NovaBay Pharmaceuticals’ Neutrox® Product Line Receives CE Mark and ISO Certification for the European Union
September 12 2016 - 6:50AM
Business Wire
Opens market opportunities outside the U.S. for
Avenova and demonstrates compliance with stringent safety and
quality standards
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.
Forward-Looking Statements
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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version on businesswire.com: http://www.businesswire.com/news/home/20160912005246/en/
NovaBay ContactsFor NovaBay
Avenova purchasing information, please contact:Email usCall us:
1-800-890-0329www.Avenova.comorFrom the
CompanyThomas J. PaulsonChief Financial
Officer510-899-8809Contact TomorInvestor
ContactLHAJody Cain310-691-7100Jcain@lhai.com
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