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Home arrow Knowledge Bank arrow News arrow FDA approves Oculus Innovative Sciences' Microcyn Skin and Wound HydroGel
FDA approves Oculus Innovative Sciences' Microcyn Skin and Wound HydroGel PDF Print E-mail
Thursday, 11 March 2010

Oculus Innovative Sciences, Inc., a commercial medical technology company that develops, manufactures and markets a family of products based upon the Microcyn® Technology platform, announced that it has received new 510(k) clearance from the U.S. Food and Drug Administration (FDA) for new dermatology indications for Microcyn® Skin and Wound HydroGel. The Rx product, under the supervision of a healthcare professional, Microcyn Skin and Wound HydroGel is intended for management of wounds including itch and pain relief associated with dermal irritation, sores, injuries and ulcers of dermal tissue.

“We are especially excited to receive our first FDA clearance for the Microcyn HydroGel for dermatology indications including the reduction of itch and pain relief for troublesome skin afflictions”

Microcyn-based products, branded as Microcyn Skin and Wound Care and Microcyn Skin & Wound HydroGel in the United States, Microdacyn60™ in Mexico, Dermacyn™ Wound Care in Europe and China and Oxum in India, have treated over two million patients worldwide without a single report of a serious adverse effect.

Noridian Administrative Services LLC, which is the pricing, data analysis and coding contractor for the Medicare program, has assigned Medicare HCPCS code #A6248 to the Microcyn HydroGel.

“We are especially excited to receive our first FDA clearance for the Microcyn HydroGel for dermatology indications including the reduction of itch and pain relief for troublesome skin afflictions,” said Hoji Alimi, founder and CEO of Oculus.

Microcyn HydroGel for dermatology indications will be commercially available in April 2010. Oculus is partnering with a series of independent sales groups in key metropolitan regions with a combined thirty-six person commissioned-based sales team experienced in dermatology, which will focus on the dermatology market including cosmetic and plastic surgeons, pediatricians, aesthetic clinics and dermatologists. For more information, pricing or pre-ordering, please telephone 1-800-931-3205.

According to a report from Business Insights, in terms of size, the United States market dominates the global dermatology market, responsible for some 41.2% of sales or $4.6 billion in 2005.

 
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