DOD to Fund a Multi-Center Randomized Clinical Trial of COVID-19 Treatment with ExThera’s Seraph 100 Blood Filter

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After encouraging preliminary results in the treatment of critically-ill COVID-19 patients at a military hospital in the United States and fourteen other hospitals in Europe, the Department of Defense has selected the Seraph®100 Microbind® Affinity Blood Filter (Seraph 100) as one of its main interventions in a pivotal, US-based randomized controlled trial. Financial support for the multi-center trial will be provided by the Department of Defense and run by investigators at the Uniformed Services University in Bethesda.

COVID-19 patients, including those with pre-existing medical conditions, have been treated with Seraph 100 after showing serious symptoms of the virus. Initial reports indicate Seraph 100 stabilizes blood pressure and inflammatory biomarkers that correlate with poor patient 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 sources of inflammation and possibly preventing further damage by reducing SARS-CoV-2 virus/RNA in the bloodstream.

Seraph 100 earned its CE Mark in Q3 2019 and is widely available in Europe where it is the subject of a large clinical trial for treatment of a variety of bloodstream infections (BSI). Prior to the COVID-19 pandemic, Seraph 100 was being used successfully to treat individual cases of sepsis and drug-resistant BSIs in the prevention of septic shock. However, over the past few months, most clinical cases have involved COVID-19.

The USFDA granted Seraph 100 Emergency Use Authorization (EUA) during the current pandemic. Under the EUA Seraph 100 is broadly available in the USA, for COVID-19 treatments. At this time there is no other blood purification therapy known to bind and remove SARS-CoV-2 virus/RNA and bacteria while also improving vital signs and laboratory parameters associated with inflammation and tissue damage.

In the treatment of bacterial infections Seraph 100 has quickly reduced drug-resistant bloodstream pathogens and consistently improved patients’ oxygen saturation. The binding of the SARS-CoV-2 virus together with the ability to treat secondary bacterial infections makes Seraph 100 therapy unique in the treatment of COVID-19. “We are excited to have this opportunity and confident that this large DOD clinical trial will firmly establish the safety and efficacy of Seraph 100 as a treatment for COVID-19 treatment. A successful trial will also support the use of Seraph 100 as a broad-spectrum countermeasure against future pandemics, especially during the critical period before vaccines are available” according to Bob Ward, NAE, President and CEO of ExThera Medical Corporation.

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.