Ampio Pharmaceuticals has 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 EU earlier April 2014, 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.
Luoxis CEO Josh Disbrow noted that regulatory approval from Health Canada provides additional validation for its 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," Disbrow added.
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.