ExThera Medical announced today that the U.S. Defense Dept. selected its Seraph 100 Microbind affinity blood filter for a U.S.-based clinical trial.

The randomized, controlled, multi-center trial will be funded by the DoD and run by investigators at the Uniformed Services University in Bethesda, Md. It comes on the back of encouraging preliminary results in the treatment of critically-ill COVID-19 patients at a military hospital in the U.S., as well as 14 other hospitals in Europe, according to a news release.

Initial reports show that Seraph 100 stabilizes blood pressure and inflammatory biomarkers that correlate with poor patient outcomes, as IL-6, Ferritin, D-dimers, LDH and Nt-proBNP all decreased during Seraph 100 treatments of COVID-19 patients.

The blood filter, which won CE Mark approval in August 2019, could improve patient outcomes by providing additional time for care while reducing sources of inflammation and possibly preventing further damage by reducing the virus’ presence in the bloodstream.

Prior to the pandemic, Seraph 100 was used to treat sepsis and drug-resistant bloodstream infections in the prevention of septic shock, but most clinical uses now involve COVID-19. It received FDA emergency use authorization (EUA) and, according to ExThera, no other blood purification therapy currently binds and removes SARS-CoV-2/RNA and bacteria while improving vital signs and laboratory parameters associated with inflammation and tissue damage.

“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,” ExThera president & CEO Bob Ward said in the news release. “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.”

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