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FDA 510(k) Clearance

14 Feb 2013 07:00

RNS Number : 8476X
PuriCore Plc
14 February 2013
 



PuriCore plc

 ("PuriCore" or the "Company")

14 February 2013

 

 

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

 

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

US

FTI Consulting

Sage Strategic Marketing

Susan Stuart/Simon Conway/

Jennifer Guinan

Victoria Foster Mitchell

+1 610.410.8111

+44 (0) 20 7831 3113

 

Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company's current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as 'anticipates,' 'expects,' 'intends,' 'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

This information is provided by RNS
The company news service from the London Stock Exchange
 
END
 
 
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