FDA Clears Expanded Label Claim for Oculus Innovative Sciences' Lead Microcyn(R) Wound Care Product
PETALUMA, Calif.--(BUSINESS WIRE)-- Oculus Innovative Sciences, Inc. (Nasdaq: OCLS), a healthcare company that develops, manufactures and markets a family of products based upon the Microcyn(R) 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(R) 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(R) 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(R) 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(TM) in Mexico, Dermacyn(TM) 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(R) Skin and Wound Cleanser with preservative along with the Microcyn(R) 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(R) 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.
Forward-Looking Statements
Except for historical information herein, some matters set forth in this press release are forward-looking within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including statements about the company's commercial and technology progress. These forward-looking statements are identified by the use of words such as "validate," "will market," and "will be," among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the Company's business that could cause actual results to vary, including risks inherent in the development and commercialization of potential products, the risk that regulatory clinical and guideline developments may change, the risk that scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, the risk that clinical results may not be replicated in actual patient settings, the risk that protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, the risk that present trends will continue and that the available market for our products will not be as large as expected, the risk that our products will not be able to penetrate one or more targeted markets, the risk that revenues will not be sufficient to fund further development and clinical studies, the Company's future capital needs, and its ability to obtain additional funding, as well as uncertainties relative to varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission including the quarterly report on Form 10-Q for the quarter ended December 31, 2008. Oculus Innovative Sciences disclaims any obligation to update these forward-looking statements
Oculus Innovative Sciences, Microdacyn60, Dermacyn and Microcyn Technology are trademarks or registered trademarks of Oculus Innovative Sciences, Inc. All other trademarks and service marks are the property of their respective owners.
Source: Oculus Innovative Sciences, Inc.
Released June 4, 2009