Healthcare Industry News:  Glucose Monitor 

Devices Monitoring Regulatory

 News Release - March 24, 2009

OrSense Receives European CE Mark Approval for Continuous Non-Invasive Hemoglobin and Pulse Oximetry Monitoring System

Data Presented at the International Symposium on Intensive Care and Emergency Medicine Demonstrate the Accuracy, Safety and Efficacy of the Device

BRUSSELS--(HSMN NewsFeed)--OrSense Ltd., developer of monitors for non-invasive measurements of various blood parameters, announced today at the 29th International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels, Belgium, that it has received a European CE Mark (Conformité Européenne) approval for its NBM-200MP, a multi-parameter sensor for non-invasive continuous hemoglobin, low signal oximetry and pulse rate measurements.

"We are excited about receiving the European CE approval for NBM-200MP. This is an important milestone for OrSense in the path for developing and marketing our unique non-invasive multi-parameter blood monitoring device, which is expected to enhance the quality of treatment and reduce operational costs in hospitals," said Lior Ma'ayan, CEO of OrSense. “Upon receiving the CE mark, we will soon initiate sales in various counties in Europe.”

The Company is holding a symposium that will be chaired by Professor Pierre Singer, MD, Head of the Intensive Care Department, Rabin Medical Center, Petah-Tikva, Israel and Sackler School of Medicine, Tel Aviv University, who will present new data indicating that OrSense's non-invasive continuous monitoring system accurately measures levels of oxygen saturation, hemoglobin and glucose in an intensive care unit.

Hemoglobin (Hb) level, a parameter which indicates hemorrhage or anemia, is a key measurement in hospitals and outpatient wards. However, current hemoglobin measurements are invasive, time consuming, labor intensive and costly. Non-invasive pulse oximetry has become a standard of care throughout the medical world, yet it has been known to provide erroneous oxygen saturation readings in states of low perfusion, low cardiac output and/or low blood flow. The NBM-200MP system offers for the first time a non-invasive, continuous and accurate measurement of oxygen saturation under all physiological conditions, as well as a unique, breakthrough non-invasive solution for accurate continuous and spot Hb measurements.

About NBM-200MP

NBM-200MP operates via a ring-shaped sensor that is fitted on the patient’s finger and applies a gentle pressure, temporarily occluding 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 constituent, while greatly improving patient comfort, eliminating infection risk, and providing the caregiver with superior accuracy and immediate results.

About OrSense

OrSense is a medical device company developing non-invasive monitoring systems for measurements of oxygen saturation, hemoglobin, glucose and other blood parameters. The Company's flagship product is the CE approved NBM-200MP, a multi-parameter non-invasive continuous blood oximetry and hemoglobin monitor for use in hospitals. OrSense’s non-invasive hemoglobin/hematocrit monitor was also granted the CE approval and was tested on over 4,000 patients at 15 sites in the U.S. and Europe. The Company's products are based on its proprietary Occlusion Spectroscopy technology, which overcomes key obstacles that hinder the performance of competing approaches. OrSense's CE approved Glucose Monitor was tested on over 450 diabetic subjects, showing performance similar to those of invasive glucose sensors. Investors in the Company include Israel Health Care Ventures and STAR Ventures. For additional information, please visit OrSense’s corporate website at www.orsense.com.


Source: OrSense

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