EMERYVILLE, Calif. and DUNBRIDGE, Ohio – NovaBay Pharmaceuticals, Inc. (NYSE MKT: NBY), a clinical-stage biopharmaceutical company developing non-antibiotic antimicrobial products, announced today that it has entered into an exclusive distribution agreement with Principle Business Enterprises (PBE). Under the agreement, PBE will market NovaBay’s NeutroPhase®* Skin and Wound Cleanser in the United States for acute and chronic wounds.
As a stable and pure form of hypochlorous acid produced by NovaBay’s proprietary manufacturing process, NeutroPhase has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Pure hypochlorous acid is a natural substance produced by the immune system to fight microbial invaders. In a recent peer-reviewed publication, NeutroPhase achieved better in vitro results than 18 of the top commercial wound cleansing products; killing bacteria in less than a minute at concentrations that are safe for human cells.
NeutroPhase contains 0.01% pure hypochlorous acid in saline with no bleach impurities, unlike other Dakin and Dakin-like solutions. In extensive in vitro testing, NeutroPhase kills bacteria in seconds and inactivates toxins generated by flesh eating bacteria. NovaBay has found a way to make pure HOCl in saline shelf-stable. In recent patient cases, physicians demonstrated clinical success using NeutroPhase irrigation therapy combined with negative pressure wound therapy (NPWT) for severe wounds caused by flesh eating bacteria.
“We are delighted to enter into a distribution agreement with NovaBay Pharmaceuticals,” commented Houston Legg, Executive Director of the Acute Care Division of PBE. “We believe NeutroPhase has a significant market opportunity in wound care in the United States. We look forward to the formal launch at the Society of Advanced Wound Care meeting later this spring.”
“PBE will bring NeutroPhase to medical facilities and emergency rooms all across the country,” said Dr. Ron Najafi, Chairman and CEO of NovaBay Pharmaceuticals. “Once doctors begin to use it, we believe they will quickly see its advantages over any other similar wound care product.”
Under the agreement, PBE is responsible for marketing and commercialization of NeutroPhase in the United States. NovaBay will assist in the training of PBE sales representatives and support PBE with key opinion leader development in the United States.
About Principle Business Enterprises, Inc.
PBE is a woman-owned enterprise celebrating over 50 years of business. Headquartered in Dunbridge, OH, PBE has a healthcare focused sales force with representatives located throughout the United States in all major cities and metropolitan areas. PBE is a key supplier to consumers, caregivers, medical professionals, home health, and health care institutions.
About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics®
NovaBay Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing topical non-antibiotic anti-microbial products.
NeutroPhase® is a 510(k)-cleared wound and skin cleanser and is intended for use under the supervision of healthcare professionals for cleansing and removal of foreign material, including: microorganisms and debris from wounds; cleaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin; as well as moistening absorbent wound dressings. 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, as well as grafted and donor sites.
NeutroPhase contains 0.01% pure hypochlorous acid in saline (with no bleach impurities, which is often present in Dakin and Dakin-like solution). In in vitro laboratory models, NeutroPhase in solution has shown to be fast-acting against bacteria, biofilm and toxins. Reductions of microbial growth in solution have not been shown to correlate with reductions in patients, as clinical trials to evaluate reductions in infections have not been performed. Statements regarding the use of NeutroPhase for necrotizing fasciitis and flesh-eating bacteria have not been reviewed by the FDA.
In addition to the United States, NovaBay has established marketing partnerships in China, eleven countries throughout Southeast Asia and South Korea. NovaBay expects to announce additional marketing partnerships in other counties around the globe in the coming months. More information on NeutroPhase and how to purchase it can be found at: www.neutrophase.com.
This release contains forward-looking statements and opinions, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. These statements include, but are not limited to, statements regarding the effectiveness of NovaBay’s products against bacteria and ‘flesh-eating disease’. The words “believe”, and “will” are intended to identify these 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, 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 latest 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.
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