| OCULUS
INNOVATIVE SCIENCES ANNOUNCES FDA 510K CLEARANCE OF MICROCYN®
TECHNOLOGY
Clearance permits the use of super-oxidized,
non-toxic and pH-neutral Microcyn® Technology in moistening
and lubricating of acute and chronic wounds.
PETALUMA, CA-- (May 9, 2005)—
Hoji Alimi, founder and president of Oculus Innovative Sciences,
today announced that the company has received its first 510K
clearance from the U.S. Food and Drug Administration to market
Dermacyn® Wound Care, formulated with Microcyn®
Technology, as a medical device for moistening and lubricating
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 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 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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