ExThera Medical Successfully Completes Phase I of PURIFY RCT: US Investigational Device Exemption Trial Evaluating Seraph 100 for the Treatment of Septic Shock
April 18 2023 - 4:35PM
Business Wire
A Prospective Interventional Multicenter
Randomized Controlled Trial
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
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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.
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Sam Shull sam.shull@extheramedical.com