| RESULTS
OF CLINICAL STUDY EVALUATING TREATMENT OF DIABETIC FOOT ULCERS
USING MICROCYN® TECHNOLOGY PRESENTED AT STUTTGART2005
218-patient study indicates Microcyn®
Technology superior in microbial load reduction, healing time,
surgical dehiscence and adverse side effects as compared to
povidone iodine (10%).
STUTTGART, GERMANY-- (October 4,
2005)— Oculus Innovative Sciences, Inc. announced
that Dr. Luca Dalla Paola, a surgeon with the diabetic foot
unit of the Abano Terme Hospital in Italy, recently presented
the results of a 218-patient controlled clinical study that
assessed the safety and efficacy of Microcyn® Technology
in treating diabetic foot ulcers as compared to povidone iodine
(10%) antiseptic, which is often used as the “standard
care” in treatment of open wounds.
 In
the study, the Microcyn® Technology proved superior
to the iodine relative to the reduction of the number of bacterial
strains, local adverse effects, surgical dehiscence (incidence
of not healing after surgery due to infection or ischemia)
and healing time. The key endpoint of the study was microbial
load reduction at both entry and at surgery (or follow-up).
The Microcyn® Technology showed a significantly improved
rate of reduction of microbial load and healing time in open
wounds as compared to the povidone iodine group. 88.2% of
ulcers in the Microcyn® group had a negative microbiological
specimen versus 68.5% of ulcers in the povidone iodine group.
The Microcyn® group showed no local adverse effects,
while the povidone iodine group experienced 18 incidences
of such effects.
Foot ulcers are a common complication of
diabetes and account for high morbidity and mortality. Infection
in the presence of this peripheral vascular disease is the
most important prognostic factor for the risk of amputation
in the diabetic foot. Antibiotic therapy, surgical treatment
of deep infection and antiseptic dressings are commonly used
to treat infection in the diabetic foot. While local antiseptic
agents are widely used, there is little data about their efficacy.
This first European study using Microcyn®
Technology was a retrospective, open-label single-center (Abano
Terme Hospital) study conducted by Dr. Dalla Paola. The results
were presented at Stuttgart2005, an international wound management
conference jointly sponsored by the European Wound Management
Association (EWMA), the European Tissue Repair Society (ETRS)
and Deutsche Gesellschaft für Wundheilung and Wundbehandlung
e.V. (DsfW).
“In light of the positive evidence
generated by this study,” said Dr. Dalla Paola, “my
associates and I are highly enthusiastic about Microcyn’s
potential to redefine the standard of treatment in diabetic
foot ulcers. This study certainly warrants further examination
of this super-oxidized water formula, not only in the treatment
of diabetic foot ulcers, but also in dealing with other chronic
wounds and burns—essentially in any wound where infection
is a challenge.”
Regulatory
Oculus Innovative Sciences, the developer and manufacturer
of the Microcyn® Technology, received CE approval according
to the European Medical Devices Directive (93/42/EEC) for
Dermacyn® Wound Care in November 2004. 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.
Two FDA 510K clearances were also received
in May 2005 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. Dermacyn® Wound Care also received
regulatory approval in November 2004 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. The technology has also received antiseptic
approval in Mexico for treatment of open wounds.
About Oculus
Oculus Innovative Sciences, headquartered in Petaluma, California
has developed a proprietary technology platform, Microcyn®
super-oxidized water. The Microcyn® Technology is a
non-toxic, shelf-stable anti-microbial which has been proven
effective in safely and quickly killing bacteria (including
antibiotic-resistant strains such as MRSA, Methicillan-Resistant
Staphylococcus; and VRE, Vancomycin-resistant Enterococcus,
in vitro), viruses, spores, and fungi.
Oculus’ principal operations are
in Petaluma, California, and it conducts operations in Europe
and Latin America through its wholly-owned subsidiaries, Oculus
Innovative Sciences Netherlands B.V. and Oculus Technologies
of Mexico, S.A. de C.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, the attributes of
our products and their use in various markets. 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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