Sphere Medical Holding Regulatory News (SPHR)

14 October 2014

Sphere Medical Holding plc

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."

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Notes for Editors

About Proxima

CE marked and specifically designed for critical care environments, the Proxima System incorporates a dedicated bedside monitor and a Proxima Sensor that is integrated into a patient's arterial line. This enables blood to be measured directly at the point of care without need to leave the patient or manipulate samples and cartridges which can all add to the workload of front line care staff. Measured to laboratory analyser accuracy, results are rapidly displayed on the bedside monitor and can be electronically transferred for permanent record.

Simple to use, the in-line Proxima System enables closed blood sampling and is operated via the touch screen interface of its bedside monitor. When a blood gas analysis is required, blood is withdrawn from the patient directly into the Proxima Sensor without the need to open the line, take a sample and walk away from the patient for analysis. Once analysis is completed, all blood is returned to the patient, thereby ensuring blood conservation and reducing the possibility of hospital acquired anaemia and subsequent transfusions.

A Proxima Sensor is a disposable transducer which can be used for monitoring blood gases and electrolytes over a 72 hour period as many times as required. The system also carries out all quality control checks that would be undertaken on a traditional blood gas analyser to ensure validity of test results. It also includes a facility to be challenged with liquid controls.

About Sphere Medical (AIM: SPHR.L) 

Sphere Medical is a medical device company developing a range of innovative monitoring and diagnostic devices designed to significantly improve patient care.

Sphere Medical's vision is to become a leading solution provider to the critical care market offering innovative, near real time, point of care diagnostic and monitoring products to enable closer control of therapeutic response and improve patient outcomes and reduce the overall cost of care.

Sphere Medical's strategy is focused on developing the Proxima platform for measuring blood gases, electrolytes and metabolites and partnering on the development of the Pelorus platform for measuring drug levels in blood.

The Company plans to sell its products directly to the critical care market, which includes the ICU and OR, with dedicated field sales forces in the UK, Germany and Benelux, and work with partners for worldwide distribution.

Sphere Medical's products deliver near 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.

Sphere Medical entered into a collaboration agreement with Ortho Clinical Diagnostics, Inc. in 2013 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 and has received a strategic investment from Ortho Clinical Diagnostics (now part of Carlyle Group). Other significant investors include Life Sciences Partners (LSP Life Sciences Fund).

For further information, please visit www.spheremedical.com