Positive Study Results with Pelorus 1500

2 December 2013

Sphere Medical Holding plc

Study Results using Pelorus 1500 at Great Ormond Street Hospital for Children Presented at Scientific Meeting

~ Pelorus 1500 accurately measured propofol concentrations and identified significant dosing errors in current methods of anaesthesiology

~ Further validation that Pelorus 1500 system provides large commercial opportunity for Sphere Medical

Cambridge, UK, 2 December 2013: Sphere Medical Holding plc ("Sphere Medical") (AIM: SPHR.L), a leading developer of innovative monitoring and diagnostic products for the critical care setting, today announces the results from a study using its Pelorus 1500 analyser that demonstrate the device can accurately measure propofol concentrations and thus identify significant dosing errors in anaesthesiology. The study was conducted at Great Ormond Street Hospital for Children ("GOSH") and the results provide an important step towards improved management of propofol dosing during surgery. Results of the study were presented at the Society of Intravenous Anaesthesia's Annual Scientific Meeting ("SIVA") on 29 November 2013. 

The study, involving 20 children undergoing major spinal surgery, was used to assess the performance of the Pelorus 1500 analyser against currently available paediatric Target Controlled Infusion ("TCI") systems using either the Paedfusor or Marsh dosing algorithm. Blood samples were analysed throughout the surgical procedure using the Pelorus 1500 analyser and the measured propofol concentrations were compared to a target level. Detailed analysis of the results by a team of researchers at GOSH, led by Dr Mike Sury, Consultant Paediatric Anaesthetist, showed significant differences between the actual and target blood concentration of propofol. Average dosing errors of 27% and 46% were recorded using the Marsh model and the Paedfusor, respectively.

Following this study, a further investigation will commence looking at ways to improve the control of propofol dosing, including the use of rapid propofol measurement during surgery utilising the Pelorus 1500 to personalise the TCI system algorithm to the patient. To this end, Sphere Medical is collaborating with the Department of Anesthesiology at the University Medical Centre Groningen (UMCG) in the Netherlands and clinicians are investigating the real time adaptation of dosing models to the individual patient using rapid propofol measurements provided by the Pelorus 1500 system.

Commenting on this announcement: Stuart Hendry, CEO for Sphere Medical, said: "The results generated in this study using our Pelorus 1500 analyser highlight that current approaches to propofol dosing can be significantly improved in surgery. Rapid propofol measurement using the Pelorus 1500 offers great potential to personalise and optimise the care of each individual patient. The work at GOSH and in Groningen is expected to result in the development of the next generation of propofol infusion protocols and control systems which we believe represent a large commercial opportunity for Sphere Medical."

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 [email protected]

Amber Bielecka

Matthew Neal

Ivar Milligan

Notes for Editors

The Society for Intravenous Anaesthesia (SIVA) is a leading international society that promotes research and education into the use of drugs administered intravenously in anaesthesia and related science areas. The Annual Scientific Meeting is a prestigious forum for presentation of leading edge research in the field of intravenous anaesthesia. For more information, visit www.siva.ac.uk

The Department of Anesthesiology at the University Medical Centre Groningen (UMCG) in the Netherlands is a leading clinical innovator in the field of anaesthetic pharmacology. Initial computer modelling to develop real time adaptation of Target Controlled Infusion ("TCI") system dosing models to the individual patient using rapid propofol measurements provided by the Pelorus 1500 system the methodology has been completed and ethics approval has been sought to carry out clinical evaluation trials in adult patients. 

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 from Johnson & Johnson Development Corporation and Sorin Group.

For further information, please visit www.spheremedical.com