GREENWOOD VILLAGE, Colo., April 22, 2014 /PRNewswire/ -- Ampio Pharmaceuticals, Inc., (NYSE MKT: AMPE) today announced that its subsidiary Luoxis, an in vitro diagnostics company, has obtained Health Canada Class II Medical Device approval for its RedoxSYS™ Diagnostic System, the company's blood-based platform for assessing the level of oxidative stress in the body.
The RedoxSYS System received CE Marking in the European Union (EU) earlier this month, where Luoxis has begun collaborating with leading hospitals and research centers. With Health Canada approval now in place, the company will begin building partnerships with prominent hospitals and academic centers to develop the market in Canada. In parallel with the company's development of the clinical market, Luoxis is working with pharmaceutical and biotechnology companies on a range of pharmaceutical pre-clinical and clinical programs. Luoxis has recently signed a long-term research agreement with a global, US-based pharmaceutical company.
Josh Disbrow, Chief Executive Officer of Luoxis, stated, "Regulatory approval from Health Canada provides additional validation for our RedoxSYS System, and it demonstrates the company's commitment to move the RedoxSYS System toward commercialization in key markets around the world. We are making substantial progress on the company's three key objectives – establishing clinical validation and utility of the RedoxSYS System, gaining regulatory clearance in key markets around the world, and introducing this novel platform to pharmaceutical companies for use in drug development. By achieving these objectives we expect to enable broad clinical and scientific adoption worldwide for the RedoxSYS System."
With regulatory clearances in both Europe and Canada, the company is now engaged in discussions with potential commercialization partners. Luoxis is evaluating various strategic options to maximize the commercial success of the RedoxSYS System, inclusive of both global and regional distribution arrangements.
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 illness and predict potential complications may enable physicians to improve resource allocation and align higher levels of care with the most critically injured and ill patients, leading to improved outcomes and optimal workflows.
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 and Luoxis are trademarks 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.
For Investors & Media:
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D.
[email protected]; (212) 375-2664
[email protected]; (646) 362-5750