| OCULUS INNOVATIVE SCIENCES ANNOUNCES SECOND FDA 510K CLEARANCE OF MICROCYN® TECHNOLOGY
Clearance permits the use of super-oxidized, non-toxic and pH-neutral Microcyn® Technology in cleansing and debriding of acute and chronic wounds.
PETALUMA, CA-- (May 18, 2005)—
Hoji Alimi, founder and president of Oculus Innovative Sciences,
today announced that the company received its second 510K
clearance in as many weeks from the U.S. Food and Drug Administration.
This second clearance allows the company to market Dermacyn®
Wound Care, formulated with Microcyn® Technology, as
a medical device for cleaning and debriding of acute and traumatic
wounds and burns.
Microcyn® Technology is a super-oxidized,
pH-neutral solution that is ready for use with no dilution
or mixing, and requires no special handling or disposal. It
is manufactured using a sophisticated, multi-chamber electrolysis
process in which ionic species are selectively produced and
isolated. This process allows for the production of a pH-neutral
solution while minimizing the level of chlorine in the final
product.
This second FDA 510K clearance as a medical
device allows the company to market its label claims and enter
into negotiations with distributors for commercialization
purposes. Dermacyn® Wound Care, the first Microcyn®
Technology product for human use in the United States, will
be available to physicians in June 2005 by phoning 1(800)
759-9305.
The first FDA 510K clearance, announced
on May 5th, was to market Dermacyn® as a medical device
to lubricate and moisten wounds and burns. The company also
received CE approval according to the European Medical Devices
Directive (93/42/EEC) for Dermacyn® Wound Care in November
of this past year. It was certified as a Class IIb medical
device for treating acute and chronic wounds (e.g. diabetic
foot ulcers and burns) as part of a comprehensive wound care
regimen. The Microcyn® Technology received approval
as a disinfectant, antiseptic and sterilant from the Mexican
Ministry of Health in 2003 where the product is now widely
commercialized and in use for the treatment of myriad wounds
and burns. Dermacyn® Wound Care also received regulatory
approval this past November from the Therapeutic Product Directorate,
the Canadian federal authority that regulates pharmaceutical
drugs and medical devices, as a dermal wound irrigant that
facilitates removal of wound debris as it cleanses and debrides.
About Oculus
Oculus Innovative Sciences, headquartered in Petaluma, California,
is an innovator in the development of “landscape-altering”
medical devices and pharmaceutical products.
The company’s first proprietary
technology platform, Microcyn® super-oxidized water,
is a non-toxic, shelf-stable anti-microbial with the potential
to revolutionize the wound treatment market. It has proven
effective in safely and quickly killing bacteria (including
antibiotic-resistant strains such as MRSA and VRE in vitro),
viruses, spores, and fungi. The company also has a promising
oncology compound under development that will be entered into
clinical trials for the treatment of cervical dysplasia, a
pre-cancerous condition.
Oculus has employees and operations
in Mexico, Europe and the U.S. and includes two wholly owned
subsidiaries, Oculus Technologies of Mexico, S.A. de C.V.,
and Oculus Innovative Sciences Netherlands B.V. Please visit
us at www.oculusis.com.
Forward-Looking
Statements
This press release contains forward-looking
statements that involve risks and uncertainties. These forward-looking
statements relate to, among other things, plans and timing
for the introduction of our products, statements about future
market conditions, supply and demand conditions, revenues,
gross margins, operating expenses, profits and other expectations,
intentions and plans contained in this press release that
are not historical fact. Our expectations as expressed in
this press release depend upon our ability to develop, manufacture
and supply products that meet defined specifications. When
used in this press release, the words "plan," "expect,"
"believe," and similar expressions generally identify
forward-looking statements. These statements reflect our current
expectations. They are subject to a number of risks and uncertainties,
including, but not limited to, changes in technology and changes
in the health sciences market. In light of the many risks
and uncertainties surrounding this market, you should understand
that we cannot assure you that the forward-looking statements
contained in this press release will be realized.
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