OrSense Ltd. Presents Non-Invasive Hemoglobin Screening Device for Use in Blood Collection Centers
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.
A non-invasive Hb measurement has many advantages including the prevention of pain and potential transmission of infectious diseases, a reduced need for trained personnel, a relatively 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. The 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.
"We are proud to introduce our truly revolutionary solution for non-invasive Hb screening for use in blood banks, which has demonstrated comparable performance to that of invasive POC devices," said Lior D. Ma'ayan, CEO of OrSense. "Our novel non-invasive oximetry and hemoglobin monitor, which was introduced earlier this year in Europe, addresses markets that represent annual revenue opportunities of over $U.S. 2 billion. The product will be submitted for FDA review in the coming months."
Results of Non Invasive Hemoglobin Measurement In order to test the safety and efficacy of the NBM-200 for measurement of Hb and anemia screening, a clinical trial was conducted in the hematology and blood bank department of Assaf Harofeh Medical Center in Israel on a group of 552 volunteers (297 male, 255 female), in the ages of 18-68 years. The NBM-200 results were compared to a reference value obtained from a venous sample and evaluated on a Sysmex 2100 blood analyzer. Hb reference values ranged from 7.0-17.2 g/dL. The mean bias between the NBM200 Hb readings and the venous reference was 0.06 g/dL, mean absolute error (MAE) was 0.82 g/dL and standard deviation (STD) was 0.99 g/dL. Repeatability was tested on 10 volunteers who were enrolled for an hour of repeated Hb measurements, approximately 35 measurements each. The Hb range was 11.5-16.2 g/dL. Measurement precision, defined as the mean patient's standard deviation, was 0.5 g/dL. The MAE and STD were 0.61 and 0.7 g/dL respectively and the bias was –0.4 g/dL. The staff found NBM-200 easy to use, reliable and safe. Training was quick, lasting no more than 30 minutes and did not require any special expertise. Acceptance by volunteers was very good, describing it as comfortable and much preferred over invasive measurements. About OrSense 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 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 A Weinstein, O Herzenstein, S Zilberman, E Gabis, E Carlebach and A Korenberg “Anemia screening by non-invasive measurement of Hemoglobin using occlusion spectroscopy ” AABB 2009 Contacts OrSense Ltd. Tsipi Haitovsky Media Liaison Tel: +972-52-598-9892 tsipi.haitovsky@orsense.com Source: OrSense Ltd.