diagnostic device designed to quickly detect elevated crystalline lens fluorescence as well as biomarkers of diabetes and pre-diabetes. The ClearPath DS-120™ is planned for future sale and screening use within optometry and ophthalmology practices in the United States (US) as well as pharmacies and hospitals internationally and is estimated to be a global market of $3 billion annually. Currently, there are no FDA approved non-invasive diabetes screening or glucose monitoring devices available for sale or use in the US.
The company maintains corporate offices and diabetes screening product commercialization activities in San Diego, California, with glucose monitoring research and development conducted throughout Ohio. For more information, visit www.freedom-meditech.com.