Oculus Innovative Sciences Receives FDA Clearance For Microcyn(R) Skin And Wound Gel

Main Category: Dermatology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 29 May 2009 - 3:00 PDT

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Oculus Innovative Sciences, Inc. (Nasdaq: OCLS), a healthcare company that develops, manufactures and markets a family of products based upon the Microcyn® Technology platform, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Microcyn® Skin and Wound Gel as both a prescription and over-the-counter formulation. The Rx product, under the supervision of a health care professional, is intended for management of exuding wounds such as leg ulcers, pressure ulcers, diabetic ulcers and for the management of mechanically or surgically debrided wounds. This is the first hydrogel product based upon the Microcyn Technology platform and is reimbursable by both Medicare and Medicaid.

The original Microcyn-based solution, branded as Microcyn Wound Care in the United States, Microdacyn60™ in Mexico, Dermacyn™ Wound Care in Europe and China and Oxum in India, has treated over one million patients worldwide without a report of a single serious adverse effect.

"We are pleased to receive FDA clearance for this Microcyn hydrogel product," said Hoji Alimi, founder and CEO of Oculus. "We understand the critical role that reimbursement plays in the successful commercialization of a medical product, and in that this is our first reimbursable product, we plan to aggressively market to the U.S. healthcare community. At the same time, we are taking all steps necessary to secure regulatory approvals outside North America so as to begin generating international sales through our existing distribution channels worldwide."

Source
Oculus Innovative Sciences, Inc.