Breakthrough Device Designation is obtainable from the US FDA for our PliNOSa IVD test for the early detection of the onset of sepsis. This same or similar regulatory designation/status is also obtainable from most national/regional regulatory agencies worldwide.
Our PliNOSa® Test: The unique capabilities of the microfluidic chip platform enable our novel rapid quantitative point of care test (POCT) device to detect the onset of sepsis to obtain US FDA Breakthrough Device Designation which is superior to a patent because the FDA will not allow a competing product onto the market for many years. Thus, our unique IVD device will have years of market exclusivity based upon regulatory agency status. Also, Emergency Use Authorization (EUA) marketing clearance from the US FDA is obtainable for the microfluidic chip POCT devise to detect the onset of sepsis in COVID-19 patients. EUA for our POCT is also obtainable from national/regional regulatory agencies worldwide.
Our aSeptiMab® Immunotherapeutic: The unique immunotherapeutic properties for our first-in-class drug to treat sepsis will be able to obtain US FDA Breakthrough Therapy Status, PRIME status in the EU, and SAKIGAKE status in Japan. All of these are superior to a patent because the regulatory agencies will not allow a competing product onto the market for many years. Also, Emergency Use Authorization (EUA) marketing clearance from the US FDA and the EU EMA is obtainable for our aSeptiMab humanized monoclonal antibody immunotherapy to treat sepsis in COVID-19 patients as are the corresponding EUA statuses from other national/regional regulatory agencies worldwide.