New Device to Predict Severe TBI Outcome Almost Ready for FDA
On October 1, 2013, Luoxis Diagnostics (a subsidiary of Ampio Pharmaceuticals, Inc) announced the results of its five year multi-center study on the use of a device at bedside to predict the outcome of severe TBI.
The results confirmed that measurement of ORP is an accurate gauge to outcome. ORP stands for oxidation-reduction-potential. When ORP is high it means the patient’s brain is highly inflammed and undergoing severe oxidative stress along with severe depletion of anti-oxidants to combat inflammation. When the device shows very high ORP the patient is likely to die or come out with severe disability. At this point the device is nearly ready to submit to the FDA for regulatory approval.