PETALUMA, Calif.--(BUSINESS WIRE)--Oculus Innovative Sciences, Inc. (Nasdaq: OCLS - News), 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.”
Oculus, in partnership with its North American contract sales organization, Advocos, will market and sell the Microcyn® Skin and Wound Gel to the North American medical community as well as consumers beginning in June 2009. Medical professionals interested in more information should contact Advocos at (678) 213-0649 or email info@advocos.com.
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.
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 “plan,” “will market,” and “secure,” 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.
Contact:
Media and Investors: Oculus Innovative Sciences, Inc. Director of Public and Investor Relations Dan McFadden, 425-753-2105 dmcfadden@oculusis.com
