18th Nov 2013 10:22
LONDON (Alliance News) - Sphere Medical Holding PLC Monday said it has secured an option to enter talks with Ortho-Clinical Diagnostics to sell global commercialisation rights to Proxima, as it prepares to launch its monitoring device for blood gases in the UK next year.
The Proxima system is a arterial blood analyser for use in the intensive care unit and operating room.
Earlier this year, Ortho-Clinical Diagnostics, a subsidiary of American healthcare giant Johnson & Johnson said it would collaborate in the development of Sphere's blood gases monitoring device.
Under the terms of the collaboration agreement, Sphere must complete a data package containing Milestone Reports which is currently anticipated to be achieved by the middle of 2015.
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.
Sphere said work towards achieving the CE mark is now advanced, with authorisation expected next year.
The CE mark is a mandatory conformity marking for certain products sold within the European Economic Area since 1993.
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.
The stock was trading at 27.00 pence Monday morning, down 0.50 pence or 1.8%.
By Anthony Tshibangu; [email protected]; @AnthonyAllNews
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