Sphere Medical Holding Regulatory News (SPHR)

25 October 2013

Sphere Medical Holding plc

Successful Completion and Positive Findings from Proxima Usability Study at Queen Elizabeth Hospital, Birmingham

Further Significant Step Towards Achieving Proxima CE Mark

Cambridge, UK, 25 October 2013: Sphere Medical Holding plc (AIM: SPHR.L), a leading developer of innovative monitoring and diagnostic products for the critical care setting, today announces that it has successfully completed an extensive Proxima system usability study at the Queen Elizabeth Hospital, Birmingham, UK. These positive findings from the usability study form an important part of the dossier for CE Marking of Proxima.

Results from the study, the largest of its kind undertaken to date by Sphere Medical and conducted by an independent third party, found that all of the usability targets for the Proxima system were met and that of the 50 participants that rated the system, 42 said it was either "Very Easy" or "Easy" to use while 8 were "Neutral" on ease of use. During the study, anesthetists, ICU nurses and operating department practitioners were trained for one hour in the use of the Proxima system before being assessed on their ability to operate the device under both ICU and operating theatre conditions.

Following receipt of CE Mark authorisation, Sphere Medical intends to launch Proxima in the UK, initially in key strategic UK teaching hospitals and subsequently in targeted clinical application areas suitable for early adoption of the Proxima system.

 Commenting on this announcement: Stuart Hendry, CEO for Sphere Medical, said: "We are all delighted with the results from this study. The clinical usability of our Proxima medical device design is hugely important to its commercial success once it reaches the marketplace. Furthermore, the successful completion of the study is an important additional milestone towards achieving CE marking of Proxima. Today's news further de-risks Proxima and is another step closer to the launch of Proxima in the UK which we are planning for the first half of next year."

For further information, please contact:

Sphere Medical Holding plc Tel: +44 (0)1223 875222

Dr Stuart Hendry, Chief Executive Officer

Matthew Hall, Chief Financial Officer

Peel Hunt LLP Tel: +44 (0) 20 7418 8900

James Steel

Dr Vijay Barathan

Jock Maxwell Macdonald

finnCap Tel: +44 (0) 20 7220 0500

Geoff Nash / Simon Hicks

Stephen Norcross

Consilium Strategic Communications Tel: +44 (0) 20 7920 2354

Mary-Jane Elliott spheremedical@consilium-comms.com

Amber Bielecka

Matthew Neal

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 products deliver real time analysis of blood gases, electrolytes and drug levels with laboratory accuracy, at the patient's bedside. Sphere Medical's products can be used in a wide range of medical applications, enabling faster clinical decision making and improved patient outcomes, whilst reducing costs for healthcare payers.

On 28 June 2013, Sphere Medical announced that it has entered into a Collaboration agreement entered with Ortho-Clinical Diagnostics, Inc., part of the Johnson & Johnson family of companies, for the development of Proxima and enhancement of Sphere's operational and production capabilities.

Sphere Medical has a number of partnerships with industry leading medical device companies with strategic investments such as Ortho-Clinical Diagnostics, Inc. and Sorin Group.

For further information, please visit www.spheremedical.com