Ampio Pharmaceuticals subsidiary Luoxis Diagnostics has obtained CE Mark approval for its RedoxSYS, a point-of-care diagnostic instrument with accompanying disposable sensors that rapidly measure and report unique oxidative stress parameters by analysing a single drop of a blood or plasma.
It measures oxidation-reduction potential (ORP) in the body, a homeostatic measurement of oxidative stress that changes in response to traumatic injury or illness.
The first-in-class clinical diagnostic platform 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.
According to the company, ORP is an important measure in detecting both critical and chronic illnesses and is a novel marker of patient morbidity across a wide range of diseases and conditions.
Novel measures such as ORP enable rapid analysis of oxidative stress and antioxidant reserves, allowing for improved clinical insights into traumatic brain injury patients and potentially improve clinical management based on their condition's severity and ORP measures.
Multiple clinical trials have been completed using the RedoxSYS diagnostic system and have demonstrated the predictive value of ORP across numerous conditions.
With this clearance, the company expects the European launch in 2015.
The company also plans to engage in strategic market development activities designed to establish the clinical utility of the RedoxSYS system in the critical care setting.
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 recognised thought leaders in critical care throughout Europe," Disbrow said.
"In parallel, we are working toward obtaining US clearance for the RedoxSYS System from the FDA by conducting a number of prospective clinical studies in critical care indications."
Luoxis has engaged numerous prominent investigators to validate the clinical utility of RedoxSYS and expects to establish and strengthen relationships with leading hospitals in EU countries, where the company has identified parties who are focusing on oxidative stress.
The company is currently engaged in developing RedoxSYS as a simple, rapid blood test for use in the critical care setting, where it can help provide an objective measurement of patient injury and predict potential complications.
The new test will help enable physicians improve resource allocation and align higher levels of care with the most critically injured patients, leading to improved outcomes and optimal workflows.