Luoxis Awarded ISO 13485:2003 and ISO 9001:2008 Certifications

        Luoxis Awarded ISO 13485:2003 and ISO 9001:2008 Certifications

ISO certifications position Luoxis for regulatory clearance and
commercialization of the RedoxSYS™ diagnostic system.

PR Newswire

GREENWOOD VILLAGE, Colo., Jan. 9, 2014

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.

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The ISO 13485:2003 certification covers the design, development, production,
sales, and service of the RedoxSYS™ 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™ 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.

About Luoxis
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.

Investor Contact:
Rick Giles
Director of Investor Relations
Ampio Pharmaceuticals, Inc.
Direct: (720) 437-6530
Email: rgiles@ampiopharma.com

SOURCE Ampio Pharmaceuticals, Inc.

Website: http://www.ampiopharma.com
 
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