I understand that it is already being sold. Right now, Spectral has a clinical trial in the US for the Toray device for patients with Endotoxemia and Septic Shock. In the trial one of the patient's inclusion criteria is "Endotoxin Activity Assay = 0.60 EAA units" which is where their EAA test would come in.
What I don't understand is if the Toray device is a critical care device. To hook a patient up, they would need to be in the ICU. After hook up, do the Toray patients get moved out of the ICU and into the normal ward? Does that make sense? From what I understand, I think Toraymyxin requires trained staff for hookup which can include the ICU. But the ICU will only accept severe sepsis patients. I guess I'm confused of how the Toray device gets used and the role of the ICU, the balance between the two. If a Spectral patient have Endotoxemia, are they allowed in the ICU? For Septic Shock, I think they are allowed?
Dr Chan's explanation:
"Going back to Toraymyxin, it would be improbable or impossible to use Toraymyxin in an outpatient setting. It would even be problematic to use this in the emergency room, as the emergency room's role in severe sepsis is to give antibiotics, stabilize and triage the patient...not to treat definitively. By the time a patient reaches the intensive care unit, it is likely too late to use Toraymyxin, as the problem is much more about cytokine storm than endotoxemia. But for CytoSorb, as a highly efficient cytokine filter, this is a perfect time and place to intervene. "
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