Proxima Generation 2 Achieves European CE Marking

Sphere Medical based in Cambridge, UK received the European CE Mark of approval for its Proxima Generation 2 disposable arterial blood analyser. The device is intended for continuous monitoring of glucose, blood gas & electrolytes in patients in the OR and ICU and a recent clinical study has shown that the Proxima Generation 2 provides an equivalent performance when compared to lab and point-of-care blood gas analysers of arterial blood.proxima-generation

Because measurements are made on a continuous basis and all the blood is immediately returned to the patient, the device lets clinicians keep a steady eye on patients without having to take regular readings and run samples to the lab.

Cambridge, UK, 19 December 2011: Sphere Medical Holding plc (AIM:SPHR.L) (“Sphere Medical” or the “Company”), a leading developer of  innovative monitoring and diagnostic products for the critical care setting, is pleased to announce that Proxima Generation 2 has achieved European CE Marking as an in-vitro diagnostic device. Proxima Generation 2 is Sphere Medical’s disposable patient-attached arterial blood analyzer.
The CE Marking of Proxima Generation 2 follows the announcement on 21 November that the clinical trial on Proxima Generation 2 had met its primary endpoint to demonstrate equivalent performance to laboratory and Point of Care blood gas analysers measuring arterial blood in a clinical setting.
The Company now intends to initiate a number of marketing studies in leading UK hospitals which will utilise the CE Marked Proxima device to build up substantial feedback on clinical use. Commenting on the Proxima Generation 2 CE Marking,  Chief Executive Officer, Dr Stuart Hendry, said: “The achieving of CE Marking for Proxima Generation 2 is a major milestone achievement for Sphere Medical and sets the foundations for the commercialisation of our
lead product.”

Cambridge, UK, 19 December 2011: Sphere Medical Holding plc (AIM:SPHR.L) (“Sphere Medical” or the “Company”), a leading developer of  innovative monitoring and diagnostic products for the critical care setting, is pleased to announce that Proxima Generation 2 has achieved European CE Marking as an in-vitro diagnostic device. Proxima Generation 2 is Sphere Medical’s disposable patient-attached arterial blood analyser. The CE Marking of Proxima Generation 2 follows the announcement on 21 November that the clinical trial on Proxima Generation 2 had met its primary endpoint to demonstrate equivalent performance to laboratory and Point of Care blood gas analysers measuring arterial blood in a clinical setting. The Company now intends to initiate a number of marketing studies in leading UK hospitals which will utilise the CE Marked Proxima device to build up substantial feedback on clinical use.   Commenting on the Proxima Generation 2 CE Marking,  Chief Executive Officer, Dr Stuart Hendry, said: “The achieving of CE Marking for Proxima Generation 2 is a major milestone achievement for Sphere Medical and sets the foundations for the commercialisation of our lead product.”

Sphere Medical commenced trading on the AIM, a market operated by the London Stock  Exchange (LSE) on 17 November 2011 having raised £14m (£12.8m net of expenses) in a  placing of ordinary shares.  Sphere Medical is a UK based medical device company completing the development of a  range of monitoring and diagnostic products designed to provide significant improvements in  patient management in a number of hospital specialities. Sphere Medical’s products are expected to allow near real time measurement of blood gases, various electrolytes and drug levels with laboratory accuracy, at the patient’s bedside. This information can be used in a wide range of medical applications and is intended to enable faster clinical decision making and consequently to improve the management of patients. Sphere Medical’s two most advanced products, based  on its proprietary micro analyser Intensive Care Unit and Operating Room (‘Proxima’)  and a device for continuous blood monitoring in the bypass circuit in patients undergoing cardiopulmonary bypass surgery (“CPB device”). Sphere Medical has also developed and is selling a device (‘Pelorus 1000’) that can measure blood levels of the intravenously administered anaesthetic drug, propofol. In each case, these products will ultimately target patients requiring close monitoring and frequent levels of blood testing. Sphere Medical employs approximately 45 staff in the areas of research and development, product development, sales and marketing and management and operations at its premises at Harston, Cambridge, UK. platform technology, are a disposable patient-attached arterial blood analyser for use in the Intensive Care Unit and Operating Room (‘Proxima’)  and a device for continuous blood monitoring in the bypass circuit in patients undergoing cardiopulmonary bypass surgery (“CPB device”). Sphere Medical has also developed and is selling a device (‘Pelorus 1000’) that can measure blood levels of the intravenously administered anaesthetic drug, propofol. In each case, these products will ultimately target patients requiring close monitoring and frequent levels of blood testing. Sphere Medical employs approximately 45 staff in the areas of research and development, product development, sales and marketing and management and operations at its premises at Harston, Cambridge, UK.

Source:http://medgadget.com/2011/12/proxima-generation-2-arterial-blood-analyser-gets-eu-clearance.html,http://www.spheremedical.com/documents/news/Proxima%20Generation%202%20Achieves%20European%20CE%20Marking.pdf

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  • Anonymous

    Nice information…….Thanks for sharing

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