Luoxis Awarded ISO 13485:2003 and ISO 9001:2008 Certifications
ISO certifications position Luoxis for regulatory clearance and commercialization of the RedoxSYS(TM) diagnostic system.
GREENWOOD VILLAGE, Colo., Jan. 9, 2014 /PRNewswire/ — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced that subsidiary Luoxis has received ISO 13485:2003 certification, an internationally recognized quality standard for medical devices and diagnostics. The company has also earned ISO 9001:2008 certification, a broadly established international quality standard.
The ISO 13485:2003 certification covers the design, development, production, sales, and service of the RedoxSYS(TM) diagnostic system, Luoxis’ proprietary oxidation-reduction potential (ORP) platform assessing novel markers of oxidative stress. These certifications demonstrate that Luoxis has successfully implemented a quality management system that conforms to the world-wide standard for medical device and diagnostic manufacturing. With this quality system in place, Luoxis may now progress with regulatory submissions to gain market clearance throughout the world.
“Receiving this ISO 13485 certification marks a significant achievement in the twelve-month history of Luoxis that demonstrates the importance we place on developing and commercializing the RedoxSYS(TM) system according to the highest quality standards,” says Josh Disbrow, President and Chief Executive Officer of Luoxis. “With this certification now in place, we look forward to advancing our regulatory activities to enable near-term commercialization in Europe, Canada, and other major markets throughout the world.”
The ISO (International Organization for Standardization) is the world’s largest developer and publisher of International Standards. Luoxis’ ISO 13485:2003 and ISO 9001:2008 certificates were awarded by BSI Group (also known as the British Standards Institution) through its subsidiary BSI Group America, Inc. BSI Group is the world’s largest certification body.
About the RedoxSYS Diagnostic System
The RedoxSYS diagnostic system is a patented diagnostic device with accompanying disposable sensors that rapidly measures and reports unique oxidative stress parameters by analyzing a single drop of a biologic specimen. Prior to the development of the RedoxSYS diagnostic system, oxidative stress measurement was incomplete, time consuming and impractical in a clinical setting. The RedoxSYS diagnostic system enables robust and rapid assessment of oxidative stress via measurement of oxidation-reduction potential (ORP) in the clinical setting. ORP is a homeostatic parameter capturing the balance of oxidants and reductants in a biologic system, a complete measure of oxidative stress. Multiple clinical trials have been completed using the RedoxSYS diagnostic system and have demonstrated the predictive value of ORP across numerous conditions.
Luoxis is a biotechnology company focused on the development and global commercialization of the RedoxSYS diagnostic system. The RedoxSYS diagnostic system is comprised of a portable analyzer and disposable sensors that rapidly measure the level of oxidative stress and antioxidant reserves in biologic specimens via assessment of oxidation-reduction potential (ORP). ORP has been shown to be an important measure in both critical and chronic illnesses and is a novel marker of patient morbidity across a wide range of conditions. There are numerous clinical indications for this homeostatic parameter for which there is no currently available test. Luoxis is a majority-owned subsidiary of Ampio Pharmaceuticals, Inc.
About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process; and (iii) decreasing vascular permeability.
Forward Looking Statement
Ampio’s statements in this press release that are not historical fact and that relate to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by use of words such as “believe,” “expect,” “plan,” “anticipate,” and similar expressions. These forward-looking statements include risks associated with clinical trials, expected results, regulatory approvals, and changes in business conditions and similar events. The risks and uncertainties involved include those detailed from time to time in Ampio’s filings with the Securities and Exchange Commission, including Ampio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.
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