Oculus Innovative Sciences Receives Australian Approvals to Market Sterile Microcyn®-Based Antimicrobial Solutions and Hydrogel Dressings
PETALUMA, Calif., Aug. 11, 2016 (GLOBE NEWSWIRE) -- Oculus Innovative Sciences, Inc. (NASDAQ: OCLS, warrants OCLSW), a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care, today announced that the company’s Microcyn®-based antimicrobial wound solution and wound hydrogel dressing have received Class IIb medical device registrations from the Australian Government Department of Health as well as Class IIb registrations from the New Zealand Medicines and Medical Devices Safety Authority.
The registrations, similar in substance, provide for the Microdacyn60® wound care products to be used in the debridement and moistening of chronic wounds, ulcers, cuts, abrasions and burns including those located in any human cavity such as the oral, nasal and ear. By reducing the microbial load via a local antimicrobial effect, these products assist in creating a moist environment, enabling the body to perform in its own healing process.
“Australia and New Zealand are two of the more challenging countries in terms of securing medical device registration,” said Bruce Thornton, Oculus VP for international marketing/sales. “They set the bar high relative to validating both product safety and efficacy. For that reason, we recognize these registrations as continued substantiation of the Microcyn Technology’s unparalleled performance in the treatment of wounds, rashes and skin infections. With these two new registrations in hand, the Microcyn Technology is now approved in over 45 countries worldwide.”
For the next four months, the Microdacyn60 products will be in pre-marketing mode with various sampling programs deployed for healthcare professionals in both countries. The planned commercial launch is scheduled for January 2017 with the Microcyn-based products being distributed exclusively by Oculus’ Australian/New Zealand partner, Te Arai Biofarma Limited.
About Oculus Innovative Sciences, Inc.
Oculus Innovative Sciences is a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care. The company’s products, which are sold throughout the United States and internationally, have improved outcomes for more than five million patients globally by reducing infections, itch, pain, scarring and harmful inflammatory responses. The company's headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. European marketing and sales are headquartered in Roermond, Netherlands. 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 commercial and technology progress and future financial performance of Oculus Innovative Sciences, Inc. and its subsidiaries (the “Company”). These forward-looking statements are identified by the use of words such as “planned” and “scheduled,” 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 common stock and warrants may be delisted from NASDAQ, 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, the Company may not be able 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 its annual report on Form 10-K for the fiscal year ended March 31, 2016. The Company disclaims any obligation to update these forward-looking statements, except as required by law.
Oculus®, Microdacyn60® 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.
Media and Investor Contact: Oculus Innovative Sciences, Inc. Dan McFadden VP of Public and Investor Relations (425) 753-2105 dmcfadden@oculusis.com
Released August 11, 2016