NovaBay Pharmaceuticals, Inc. Receives Additional FDA 510(k) Clearance for NeutroPhase(R) Wound Cleanser
8/27/2012 9:36:48 AM
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.
NovaBay is currently seeking appropriate potential partners to out-license rights to NeutroPhase in North America and Europe. For more information, visit www.NeutroPhase.com.
About NovaBay Pharmaceuticals, Inc.
Going Beyond Antibiotics
NovaBay Pharmaceuticals is a clinical-stage biotechnology company focused on addressing the large unmet therapeutic needs of the global anti-infective market with its two distinct categories of products.
NovaBay's first-in-class Aganocide compounds, led by NVC-422, are patented, synthetic molecules with a broad spectrum of activity against bacteria, viruses and fungi. Mimicking the mechanism of action that human white blood cells use against infections, Aganocides possess a very low likelihood that bacteria or viruses will be able to develop resistance, which is critical for advanced anti-infectives. Having demonstrated clinical efficacy in Phase 2 proof-of-concept clinical studies, NVC-422 is suited to treat and prevent a wide range of local, non-systemic infections. NovaBay's clinical development activities are focused on three disease areas:
Dermatology – Partnered with Galderma, a leading dermatology company, to develop a formulation of NVC-422 for treatment of highly contagious skin infection, impetigo, caused primarily by S. aureus and Group A Beta-hemolytic streptococci. A major global Phase 2b clinical study is planned for 2012.
Ophthalmology – NovaBay is developing an eye drop formulation of NVC-422 for treating adenoviral conjunctivitis. Enrollment into a global Phase 2b clinical study has begun with top-line data expected in the first half of 2013.
Urology – NovaBay's urinary catheter irrigation solution containing NVC-422 is currently enrolling patients in its Phase 2 proof-of-concept clinical studies, with the goal of reducing the incidence of urinary catheter blockage and encrustation (UCBE) and associated urinary tract infections. The Company reported positive data from Part A of this study and expects to announce top-line results from Part B later in 2012.
NeutroPhase is an FDA 510(k)-cleared product for advanced wound care. We believe that NeutroPhase is the only patented pure hypochlorous acid solution available and has the potential to be best suited to treat the six-million-patients in the U.S. who suffer from chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers. For additional information, visit: www.neutrophase.com.
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This release contains forward-looking statements, which are based upon management's current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding the expected timing of enrollment and commencement of clinical trials, expected timing of receipt and announcement of results of clinical studies, and expected efficacy of NeutroPhase. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results or achievements to be materially different and adverse from those expressed in or implied by the forward-looking statements. Factors that might cause or contribute to such differences include, but are not limited to, risks and uncertainties relating to difficulties or delays in development, clinical trial, regulatory approval, production and marketing of the company's product candidates, unexpected adverse side effects or inadequate therapeutic efficacy of the product candidates, the uncertainty of patent protection for the company's intellectual property or trade secrets, the company's ability to obtain additional financing as necessary and unanticipated research and development and other costs. Other risks relating to NovaBay and Aganocide compounds, including risks that could cause results to differ materially from those projected in the forward-looking statements in this press release, are detailed in NovaBay's Form 10-K and Form 10-Q filings with the Securities and Exchange Commission, especially under the heading "Risk Factors." The forward-looking statements in this release speak only as of this date, and NovaBay disclaims any intent or obligation to revise or update publicly any forward-looking statement except as required by law.
CONTACT: NovaBay Pharmaceuticals, Inc.
Thomas J. Paulson (Investors)
Chief Financial Officer
The Ruth Group
Stephanie Carrington / Nicole Greenbaum (Investors)
(646) 536-7017 / 7009
firstname.lastname@example.org / email@example.com
Victoria Aguiar (Media)