NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a biopharmaceutical company focusing on the development and commercialization of topical non-antibiotic anti-infective products, announces the rebranding of its i-Lid Cleanser with Neutrox™ as Avenova™ with Neutrox. This name change, effective immediately, helps NovaBay to differentiate prescription Avenova from other products marketed as eye cleaners, in particular over-the-counter (OTC) products not intended for continuous daily use.
Avenova is the only eye care product to contain Neutrox, NovaBay’s pure hypochlorous acid (HOCl), which is a naturally occurring substance produced by white blood cells to fight microbial invaders. Laboratory tests show it has potent antimicrobial activity in solution yet is non-toxic to mammalian cells; it also neutralizes bacterial toxins.
“Avenova is uniquely suited for daily use by the millions of Americans who suffer from chronic eye conditions like blepharitis and dry eye. Yet far too many ophthalmologists and optometrists have confused prescription Avenova with OTC surfactant lid cleaners,” explained Glenn Moro, NovaBay’s Vice President for Sales and Marketing. “While those OTC products are effective for their intended uses, none is designed for continuous daily eyelid hygiene.”
“Avenova is a real breakthrough in eye care,” said Terrence P. O’Brien, M.D., Director of the Refractive Surgery Service, Bascom Palmer Eye Institute at Palm Beach Gardens. “This product fills a medical need not being met by current products.”
According to Art Epstein, O.D., Director of the Dry Eye & Ocular Surface Disease Center and Director of Clinical Research at Phoenix Eye Care, Avenova makes possible a new paradigm for eye care. “Historically eye care specialists have brought relief to patients who present with conditions like blepharitis, where Staphylococci bacteria grow on eyelids and cause swelling, redness, inflammation, irritation and a crusty build-up. While Avenova is effective as part of the regimen for managing those conditions, regular use of Avenova may prevent such problems before they occur, much as daily flossing helps to prevent dental problems,” he said.
“Changing the name of our ophthalmic anti-infective cleanser from i-Lid Cleanser to Avenova will reinforce our marketing message that Avenova brings a powerful new prescription tool to eye care,” said Ron Najafi, Ph.D., Chairman and CEO of NovaBay. “Once eye care professionals prescribe Avenova, we believe they will quickly experience the improvement it has on the lives of their patients.”
Avenova was cleared by the U.S. Food and Drug Administration as a prescription medical device through the 510(k) process (see below for Indications for Use statement). As previously announced, NovaBay signed a distribution agreement with McKesson Corporation, the largest pharmaceutical distributor in North America, making Avenova available to the 45,000 pharmacies it services across the U.S. In addition, Avenova is now available to the members of the Vision Source Independent Optometry Network. Vision Source is the largest independent optometry network in the country, representing 2,800 independent optometrist offices.
About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics®
NovaBay Pharmaceuticals is a biopharmaceutical company focusing on the development and commercialization of its non-antibiotic anti-infective products to address the unmet therapeutic needs of the global, topical anti-infective market with its two distinct product categories: FDA-cleared NEUTROX™ Family of Products: AVENOVA™ for the eye care market, NEUTROPHASE® for wound care and CELLERX™ for the dermatology market; and its AGANOCIDE® compounds, led by AURICLOSENE™.
*Avenova Skin and Wound Cleanser is intended for use under the supervision of healthcare professionals for 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 to IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post surgical wounds, first and second degree burns, grafted and donor sites.
This release contains forward-looking statements and opinions regarding the commercial potential of Avenova, which are based upon management’s current expectations, assumptions, estimates, projections and beliefs. 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 the actual market acceptance of Avenova, the clinical effectiveness of Avenova, and the possibility that customers will not perceive the benefits of Avenova to be the same as NovaBay believes. Other risks relating to NovaBay and its products, 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-Qs as filed 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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