Oculus Innovative Sciences Receives U.S. FDA Approval for New Post-Dermal-Procedures Product for Removal of Foreign...
24 August 2016 - 7:05PM
Oculus Innovative Sciences, Inc. (NASDAQ: OCLS, warrants OCLSW), a
specialty pharmaceutical company that develops and markets
solutions for the treatment of dermatological conditions and
advanced tissue care, today announced it has received a new 510(k)
clearance from the U.S. Food and Drug Administration (FDA) for the
company’s new post-dermal-procedures product.
Under the supervision of a healthcare professional, the product
is intended for the removal of foreign material including
microogranisms and debris from postdermal procedures.
“Within my practice I utilize the Microcyn Technology
(hypochlorous acid or HOCl) post-procedure and have been most
impressed with its ability to accelerate the healing process,
manage post-procedure symptoms and protect against secondary
infections. I find these HOCl products to be safer, non-cytotoxic
and a more effective alternative to povidone-iodine and
chlorhexidine. Now, with this approval from the FDA, I believe my
peers will benefit from adding Microcyn-based products to their
treatment protocols,” said Dr. Michael Gold, board-certified
dermatologist and cosmetic surgeon, and founder of Gold Skin Care
Center, Advanced Aesthetics Medical Spa, the Laser &
Rejuvenation Center and Tennessee Clinical Research Center, all
located in Nashville, Tennessee.
Oculus’ dermatology division, IntraDerm, will begin marketing
the postdermal-procedures product in the United States beginning
in March 2017.
About IntraDerm PharmaceuticalsA division of
Oculus Innovative Sciences, IntraDerm Pharmaceuticals is a global
dermatology enterprise with an initial focus on Microcyn®
Technology and LipoGrid® Technologies. The division’s
headquarters are in Petaluma, California with the international
sales operations in the Netherlands, and manufacturing operations
in the United States and Latin America. More information can
be found at www.intraderm.com.
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 “will begin” and “marketing,” 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® 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
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