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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:

  1. SurgiClear combines the comfort of skin-friendly silicone adhesive technology with the advanced antimicrobial protection of two gold-standard antimicrobial agents - chlorhexidine and silver.
  2. 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.
  3. 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.
  4. SurgiClear is breathable unlike most other silicone dressings.
  5. Patients are able to bathe while wearing the waterproof silicone SurgiClear wound dressing.
  6. Studies have shown that SurgiClear is up to ten times less painful on removal than leading film dressings that use acrylic adhesives.
  7. 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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