OCD Option for Proxima Commercial Negotiations

18 November 2013

Sphere Medical Holding plc

Ortho-Clinical Diagnostics, Inc. Granted Option to Enter into Negotiations for Exclusive Commercial Rights to Proxima

~ Sphere Medical prepares to launch Proxima in UK in the first half of 2014 once CE Mark received ~

Cambridge, UK, 18 November 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 that, in accordance with the collaboration announced on 28 June 2013, Ortho-Clinical Diagnostics, Inc. ("OCD") now has an option to enter into negotiations with Sphere Medical to acquire exclusive global commercialisation rights to Proxima.

The option agreement allows OCD to require both parties to enter into negotiations to allow OCD to acquire exclusive commercialisation rights to market Proxima worldwide on behalf of Sphere. Under the terms of the Collaboration Agreement, the trigger for these negotiations, which must be conducted in good faith by both parties, is completion by Sphere of the Data Package containing the Milestone Reports, and this is currently anticipated to be achieved by the middle of 2015 which is within the originally anticipated time frame set out in the Collaboration Agreement.

When prepared in due course, the Milestone Reports will cover a number of Sphere's operational and production capabilities, which are designed to provide evidence that Proxima is ready for global commercial launch. These Milestone Reports cover, among other things, CE Marking, post-marketing surveillance for Proxima, manufacturing improvements, clinical cost benefit analyses, utility analyses and the achievement of certain clinical specifications for Proxima. 

Meanwhile, work towards achieving the Proxima CE Mark is well advanced and authorisation is expected during the first half of 2014. Upon receipt of CE Mark authorisation, Sphere Medical intends to launch Proxima in the UK, initially in key strategic 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: "Our collaboration agreement with OCD covers the development of the Proxima platform and the enhancement of our operational and production capabilities. We are very satisfied with the progress of the collaboration project to date and look forward to commencing the commercial launch of Proxima in the UK 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 [email protected]

Amber Bielecka

Matthew Neal

Ivar Milligan

Notes for Editors

Collaboration Agreement: Pursuant to the Collaboration Agreement, Sphere Medical and OCD will collaborate in relation to the development of Proxima, Sphere Medical's disposable patient-dedicated arterial blood gas analyser for use in the hospital intensive care units, theatres and other acute care settings, and the enhancement of Sphere Medical's operational and production capabilities. The Collaboration Agreement also provides a framework to negotiate a proposed global commercialisation deal for Proxima 4.

Data Package: Pursuant to the Collaboration Agreement, Sphere Medical has obligations to compile and deliver to OCD a data package containing milestone reports detailing key product attributes and commercial observations related to Proxima.

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