Ampio Pharmaceuticals 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.
Luoxis CEO Josh Disbrow said 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," Disbrow added.
"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.