U.S. Federal Supply Schedule Contract Awarded to ExThera Medical for Seraph 100

ExThera Medical Corporation has been awarded a five-year U.S. Department of Veterans Affairs (VA) Federal Supply Schedule (FSS) contract, which allows the company to pursue contracts with federal healthcare organizations including the U.S. Department of Veteran Affairs, U.S. Federal Prison System, Indian Reservations, and the Department of Defense. The contract grants streamlined access to the company’s Seraph 100 MicroBind Affinity Blood Filter, a product that military and VA clinicians have been using to treat COVID-19.  
 
“ExThera is proud to be contracted by the Federal Supply Schedule, working closely with federal agencies to expand access to the Seraph 100. We have a growing body of evidence demonstrating lifesaving treatment for critically ill COVID-19 patients who often suffer from other ‘superinfections’ caused by bacteria and fungi,” ExThera Medical Founder/President/Chairman Robert Ward said.
 
The Seraph 100 has received both European Union CE Mark under the Medical Device Directive and U.S. Food and Drug Administration Emergency Use Authorization (EUA) to treat COVID-19 in the United States and Canada. 

As a patient’s blood flows through the Seraph 100 filter, it passes through a bed of small 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 subtracted from the bloodstream. Seraph adds nothing to the bloodstream. It 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 proprietary 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 circulating tumor cells, bacteria, viruses, fungi, and important sepsis mediators reported to contribute to organ failure during sepsis.
 
“ExThera is committed to pursuing wider domestic and global access to its Seraph 100, to reach more patients, and provide treatment options to those who need them most. The FSS contract is a major step in achieving that goal for the United States,” ExThera Medical Chief Commercial Officer Sam Shull stated.
 
Recent studies have shown the Seraph 100 quickly lowers the concentration of bacteria, viruses, and fungi, and most notably in critically ill patients suffering from SARS-CoV-2. In addition, Seraph 100 has been shown to significantly reduce the bloodstream concentration of many drug-susceptible and drug-resistant pathogens, providing a long-awaited therapy that addresses the severe problem of drug-resistance along with new and future microbial threats like variants of the SARS-CoV-2 virus.
 
ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph 100 MicroBind Affinity Blood Filter for removing various pathogens from the bloodstream. Seraph can be used in hospitals, clinics, on battlefields and in other austere environments to address nosocomial and community-acquired infections as well as those caused by battlefield wounds, pandemics, and biological warfare agents. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis, COVID-19, and many other severe bloodstream infections. A growing body of outcome and health economic evidence on the Seraph 100 has been gained from independent clinical studies, success in the DARPA Dialysis-Like Therapeutics program, and from successful clinical use in the United States, European Union, and the Middle East.