BERLIN, Germany--(BUSINESS WIRE)--OrSense Ltd., developer of monitors for non-invasive measurements of various blood parameters, announced at the XXXIst International Congress of the International Society of Blood Transfusion (ISBT), in Berlin, Germany, the presentation of NBM 200, a non-invasive hemoglobin (Hb) measurement system for various hematological applications including anemia monitoring, hemorrhage detection and pre-donation screening. The Company presented results showing that Hb measurements obtained by the NBM 200 showed accurate performance compared with invasive point of care (POC) devices.
Hemoglobin (Hb) measurements allow the detection of anemia and hemorrhage, and are widely used by hospital wards such as operation rooms, ICU, ER and delivery rooms. In blood donation centers, a predonation Hb measurement of blood donors is required by most countries to protect anemic donors, and to ensure adequate Hb content of blood units. The determination of Hb levels of prospective blood donors is usually performed using capillary blood obtained by ?nger pricking, rendering current Hb screening methods invasive, painful, time consuming and labor intensive.
Dr. Paul Holland, Former President of the ISBT, said, "OrSense's non-invasive solution has the potential for improving anemia screening and monitoring by eliminating pain, reducing infection risk and enabling a simple and fast diagnosis."
"Hb measurements obtained by the NBM 200 in multiple applications, showed accurate performance compared with the gold standard invasive reference values. Our non-invasive system was found to be environmentally friendly, safe, fast and easy to use by the operating staff," said Lior D. Ma'ayan, OrSense's CEO. "Our spot and continuous non-invasive devices, which we launched last year, are already in use for various hematological applications, improving donor and patient safety and care."
Non-Invasive Hemoglobin Measurement
OrSense's non-invasive Hb measurement has many advantages including the prevention of pain and potential transmission of infectious diseases, a reduced need for trained personnel, short measurement time, and the absence of bio-hazardous waste. NBM 200 offers a unique, breakthrough, non-invasive solution for accurate and quick Hb measurements. This portable device operates via a ring-shaped sensor that is fitted on the donor'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.
Results of the Hb Clinical Trial
The bulk of the clinical trials for Hb measurement were conducted in a hematology department and in a blood donation center on 662 volunteers (370 male, 292 female), in the age range 18–65 years. Another clinical trial was performed in an intensive care unit, on 19 critical care patients (5F 14M, ages 22–90), and was reported earlier this month in the European Anesthesiology Association meeting in Helsinki. The NBM 200 results were compared with reference values obtained from invasive measurements measured with a gold standard hematology analyzer.
Hb reference values ranged from 7 g/dl to 17.7 g/dl, with an average of 13.6 g/dl. The mean difference (error) between the NBM Hb readings and the venous references was 0.1 g/dl, the mean absolute error (MAE) was 0.85 g/dl, and the standard deviation of error (STD) was 0.98 g/dl.
In the second part of the trial, the repeatability of NBM 200 was evaluated on 10 volunteers, each undergoing approximately 35 measurements each. For the 349 data points obtained, in the range 11.5–16.2 g/dL, the MAE and STD were 0.61 and 0.7 g/dL respectively and the bias was –0.4 g/dL. Measurement precision, defined as the mean patient's standard deviation, was 0.5 g/dL.
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 FDA cleared NBM 200MP is a non-invasive blood oximetry monitor for use in hospitals. OrSense's non-invasive hemoglobin/hematocrit monitor was granted the CE approval and was tested on over 8,000 patients and donors at 20 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.