NEW ORLEANS--(BUSINESS WIRE)--OrSense Ltd., developer of monitors for non-invasive measurements of various blood parameters, presented today at the American Association of Anesthesiologists (ASA) annual meeting, in New Orleans. The results from a multi-center study indicate that NBM-200MP, a continuous, non-invasive monitoring system, measures levels of oxygen saturation and hemoglobin accurately and reliably in comparison to accepted methods1
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. In addition, Pulse Oximetry has become a standard of care in the operating and recovery rooms, intensive care units and emergency services, yet is 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 accurate non-invasive, continuous measurements of both Hb and oxygen saturation in states of hypovolemia, hypothermia and vasoconstriction or during open heart surgery, as well as during regular perfusion.
Non Invasive Hemoglobin Measurement
In order to investigate the safety and efficacy of the NBM-200MP, a two-phase clinical study was conducted. The first phase was performed on healthy volunteers in the VA Medical Center in Milwaukee and the second on critically ill patients at Rabin Medical Center ICU, Petach Tikva, Israel. The first phase of the study was designed to determine the performance of the OrSense device under weak pulse conditions. Ten healthy volunteers underwent induced hypoxia. Weak pulse conditions were emulated by a brachial cuff. The readings were compared to arterial blood reference values. 358 measurements were taken with a Hb Reference range of 11.5-16.2 g/dL and overall results showed a standard deviation (STD) of 0.70 g/dL and a precision of 0.50 g/dL. The second phase was performed on 19 ICU patients who were monitored for up to 24 hours; readings were compared to reference arterial blood measurements. 287 measurements were taken with a Reference Hb range of 7-14.5 g/dL and the STD was 1.17 g/dL. Results of both trials show that in Hb monitoring, the NBM-200MP device exhibits accuracy similar to invasive point-of-care solutions while allowing for continuous trending information and demonstrating clear superiority in safety and ease of use.
Low signal Oxygen Saturation Measurement
In order to evaluate the OrSense oximeter, in the first phase of the study, the readings were compared to “high end” pulse oximeters in addition to arterial blood reference values. The study included 438 readings. Under all conditions, NBM-200MP error levels were 2.2% (Arms), with a correlation of 0.96 and a bias of 0.05%, while in over 70% of limited pulse conditions the alternative pulse oximeters either failed to work or showed erroneous values. In the second phase, during a 24 hour ICU session, reference values of arterial oxygen saturation were in the range of 60% - 99%. The error of the non-invasive occlusion-based device was 3.7% (Arms), with a correlation of 0.91. In all above cases, the OrSense device continued to function accurately under weak pulse conditions.
"The results of this study are indicative of our superior capabilities in delivering breakthrough non-invasive technology for monitoring various blood parameters," said Lior D. Ma'ayan, CEO of OrSense Ltd. "Our product, which was introduced earlier this year in Europe, addresses markets that represent annual revenue opportunities of over $U.S. 2 billion. We believe that our system will enhance the quality of treatment and reduce cost of operation in hospital wards and outpatient clinics."
NBM-200MP operates via a ring-shaped sensor that is fitted on the patient’s finger and applies a 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 constituents, while greatly improving patient comfort, eliminating infection risk, and providing the caregiver with superior accuracy and immediate results. The device is well suited for use in a variety of clinical environments, including perioperative and critical care, emergency medicine, blood donation facilities, women’s health, primary care physician’s offices and homecare.
OrSense develops and commercializes non-invasive monitoring systems for measurements of oxygen saturation, hemoglobin, glucose and other blood parameters. The Company's flagship product is the NBM-200MP, a multi-parameter non-invasive continuous blood oximetry and hemoglobin monitor for use in hospitals. OrSense’s non-invasive hemoglobin/hematocrit and oxygen saturation monitor was granted the CE approval and was tested on over 5,000 subjects 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.
1 Weinstein A, Herzenstein O, Gabis, E, Kagan, I, Singer P. & Clifford P. “Pulse-independent, Non-invasive Hemoglobin and Oxygen Saturation Monitor - A Multi-Center Study” ASA 2009