Covalon Announces Major Milestone: FDA Clearance for MediClear™ PreOp
MISSISSAUGA, Ontario -- (Business Wire) --
Covalon Technologies Ltd. (the "Company" or "Covalon") (TSXV: COV; OTCQX: CVALF), an advanced medical technologies company, announced today it has received United States Food and Drug Administration (“FDA”) clearance to legally market and sell MediClear™ PreOp in the US 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 Chief Executive Officer. "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% reduction at 10 minutes and a 99.99% reduction at 30 minutes, and prevents their re-growth for up to 7 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. Invitro testing demonstrates that the chlorhexidine and silver incorporated within the silicone adhesive provide a rapid bactericidal and fungicidal effect against microorganisms including Staphylococcusaureus (MRSA), Staphylococcusepidermidis, Enterococcusfaecalis (VRE), Klebsiellapneumoniae, Pseudomonasaeruginosa, Enterobactercloacae, Candidaalbicans, and Candidatropicalis, and prevents their re-growth for up to 7 days while wearing MediClear PreOp.
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
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