Healthcare Industry News: blood glucose
News Release - September 14, 2006
OrSense's Non-Invasive Continuous Glucose Monitoring System Demonstrates Excellent Results in Home Use SettingNES ZIONA, Israel--(HSMN NewsFeed)--Sept. 14, 2006--Results of a study by a group of clinicians at the Chaim Sheba Medical Center and Tel Aviv University, presented at the 42nd Annual Meeting of the European Association for the Study of Diabetes taking place September 14-17, 2006 in Copenhagen-Malmo, indicate that NBM-100G, a non-invasive continuous glucose monitoring system developed by OrSense Ltd., accurately measures levels of glucose in a home-like setting.
A multi-center trial was performed in order to study the performance of the NBM-100G device over a full dynamic range of blood glucose and a variety of continuous glucose monitoring applications as follows: one simulated a home-use trial, and two additional trials ran for 24 hours, including nighttime measurements. The trials consisted of 119 daily sessions measuring 27 subjects, 10 females and 17 males, between the ages 20-74; 17 subjects were Type I diabetes patients and 10 were Type II.
In all three trial settings, the non-invasive data were collected every 10 minutes, and the results were compared to measurements obtained by conventional invasive methods collected every hour. The range of glucose levels measured in the study was 38-488 mg/dl. The resulting Mean Relative Absolute Difference was 19.5%. A Deming Regression yielded a slope of 0.92, and a Clarke error grid analysis showed that 94.7% of the measurements fell within the clinically accurate and acceptable zones A and B.
The NBM-100G device is based on "Occlusion Spectroscopy", OrSense's proprietary measurement technology. This breakthrough technology enables, for the first time, the generation of optical signals across the finger which overcomes the key technological barrier related to the very low signal to noise ratio and non-specificity inherent in competing approaches. Analysis of the signal provides the sensitivity necessary to measure blood glucose and other analyte concentrations.
"Continuous non-invasive glucose monitoring holds the potential to significantly improve the treatment and health of people with diabetes," said Prof. Avraham Karasik, Director of the Institute of Endocrinology, Chaim Sheba Medical Center, Tel Hashomer, Israel and the principal investigator of the study. "For over a year, we have been conducting extensive research with OrSense's non-invasive continuous monitoring device in various clinical settings, including home-like environments and critical care units. We are happy to report that in all these settings performance was very good and user compliance was positive," Prof. Karasik concluded.
Lior D. Ma'ayan, Chief Executive Office of OrSense said, "This trial, conducted by researchers at the Sheba Medical Center and Tel Aviv University, is yet another external validation of the performance of OrSense's NBM-100G system in various settings, showing accurate measurements across the full range of glucose levels, during both day and night. OrSense's device is expected to begin a regulatory approval process next year, and we believe we are positioned to bring to market the world's first non-invasive glucose monitor, promising a dramatic improvement in the quality of life of millions of people with diabetes worldwide," added Mr. Ma'ayan.
OrSense is a medical device company developing non-invasive glucose monitoring systems for people with diabetes. The Company's products are based on its proprietary Occlusion Spectroscopy technology. OrSense also develops and markets non-invasive monitoring products for other critical blood parameters, such as hemoglobin. The Company's first commercial product is CE approved for monitoring hemoglobin and hematocrit. OrSense's intellectual property portfolio consists of 20 granted patents, with over 25 additional applications in process. Investors include Israel Health Care Ventures and STAR Ventures. For additional information, please visit OrSense's corporate Website at www.orsense.com.
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