Breakthrough Technology Study for Patients Suffering From Life-threatening Bloodstream Infections Proceeds Into Next Phase With First Patient Enrollment
10 Julio 2024 - 7:00AM
Business Wire
Mayo Clinic enrolls first patient for ExThera
Medical’s PURIFY-RCT II trial
ExThera Medical Corporation’s PURIFY-RCT II trial to evaluate
the efficacy of pathogen removal from severely ill patients
suffering from pathogen shock is moving forward with the first
patient enrollment at Mayo Clinic. This comes after ExThera Medical
completed the first phase of the prospective interventional
multicenter PURIFY-RCT trial, where pharmacokinetic/pharmacodynamic
safety was demonstrated. This means the 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,” said Erin Borger, CEO of ExThera
Medical. “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. FDA.
“Reducing pathogens from bloodstream infection patients in the
ICU addresses a tremendous unmet need,” said Mink Chawla, M.D., and
Chief Medical Officer of ExThera Medical. “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 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.
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, 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 U.S.,
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 under a
broad Indication For Use. 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 and the ONCOBind Procedure
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.
For more news stories on the Seraph 100 and the ONCOBind
(cancer) Procedure, click here.
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Stephanie Connolly media@extheramedical.com