9 August 2010: Sphere Medical, the UK-based medical monitoring innovator, is pleased to announce the positive results from its FDA regulatory clinical evaluation of the In Vitro Blood Gas Monitor, proving that its microanalyser technology has the potential to bring laboratory standard monitoring to the patient’s bedside.
Following Research Ethics Committee approval and performed to CLSI guidelines, the trial evaluated and compared Sphere Medical’s In Vitro Blood Gas Monitor to a current gold standard laboratory blood gas analyser and was completed at the Queen Elizabeth Hospital, Birmingham, UK. Data for glucose, pH, carbon dioxide, oxygen and potassium ion levels were collected from over 100 Intensive Care Unit (ICU) patient samples. Analysis of the data collected demonstrated that the In Vitro Blood Gas Monitor met clinically acceptable standards for measuring critical blood parameters.
The In Vitro Blood Gas Monitor uses Sphere Medical’s patented microanalyser technology. It is based on a pair of silicon chips, one with a sensor array, the second containing the electronics required to control the sensors. The platform technology is being applied by Sphere Medical to a number of point-of-care devices that will deliver substantial practical and economic benefits in the hospital environment. They have the ability to provide high quality, reliable real data at the patient’s bedside enabling improved monitoring and patient care.
Dr Tom Clutton-Brock, Senior Lecturer in Anaesthesia & Critical Care at the University of Birmingham commented:
“The microanalyser based In Vitro Blood Gas Monitor performed extremely well in the clinical environment and measured glucose, pH, carbon dioxide, oxygen and potassium levels across a wide range with a level of accuracy and precision comparable to our standard bench top laboratory analysers. The development of true point-of-care testing will be an important advancement in the care of critically ill patients.”
Dr. Stuart Hendry, CEO of Sphere Medical noted:
“This clinical study demonstrated unambiguously that Sphere’s microanalyser technology is capable of analysing critical blood parameters with a performance that is equivalent to that of the current standard of care laboratory analysers. Current systems are large, expensive and are usually sited a distance from the patient. Sphere’s microanalyser technology is at the heart of a number of products in late stage development that will begin to be rolled out this year. These will, for the first time, provide real time data of a quality equal to that from a central laboratory but available at the patient’s side. This is a major step forward for Sphere Medical.”
About Sphere Medical
Sphere Medical is developing highly innovative monitoring products to provide clinical and economic benefits in the critical care environment, based on the Company’s proprietary microsensor technology. The products allow minimally invasive, real time measurement of clinical chemistry parameters and therapeutic drug concentrations, giving healthcare professionals the information they require to more effectively manage therapy and optimise patient outcomes. Sphere Medical was founded in 2002 and is based in Cambridge, UK.
For more information, please visit www.spheremedical.com, or contact:
Dr. Stuart Hendry Tim Anderson, Catherine Breen Chief Executive Officer Buchanan Communications Sphere Medical Holding PLC Tel: +44 (0) 20 7466 5000 Tel: +44 (0)1223 875222
