OptiScan Biomedical Enrolls First Patient in Pivotal U.S. Clinical Study of OptiScanner® 5000 Pivotal Trial to Build on Previous Positive Studies; Aims to Further Demonstrate Paradigm-Shifting Potential of Automated, Bedside Glucose Monitoring System in the ICU
HAYWARD, Calif., April 28, 2014 /PRNewswire/ -- OptiScan Biomedical Corporation, a developer of innovative continuous monitoring systems for use in the intensive care unit (ICU), today announced the enrollment of the first patient in a pivotal, multi-center Investigational Device Exemption (IDE) clinical study of the OptiScanner® 5000. The OptiScanner 5000 is the company's first-of-its-kind automated, bedside glucose monitoring system that provides physicians with critical information to manage patient glucose levels in the ICU.
The pivotal trial, known as the MANAGE IDE Study (Manual vs. Automated moNitoring Accuracy of GlucosE IDE), is expected to enroll 200 patients at up to 10 sites, most of which will be located in the U.S. The study's initial three clinical sites include: Washington University School of Medicine in St. Louis, MO; Tufts University School of Medicine in Boston, MA; and Saint Luke's Mid-America Heart Institute in Kansas City, MO. If successful, the MANAGE IDE study will serve as the basis for an application for approval in the U.S.
The OptiScanner 5000 represents a significant advancement in the delivery of care to ICU patients by automating the measurement of patients' plasma glucose, as opposed to current manual measurement of glucose in whole blood. It is estimated that approximately 20 percent of ICU patients have pre-existing diabetes and an additional 40 to 60 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 glycemic control.
"The initiation of this pivotal study of the OptiScanner 5000 represents a key milestone for OptiScan as we continue our efforts to bring the paradigm-shifting potential of this platform to critically ill patients and those ICU physicians responsible for their care," said Peter Rule, chairman and chief executive officer of OptiScan Biomedical. "There is an acute need for breakthrough technologies that enable the automated, real-time monitoring of blood glucose in ICU patients in order to combat both the hyperglycemia and hypoglycemia that further complicate their already challenging health conditions. Our extensive clinical research to date demonstrates the OptiScanner 5000's ability to safely and effectively meet these needs and we are eager to see the MANAGE IDE trial further corroborate those findings."
This pivotal MANAGE IDE study follows OptiScan's previously completed MANAGE I and MANAGE II trials, which were conducted at two world class European research centers and evaluated the OptiScanner 5000 in very sick ICU patients. Taken together, these studies represent the most comprehensive clinical validation program conducted to date with a continuous blood monitoring platform in the critical care setting. Results from these studies demonstrated the ability of the OptiScanner 5000 to combine accurate blood glucose measurement with the convenience of continuous, real-time bedside monitoring.
Based on previous studies, the OptiScanner 5000 has received CE Mark certification for use in the European Union, allowing it to be sold and marketed in the 30 countries that make up the European Economic Area (EEA). OptiScan has initiated commercial efforts in the EU in 2014.
About the OptiScanner® 5000
The OptiScanner® 5000 is a first-of-its-kind automated, bedside glucose monitoring system that provides physicians with information on glucose levels in the ICU. Through automated monitoring of a patient's glucose values in plasma (as opposed to whole blood), the OptiScanner has alarms to alert clinicians to the existence of hyperglycemia (values that are too high) and hypoglycemia (values that are too low). It is estimated that between 60-80% of all ICU patients suffer from elevated glucose values, requiring insulin delivery and frequent glucose monitoring.
About OptiScan Biomedical
OptiScan Biomedical is the world leader in developing innovative continuous monitoring systems for use in hospital intensive care units (ICU). The company has developed the OptiScanner® 5000, a first-of-its-kind automated, bedside glucose monitoring system that provides accurate, automated monitoring of patients' glucose levels measured in plasma, as opposed to whole blood. The system prominently displays glucose level trend data updated every 15 minutes to help manage patients' glucose levels within an optimum target range.
The company is currently developing a next-generation OptiScanner product. The OptiScanner 6000 will expand the glucose monitoring capability of the platform technology to include monitoring of two leading measures of cardiac output and oxygenation (hemoglobin and ScvO2) in the same single blood sample, thereby providing additional information about the condition of a critically ill patient.
For more information visit: www.optiscancorp.com
SOURCE OptiScan Biomedical Corporation