Healthcare Industry News:  ventilator 

Diagnostics Regulatory

 News Release - April 2, 2014

Luoxis Obtains CE Marking for RedoxSYS(TM) Diagnostic System

Regulatory Clearance Enables Commercialization in Europe and other Key Markets

GREENWOOD VILLAGE, Colo., April 2, 2014 -- (Healthcare Sales & Marketing Network) -- Ampio Pharmaceuticals, Inc., (NYSE MKT: AMPE) today announced that its subsidiary Luoxis, an in vitro diagnostics company, has obtained CE Marking in Europe for its RedoxSYS™ Diagnostic System, the company's blood-based platform for assessing the level of oxidative stress in the body. This regulatory clearance allows Luoxis to engage in strategic market development activities designed to establish the clinical utility of the RedoxSYS System in the critical care setting, and position the company for a successful launch in Europe, which is currently anticipated for 2015.

European market development will focus on several key areas within critical care medicine, including monitoring injury severity and patient oxidative stress following traumatic brain injury or multi-trauma injury, which combined, are estimated to account for nearly six million hospital admissions in Europe every year. These are areas of significant medical need, and medical conditions for which Luoxis has established proof-of-concept and demonstrated significant clinical validation in prospective clinical studies.

Josh Disbrow, Chief Executive Officer of Luoxis, stated, "Obtaining the first market clearance for our RedoxSYS platform is a significant milestone for Luoxis. Most importantly, it allows us to begin strategically developing the market by aligning with internationally recognized thought leaders in critical care throughout Europe. In parallel, we are working toward obtaining U.S. clearance for the RedoxSYS System from the FDA by conducting a number of prospective clinical studies in critical care indications."

Luoxis is conducting market development at leading hospitals and research centers in EU countries where the company has identified thought leaders who are focusing on oxidative stress. The company has engaged numerous prominent investigators to validate the clinical utility of RedoxSYS. Through these efforts, Luoxis also expects to establish and strengthen relationships with leading hospitals in these target territories, which should facilitate adoption of the product during the clinical launch.

About the RedoxSYS Diagnostic System

The RedoxSYS Diagnostic System is a first-in-class clinical diagnostic platform that measures oxidation-reduction potential (ORP) in the body, a homeostatic measurement of oxidative stress that changes in response to traumatic injury or illness. The result of nearly two decades of clinical, scientific and technical R&D, the RedoxSYS System is able to provide the only complete assessment of a patient's oxidative status, which has broad diagnostic application across multiple disease areas where oxidative stress is implicated. Luoxis is currently developing RedoxSYS as a simple, rapid blood test for use in the critical care setting, where its ability to provide an objective measurement of patient injury and predict potential complications may enable physicians to improve resource allocation and align higher levels of care with the most critically injured patients, leading to improved outcomes and optimal workflows.

About Luoxis

Luoxis is an in vitro diagnostics company focused on developing and commercializing its proprietary, CE Marked RedoxSYS Diagnostic System. The company is currently developing RedoxSYS to address the $4+ billion critical care market, where it has the potential to provide hospitals with a single, rapid solution with unmatched diagnostic/prognostic value for conditions with significant medical need, and for which few diagnostic biomarkers exist. Luoxis is conducting initial market development for RedoxSYS in select European territories in order to validate and quantify the clinical value of RedoxSYS for monitoring injury severity and patient oxidative stress following traumatic brain injury, multi-trauma injury, and other critical illnesses. Luoxis is also pursuing U.S. regulatory clearance for RedoxSYS, based on completed and ongoing clinical studies in multiple critical care conditions in the United States, including TBI, multi-trauma injury, stroke, sepsis, ventilator-associated pneumonia (VAP), and other life-threatening conditions. Luoxis has research collaborations in place with leading centers around the world. Luoxis is a majority-owned subsidiary of Ampio Pharmaceuticals, Inc. For more information, visit www.luoxis.com.

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.

RedoxSYS is a trademark of Luoxis Diagnostics, Inc.

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.


Source: Ampio Pharmaceuticals

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