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TheStreet Open House

NovaBay Pharmaceuticals Receives Additional FDA 510(k) Clearance For NeutroPhase(R) Wound Cleanser

New Indications Gives Surgeons Greater Flexibility in the Management of Graft and Donor-SiteSurgical Procedures

NeutroPhase Now Available in Convenient Spray Pump

EMERYVILLE, Calif., Aug. 27, 2012 (GLOBE NEWSWIRE) -- NovaBay ® Pharmaceuticals, Inc. (NYSE Amex:NBY), a clinical-stage biotechnology company developing its first-in-class, anti-infective Aganocide ® compounds for the local non-systemic treatment and prevention of infections, today announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) to market NeutroPhase® Skin and Wound Cleanser under widened indications including the moistening and debriding of graft and donor sites. Concurrently, the FDA cleared NeutroPhase to be administered through a new convenient spray pump.

Ron Najafi, PhD, Chief Executive Officer and Chairman of NovaBay Pharmaceuticals commented, "This new FDA clearance is a major milestone in the recognition of NeutroPhase as an effective wound cleanser and significantly strengthens and enhances its use throughout the surgical community. We believe surgeons will be attracted to the flexibility it offers in the grafting and donor arena and its availability in a new easy-to-use spray pump."

Jack Fisher, M.D., FACS, Associate Clinical Professor of Plastic Surgery and President-Elect of the American Society for Aesthetic Plastic Surgery, stated, "The use of a specialized wound cleanser like NeutroPhase during surgical procedures such as skin grafting can be a valuable and effective tool in patients. Donor site infections after skin grafting are a major problem which can lead to delayed healing since burn patients have a high risk of infection. NeutroPhase therefore has application at both the donor site and recipient site since controlling infection leads to better and quicker healing. I have also used NeutroPhase at drain sites which are also prone to infection and other high risk surgical sites with excellent results."

NeutroPhase Skin and Wound Cleanser, first cleared in 2007, is intended for use under the supervision of healthcare professionals for the cleansing and removal of foreign material including microorganisms and debris from wounds and for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. It is also intended for moistening and debriding 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, grafted and donor sites.

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