Healthcare Industry News: spectroscopy
News Release - June 20, 2007
OrSense Receives European CE Mark Approval for Continuous Non-Invasive Glucose Monitoring SystemNES ZIONA, Israel--(HSMN NewsFeed)--OrSense Ltd. announced today that it received European CE Mark (Conformite Europeene) approval for its NBM-200G, a non-invasive continuous monitor of blood glucose for people with diabetes.
Blood-glucose monitoring plays a key role in the treatment of diabetes, where frequent measurements are essential for managing the disease. There is a dramatic increase in the incidence of diabetes in recent years, leading to large numbers of patients who require a simple, comfortable glucose measurement method in order to comply with the difficult self-monitoring regimen required to maintain their health. However, the usual invasive glucose measurement method, based on highly uncomfortable finger pricking, is not feasible for frequent implementation, calling for a non-invasive alternative. OrSense's non-invasive blood glucose measurement device is therefore poised to provide a dramatic improvement in the quality of care and quality of life of people with diabetes.
The NBM-200G is based on OrSense's proprietary breakthrough technology that allows non-invasive measurement of analytes including glucose, hemoglobin, and oxygen saturation with very high sensitivity. The NBM-200G is operated by placing a ring-shaped probe around the patient's finger, which applies a gentle pressure to the finger, similar to that applied during non-invasive blood-pressure measurement and temporarily occludes the blood flow. During the occlusion, optical elements in the sensor perform a sensitive measurement of the light transmitted through the finger. This method, called Occlusion spectroscopy, provides a quick, accurate and painless measurement of the patient's blood glucose. The method was tested on over 400 subjects, exhibiting comparable accuracy to invasive solutions, while providing superior ease of use and safety. In addition, the NBM-200G enables the identification of glucose trends and the detection of hypo- and hyperglycemia events and may also optimally answer the growing need for tight glycemic control in acute care settings, thereby reducing morbidity and mortality.
"There is a growing body of work supporting the benefit of continuous glucose monitoring in improving the treatment and health of people with diabetes," said Professor Avraham Karasik, Director of the Institute of Endocrinology, Chaim Sheba Medical Center, Tel Hashomer, Israel. "We have been studying OrSense's non-invasive continuous monitoring device on a significant number of patients in a home-like environment and in acute care settings. The device's performance is extremely robust and reliable, user compliance is very good with no adverse effects, and the results are promising."
"We are excited about receiving the European CE approval for NBM-200G. This is an important milestone for OrSense in the path for developing the first fully non-invasive glucose monitoring device," said Shimon Eckhouse, Ph.D., Chairman of OrSense. "This unique achievement is a result of the hard work, persistence and the high level of the management and the scientific teams at OrSense and it will play a very significant role in improving the quality of life of millions of diabetic patients around the world," concluded Dr. Eckhouse.
Clinical Trials Results
The accuracy, safety and efficacy of the NBM-200G were demonstrated in a clinical trial which assessed a full range of blood glucose levels and a variety of glucose monitoring applications.
The trial was conducted at the Sheba Medical center and in an outpatient clinic representing a home-like setting. The trial served to demonstrate the NBM-200G's reliability and patient compliance. Twenty eight subjects with diabetes type I or II participated in the trail, with 1 to 8 sessions of glucose measurements for up to 24 hours. In the 150 sessions collected in the trial, reference blood glucose ranged from 40 to 496 mg/dL. The Median Relative Absolute Error (MRAE) of the evaluated glucose was 10.1%, and the correlation was r = 0.84. A Clarke grid analysis yielded 95.3% of all points in the A+B zones (69.0% A, 26.4% B) and no points in the E zone.
An abstract containing data from clinical trails demonstrating the reliability of NBM-200G was accepted for a poster presentation (number 442-P) entitled "A Non-Invasive Prospective Continuous Glucose Monitoring System" by Amir et. al. at the 67th Scientific Session of the American Diabetes Association (ADA), taking place on June 22-26 in Chicago. In addition, clinical trails results have been accepted for publication at the 4th issue of Diabetes Science and Technology (July, 2007) in a paper entitled "Continuous Non-Invasive Glucose Monitoring Technology Based on "Occlusion spectroscopy".
The World Health Organization (WHO) estimates that 180 million people worldwide have diabetes, and this number is likely to double by 2030. Diabetes is a chronic disease that occurs when the pancreas does not produce enough insulin, or, when the body cannot effectively use the insulin it produces. Insulin is a hormone that regulates blood sugar. Hypoglycemia (low blood sugar) and hyperglycemia (high blood sugar) is a common effect of uncontrolled diabetes and over time can lead to serious complications and cause damage to the body's systems, including the heart, blood vessels, eyes, kidneys, and nerves.
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. OrSense's intellectual property portfolio consists of 44 granted patents with over 20 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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