Business
CE Mark Authorisation
CE Mark Authorisation.
About this update from Cellbxhealth Plc
[{"type":"text","content":"\n \nRNS Number : 6888V Angle PLC 17 December 2013 \n \n\n\n\n\n\nFor immediate release \n\n\n17 December 2013\n\n\n\n\n \n \nANGLE plc \n(\"ANGLE\" or \"the Company\")\n \nPARSORTIX IN VITRO DIAGNOSTIC DEVICE CE MARK AUTHORISATION\n \nANGLE plc (AIM: AGL), the specialist medtech company, is delighted to announce the CE Mark authorisation of its Parsortix cell separation system for use as an in vitro diagnostic device in the European Union.\n \nAchievement of this key milestone confirms that the Parsorter PC1 clinical system meets the Essential Requirements of the European Union In Vitro Device Directive (98/79/EC), a pre-requisite for the product's use in clinical applications (i.e. with patients) throughout Europe.\n \nANGLE is preparing an FDA 510(k) submission for clinical use of the Parsortix system in the United States. This builds on the work completed for the CE Mark and is on track for submission to the FDA by the end of Q1 2014. \n \nANGLE's ultimate objective is the widespread adoption of the Parsortix system in the diagnosis and treatment of cancer patients. There were 14 million new cancer cases worldwide in 2012, a marked rise on the 12.7 million cases in 2008, according to the World Health Organisation. We estimate that this represents a potential market for ANGLE's Parsortix system worth in excess of £8 billion per annum worldwide. \n \nTo achieve widespread market adoption, ANGLE needs to establish the use of Parsortix in clinical practice through (i) identifying key clinical applications with medical utility, (ii) securing positive clinical data demonstrating the medical utility of those applications in patient trials and (iii) obtaining Key Opinion Leader support for the adoption of Parsortix in the routine medical care of cancer patients. \n \nCE Mark authorisation of the Parsortix system for clinical use throughout Europe is a major step forward as it enables ANGLE to drive commercialisation of the system on three fronts:\n \n1) Expansion of the market from the existing research use market to the much larger clinical use market. \n \nAs evidence of the medical utility of circulating tumour cell (CTC) analysis is developed, ANGLE will have a product that can be sold eventually for the routine treatmen...