At the end of September 2007, NovaBay received clearance from the
U.S. Food and Drug Administration (FDA) for its NeutroPhase woundcare
product. NeutroPhase is NovaBay's proprietary solution of
hypochlorous acid, a molecule that is naturally produced by the
body's immune system to protect against pathogens. NeutroPhase has
been cleared by the FDA as a prescription product for moistening
absorbent wound dressings, irrigating and cleaning minor cuts, minor
burns, superficial abrasions and minor irritations of the skin, and
moistening, debriding and irrigating acute and chronic dermal
lesions, such as stage I-IV pressure ulcers, stasis ulcers, leg
ulcers, diabetic foot ulcers, post-surgical wounds, first and second
degree burns, and abrasions and minor irritations of the skin.
NeutroPhase has been licensed to an affiliate of Kinetic Concepts,
Inc. for development and commercialization purposes within the field
of wound healing.
At the end of September 2007, NovaBay completed the treatment phase
of the Phase I safety trial for NVC-422, NovaBay's lead compound in a
class of antimicrobial compounds that it calls the Aganocide
compounds, for the decolonization of the nasal passages prior to
surgery. A total of 96 subjects were enrolled in the trial. NVC-422
is being developed for use prior to surgery to kill pathogens in the
nasal passages, including Methicillin-Resistant Staphylococcus aureus
(MRSA). The presence of MRSA in the nasal passages has been
associated with a significant increase in the risk of surgical
infection and our development program is aimed at reducing this risk.
During the third quarter of 2007, NovaBay initiated toxicology
studies for NVC-422 for the prevention of cathet
|SOURCE NovaBay Pharmaceuticals, Inc.|
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