Covalon Announces FDA Clearance for MediClear PreOp

Covalon Technologies Ltd. announces that it has received Food and Drug Administration (FDA') clearance to legally market and sell MediClear™ PreOp in the U.S. to hospitals, clinics and directly to patients, without the need for a prescription.

MediClear PreOp is a breathable, transparent, self-adhesive, silicone barrier film-drape that smoothly conforms to the contours of a patient's skin at the planned incision or insertion site to protect the patient from exposure to bacteria, yeast and viruses. MediClear PreOp's application is so simple, it can be applied by patients themselves or by clinicians at a consultation before their surgery. MediClear PreOp is then removed immediately prior to surgery by a clinician in the operating room under sterile conditions.

"MediClear PreOp is Covalon's first product to be cleared that enables us to enter the multi-billion dollar pre-surgical skin antisepsis market," said Brian Pedlar, Covalon's CEO. "With an over-the-counter ("OTC") designation by the FDA, Covalon can now provide patients easy access to a world-class infection prevention product to protect themselves from exposure to bacteria, viruses and fungi before a surgery."

The silicone adhesive in MediClear Pre-Op contains two antimicrobials - chlorhexidine and silver. The chlorhexidine and silver contained in the adhesive provides continuous antimicrobial activity while a polyurethane barrier film acts as a protective barrier to isolate a procedural site from microbial and other contamination. MediClear PreOp's silicone adhesive provides a rapid bactericidal and fungicidal effect against a broad-spectrum of microorganisms, averaging a 99.9 percent reduction at 10 minutes and a 99.99 percent reduction at 30 minutes, and prevents their re-growth for up to seven days during wear.

"In an effort to reduce surgical site infections, hospitals in the United States spend billions of dollars every year on products to antiseptically clean and prep patients' skin before surgery and a further $3.3 billion a year treating surgical site infections that current products and practices couldn't prevent," said Pedlar. "We see great promise with MediClear PreOp to help in reducing the instances of surgical site infections by protecting patients all the way into the operating room. There is no other OTC product on the market that provides the dual-antimicrobial and physical protection of MediClear PreOp."

MediClear™ PreOp provides an effective physical barrier against external contamination including fluids, bacteria, and yeast. In vitro testing demonstrates that the chlorhexidine and silver incorporated within the silicone adhesive provide a rapid bactericidal and fungicidal effect against microorganisms including Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Enterococcus faecalis (VRE), K/ebsie//a pneumoniae, Pseudomonas aeruginosa, Enterobacter cloacae, Candida a/bicans, and Candida tropicalis, and prevents their re-growth for up to seven days while wearing MediClear PreOp.

Source: Covalon Technologies Ltd.