ExThera Medical has announced the recruitment of the first patient in the blood purification for the treatment of pathogen associated shock (PURIFY-RCT) trial.
Sponsored by the Department of Defense in association with the Henry M. Jackson Foundation and the Uniformed Services University of Health Sciences, the trial is designed to assess the safety and efficacy of the Seraph 100 Microbind affinity blood filter.
Seraph 100 Microbind affinity blood filter has been developed to remove a range of pathogens from the bloodstream of patients.
Seraph is suitable for use in hospitals, clinics and field hospitals to deal with nosocomial and community-acquired infections, in addition to those infections caused by battlefield wounds and pandemics.
Its adsorption media consists of a flexible platform that uses immobilised (chemically bonded) heparin for its blood compatibility, as well as its potential to bind bacteria, viruses, fungi, and important sepsis mediators anticipated to contribute to organ failure during sepsis.
PURIFY-RCT trial principal investigator Dr Kevin Chung said: “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.”
The prospective, interventional, multicentre and randomised controlled trial is anticipated to recruit up to 60 patients over a 12-month period.
With an objective to enhance both clinical outcomes and health economic endpoints, the clinical study will be carried out across 10 centres in the US.
The company is planning to reveal the preliminary results in early 2023.
ExThera Medical CEO Robert Ward said: “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.”
In June last year, ExThera Medical received a conditional investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to conduct the randomised control trial of the Seraph 100 to treat septic shock.
