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 antibiotic-resistant infections, presented a poster on the efficacy of NeutroPhase® solution (NVC-101) with the hydrophobic mesh Sorbact® in healing chronic non-healing wounds at the 2011 Symposium on Advanced Wound Care (SAWC) in Dallas on April 15-16.
The poster, entitled “NeutroPhase® with Sorbact® Dramatically Enhances the Speed of Wound Healing,” was written by researchers at NovaBay and the San Francisco Center for Advanced Wound Care at the Seton Medical Center in Daly City, CA. The poster reported on multiple case studies in the clinic in which a combination of 0.01% NeutroPhase, (used as a fast-acting, broad-spectrum anti-infective irrigant, capable of destroying biofilms associated with infections) with Sorbact (distributed by Pioneer Technology, Inc.) as a wound mesh dressing capable of reducing maceration of adjacent skin and binding and inactivating pathogenic microorganisms, in conjunction with Negative Pressure Wound Therapy (NPWT) administered to 26 patients with chronic non-healing wounds.
These infected wounds were culture positive for a variety of pathogens which were treated successfully with NeutroPhase; most notably, methicillin-resistant staphylococcus aureus (MRSA), pseudomonas aeruginosa and vancomycin-resistant enterococci (VRE). The poster shows the clinical case study results from patients with non-healing wounds following amputation, a chronic venous girdle ulcer, a traumatic venous ulcer and a MRSA infection post radical excision of a squamous cell cancer with exposed cranial bone. The inability of these wounds to heal can be exacerbated by the presence of bacteria-rich biofilm.
The researchers demonstrated that NeutroPhase was capable of destroying biofilm in the wounds without damaging the surrounding tissues and was an effective topical antimicrobial that improved wound healing. Moreover, Sorbact was found to help reduce tissue maceration, a process in which the skin softens, turns white, and can easily get infected with bacteria or fungi. NovaBay has two FDA 510(k) clearances for NeutroPhase® solution and has begun to move forward towards large-scale manufacturing and eventual marketing by its Hospital Business Unit. NovaBay’s Hospital focused Business Unit directs all activities relating to manufacturing, partnering and development of additional application of NeutroPhase.
“Infected wounds do not heal!” said John Crew, MD, FACS, Vascular Surgeon and Medical Director of San Francisco Center for Advanced Wound Care at the Seton Medical Center in Daly City, CA. and one of the poster’s co-authors. Dr. Crew continued, “Biofilm associated with infected wounds can severely delay or inhibit wound healing contributing to the patients’ morbidity and mortality. These clinical case results are very impressive. We are grateful to NovaBay and their research and development team for developing NeutroPhase for this growing patient population. Furthermore, these case studies reveal that NeutroPhase, applied in combination with Sorbact, was well-tolerated by the patients and has the potential to be a very effective wound care product. We have observed accelerated healing based on historical experience and exceptional versatility in terms of the types of wounds that can be successfully treated in this way.”
To view the NeutroPhase poster, please follow this link: http://www.novabaypharma.com/docs/NeutroPhase%20with%20Sorbact.pdf
NeutroPhase® consists of pure and stable hypochlorous acid in saline. NeutroPhase has broad-spectrum anti-infective and anti-biofilm properties. Hypochlorous acid is the same molecule produced by the body when white blood cells defend against bacteria. The solution has been shown not to harm living cells and is rapidly effective against common wound pathogens. The characteristics and mechanisms of action of NeutroPhase make it highly unlikely that resistant strains of bacteria could develop over time. NeutroPhase has two 510(k) clearances at 0.01% to 0.1% concentration.
About NovaBay Pharmaceuticals, Inc.
NovaBay Pharmaceuticals is a clinical-stage biotechnology company focused on developing its proprietary and patented Aganocide compounds. These are novel, synthetic anti-infectives with activity against bacteria, fungi and viruses, and are being developed to treat and prevent a wide range of local, non-systemic infections with a low likelihood of developing bacterial resistance.
NovaBay is focusing its technology on four distinct therapeutic areas: dermatology, ophthalmology, urology and hospital infections. In dermatology, the focus is on developing NVC-422 gel for impetigo and acne. NovaBay has the advantage of being partnered with Galderma, the leading dermatology company in the world. In ophthalmology, the goal is to develop an eye drop for conjunctivitis with Alcon, the world’s foremost ophthalmology company. In urology, NovaBay aims to reduce the incidence of urinary catheter blockage and encrustation (UCBE) and the potential for urinary tract infections with an irrigation solution containing NVC-422. In hospital infection, NovaBay is targeting the six-million-patient market of chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers with its proprietary anti-infective solution, NeutroPhase, which has received two 510(k) clearances from the Food and Drug Administration. For additional information, visit www.novabaypharma.com.
Cautionary Information Regarding Forward-Looking Statements
This release contains forward-looking statements, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. The statements in this press release including, but not limited to, statements regarding NovaBay’s expectations and potential regarding the potential of NeutroPhase to be a very effective wound care product and the eventual marketing of NeutroPhase by NovaBay’s Hospital Business Unit as well as other statements that relate to future events or results, are forward-looking statements. 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: the risk that NovaBay may experience unexpected results in further studies which may limit, delay or prevent NovaBay from manufacturing NeutroPhase; unexpected adverse side effects or inadequate therapeutic efficacy of NeutroPhase may inhibit it from becoming a treatment for chronic wound and the risk of unexpected delays in the regulatory process which may delay the manufacturing and potential marketing of NeutroPhase. Other risks relating to NovaBay and its 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 Annual Report on Form 10-K for the period ended December 31, 2010, under the caption “Risk Factors” in Item 1A of Part I of that report, filed with the Securities and Exchange Commission on March 10, 2011. 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.
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