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OrSense's Non-Invasive Hemoglobin Monitor Offers for the First Time the Ability to Detect Hemorrhage Accurately and Within Minutes

Oct. 15, 2011

Nes Ziona, Israel, October 17, 2011 - OrSense Ltd., developer of monitors for non-invasive measurements of various blood parameters, presented in an oral presentation at the American Society of Anesthesiologists (ASA) annual meeting in Chicago, results showing that its NBM 200MP, a non-invasive Hemoglobin (Hb) measurement system, detects hemorrhage accurately and within minutes. The sensitivity of the NBM 200MP was 96% compared to an invasive, "golden standard" measurement, and the non-invasive monitor detected hemorrhage in less than 4 minutes.

Hemorrhage is a significant cause of complications and death in various clinical situations. For example, post-partum hemorrhage is responsible for approximately 8% of direct pregnancy-related deaths in the industrialized countries, and 25% of maternal deaths in the developing world. Hemorrhagic shock is the second most frequent cause of death in trauma patients and is the leading cause of early in-hospital trauma deaths, and pre-operative hemorrhage leads to up to 4 times complications and death.
In hospitalized patients, who routinely receive liquid infusions, blood loss is accompanied by a rapid drop in Hb concentration, due to the dilution of the remaining blood with the infusion solution. Most trauma patients (up to 90%) also present with lower hemoglobin concentrations already upon arrival in the ER. Therefore, it is possible to monitor hemorrhage and blood loss by measuring Hb levels.

And yet, although it is a common, and often deadly complication, hemorrhage is often detected too late, due to lack of continuous methods for monitoring blood loss and Hb levels. The OrSense NBM 200MP, non-invasive, continuous Hemoglobin monitor offers, for the first time, the ability to monitor blood loss continuously and to detect hemorrhage within minutes.
Lior Maayan, CEO of OrSense, said, "The study presented at the ASA meeting substantiates the potential of the non-invasive NBM 200MP for accurate, continual, safe, and easy-to-use monitoring of Hb, in particular under technological-challenging, potentially life-threatening conditions such as hemorrhage. The study shows that our continuous Hb monitor offers, for the first time, the ability to detect hemorrhage within minutes, and with minimal effort and cost. The NBM 200MP can be instrumental in saving lives and reducing hospitalization complications and costs."

Results of NBM 200MP hemoglobin clinical trial

The trial was conducted on 12 healthy volunteers in the VA Medical Center, Milwaukee, Wisconsin, and hemorrhage conditions were emulated by drawing 2 units of blood each subject. Subjects then received an infusion of isolyte fluid, which compensated for the missing blood volume and rapidly reduced the level of Hb. The removed 2 units of blood were then reinfused and increased the Hb back to normal.
Reference Hb values ranged from 8.4 g/dl to 15 g/dl and the reduction in Hb was between 2.6 g/dl and 3.8 g/dl. A reduction of 1 g/dL was taken to signify the onset of hemorrhage and was detected by the NBM 200MP in less than 4 minutes, with a sensitivity of 96%. For a total of 445 paired data points, the mean error between NBM 200MP readings and the arterial reference values was 0.29 g/dl. The standard deviation of error was 0.78 g/dl and the correlation 0.87. Use of the device did not cause any discomfort to subjects, was safe and well tolerated.

About NBM 200MP

Monitoring of Hb is essential for the detection of anemia and hemorrhage, and is widely used in the ICU, ER, operating and delivery rooms. The current measurement methods are invasive, painful, time consuming and labor intensive, and are inadequate for continuous Hb monitoring, often necessary during emergency situations, in order to detect hemorrhage. Non-invasive measurement of Hb has many advantages including the prevention of pain and potential transmission of infectious diseases, the reduced need for trained personnel and the freedom to take multiple measurements continuously. NBM 200MP offers a unique, breakthrough, non-invasive solution for accurate and quick Hb measurements.
OrSense's portable non-invasive device operates via a ring-shaped sensor that is fitted on the subject's finger and applies pressure, temporarily occluding local 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 donor's blood constituents, while greatly improving the donor's comfort, eliminating infection risk, and providing the medical staff with accurate readings and immediate results.

About OrSense

OrSense is a medical device company developing and marketing non-invasive monitoring systems for measurements of hemoglobin, oxygen saturation, glucose and other blood parameters. OrSense’s CE approved non-invasive hemoglobin monitor is available in 40 countries world-wide, and has been successfully installed in multiple environments including hospitals, physician offices, blood donation facilities, as well as used for various applications including public screening, women health and homecare. In addition, the Company's FDA cleared NBM 200MP is a non-invasive blood oximetry monitor for use in hospitals. OrSense's s products are based on its proprietary Occlusion Spectroscopy technology, which overcomes key obstacles that hinder the performance of competing approaches. The Company'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.

Press Contact:

Tsipi Haitovsky
Media Liaison OrSense Ltd.
Tel: +972-52-598-9892
Email: tsipi.haitovsky@orsense.com

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