NovaBay Pharmaceuticals’ Neutrox® Product Line Receives CE Mark and ISO Certification for the European Union
Opens market opportunities outside the U.S. for Avenova and demonstrates compliance with stringent safety and quality standards
EMERYVILLE, Calif. (September 12, 2016) – NovaBay® Pharmaceuticals, Inc. (NYSE MKT: NBY), a biopharmaceutical company focusing on commercializing prescription Avenova® lid and lash hygiene in the domestic eye care market, announces that its Neutrox® product line has received the CE mark, clearing the way for this product to be sold in European Union and certain other countries, and ISO 13485 certification, satisfying a critical step in European approval process.
“It’s gratifying to report that our Neutrox product line, which includes Avenova, has met the rigorous quality and safety standards to successfully complete the applications for both the CE mark and ISO certification,” said Mark M. Sieczkarek, NovaBay’s Chairman, President and CEO. “While we are committed to accelerating sales in the largely untapped U.S. market, these authorizations provide future opportunities to expand into significant new markets either through distributors or with our own sales organization.
“Avenova’s distinct advantages in managing chronic blepharitis are increasingly gaining recognition by eye care specialists both in the U.S. and abroad,” he added. “Avenova is the only eye care product based on our unique formulation of hypochlorous acid with no bleach impurities, and is the only commercial eye care product proven in a multicenter clinical study to substantially reduce bacteria that can cause blepharitis.”
About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics
NovaBay Pharmaceuticals is a biopharmaceutical company focusing on the commercialization of prescription Avenova® lid and lash hygiene for the eye care market. Avenova is formulated with Neutrox™, which is cleared by the U.S. Food and Drug Administration (FDA) as a 510(k) medical device. Neutrox is NovaBay’s pure hypochlorous acid. Laboratory tests show that hypochlorous acid has potent antimicrobial activity in solution yet is non-toxic to mammalian cells and it also neutralizes bacterial toxins. Data from a multicenter clinical study show that Avenova reduced bacterial load, the underlying cause of blepharitis, on ocular skin surface by more than 90%. Avenova is marketed to optometrists and ophthalmologists throughout the U.S. by NovaBay’s direct medical salesforce. It is accessible from more than 90% of retail pharmacies in the U.S. through agreements with McKesson Corporation, Cardinal Health and AmeriSource Bergen.
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 implied impact of obtaining the CE Mark and ISO certification on the Company’s future financial results. These 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 quality of our products, and possible difficulties or delays in manufacturing and distribution. Other risks relating to NovaBay’s business, 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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At the Company
Thomas J. Paulson
Chief Financial Officer