OptiScan Biomedical Receives CE Mark for OptiScanner® 6000 Automated Device for Monitoring Multiple Key Analytes in ICU Patients
Company Secures EU Certification for World’s First Non-Calibrated Automated System for Near Continuous Monitoring of Multiple Analytes in Critically Ill Patients
San Francisco, CA, January 9, 2017 – OptiScan Biomedical Corporation, a developer of innovative automated bedside monitoring for use in the intensive care unit (ICU), today announced that the OptiScanner® 6000 has received CE Mark certification for use in the European Union. The OptiScanner 6000 combines near-continuous glucose monitoring with the complementary ability to automatically and serially monitor levels of lactate using the same micro-sample of the patient’s blood. CE Mark certifies that the OptiScanner 6000 has met all relevant EU consumer safety, health and environmental requirements, allowing it to be sold and marketed in the 30 countries that make up the European Economic Area (EEA). OptiScan plans to initiate marketing of the OptiScanner 6000 in the EU later this year.
The OptiScanner 6000 is an automated bedside monitoring technology capable of providing near continuous tracking of glucose and lactate within a single patient micro-sample of blood. The system is designed to overcome the limitations of today’s intermittent, manually operated monitoring devices and provide physicians with the tools and information they need to best manage patient glucose and lactate levels in the ICU.
With its glucose monitoring capabilities, the OptiScanner 6000 represents a significant advancement in the delivery of care to ICU patients by helping to prevent and combat both hyperglycemia and hypoglycemia through automated monitoring of patients’ glucose in plasma, as opposed to whole blood. It is estimated that approximately 20 percent of ICU patients have pre-existing diabetes and an additional 40 to 70 percent of ICU patients suffer from “stress hyperglycemia” or a temporary elevation of glucose levels, with all of these patients requiring accurate glucose monitoring to maintain tight glycemic control.
The ability to serially measure patient lactate levels further expands the capability of the OptiScanner 6000 to optimize patient care in the ICU. Medical literature demonstrates that elevated lactate levels are common in patients with critical illnesses such as sepsis, burns and trauma, and are associated with adverse clinical outcomes. Recent sepsis definition changes suggest interventions for these conditions are considered effective if lactate is shown to decrease over a given time period, though verifying a reduction in lactate levels is very problematic with today’s intermittent, manually based systems. Accordingly, the near continuous tracking of lactate levels represents an important advancement in monitoring and guiding interventions in critically ill patients.
“The receipt of the CE Mark for the OptiScanner 6000 is a key milestone for our company as it demonstrates the potential of our proprietary technology to function as a broad expanding platform capable of monitoring multiple analytes using a single micro-sample of blood. While near continuous monitoring of glucose in the ICU is critical, there are a number of additional metabolic analytes, including lactate, whose serial measurement is also important for optimizing patient care,” said Peter Rule, chairman and chief executive officer of OptiScan Biomedical. “By providing ICU physicians the means to serially monitor both lactate and glucose in the same, single micro-sample of the patient’s blood, we believe that the OptiScanner 6000 will play an important role in continuing to elevate the level of care delivered to ICU patients.”
The OptiScanner platform offers several key advantages as compared to intermittent, manually operated technologies including:
- Measuring analytes in plasma as opposed to measurement in whole blood, which is used by various intermittent, manually operated technologies, yields superior accuracy.
- Providing a trend to assess both glucose and lactate therapies with automated measurement every 15 minutes. Trending is not available in intermittent, manual systems.
- Freeing nursing to perform direct patient care by improving Nursing Hours per Patient Day (NDNQI Indicator). Current studies suggest that up to two hours per day of nursing time could be required for intermittent, manually operated technologies.
- Eliminating handling errors associated with blood samples drawn for intermittent, manually operated technologies.
- Triggering alarms to prompt clinical action.
- Incorporating a range of ease-of-use features including: touch screen; graphic user interface that virtually eliminate the need for in-service to assist in set up or operation; and reagent-free measurement which removes the need for daily calibration.
The OptiScanner’s measurement technology has been studied in a variety of ICU settings involving a broad range of critically ill patients, with results from this research being presented at several major medical conferences. OptiScanner is broadly protected by OptiScan’s portfolio of 38 issued U.S. patents which cover key technologies such as fluid separation, automatic sample anti-coagulation without return to patient and network connectivity, among others.
About OptiScan Biomedical
OptiScan Biomedical is a leading developer of innovative automated bedside monitoring systems for use in intensive care units (ICU). The company’s OptiScanner® platform is an automated bedside monitoring technology that provides highly accurate, near-continuous monitoring of key analyte levels, including glucose and lactate, measured in plasma, as opposed to whole blood. The system prominently displays analyte level trend data updated every 15 minutes to help manage patients’ glucose levels and optimize patient care in the ICU. The company’s OptiScanner 6000 is designed to automatically and serially monitor levels of both glucose and lactate in the same micro-sample of patient blood. OptiScan has received CE Mark certification for the OptiScanner 6000 in the EU.