updated: 5/8/2006 9:27:20 AM

Oxford BioSignals Receives FDA Approval For Medical Device

InsideIndianaBusiness.com Report

Oxford BioSignals in Indianapolis has received U.S. Food and Drug Administration approval for a new device to monitor patients.

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BioSign is aimed at helping health care professionals and rapid response teams to assess multiple vital signs of a patient to identify changes that might not be seen through individual vital signs.

Source: Inside INdiana Business

Press Release

INDIANAPOLIS--May 8, 2006--Oxford BioSignals announced today that the Food and Drug Administration has approved its 510(k) application to market BioSign(TM) in the United States. BioSign, an accessory device to multi-parameter patient monitors, analyzes five vital signs and assigns a Patient Status Index(TM) which continuously represents how different a patient's vital signs are with respect to normal patient conditions. BioSign is intended to help health care professionals and Rapid Response Teams identify patients in crisis and intervene earlier to correct the problem. Earlier intervention is expected to lead to reduced code calls and lower mortality within the hospital.

A rapid response team (RRT) or medical emergency team (MET) is summoned when a patient's condition deteriorates. In the case of a potential cardiac arrest, the RRT can save lives among patients who may otherwise experience cardiac arrest, by initiating changes in care that prevent the arrest or by facilitating transfer to an intensive care unit (ICU). The implementation of RRT has already been recognized by The Institute for Healthcare Improvement (IHI) www.ihi.org as a major health improvement process driver to deliver its 100,000 lives campaign. The 100,000 lives campaign is an 18 month initiative to reduce mortality within hospitals and save 100,000 patients that otherwise would have died if improvements had not been made. The IHI estimates that over 60% of the 100,000 goal can be achieved by hospitals implementing RRT. Over 3000 hospitals have enrolled in the IHI initiatives. The findings regarding RRT effectiveness are not universally proven, however. One reason given is inconsistent standards of operation adopted across individual hospital RRT programs. BioSign is intended to provide an easy, automated and standardized way for medical professionals to communicate the condition status of patients in crisis.

"Traditional patient monitoring focuses on collecting and displaying individual vital signs, while clinical information systems focus on integrating collected data," said Frank Cheng, President of Oxford BioSignals (US) Inc. "Beyond these traditional means of clinical data management, BioSign focuses on advanced interpretation of collected and integrated data to generate new clinical insights. The patented technology uses data fusion to assess patterns of multiple vital signs and to identify patient changes that may not be derived by looking at each vital sign separately."

The first BioSign clinical trial, lasting two and half years, was recently completed at John Radcliffe Hospital in Oxford UK. A white paper on the BioSign technology is available at www.biosign.net/whitepapers.asp General information is available on the product website at www.biosign.net.

About Oxford BioSignals:

Oxford BioSignals Ltd. provides intelligent data acquisition and advanced signal interpretation for Medical and Industrial sectors. Based on intelligent algorithms such as neural networks, data fusion and wave-form recognition, Oxford BioSignals technologies cover a range of medical applications including automated early crisis warning, automated assessment of ECG intervals, and EEG analysis for brain-state assessment. Oxford BioSignals industrial applications span aircraft engines, railways, pipelines and energy. Oxford BioSignals Ltd. is headquartered in Oxford UK and its U.S. subsidiary Oxford BioSignals (US) Inc. is located in Indianapolis, Indiana. Since 2003, Rolls-Royce, Oxford BioSignals and Oxford University have partnered on engine health monitoring technology that has been tested on Rolls-Royce Trent 900s and is due to go into revenue service this year. Rolls-Royce plc www.rolls-royce.com is one of the major shareholders of Oxford BioSignals. More information can be found at www.oxford-biosignals.com

Source: Oxford BioSignals Ltd.

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