ExThera Seraph - Model 100 - Affinity Blood Filter
ExThera’s proprietary Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a first and only commercially available pathogen agnostic adsorption therapy, CE Marked for Europe, and given Emergency Use Authorization (EUA) in the United States. Seraph 100 has been validated through several preclinical studies and a clinical study in Europe to reduce both drug-resistant and drug-susceptible pathogens during bloodstream infections. The Seraph 100 promises to address significant unmet needs for patients before mechanical ventilation or pathogen identification. Seraph’s broad-spectrum reduction of pathogen concentration occurs without observed hemolysis.
Details
Pathogen Adsorption
In preclinical studies, ExThera’s scientists and independent labs have demonstrated that many toxins, inflammatory cytokines and a wide range of bacteria, viruses, toxins and disease-causing sepsis mediators are captured by Seraph when whole blood or serum is passed through the device. Notably, in vitro studies have demonstrated that MRSA, S. aureus, K. pneumoniae (CRE), K. pneumoniae, E. coli (CRE), E. coli, S. pneumoniae, E. faecalis, E. faecalis (VRE), E. faecium, A. baumannii, S. epidermidis, Methicillin resistant S. epidermidis, S. pyogenes, and Serratia marcescens are bound to the Seraph hemofilter's adsorption media as blood passes over it. This allows the concentration of bacteria in the incoming blood to be reduced by up to 99 percent in just a single pass through the filter. Continued recirculation of the blood through Seraph results in a 3 to 4 log reduction in pathogen concentration in the blood in just a few hours. Reducing the patient's pathogen load in blood lowers the risk of metastatic infection and a dysfunctional host response, stemming from the release of a variety of virulence factors, toxins, and cytokines.
Defense Advanced Research Programs Agency (DARPA) - DLT
ExThera’s technology was evaluated in a collaborative research program with Battelle Memorial Institute, with the goal of developing a Dialysis-Like Therapeutic (DLT) intrinsic separation device to treat sepsis in wounded warriors. The DLT program was funded by a grant from DARPA and ExThera had the only device evaluated in the final phase of the competitive program after other technologies were ‘down selected’ after being unable to meet the program’s goals. Due to the participation of ExThera Medical, DARPA considers the DLT program as having been successful.
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