Healthcare Industry News: disinfection
News Release - July 7, 2006
PuriCore Announces 510k Approval From FDA for VASHE(TM) Wound Cleansing System
MALVERN, Pa., and STAFFORD, England, July 7 (HSMN NewsFeed) -- PuriCore plc ("PuriCore") (London Stock Exchange: PURI), the developer of a novel, safe technology that mimics the human body's natural anti-microbial, hypochlorous acid, today announces that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) allowing it to market its proprietary VASHE(TM) Wound Cleansing System as a medical device.The VASHE(TM) System produces a highly effective solution which is indicated for use in wound cleansing, irrigating, moistening and debriding acute and chronic dermal lesions. It will target indications such as Stage I-IV pressure ulcers, stasis ulcers, diabetic ulcers, post surgical wounds, first and second degree burns, abrasions and minor irritations of the skin.
The VASHE(TM) System is based on existing patented and patent pending PuriCore technology and products that produce hypochlorous acid from the electrolysis of a saline solution from a table top or floor mounted system. It is the first wound cleansing system of its kind that can produce a solution on-site at the point of use by the clinician.
PuriCore CEO, Greg Bosch, commented, "This is a significant step in the Company's execution of its wound care business plan and builds on the clinical work already conducted that supports the VASHE(TM) solution benefits." Mr. Bosch continued, "With this approval, we look forward to initiating discussions with potential commercial partners."
Earlier this year, results from a multi-year clinical study conducted at the University of Oxford in England were published in the Journal of Wound Care and presented at the Symposium of Advanced Wound Care in San Antonio, Texas and the Wound Healing Society Annual Meeting in Scottsdale, Arizona. Results from this study showed a positive and observable improvement in healing rates, pain reduction, effective wound debridement and cleansing action. PuriCore anticipates expanded clinical activities to further substantiate the VASHE(TM) System benefits and support additional regulatory approvals.
For further information:
PuriCore plc T: +1(484) 321-2701
Greg Bosch, Chief Executive Officer
Keith A. Goldan, Chief Financial Officer
Financial Dynamics T: +44(0)20-7831-3113
David Yates
Sarah MacLeod
John Gilbert
ABOUT PURICORE PLC
PuriCore is a life sciences company focused on the development and commercialization of its proprietary technology that mimics the production by the human body of its natural anti-microbial, hypochlorous acid. Hypochlorous acid is highly effective at killing pathogens such as bacteria, viruses and fungal spores and yet is safe and environmentally friendly. PuriCore's solutions have applications in a wide range of markets where it is important to control microbial contamination. These markets include medical device disinfection, food safety, dental equipment, hospitality, water safety, wound management and other applications intended to limit the spread of infectious disease, including major global disease threats such as Tuberculosis, MRSA, E. coli, norovirus, HIV, polio virus, Helicobater pylori and Legionella.
PuriCore markets a portfolio of branded systems which produce hypochlorous acid solutions on-site at a customer's location from water, electricity and common salt. These solutions are generated at a range of concentrations and at a nearly neutral pH range similar to the human body. They are effective as soaks, sprays, mists and in other forms.
PuriCore is headquartered in Malvern, Pennsylvania and has offices in Stafford, England.
To receive additional information on the Company, please visit our Web site at http://www.puricore.com, which does not form part of this press release.
Source: PuriCore
Issuer of this News Release is solely responsible for its
content.
Please address inquiries directly to the issuing company.
FindReps: Screen and connect with Medical Sales Rep candidates (Direct Reps and Independents) – anonymously, in real time.
RepJobs: Job Opportunities for Direct Sales Reps and New Product Lines for Independents!