Berkeley, Calif.-based ExThera Medical has announced approval for a CE Mark trial for its Seraph blood filter device.
The filter designed to remove pathogens from the bloodstream, specifically when treating dialysis patients with Staphylococcus aureus and MRSA bloodstream infections, but 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.
“Certain bloodstream infections have a mortality rate as high as 50% due to the lack of effective antibiotics. With fewer anti-infective drugs being developed, and the continuing emergence of drug- resistant pathogens, clinicians need new tools to fight bloodstream infections,” CEO Bob Ward said in a company statement.
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“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,” added chief technology officer 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 preclinical 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.”
ExThera Medical was the first to report the removal of bacteria from whole blood using a device instead of a drug. Seraph can reportedly remove 99.9% of two Carbapenem-Resistant Enterobacteriaceae (‘CRE Superbugs’) E. coli and Klebsiella pneumoniae from blood after just one contact with the Seraph adsorption media.
Photo: Flickr user rosemary
