OrSense Ltd., developer of monitors for non-invasive measurements of various blood parameters, introduced at the European Congress for Perinatal Medicine (ECPM), held in Paris, France at June 13-16, results of a successful clinical trial using NBM200, a non-invasive hemoglobin (Hb) measurement system for anemia screening and hemorrhage detection. Dr. Eran Hadar, of the Department of Maternal Fetal Medicine at Rabin Medical Center, Israel, presented results showing that OrSenes's device was as accurate as invasive point of care (POC) devices in measuring Hb levels in pregnant women.
"The clinical trial shows that OrSense's system is accurate and user friendly for determining Hb levels non-invasively," said Professor Moshe Hod, Director, Maternal Fetal Division of the Women’s Hospital at Rabin Medical Center, Israel. "Pregnant women are a particularly vulnerable anemia risk group that will greatly benefit from the ability offered by OrSenes's solution to immediately and routinely screen for anemia, as part of a regular physician checkup. However, non-invasive monitoring of Hb levels is invaluable for anemia screening and hemorrhage detection not only in hospitals and physician offices, but also in community clinics throughout the world and for home care."
Over one billion people suffer from iron deficiency anemia worldwide. During pregnancy the need for iron increases and exposes the mother to a higher risk of anemia. Anemia is a prime reason for maternal mortality and acts as a predisposition for low neonate birth weight. In addition, severe anemia may aggravate the negative effect of postpartum hemorrhage, and endanger the mother. It is estimated that 40% of maternal deaths are caused directly or indirectly by anemia.
Reducing maternal mortality is one of the key global healthcare objectives. Close to 350,000 women die each year due to lack of proper diagnosis and treatment and several millions are effected. The inability to identify and treat anemia and hemorrhage in the developing world due to lack of infrastructure and personnel is a key limitation in the UN and WHO efforts to reduce maternal mortality.
OrSense has developed and commercialized a non-invasive, portable point of care (POC) monitoring system for measuring spot and continuous hemoglobin. The device offers, for the first time an accurate, safe, fast, easy to operate and affordable solution that would allow for anemia screening and monitoring.
Being non invasive, it eliminates the need for finger prick and biochemistry based blood test, prevents infection risks and eliminates the need for handling bio-hazardous material. The continuous non-invasive hemoglobin functionality can serve for early detection of post partum hemorrhage and improved blood management post delivery. It has the potential of improving maternal health in the developed world by offering online needed information and eliminating safety risks while reducing cost of care. The system was tested on over 8,000 patients and blood donors at 20 sites in the U.S., Europe and South Africa exhibiting comparable accuracy to invasive POC solutions while also demonstrating a strong safety profile, ease of use and substantial cost reduction.
The product has received CE and CDN approvals and was submitted for FDA 510(k) clearance. The device is based on OrSense's proprietary Occlusion Spectroscopy technology, which uses a non-invasive optical measurement platform combined with a ring-shaped pneumatic probe that fits on the finger.
About the clinical trial
OrSense system non-invasive Hemoglobin (Hb) system was tested by Dr. Eran Hadar, Dr. Kinneret Tennebaum and Dr. Tal Bouganim in the Women’s Hospital of Rabin Medical Center in Petah Tikva, Israel. Two non-invasive Hb measurements were performed on the right and left thumbs of the pregnant subject. Reference Hb values were obtained from venous blood samples and evaluated on a Beckman Coulter LH 750 counter, acting as reference “gold standard”.
A total of 126 data pairs were obtained in the trial from 63 pregnant women, and the values obtained by the device were in the range 7.7 – 14 g/dL. The mean error (bias) of the NBM200 readings comparing to the reference was 0.1 g/dL and the accuracy, defined as the standard deviation of error, was 0.86 g/dL. The correlation was 0.82 and the mean absolute error was 0.71 g/dL.
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.