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.

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About ExThera Medical Corporation
ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph^® 100 Microbind^® Affinity Blood Filter (Seraph 100) for removing a broad range of pathogens from the bloodstream of patients. Seraph 100 can be used in hospitals, clinics, on battlefields and in other austere environments to address nosocomial and community-acquired infections as well as those caused by battlefield wounds, pandemics, and biological warfare agents. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis, COVID-19, and many other severe bloodstream infections. With a growing body of outcome and health economic evidence from independent clinical studies, success in the DARPA Dialysis-Like Therapeutics program, and from successful clinical use in the U.S., the EU, and the Middle East, the company is well positioned to serve healthcare professionals and patients alike. 

The Seraph 100 Microbind Affinity Blood Filter (Seraph 100) attained CE Mark in 2019 and is commercially available in the EU for the treatment of blood stream infections. The Seraph 100 device has neither been cleared nor approved by the U.S. Food and Drug Administration (FDA) for any indication. The Seraph 100 has been authorized by FDA under an Emergency Use Authorization (EUA) to treat patients with COVID-19 infection. The Seraph 100 is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Seraph 100 device under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

For more information, visit the company’s website at https://extheramedical.com/.

About Seraph 100 and the ONCObind Procedure
As a patient’s blood flows through the Seraph^® 100 Microbind^® Affinity Filter (Seraph 100), it passes through a bed of small beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Many harmful substances are quickly captured and adsorbed onto the surface of the beads and are thereby subtracted from the bloodstream. Seraph 100 adds nothing to the bloodstream. It 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 proprietary 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 circulating tumor cells, bacteria, viruses, fungi, and important sepsis mediators reported to contribute to organ failure during sepsis.

ExThera Medical is currently developing the ONCObind Procedure Hemoperfusion Filter (ONCObind) to support cancer treatment. ONCObind is part of the same platform technology as Seraph 100.

For more news stories on Seraph 100 and ONCObind, click here.

Disclaimer
All information contained in this news release derives from plausible, reliable sources, however they have not been independently examined or verified. There is no representation, warranty, or guarantee provided herein. Except as otherwise required by appliable law, all liability for any direct or indirect claims, damages or losses are hereby disclaimed whether or not foreseeable. This communication includes forward-looking statements regarding events, trends and business prospects that may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Accordingly, the investment and/or the revenues that arise from it can rise or fall or fail entirely. We assume no responsibility to update or revise any statements contained in this news release, including forward-looking, to reflect events, trends, or circumstances that might arise after the date of this news release. Results from case studies (reviews) may not be predictive of future results.

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