Oculus Innovative Granted Reclassification for Microcyn-Based Advanced Wound Management Products in Europe

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Oculus Innovative Sciences, Inc.
OCLS
a healthcare company a global healthcare company that designs, manufactures and markets prescription and non-prescription products in over 20 countries, today announced that is has been granted a reclassification of the company's CE Mark for the European formulation Dermacyn™ Wound Care. The reclassification was approved by the British Standards Institution (BSI), which is the world's largest certification body, and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.  Reclassified as a class III medical device, the newest indication is for "use in the debridement, irrigation and moistening of acute and chronic wounds, ulcers, cuts, abrasions and burns. Through reducing the amount of microorganisms and contributing to a moist environment, it enables the body to perform its own healing process."  Additionally, the actives in Dermacyn™ are classified in Europe as medicinal substances that may have a local antimicrobial effect. "This expanded label indication strengthens our European partners' product portfolios since they now are able to discuss the issue of antimicrobial effectiveness of Dermacyn in the wound bed with EU medical professionals," said Bruce Thornton, Oculus EVP of international operations. "This will provide doctors with a safe and effective alternative to more costly and toxic wound care regimens, thus improving patient outcomes."
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