Oculus Innovative Sciences Expands Regulatory Claims for Microcyn-Based Advanced Wound Management Products in Europe
Upgraded Class III CE Mark to Include Claim of Reduction of Microorganisms
PETALUMA, Calif., March 26, 2013 (GLOBE NEWSWIRE) -- Oculus Innovative Sciences, Inc. (Nasdaq:OCLS) a healthcare company a global healthcare company that designs, manufactures and markets prescription and non-prescription products in over 20 countries, today announced that is has been granted a reclassification of the company's CE Mark for the European formulation Dermacyn™ Wound Care. The reclassification was approved by the British Standards Institution (BSI), which is the world's largest certification body, and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom. Reclassified as a class III medical device, the newest indication is for "use in the debridement, irrigation and moistening of acute and chronic wounds, ulcers, cuts, abrasions and burns. Through reducing the amount of microorganisms and contributing to a moist environment, it enables the body to perform its own healing process." Additionally, the actives in Dermacyn™ are classified in Europe as medicinal substances that may have a local antimicrobial effect.
"This expanded label indication strengthens our European partners' product portfolios since they now are able to discuss the issue of antimicrobial effectiveness of Dermacyn in the wound bed with EU medical professionals," said Bruce Thornton, Oculus EVP of international operations. "This will provide doctors with a safe and effective alternative to more costly and toxic wound care regimens, thus improving patient outcomes."
About Oculus Innovative Sciences
Oculus Innovative Science is a global healthcare company that designs, manufactures and markets prescription and non-prescription products in over 20 countries. The company's products are used to treat patients in surgical/advanced wound care, dermatology, women's health and animal health; addressing the unmet medical needs of these markets—while raising the standard of patient care and lowering overall healthcare costs. The company's headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. More information can be found at www.oculusis.com.
Forward-Looking Statements
Except for historical information herein, 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 and future financial performance. These forward-looking statements are identified by the use of words such as "strengthens," "improving" and "will provide," 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 such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company's products will not be as large as expected, the Company's products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its 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 annual report on Form 10-K for the year ended March 31, 2012. Oculus Innovative Sciences disclaims any obligation to update these forward-looking statements except as required by law.
Oculus 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 Investor Contact: Oculus Innovative Sciences, Inc. Dan McFadden Vice President of Public and Investor Relations (425) 753-2105Source: Oculus Innovative Sciences, Inc.
Released March 26, 2013