ExThera Medical’s PURIFY-RCT II Trial Advances to Enrollment Phase

The Mayo Clinic has enrolled the first patient in ExThera Medical Corporation’s PURIFY-RCT II trial, which aims to evaluate the efficacy of pathogen removal from severely ill patients suffering from pathogen shock.

The start of patient enrollment in the study is moving forward upon completion of the trial’s first phase, where pharmacokinetic/pharmacodynamic safety was demonstrated. That phase demostrated the company’s Seraph 100 blood filter treatment does not reduce bloodstream concentrations of tested anti-infective medications that are currently used as a critical frontline/standard of care treatment against bloodstream infections.
 
“Having successfully completed the PK/PD phase of the PURIFY-RCT trial, we are excited to begin enrolling patients to further demonstrate efficacy of Seraph 100 in the treatment of pathogen-induced septic shock,” ExThera Medical CEO Erin Borger said. “Enrolling the first patient in this phase of the trial is a crucial milestone toward commercial availability and growth in this therapy space.”
 
The Seraph 100 enables infection source control through rapid extracorporeal blood filtration of pathogens and has been granted multiple Breakthrough Device Designations for patients suffering from life-threatening bloodstream infections, having been deemed a “First-In-Class” medical device by the U.S. Food and Drug Administration (FDA).
 
“Reducing pathogens from bloodstream infection patients in the ICU addresses a tremendous unmet need,” ExThera Chief Medical Officer Mink Chawla, M.D., stated. “We are excited about the prospects of this study, and if successful, this investigational treatment can be used for patients where anti-infective drugs are inadequate or to combat the next pandemic.”
 
The prospective interventional multicenter PURIFY-RCT trial is sponsored by the 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 across the United States, targeting improvements in both clinical outcome and health economic endpoints.

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. Many 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 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, 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. 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 under a broad Indication For Use. The Seraph 100 has FDA Emergency Use Authorization (EUA) for treatment of COVID-19.

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