ExThera Medical said it won approval for a CE Mark trial for its Seraph blood filter, which is designed to remove pathogens from the bloodstream.
Berkeley, Calif.-based ExThera said Germany’s Bundesinstitut für Arzneimittel und Medizinprodukte approved the protocol for a trial of the Seraph device in treating dialysis patients with Staphylococcus aureus and MRSA bloodstream infections.
“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 prepared remarks.
“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. 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,” added chief technology officer Keith McCrea.
A year ago ExThera unveiled data from a study showing 99.9% removal of drug-resistant strains of E. coli and Klebsiella pneumonia bacteria from blood samples.