A Prospective Interventional Multicenter Randomized Controlled Trial
MARTINEZ, Calif.–(BUSINESS WIRE)–Investigators today announced completion of patient enrollment in the pharmacokinetic/pharmacodynamic phase of the PURIFY Randomized Clinical Trial (RCT), as required by the US Food Drug Administration. Data is now being collected and analyzed to submit to the 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,” according to Ian Stewart, M.D., principal investigator and Lt. Colonel in the U.S. Air Force. “We have observed safe delivery of treatments so far and are keen to proceed to the next phase of this trial to establish efficacy.”
“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,” said Bob Ward, CEO of ExThera Medical.
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. The clinical trial will be conducted in centers across the United States, targeting improvements in both clinical outcome and health economic endpoints.
“Completion of this first phase of evaluating the safety of Seraph 100 in treating pathogen associated shock is an exciting milestone,” said Mink Chawla, M.D., and Chair of the ExThera Medical Scientific and Medical Advisory Board. “After completion of this data analysis, we can begin broad pivotal enrollment.”
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 attained CE mark and is commercially available in the EU. The Seraph 100 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.
Disclaimer
All information contained in this news release derives from plausible reliable sources, which, however, have not been independently examined. There is no warranty, confirmation or guarantee, and no responsibility or liability is taken concerning correctness or completeness. As far as it is allowed by the relevant law, no liability whatsoever is taken on for any direct or indirect loss caused by the deployment of this news release or its contents. This communication includes forward-looking statements regarding events, trends and business prospects that may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. The investment and/or the revenues that arise from it can rise or fall. A total loss is possible. Persons who are in possession of this news release are requested to obtain information concerning possible legal limitations and to observe them accordingly. We assume no responsibility to update or revise any forward-looking statements contained in this news release to reflect events, trends, or circumstances after the date of this news release. The views presented do not represent that of the U.S. Air Force or the U.S. Department of Defense and should not be construed as an endorsement of ExThera Medical.
Contacts
Sam Shull
sam.shull@extheramedical.com