PuriCore Receives FDA 510(k) Approval for Endoscope Disinfectant System in US
05 Apr 2007
MALVERN, Pa., & STAFFORD, England--(BUSINESS WIRE)--PuriCore (LSE:PURI), the life sciences 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 market its proprietary Sterilox Endoscopy High-Level Disinfectant System as a medical device in the US. The Sterilox System produces a highly effective and safe high-level disinfectant solution that is indicated for use in reprocessing and disinfecting heat-sensitive medical instruments, including endoscopes, between patient procedures.
The Sterilox Endoscopy System is based on existing patented and patent-pending PuriCore technology and products that are currently marketed in Europe (primarily in the UK). It produces principally hypochlorous acid, the natural antimicrobial produced by the human body to fight pathogens, from the electrolysis of a saline solution. Sterilox Solutions are completely non-toxic and are of no risk to patients, healthcare professionals, or the environment.
“This is a big step in bringing Sterilox to the US endoscopy market, which is the largest in the world,” said Greg Bosch, PuriCore CEO. "We are now developing our commercialization plan and, upon the completion of post-clearance testing, we anticipate installing our first US beta sites for Sterilox Endoscopy Systems by year end.”
About PuriCore
PuriCore (London Stock Exchange:PURI) is a life sciences company focused on developing and commercializing proprietary products that safely, effectively, and naturally kill contagious pathogens. PuriCore’s technology mimics the human body’s production of the natural antimicrobial hypochlorous acid, which is highly effective in killing bacteria, viruses, and fungal spores. PuriCore's technology provides a potential solution in a broad range of markets that depend upon controlling contamination, including food safety, medical device disinfection, wound management, and hospitality. Deploying hypocholous acid solutions as soaks, sprays, mists and in other forms, PuriCore’s technology is designed to limit the spread of infectious disease, including major public health threats of Tuberculosis, MRSA, E.coli, norovirus, avian influenza, HIV, polio virus, Helicobater pylori, and Legionella.
To receive additional information on PuriCore or its Sterilox Endoscopy division, please visit our web site at which does not form part of this press release.
Contacts
PuriCore
Keith A. Goldan, 484-321-2700
or
Sage Strategic Marketing
Jennifer Guinan, 610-410-8111
Jennifer@sagestrat.com
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