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Covalon Technologies Ltd. Announces FDA Clearance for SurgiClearâ„¢ Antimicrobial Silicone Wound Dressing
8/21/2012 8:13:53 AM
MISSISSAUGA, ON, Aug. 21, 2012 /PRNewswire/ - Covalon Technologies Ltd. (the
"Company" or "Covalon") (TSXV: COV), an advanced medical technologies
company, today announced United States Food and Drug Administration
("FDA") clearance of SurgiClear antimicrobial silicone adhesive film
dressing designed to cover and protect wound sites and wound closure
devices, as well as secure other primary dressings to a patient's skin.
With its proven ability to kill over 99.99% of bacteria that contact the
wound dressings antimicrobial silicone adhesive and its potential to
prevent scarring, SurgiClear is a major advancement in the treatment of
wounds. Covalon's proprietary antimicrobial silicone adhesive allows
clinicians to monitor wounds through its clear waterproof film so
patients can resume normal activity without fear of contamination or
damage to a wound site.
"The FDA clearance of SurgiClear, the clearance of its sister product IV
Clear a few months ago, and very strong clinical feedback received to
date provides Covalon with all of the validity necessary to license and
sell both products," said Brian Pedlar, Covalon's Chief Executive
Officer. "Every year in the United States, over 48 million in-patient
procedures result in wounds that could benefit from SurgiClear's
antimicrobial silicone technology."
Like its recently cleared sister product IV Clear, Covalon's SurgiClear
antimicrobial film dressings for wounds have a number of unique and
highly desirable characteristics:
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SurgiClear combines the comfort of skin-friendly silicone adhesive
technology with the advanced antimicrobial protection of two gold-standard antimicrobial agents - chlorhexidine and silver.
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SurgiClear has uniquely bonded the two antimicrobials into the actual
adhesive of the soft and non-sensitizing silicone that allows the clear
film wound dressing to comfortably adhere to the skin while providing
antimicrobial protection.
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SurgiClear kills over 99.99% of bacteria that come into contact with the
dressing's antimicrobial adhesive and prevents the re-growth of
bacteria on patient's skin over 7 days of wear.
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SurgiClear is breathable unlike most other silicone dressings.
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Patients are able to bathe while wearing the waterproof silicone
SurgiClear wound dressing.
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Studies have shown that SurgiClear is up to ten times less painful on
removal than leading film dressings that use acrylic adhesives.
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Studies have shown that the use over a 14-day period of silicone similar
to SurgiClear prevents keloid and hypertrophic scarring following
surgical procedures.
SurgiClear is available for sale and/or license in the United States and
Canada by contacting Covalon at surgiclear@covalon.com or calling 1.877.711.6055.
About Covalon
Covalon Technologies Ltd. researches, develops and commercializes new
healthcare technologies that help save lives around the world.
Covalon's patented technologies, products and services address the
advanced healthcare needs of medical device companies, healthcare
providers and individual consumers. Covalon's technologies are used to
prevent, detect and manage medical conditions in specialty areas such
as wound care, tissue repair, infection control, disease management,
medical device coatings and biocompatibility. To learn more about
Covalon, visit our website at www.covalon.com Neither TSX Venture Exchange nor its Regulation Services Provider (as
that term is defined in the policies of the TSX Venture Exchange)
accepts responsibility for the adequacy or accuracy of this release. This news release contains forward-looking statements which reflect the
Company's current expectations regarding future events. The
forward-looking statements are often, but not always, identified by the
use of words such as "seek", "anticipate", "plan, "estimate", "expect",
"intend" and statements that an event or result "may", "will",
"should", "could" or "might" occur or be achieved and other similar
expressions. These forward-looking statements involve risk and
uncertainties, including the difficulty in predicting product
approvals, acceptance of and demands for new products, the impact of
the products and pricing strategies of competitors, delays in
developing and launching new products, the regulatory environment,
fluctuations in operating results and other risks, any of which could
cause results, performance, or achievements to differ materially from
the results discussed or implied in the forward-looking statements.
Many risks are inherent in the industry; others are more specific to
the Company. Investors should consult the Company's ongoing quarterly
filings for additional information on risks and uncertainties relating
to these forward-looking statements. Investors should not place undue
reliance on any forward-looking statements. The Company assumes no
obligation to update or alter any forward-looking statements whether as
a result of new information, further events or otherwise. SOURCE Covalon Technologies Ltd.
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