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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