PuriCore Plc FDA 510(k) Clearance (8476X)
14 Febrero 2013 - 1:00AM
UK Regulatory
TIDMPURI
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(R) 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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