ExThera Medical Begins Clinical Trials of its Seraph Blood Filter

Berkeley, Calif.-based ExThera Medical has announced approval for a CE Mark trial for its Seraph blood filter device.

The company will use Seraph in the trial to treat dialysis patients who have Staphylococcus aureus and MRSA bloodstream infections, though the product also can reportedly remove more than 60 different disease-causing bacteria, viruses and toxins. The protocol for the device trial come from Germany’s Bundesinstitut für Arzneimittel und Medizinprodukte.

S. aureus and drug-resistant MRSA are the most common causes of infection in patients undergoing routine dialysis for kidney failure, and bloodstream infections are the second-most common cause of death in end-stage renal disease patients because these infections can cause septic shock with multiple organ failure. Initially, Seraph will be used for ealy treatment of bloodstream infections to prevent severe sepsis and reduce or eliminate intensive care stays. Future clinical studies will concentrate on selected patients whose bloodstream infections have already progressed to severe sepsis or septic shock.

“Certain bloodstream infections have a mortality rate as high as 50 percent due to the lack of effective antibiotics,” CEO Bob Ward said in a prepared statement. “With fewer anti-infective drugs being developed, and the continuing emergence of drug-resistant pathogens, clinicians need new tools to fight bloodstream infections.”

ExThera Medical was the first to report the removal of bacteria from whole blood using a device instead of a drug. Early bench testing, and recent pre-clinical in-vivo studies have demonstrated that large amounts of MRSA are safely removed from blood as it passes through the Seraph device. ExThera has also published confirmation of Seraph’s ability to remove 99.9 percent of two Carbapenem-resistant Enterobacteriaceae (CRE Superbugs) — E. coli and Klebsiella pneumoniae — from blood after only brief contact with the Seraph adsorption media. Study results are published in the online journal PLOS ONE. 

Every year there are 1.8 million new cases of bloodstream infection in the United States and Europe, causing patients serious complications and imposing a high cost burden on healthcare systems. Not all are drug-resistant. However, an outbreak of CRE infections of unknown origin even occurred in the National Institutes of Health Hospital in Bethesda, Md., and was the subject of the Frontline documentary, “Hunting the Nightmare Bacteria.”

Since 2008, privately funded ExThera Medical has been developing Seraph, which is now being manufactured. It enters clinical trials as a unique broad-spectrum “hemoperfusion device.” Seraph has demonstrated its ability to bind and remove a wide variety of disease-causing agents from whole blood, including viruses, bacteria, fungi and inflammatory cytokines, according to the company. Seraph is manufactured in large quantities from readily available raw materials.

“Since its inception ExThera’s mission has been to offer simple, device-based therapies for rapid treatment of bloodstream infections — including those caused by pathogens for which there are no effective therapeutic drugs,” noted Chief Technology Officer Dr. Keith McCrea. “We are very pleased to make our device available to dialysis patients who are highly susceptible to bloodstream infections via their blood access catheters. Our pre-clinical testing has demonstrated that Seraph can be used during dialysis without negatively affecting the blood. We have also determined that Seraph acts very quickly to reduce the level of blood-borne pathogens, and has a binding capacity that greatly exceeds the entire bloodstream concentration of pathogens in bacteremic patients.”

Seraph uses a “biomimetic adsorption media” that includes chemically bound heparin adsorbent materials in a simple, flow-through cartridge. The anti-thrombogenic property of immobilized heparin also contributes to the safety of Seraph’s blood-contacting surfact, according to the company.

In addition to the potential to treat bacterial and viral infections fo the prevention of sepsis, Seraph is a flexible platform that may be configured with optional supplemental adsorbents to deal with future “weaponized” or naturally-evolved pathogens.