Sphere Medical Holding Regulatory News (SPHR)

8 July 2013

Sphere Medical Holding plc

Positive results from Proxima technology in clinical development study

~ Technology met primary end point and demonstrated equivalent performance to gold standard methods

Cambridge, UK, 8 July 2013: Sphere Medical Holding plc (AIM: SPHR.L), a leading developer of innovative monitoring and diagnostic products for the critical care setting, is pleased to announce the successful completion of a further clinical development study on the Proxima technology. The study met the primary end point to demonstrate equivalent performance to laboratory and point-of-care blood gas analysers measuring various arterial blood parameters in a clinical setting at the Queen Elizabeth Hospital, Birmingham, UK and West Suffolk Hospital, Bury St Edmunds, UK.

The study, which evaluated on a total of 105 blood samples drawn from eighteen patients undergoing surgery, incorporated a number of system enhancements that will be fully implemented in Proxima 3. These include the addition of Haematocrit (a measure of the percentage of red blood cells to the total blood volume) to the measurement panel as well as several significant design improvements which have been incorporated to improve usability of the system.

Within the study, each blood sample drawn was tested using both Sphere Medical's Proxima technology and the current gold standard laboratory and point-of-care blood gas analysers before flushing to waste. The results from the Proxima technology showed equivalence with the reference methods across all parameters. The Company is planning to submit results for publication in a peer reviewed clinical journal.

Sphere Medical is in advanced preparations for CE Marking of Proxima 3. This important European regulatory approval will enable the launch of Proxima 3 into the UK market in H1 2014.

On 28 June 2013, Sphere Medical announced that it has entered into a Collaboration Agreement with Ortho Clinical Diagnostics, Inc. ("OCD"), a subsidiary of Johnson & Johnson, for the development of Proxima 4 and the enhancement of Sphere's operational and production capabilities. The Collaboration Agreement also provides a framework for OCD and Sphere Medical to negotiate a proposed global commercialization deal for Proxima 4.

Commenting on this announcement: Dr Stuart Hendry, CEO of Sphere Medical, said: "In this study we have demonstrated in a clinical setting a number of important system enhancements and usability improvements that will be implemented in the commercial Proxima 3 product. This additional study data contributes to the significant progress we have made with Proxima and we are now in advanced preparations for CE Marking of Proxima 3 which will enable us to launch Proxima 3 into the UK market in H1 2014."

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Notes for Editors

Sphere Medical (AIM: SPHR.L), is a medical device company developing a range of innovative monitoring and diagnostic devices designed to significantly improve patient care.

Sphere Medical's Proxima and Cardiopulmonary Bypass devices deliver real time analysis of blood gases, electrolytes, glucose and drug levels with laboratory accuracy, at the patient's bedside. Globally over 240 million blood gas and electrolyte tests are carried out on patients every year in critical care and there is an unmet need for monitoring products that are small, simple to use and cost effective with improved functionality. Sphere Medical's products can be used in a wide range of medical applications enabling faster clinical decision making and consequently improved patient outcomes, whilst also reducing costs for healthcare payers.

Sphere Medical is headquartered in Cambridge, UK. The Company has existing commercial partnerships with leading global medical device companies.

For further information, please visit www.spheremedical.com