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Seraph 100

Our Technology

ExThera’s proprietary Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is the first and only commercially available pathogen agnostic adsorption therapy, CE marked for Europe and given Emergency Use Authorization (EUA) by the FDA 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.

Why use the Seraph 100?

The Seraph 100 addresses a significant unmet need for patients before mechanical ventilation or pathogen identification. Seraph 100’s broad-spectrum ability to reduce pathogen concentration occurs without observed hemolysis.

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Pathogen Adsorption – Reducing Pathogens in the Blood by Up To 99% per pass

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 bind to the Seraph hemofilter’s adsorption media. Up to 99% pathogen reduction has been observed with a single Seraph 100 treatment. 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.

ExThera and the Defense Advanced Research Programs Agency (DARPA)

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—all funded by a grant from DARPA.

ExThera had the only device evaluated in the final phase of the competitive program after other technologies were “down selected” because they were unable to meet the program’s goals. Because of ExThera Medical’s participation, DARPA considers the DLT program a success.

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ExThera Medical Corporation
757 Arnold Drive, Suite B
Martinez, California 94553
p: (925) 839-2060 | f: (925) 839-2075
e: info@extheramedical.com

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DISCLAIMERS
*The Seraph® 100 Microbind® Affinity Blood Filter (Seraph) is CE Marked and approved for commercial sale in EU member states.
**Emergency Use Authorization Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is for use in the United States under FDA EUA200165:
Authorization for Emergency Use in patients with COVID-19 admitted to the ICU with confirmed or imminent respiratory failure.
The Seraph 100 device has neither been cleared or approved for the indication to treat patients with COVID-19 infection.
The Seraph 100 device has been authorized by FDA under an Emergency Use Authorization (EUA).
The Seraph 100 device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Seraph device 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.