Positive Outcome for Proxima in Post Market Clinical Follow-up Study

Method Comparison Study completed on schedule at the Queen Elizabeth Hospital, Birmingham, UK

Cambridge, UK, 14 October 2014: Sphere Medical Holding plc (AIM: SPHR.L) (“Sphere” or “Sphere Medical” or the “Company”), a leading provider of innovative monitoring and diagnostic devices for the critical care setting, is pleased to announce a successful Proxima 3 Post Market Clinical Follow-up Study at the Queen Elizabeth Hospital, Birmingham, UK.

The study, which was completed on schedule, met the primary end point to demonstrate excellent agreement with the standard bench top blood gas analysers at the Queen Elizabeth Hospital measuring various arterial blood parameters in a clinical setting. 

A total of twenty intensive care unit patients with a range of clinical conditions, including trauma, head injury, post-surgical recovery and sepsis, were included in the study.  Patients were connected to the Proxima system for up to three days during which as many as thirty three blood gas measurements were obtained per Proxima device.  Use of the Proxima system was carried out by the clinical staff at the Queen Elizabeth Hospital who each underwent an initial ninety minute training programme. 

Within the study, each time a patient’s blood was tested using the Proxima system, a concurrent sample was drawn and tested using the hospital’s standard bench top blood gas analyser.  During the course of the study over 300 comparative measurements were taken across the Proxima system analyte range of pH, pCO2, pO2, haematocrit and K+ with each analyte showing excellent agreement with the reference bench top blood gas analyser. Results from the study are currently being prepared for submission for publication in a peer reviewed clinical journal.

Dr Tom Clutton-Brock, Chief Investigator for the study, Senior Lecturer Anaesthesia and Intensive Care Medicine, University Hospital Birmingham, said: “The main aim of this study has been to determine whether Proxima gives the same clinical results as the reference bench top blood gas analyser when it is used on patients in a clinical environment. The answer is unequivocally yes. Just as importantly, the staff using the system really appreciated how simple it was to take a measurement with Proxima. We are really excited about the impact that this could have on management of sick and unstable patients.”

Dr Wolfgang Rencken, CEO of Sphere Medical, said: “These positive study findings validate the Proxima technology within a clinical setting.  We have recently launched Proxima and have started the sales process with a number of UK hospitals.  We believe that Proxima is well suited to enable nurses and clinicians to more closely manage their unstable and critically ill patients.”