Oculus Innovative Sciences Receives Australian Approvals to Market Sterile Microcyn®-Based Antimicrobial Solutions and Hydro...
11 August 2016 - 6:05PM
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 StatementsExcept 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
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