The Department of Defense is funding a clinical trial of a COVID-19 treatment using ExThera Medical’s Seraph 100 Blood filter. The device was selected to be in the multi-center randomized clinical trial because it showed encouraging preliminary results in critically ill COVID-19 patients at a military hospital in the U.S. and 14 other hospitals in Europe.
Investigators at the Uniformed Services University in Bethesda will run the trial of the Martinez, CA-based company’s device.
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.
In a release about DoD’s funding, it was stated that it appears as if the 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.
In a March 26th release from Exthera, its president and CEO Robert Ward NAE said, “We are very pleased to confirm the feasibility of Seraph 100 treatment of COVID-19. Since Seraph 100 treatments have also consistently produced improved oxygenation/lung function, we believe that this feature together with virus reduction may be a useful combination for treating COVID-19, while simultaneously treating the dangerous secondary infections that can occur in COVID-19 patients.”
Here’s how Seraph works. 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 won Emergency Use Authorization from FDA for the treatment of COVID-19 in April, according to the company.
DoD’s funding comes as medical devices are becoming more of a factor in the fight against COVID-19. Abiomed made some rumblings in this effort.
In April, the Danvers, MA-based company acquired Breethe, a developer of an extracorporeal membrane oxygenation system, for an undisclosed sum. The Baltimore, MD-based company’s technology has the potential to serve the needs of patients whose lungs can longer provide sufficient oxygenation, including patients suffering from cardiogenic shock, cardiac arrest or respiratory failure such as due to ARDS, H1N1, SARS, or COVID-19.
And recently, Abiomed won EUA for the Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism.