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OCULUS INNOVATIVE
SCIENCES ANNOUNCES COMPANY’S FIRST U.S. CLINICAL TRIAL ON
HUMANS
Results will support new drug application
for Microcyn® Technology to be used as an anti-microbial preoperative
and pre-injection skin preparation.
PETALUMA, CA-- (June 17, 2005)—
Theresa Mitchell, vice president of regulatory and clinical affairs
for Oculus Innovative Sciences, today announced that the company
has initiated its first United States clinical trial on humans to
gain approval for the Microcyn® Technology to be marketed as
an anti-microbial preoperative and pre-injection skin preparation.
The company anticipates the technology to demonstrate both safety
and efficacy, while remaining non-irritating and non-toxic.
According to Mitchell, “This is a major
step towards Oculus’ eventual pursuit of FDA review for a
new drug application that may allow for claims of anti-microbial
characteristics on open wounds and skin ulcers, such as those experienced
by burn or diabetic foot ulcer victims.”
This Phase I study includes 290 volunteers and
is being conducted at BioSciences Laboratories in Bozeman, Montana.
Ms. Mitchell indicates the company expects significant clinical
data from this study by fall of this year.
The company will also be initiating other clinical
studies in Europe and the U.S. that it intends to announce this
summer. These studies are expected to provide supporting data for
the technology’s anti-microbial claims as they relate to treatment
of open wounds and will be submitted to the U.S. Food and Drug Administration.
This is a critical step in improving upon the “standard of
care” in healthcare institutions as a result of integrating
the Microcyn® Technology into traditional wound care regimens.
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.
The company received its first two FDA 510K clearances
last month to market Dermacyn™ Wound Care, formulated with
the Microcyn® Technology, in the United States as a medical
device to lubricate, moisten, cleanse and debride wounds and burns.
The company also received CE approval according to the European
Medical Devices Directive (93/42/EEC) for Dermacyn™ Wound
Care in April. 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, with the Microcyn® Technology, 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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