NES ZIONA, Israel--(BUSINESS WIRE)--OrSense Ltd., developer of monitors for non-invasive measurements of various blood parameters, announced today it has received U.S. Food and Drug Administration (FDA) approval for NBM-200MP, a non-invasive oximetry and low signal oximetry sensor.
Non-invasive pulse oximetry has become a standard of care in the operating and recovery rooms, intensive care units and emergency services, yet it has been known to provide erroneous oxygen saturation readings in situations of low perfusion, low cardiac output and/or low blood flow. OrSense's system offers non-invasive, continuous and accurate measurement of oxygen saturation in states of hypovolemia, hypothermia and vasoconstriction or during open heart surgery, as well as during regular perfusion. The NBM-200MP’s superior performance was validated by multi-center trials in the U.S. and Europe. The studies were comprised of desaturation (induced hypoxia) trials and long-term ICU patient monitoring. The noninvasive results were compared to an arterial "gold standard" reference1.
“The ability to accurately measure oxygen saturation in states of low perfusion in acute care patients is critical for intensive care units,” said Prof. Pierre Singer, Head of the Intensive Care Unit at Rabin Medical Center in Petah Tikva, Israel. “OrSense’s non-invasive oximeter could be used for accurate, safe and easy to use oxygen saturation evaluation in various hospital wards. Consequently, it will improve patient care and survival, as well as reduce staff workload,” Prof. Singer concluded.
"We are excited about receiving our first FDA approval. Our device exhibits superior performance, and offers for the first time, a non-invasive, continuous and accurate measurement of oxygen saturation under extreme physiological conditions, including low perfusion and cases of poor signal quality," said Lior Ma'ayan, CEO of OrSense. "This is a natural development of our business strategy, subsequent to securing our initial clients and 3rd party integration agreements in Europe for our non-invasive multi-parameter sensor for hemoglobin and low signal oximetry measurements. We are looking forward to the initiation of commercial efforts in the U.S. later this year," added Ma'ayan.
Shimon Eckhouse, Ph.D., OrSense's Chairman of the board commented, “We are very pleased with the clearance by the FDA in recognition of our proprietary occlusion release technology and extensive investment in product development and clinical work. We view this clearance as the next step in OrSense’s strategy to commercialize its technology for a wide range non-invasive measurement of blood parameters.”
NBM-200MP continuously and noninvasively monitors and displays multiple blood parameters including oxygen saturation of Hb (SpO2) and low perfusion oximetry. The system permits continuous patient monitoring with adjustable alarm limits for oximetry as well as visible and audible alarm signals. A ring-shaped sensor is fitted on the patient’s finger and applies gentle pressure, temporarily occluding the blood flow. During the occlusion optical elements in the sensor perform 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 constituent, while greatly improving patient comfort, eliminating infection risk, and providing the caregiver with superior accuracy and immediate results.
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 approved 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. For additional information, please visit OrSense’s corporate website at www.orsense.com.
1 Weinstein et al. "Monitoring of oxygen saturation in low perfusion" European Journal of Anaesthesiology, S. 45, pg. 42, 2009