NovaBay Pharmaceuticals, Inc. (NYSE MKT: NBY), a clinical-stage biopharmaceutical company developing topical non-antibiotic antimicrobial products, today announced that it received ISO (International Organization for Standardization) 13485 certification from the notified body DEKRA, for its quality management system. This is an important milestone supporting the manufacturing and commercialization of NovaBay’s NeutroPhase® skin and wound cleanser.
“In many worldwide markets, such as the European Union and Southeast Asia, ISO certification is required to register products with regulatory authorities. We are currently in the process of registering NeutroPhase in China and throughout Southeast Asia,” said Dr. Ron Najafi, Chairman and Chief Executive Officer of NovaBay Pharmaceuticals. “I am proud we have received ISO 13485 certification, which recognizes our pursuit of quality and commitment toward our customers’ needs.”
ISO 13485 is an internationally recognized quality standard that requires an organization to demonstrate that it has the comprehensive quality management systems in place to consistently meet the specific customer and regulatory requirements applicable to medical devices.
About NovaBay Pharmaceuticals, Inc.: Going Beyond Antibiotics®
NovaBay Pharmaceuticals is a clinical-stage biopharmaceutical company focused on addressing the unmet therapeutic needs of the global, topical anti-infective market with its Aganocide compounds, led by auriclosene. Company’s four business units – DermaBay, UroBay, EyeBay and MediBay – are developing treatments that tackle infections in the dermatology, urology, ophthalmology, and wound care areas.
NeutroPhase® is a 510(k)-cleared wound 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 is a 0.01% pure hypochlorous acid in saline (without bleach impurities, which are often present in Dakin and Dakin-like solutions). 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 possible registration of the Company’s products in regions around the world. Phrases such as “in the process” 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, 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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