08/13/2012

Covalon Technologies Ltd

IV Clear Receives FDA Clearance

Covalon’s IV Clear antimicrobial film dressings have a number of unique and highly desirable characteristics:

 IV Clear is the only vascular access securement dressing approved by the FDA that combines the comfort of skin-friendly silicone adhesive technology with the advanced antimicrobial protection of two gold-standard antimicrobial agents -chlorhexidine and silver.
 IV Clear has uniquely bonded the two antimicrobials into the actual adhesive of the soft and non-sensitizing silicone that allows the clear film dressing to comfortably secure vascular access devices to the skin while providing antimicrobial protection for up to 7 days.
 IV Clear is breathable unlike most other silicone dressings.
 Patients are able to bathe while wearing the waterproof silicone IV Clear dressing.
 All the current leading suppliers of vascular access securement dressings use acrylic adhesives instead of the much superior and more skin-comfortable silicone.
 Studies have shown that IV Clear is up to ten times less painful on removal than leading film dressings that use acrylic adhesives."IV Clear is truly a new innovation in the fight against Catheter Related Blood Stream Infections (CRBSI), for which the Center for Disease Control (CDC) calls one of the most deadly and costly threats to patient safety," said Brian Pedlar, Covalon's Chief Executive Officer. "Having an antimicrobial silicone adhesive is a clear advantage over the older generation of patches, pads or acrylic adhesive technologies currently available in the market. With over 350 million IV catheter stabilization devices used in the United States alone and the adoption of antimicrobial securement devices experiencing double-digit growth, we fully expect IV Clear to be a strong competitor in the market."
IV Clear is intended to cover and protect insertion sites and to secure the various intravenous devices to a patient's skin. FDA clearance included the following indications for use: IV catheters, central venous lines, peripherally inserted central catheters
(PICCs), suction catheters, epidural catheters, hemodialysis catheters, orthopedic pins, other intravascular catheters and percutaneous devices.

Mr. Pedlar continued, “This is a major achievement for Covalon’s talented team of scientists. Our lab continues to innovate and work on many other applications that will be announced in due course. It is an exciting time at Covalon.”

IV Clear is available immediately for sale and/or license in the United States and Canada by contacting Covalon at ivclear@covalon.com or calling 1.877.711.6055.