ExThera Expands European Distribution of its Blood Filter

ExThera Medical, maker of the only effective pathogen-removal, hemoperfusion filter approved for patient use in Europe, and Fresenius Medical Care, a global provider of products and services for individuals with renal diseases, announced the 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.
 
“We are excited to support the availability of Seraph 100 to additional patients in the EU and Turkey through the expansion of our partnership with Fresenius. Providing additional countries with a therapy to help critically ill patients with pathogen-oriented shock, including COVID-19, continues to be a strong interest and priority for both our companies,” said ExThera Medical Chairman and CEO Bob Ward.
 
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 celebrated investigational device exemption (IDE) approval by the U.S. Food and Drug Administration (FDA).
 
“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,” said Gunther Klotz, executive vice president of Business Development & Marketing, EMEA, at Fresenius Medical Care.
 
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.
 
ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph 100 Microbind Affinity Blood Filter for removing a broad range of pathogens from the bloodstream of patients. Seraph can be used in hospitals, clinics, or field hospitals to address infections caused by battlefield wounds or pandemics. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from severe infections. With a growing body of outcome and health economic evidence from independent clinical studies, participation in the DARPA Dialysis-Like Therapeutics program, and from successful clinical use in the US and EU, the company is well positioned to serve healthcare professionals and patients alike. The Seraph 100 is CE marked and commercially available in the EU, and has FDA Emergency Use Authorization (EUA) for treatment of COVID-19 in the United States.
 
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.