Covalon Receives FDA Approval for Antimicrobial Dressing for Securing Vascular Access Devices

Covalon Technologies Ltd. announces Food and Drug Administration (FDA) approval of IV Clear, a breakthrough antimicrobial silicone adhesive film dressing designed for securing vascular intravenous access devices.

Covalons 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 seven days.
- IV Clear is breathable.
- Patients are able to bathe while wearing the waterproof silicone IV Clear dressing.
- Studies have shown that IV Clear is up to 10 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 bloodstream infections (CRBSIs), for which the Centers for Disease Control and Prevention (CDC) calls one of the most deadly and costly threats to patient safety," says 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 more than 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 approval 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.

This is a major achievement for Covalons talented team of scientists," Pedlar adds. "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 (877) 711.6055.