RLM.L Regulatory News (RLM)

5 Apr 2007 07:01

PuriCore Plc05 April 2007 PuriCore Receives FDA 510(k) Approval for Endoscope Disinfectant System in US Sterilox Endoscopy System offers a safe and effective method for reprocessing endoscopes MALVERN, PA, AND STAFFORD, UK, April 5, 2007-PuriCore (LSE: PURI), the lifesciences company focused on the development and commercialization of its novel,safe antimicrobial technology, today announced that it has received 510(k)clearance from the US Food and Drug Administration (FDA), allowing it to marketits proprietary Sterilox Endoscopy High-Level Disinfectant System as a medicaldevice in the US. The Sterilox System produces a highly effective and safehigh-level disinfectant solution that is indicated for use in reprocessing anddisinfecting heat-sensitive medical instruments, including endoscopes, betweenpatient procedures. The Sterilox Endoscopy System is based on existing patented and patent-pendingPuriCore technology and products that are currently marketed in Europe(primarily in the UK). It produces principally hypochlorous acid, the naturalantimicrobial produced by the human body to fight pathogens, from theelectrolysis of a saline solution. Sterilox Solutions are completely non-toxicand are of no risk to patients, healthcare professionals, or the environment. Greg Bosch, CEO or PuriCore said: "This is a big step in bringing Sterilox to the US endoscopy market, which isthe largest in the world. We are now developing our commercialization plan and,upon the completion of post-clearance testing, we anticipate installing ourfirst US beta sites for Sterilox Endoscopy Systems by year end." - ENDS - For further information please contact: PuriCoreKeith A. Goldan, CFO 1 484 321 2700 Financial DynamicsBen Brewerton / John Gilbert +44 207 269 7169 About PuriCore PuriCore (London Stock Exchange: PURI) is a life sciences company focused ondeveloping and commercializing proprietary products that safely, effectively,and naturally kill contagious pathogens. PuriCore's technology mimics the humanbody's production of the natural antimicrobial hypochlorous acid, which ishighly effective in killing bacteria, viruses, and fungal spores. PuriCore'stechnology provides a potential solution in a broad range of markets that dependupon controlling contamination, including food safety, medical devicedisinfection, wound management, and hospitality. Deploying hypocholous acidsolutions as soaks, sprays, mists and in other forms, PuriCore's technology isdesigned to limit the spread of infectious disease, including major publichealth threats of Tuberculosis, MRSA, E.coli, norovirus, avian influenza, HIV,polio virus, Helicobater pylori, and Legionella. This information is provided by RNS The company news service from the London Stock Exchange