ExThera Medical, maker of the only effective pathogen-removal, hemoperfusion filter approved for patient use in Europe, and Fresenius Medical Care, the world’s leading provider of products and services for individuals with renal diseases, have expanded distribution of ExThera’s Seraph 100 Microbind Affinity Blood Filter in Turkey, Finland, and Estonia. Earlier this year ExThera Medical and Fresenius Medical Care partnered to distribute the Seraph 100 in Europe.
The Seraph 100 is used in intensive care medicine for the extracorporeal reduction of pathogens in the blood and can be operated with Fresenius Medical Care acute dialysis machines. Similar to the dialysis process, the blood is purified by pumping it through the filter. The Seraph is indicated for the reduction of pathogens during bloodstream infections, in adjunction to therapy with anti-infectives.
The device has been shown to be effectively bind pathogens like Covid-19, MRSA, and other drug-resistant bacteria. A randomized clinical trial, PURIFY RCT, is expected to begin later this year.
How the Seraph 100 filter works: As a patient’s blood flows through the Seraph 100 filter, it passes over 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 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’s adsorption media (the beads) constitute a flexible platform that uses immobilized (chemically bonded) heparin for its well-established blood compatibility and its unique ability to bind bacteria, viruses, fungi, and important sepsis mediators reported to contribute to organ failure during sepsis. The ‘antithrombogenic’ heparin media can be combined with other ExThera-proprietary media to tailor the capability of future Seraph products for the treatment of specific diseases, or to further broaden Seraph’s capability.
Gunther Klotz, Executive Vice President Business Development & Marketing, EMEA from Fresenius Medical Care, said: “More critically ill patients in ICUs will now have access to the Seraph 100, which comes at a crucial time as we prepare to have treatment options available and help those battling pathogen associated shock, including Covid-19.”
Since 2019 the therapeutic device has been used throughout the continent under a CE Mark for the treatment of certain bloodstream infections. In the United States Seraph 100 is being used to treat critically ill Covid-19 patients, and recently was awarded investigational device exemption approval by the FDA.