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PuriCore Receives FDA 510(k) Clearance for Vashe Skin and Wound Hydrogel


2/14/2013 8:47:17 AM

February 14, 2013 -- PuriCore (LSE: PURI), the water-based clean technology company, today announces that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market a new hydrogel formulation of its Vashe® technology. The new Vashe Skin and Wound Hydrogel is indicated for the management and relief of pain, burning, and itching experienced with various dermatoses including atopic dermatitis.

PuriCore intends to use this hydrogel clearance to advance new product development and partnering opportunities in dermatology, wound care, and animal health. PuriCore estimates that these three markets in total comprise annual sales of $30 billion in the US.

Michael Ashton, Executive Chairman of PuriCore, said:

“Regulatory clearance of our Vashe Hydrogel opens the door to partnering opportunities for this new formulation in multiple health sciences markets. Having a Vashe Hydrogel allows us to pursue business development and complements PuriCore’s existing suite of health sciences products.”

About Vashe Skin and Wound Hydrogel

Under the supervision of a health care professional, Vashe Skin and Wound Hydrogel is indicated for the management and relief of pain, burning, and itching experienced with various dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis as well as for the relief of pain from first- and second-degree burns, and aids to relieve dry waxy skin by maintaining a moist wound and skin environment. A moist wound and skin environment is beneficial to the healing process.

About PuriCore

PuriCore plc (LSE: PURI) is a water-based clean technology company focused on developing and commercialising proprietary solutions that protect people from the spread of infectious pathogens without causing harm to human health or the environment. The Company’s products are used in a broad range of markets that depend upon effective pathogen control. PuriCore is the leading full provider of all products and services required for a safe, efficient, and compliant endoscope decontamination to protect patients in UK hospitals. The Company’s products are the standard for food safety and are used for floral care in leading US supermarket chains. PuriCore also offers a breakthrough wound therapy solution to treat chronic and acute wounds including diabetic ulcers and burns. PuriCore is headquartered in Malvern, Pennsylvania, with operations in Stafford and Clevedon, UK. To receive additional information on PuriCore, visit www.puricore.com, which does not form part of this announcement.

Enquiries:

UK

FTI Consulting

Susan Stuart/Simon Conway

Victoria Foster Mitchell

+44 (0) 20 7831 3113

US

Sage Strategic Marketing

Jennifer Guinan

+1 610.410.8111


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