ExThera Medical Successfully Completes First Phase of PURIFY Clinical Trial

Patient enrollment has been completed in the pharmacokinetic/pharmacodynamic phase of ExThera Medical Corporation’s PURIFY Randomized Clinical Trial (RCT). Data is now being collected and analyzed to submit to the U.S. Food and Drug Administration (FDA) toward approval, allowing continuation of this pivotal study. Upon FDA approval to expand enrollment, PURIFY RCT will proceed to the critical phase of enrollment, the final clinical study required by the FDA for clearance to treat bloodstream infections in septic patients.
 
“This is an important milestone in the advancement of the fight against pathogen-oriented critical illness,” said U.S. Air Force Lt. Col. Ian Stewart, M.D., the study’s principal investigator. “We have observed safe delivery of treatments so far and are keen to proceed to the next phase of this trial to establish efficacy.”
 
PURIFY RCT is a prospective interventional multicenter randomized controlled trial, sponsored by the U.S. Department of Defense in collaboration with the Henry M. Jackson Foundation and the Uniformed Services University of Health Sciences to evaluate the safety and efficacy of the Seraph 100 Microbind Affinity Blood Filter. The clinical trial will be conducted in centers throughout the United States, targeting improvements in both clinical outcome and health economic endpoints.

“Completion of this enrollment phase is a significant milestone for both patients and the company, bringing us closer to broadly treating severely ill septic patients,” ExThera Medical CEO Bob Ward stated.

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 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 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. 
 
“Completion of this first phase of evaluating the safety of Seraph 100 in treating pathogen associated shock is an exciting milestone,” ExThera Medical Scientific and Medical Advisory Board Chair Mink Chawla, M.D., said. “After completion of this data analysis, we can begin broad pivotal enrollment.” 

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 nosocomial and community-acquired infections as well as those caused by battlefield wounds and pandemics. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis and other severe infections. With a growing body of outcome and health economic evidence from independent clinical studies, success in the DARPA Dialysis-Like Therapeutics program, and from successful clinical use in the United States, the European Union, and the Middle East, the company is well positioned to serve healthcare professionals and patients alike. The Seraph 100 attained CE mark and is commercially available in the EU. The Seraph 100 has FDA Emergency Use Authorization (EUA) for treating COVID-19 in the United States.