US FDA Grants ExThera’s Seraph-100 Blood Filter Emergency Use Authorization for the Treatment of COVID-19 After Promising Results in Europe and the USA
April 17, 2020

Martinez, Calif. – April 17, 2020 After promising COVID-19 treatments in Germany, France, Italy, Spain and the USA, ExThera Medical’s Seraph®100 Microbind® Affinity Blood Filter (Seraph 100) has been granted Emergency Use Authorization by the Food and Drug Administration (FDA). This approval comes soon after first use of the device to treat COVID-19 patients in Europe and in the United States and will facilitate Seraph 100 use in U.S. hospitals.

Seraph 100 earned its CE Mark in Q3 2019 and is widely available in Europe. Emergency Use Authorization (EUA) by the USFDA offers a pathway for immediate use of promising healthcare technologies – devices, diagnostics, and drugs – during times of health emergencies like the COVID-19 pandemic. Seraph 100 is now available for COVID-19 treatments in the USA. At this time there is no other blood purification therapy known to bind and remove SARS-CoV-2 virus/RNA while also improving vital signs and laboratory parameters associated with inflammation and tissue damage.

Several critically-ill COVID-19 patients, including those with pre-existing medical conditions, have been treated with Seraph 100 after showing serious symptoms of the virus. Initial clinician reports indicate Seraph 100 stabilizes blood pressure and inflammatory biomarkers that correlate with poor outcome: IL-6, Ferritin, D-dimers, LDH and Nt-proBNP, all decreased during Seraph 100 treatments of COVID-19 patients. It appears that Seraph 100 helps improve patient outcomes by providing additional time for supportive care while reducing the source of inflammation and potentially preventing further damage by reducing virus in the bloodstream.

“We have been in close contact with the centers treating COVID-19 and we’re pleased to see general improvement in the health of COVID-19 patients during and after treatment with Seraph 100,” says Professor Jan T. Kielstein, Director of Nephrology | Rheumatology | Blood Purification at Academic Teaching Hospital Braunschweig, Germany. “Treatment with this device has immediate and sustained effects on vital signs and laboratory parameters. Critically ill patients tolerate it very well in terms of cardiovascular stability. Aside from reducing pathogens in the blood, Seraph 100 has other features that that could benefit COVID-19 patients.” These are currently being investigated by documenting COVID-19 patients treated with the Seraph. In addition, two multi-center clinical trials of Seraph 100 treatment of COVID-19 will start soon: one in the EU and another DOD-funded study in the USA.

In the treatment of bacterial infections Seraph 100 has quickly reduced drug-resistant bloodstream pathogens and consistently improved patients’ oxygen saturation. The binding of SARS-CoV-2 virus together with the ability to treat secondary bacterial infections makes Seraph 100 therapy unique in the treatment of COVID-19. Our hope is that under the EUA Seraph 100 will quickly make its way into the hands of US clinicians.” remarked Robert Ward NAE, President and CEO of ExThera Medical.

In contrast to other blood purification technologies which only remove molecules, Seraph 100 also quickly lowers the concentration of viruses, bacteria and fungi in whole blood. In pre-clinical testing and in clinical use, Seraph 100 has been shown to significantly reduce the bloodstream concentration of both drug-susceptible and drug-resistant pathogens, providing a long-awaited therapy that addresses the severe problem of drug-resistance, and new and future microbial threats like the COVID-19 virus.

About the Seraph® 100 Microbind® Affinity Blood Filter
Seraph 100 is the first device ever approved for the reduction of pathogens in blood. As a patient’s blood flows through the Seraph filter, it passes over tiny beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Harmful substances are quickly captured and adsorbed onto the surface of the beads and are thereby removed from the bloodstream. Seraph does not add anything to the blood, which is returned to the patient with blood cells and proteins intact. Seraph targets the pathogens that cause the infection, while it also binds and removes harmful substances generated by the pathogen and by the body’s response to the infection.

Seraph’s adsorption media (the beads) constitute a flexible platform that uses immobilized (chemically bonded) heparin for its well-established blood compatibility and its unique ability to bind bacteria, viruses, fungi, and important sepsis mediators reported to contribute to organ failure during sepsis. The ‘anti-thrombogenic’ heparin media can be combined with other ExThera-proprietary media to tailor the capability of future Seraph products for the treatment of specific diseases, or to further broaden Seraph’s capability.

About ExThera Medical
Based in Martinez, California, near San Francisco, and in Vaals, The Netherlands, ExThera Medical Corporation is a privately held medical device company developing innovative blood filters capable of removing a broad range of harmful substances from the blood. The company develops therapeutic products to treat patients in the hospital or clinic, during epidemics, or on the battlefield. Led by an accomplished management team with decades-long experience in the development and manufacture of blood-contacting implants, devices, and enabling biomaterials technology, the company has strong patent protection and a growing body of data from independent laboratory studies, from its participation in DARPA’s Dialysis-Like Therapeutics program, and from successful clinical use in the EU.

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Seraph is available under Emergency Use Authorization by the USFDA for the treatment of COVID-19.

Please consult the Instructions for Use for additional details.

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