Prospective Interventional Multicenter Randomized Controlled Trial
MARTINEZ, Calif. – Investigators today announced the first patient enrollment in the Blood Purification for the Treatment of Pathogen Associated Shock (PURIFY-RCT) trial. PURIFY RCT is a prospective interventional multicenter randomized controlled trial, 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.
“With this study, we are determining if this therapy improves clinically relevant outcomes while showing no evidence of harm in a randomized controlled trial design. It is the first step towards applying the most rigorous scientific standard in an effort to definitively determine if this therapy should be included in the management of sepsis,” said Kevin Chung, MD, who is the principal investigator leading the PURIFY-RCT trial.
“The science of sepsis source control with Seraph is sound. Now we are rigorously testing whether Seraph plus cutting-edge sepsis care will save lives in the hospital. I am grateful to our first patient and their family for their contributions to the PURIFY-RCT study and the world’s knowledge of sepsis care,” said Critical Care Medical Director Brian Delmonaco, MD, at Good Samaritan Regional Medical Center in Corvallis, Ore., and first enrolling physician.
The clinical trial will be conducted across approximately 10 centers in the United States, targeting improvements in both clinical outcome and health economic endpoints.
“This sepsis trial serves as both landmark clinical proof point and investigational device exemption (IDE) trial required for FDA clearance to treat a broad spectrum of critically ill patients suffering from pathogen associated shock,” said ExThera Medical CEO Robert Ward.
The study is expected to randomize approximately 60 patients over a 12-month timeframe, with preliminary results expected in early 2023.
About ExThera Medical Corporation
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 US, the EU, and the Middle East, 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 USA.
For more information visit the company’s website at www.extheramedical.com.
About Seraph 100
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.
For more news stories on the Seraph 100 click here.
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