The trials include patients reporting to the emergency department with chest pain and undergoing clinical evaluation including the performance of Positron Emission Tomography coupled to Computerized Axial Tomography (PET/CT).
The analysis of the results of the trials will decide the utility of the technology, based on which the company will begin preparing a 510(k) submission upon completion of data analysis.
Ampio CEO Michael Macaluso said that subsets of these patients will be analyzed for the use of ORP in hospital readmission prediction/prevention/reduction.
"The lack of a metric to determine preventable and non-preventable readmission is problematic and Ampio hopes that ORP measurements at or close to discharge may reduce readmission associated costs both to hospitals and insurers," Macaluso added.