FDA Clearance forSurgiClear™ Antimicrobial Silicone WoundDressing -- MEDICA - World Forum for Medicine


Covalon Technologies Ltd.

FDA Clearance forSurgiClear™ Antimicrobial Silicone WoundDressing

Covalon Technologies Ltd. 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 dressing’s 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 inpatient
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.
To learn more about SurgiClear's availability for sale and/or license by contacting Covalon at surgiclear@covalon.com or calling 1.877.711.6055.