22 Jul 2015 07:00
Sphere Medical Holding plc
Data Package Milestone Completion for Proxima 4
Cambridge, UK, 22 July 2015: Sphere Medical Holding plc (AIM: SPHR.L), ("Sphere Medical" or the "Company") a leading provider of innovative monitoring and diagnostic devices for the critical care setting, has announced that the Company has completed the Data Package Milestone for Proxima 4, an important prerequisite for submitting the technical files and design dossiers for CE-marking as well as fulfilling its obligations to submit the Data Package to Ortho-Clinical Diagnostics, Inc. ("OCD") under the collaboration agreement between OCD and Sphere Medical (the "Collaboration Agreement").
The Data Package has recently been completed by Sphere and submitted to OCD within the originally anticipated time frame set out in the Collaboration Agreement. Sphere will continue with the finalisation of the submission process for the CE-marking, whilst OCD will now decide on whether it elects to exercise its option to enter into negotiations with Sphere Medical with regard to exclusive commercialisation rights of Proxima 4.
Commenting on the completion of the Data Package, Dr. Wolfgang Rencken, Chief Executive Officer of Sphere Medical, said: "The completion of the Data Package represents an important milestone in the development of Proxima 4 as well as a further step in the commercialisation of the Proxima system."
For further information, please contact:
Sphere Medical Holding plc | Tel: +44 (0)1223 875 222 | |
Dr Wolfgang Rencken, Chief Executive Officer | ||
Peel Hunt LLP | Tel: +44 (0) 20 7418 8900 | |
James Steel | ||
Oliver Jackson | ||
Jock Maxwell Macdonald | ||
finnCap | Tel: +44 (0) 20 7220 0500 | |
Geoff Nash / Simon Hicks | ||
Stephen Norcross | ||
Consilium Strategic Communications | Tel: +44 (0) 20 3709 5700 | |
Mary-Jane Elliott | spheremedical@consilium-comms.com | |
Chris Gardner |
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Ivar Milligan |
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Hendrik Thys |
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Notes for Editors
About Sphere Medical (AIM: SPHR.L)
Sphere Medical is a medical device company developing and commercialising 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.
The Company's strategy is focused on developing the Proxima (CE-marked device) platform for measuring blood gases, electrolytes and metabolites. The Company is already marketing its Proxima product directly to the critical care market, which includes the ICU and OR, with a dedicated field sales force in the UK, Germany, the Netherlands and Belgium. The Company also proposes to work with partners for the worldwide distribution of Proxima.
Proxima delivers near real time analysis of blood gases and electrolytes metabolites, at the patient's bedside. Proxima can be used on patients across a wide therapeutic range, enabling faster clinical decision making and improved patient outcomes, whilst potentially reducing costs for healthcare payers.
Sphere Medical entered into a collaboration agreement with Ortho-Clinical Diagnostics (now part of Carlyle Group) in 2013 for the development of Proxima and enhancement of Sphere Medical's operational and production capabilities.
For further information, please visit www.spheremedical.com