FDA Clears Expanded Label Claim for Oculus Innovative Sciences’ Lead Microcyn® Wound Care Product

Thursday, 04 June 2009 08:15

PETALUMA, Calif.--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 an expanded 510(k) label clearance from the U.S. Food and Drug Administration (FDA) to market its Microcyn® Skin and Wound Cleanser with preservatives as both a prescription and over-the-counter formulation. The new Rx product is indicated for use by health care professionals to manage the debridement of wounds such as stage I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds, first- and second-degree wounds, grafted and donor sites.

Microcyn® Skin and Wound Cleanser with preservative demonstrated rapid activity against a broad spectrum of gram-positive, gram-negative and yeast species with the following in vitro time kill method results in solution:

Name of Organism	Time to Kill	Percent Reduction

MRSA - Staphylococcus aureus	30 seconds	99.9999%
VRE - Enterococcus faecalis	30 seconds	99.9999%
Staphylococcus aureus	30 seconds	99.9999%
Escherichia coli	30 seconds	99.9997%
Acinetobacter baumannii	30 seconds	99.9999%
Bacteroides fragilis	30 seconds	99.9999%
Candida albicans	30 seconds	99.9999%
Enterobacter aerogenes	30 seconds	99.9999%
Enterococcus faecium	30 seconds	99.9999%
Haemophilus influenzae	30 seconds	99.9993%
Klebsiella oxytoca	30 seconds	99.9999%
Klebsiella pneumoniae	30 seconds	99.9999%
Micrococcus luteus	30 seconds	99.9999%
Proteus mirabilis	30 seconds	99.9999%
Pseudomonas aeruginosa	30 seconds	99.9998%
Serratia marcescens	30 seconds	99.9999%
Staphylococcus epidermidis	30 seconds	99.9998%
Staphylococcus haemolyticus	30 seconds	99.9999%
Staphylococcus homins	30 seconds	99.9996%
Staphylococcus saprophyticus	30 seconds	99.9999%
Streptococcus pyogenes	30 seconds	99.9999%

“We believe these impressive kill times further validate the Microcyn Technology’s unique and proprietary mode of action. At the same time, the Microcyn solution is safe as saline,” said Hoji Alimi, founder and CEO of Oculus. “This safety profile in combination with the FDA-reviewed rapid kill times simply can’t be equaled by silver-based products or even dated and toxic home remedies such as diluted bleach or Dakin’s solution, which impede wound healing. This is scientific fact.”

Last week, Oculus announced FDA clearance of a new Microcyn® Skin and Wound HydroGel, which 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.

Oculus, in partnership with its North American contract sales organization, Advocos, will market and sell the Microcyn® Skin and Wound Cleanser with preservative along with the Microcyn® Skin and Wound HydroGel to the North American medical community beginning in June 2009. Medical professionals interested in more information should contact Advocos at 678-213-0649 or email info@advocos.com.

There will be expanded discussion of these latest FDA clearances during the company’s Q4 2009 earnings conference call at 1:30 p.m. PDT (4:30 p.m. ET) on Thursday, June 11, 2009. Individuals interested in participating in the conference call may do so by dialing 877-397-0292 for domestic callers or 719-325-4907 for international callers.

About Oculus

Oculus Innovative Sciences develops, manufactures and markets a family of products based upon the Microcyn® Technology platform, which includes new formulations designed to significantly reduce the need for antibiotics as it reduces infections. The Microcyn Technology platform features a biocompatible, shelf-stable solution that is currently commercialized in the United States, Europe, India, China and Mexico and select Middle East countries. Several solutions derived from this platform have demonstrated, in a variety of research and investigational studies, the ability to treat a wide range of pathogens, including antibiotic-resistant strains of bacteria (including MRSA and VRE), viruses, fungi and spores, increase blood flow to the wound site, reduce both inflammation and pain while assisting in faster wound closure. The company’s headquarters are in Petaluma, California, with operations in Europe and Latin America. More information can be found at www.oculusis.com.

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