Treatment for Critically Ill COVID Patients Begins 1st Randomized Clinical Trial
September 1, 2021

MARTINEZ, Calif. – Physicians across the country are using ExThera Medical’s Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) under emergency use authorization from the U.S. Food and Drug Administration to treat critically ill COVID patients resulting in statistically significant improvements in survival rate among patients whose blood was filtered with the Seraph 100.

The first multicenter randomized controlled trial of the Seraph 100, which has successfully treated hundreds of COVID patients, will be studying the treatment’s ability to reduce ICU length of stay, hospital duration and mortality in patients suffering from septic shock.

“The initial findings in our observational study for COVID patients have been very promising. This feasibility study will get us another step closer to helping assess whether or not this therapy has a role in the care of all septic patients, not just COVID,” said Col. Kevin K. Chung, MD, a leading critical care physician and PURIFY investigator.

The study will evaluate the safety and efficacy of pathogen-removing extracorporeal blood purification therapy in critically ill patients with pathogen associated shock utilizing ExThera’s Seraph 100 filter. This trial is sponsored by the Henry M. Jackson Foundation for the Advancement of Military Medicine and is in collaboration with the Uniformed Services University (USU) of the Health Sciences. Interventional multicenter randomized controlled trials are rare in extracorporeal therapies and require robust signals of efficacy improvement as demonstrated in this case by the PURIFY OBS study.

“ExThera is proud to be saving lives during the COVID-19 pandemic under our FDA Emergency Use Authorization,” said ExThera Medical CEO Robert Ward. “We are confident this new trial will further the expansion of Seraph 100 use in the United States, not only in the treatment of COVID-19 patients, but also in deadly sepsis caused by other viral, bacterial and fungal bloodstream infections.”

Enrollment is slated to begin this Fall.

“The more we are able to study the Seraph 100 in a clinical setting will only help us reach more patients fighting COVID-19, which continues to be a concern across the United States,” said ExThera Medical Scientific Advisory Chair Lakhmir Chawla, MD.

The study’s primary outcome measures include the following:

1. Efficacy: ICU-free days in the first 28 days
a. Alive and not in the ICU (for at least a full 24 hours) in the first 28 days from the time of randomization
2. Safety: Adverse Events
a. SAEs and >/= grade 3 AEs per CTCAE v5 evaluated from enrollment until the end of hospitalization

The study’s secondary outcome measures include the following: mortality evaluated in-hospital at 28 days; ventilator free days in the first 28 days; vasopressor-free days in the first 28 days; kidney replacement therapy-free days in the first 28 days; hospital stay duration; and survival, 90 days after enrollment.

As this study will also serve as the investigational device exemption (IDE) research needed for Seraph 100’s FDA clearance, the first 10 patients enrolled will study additional parameters demonstrating avoidance of antibiotic adsorption as has been demonstrated in the past.

 

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About ExThera Medical Corporation
ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) for removing a broad range of pathogens from the bloodstream of patients. Seraph 100 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 Microbind Affinity Blood Filter (Seraph 100) attained CE Mark in 2019 and is commercially available in the EU for the treatment of blood stream infections. The Seraph 100 device has neither been cleared nor approved by the U.S. Food and Drug Administration (FDA) for any indication. The Seraph 100 has been authorized by FDA under an Emergency Use Authorization (EUA) to treat patients with COVID-19 infection. The Seraph 100 is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Seraph 100 device under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

For more information, visit the company’s website at https://extheramedical.com/.

About Seraph 100 and the ONCObind Procedure
As a patient’s blood flows through the Seraph® 100 Microbind® Affinity Filter (Seraph 100), 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 100 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.

ExThera Medical is currently developing the ONCObind Procedure Hemoperfusion Filter (ONCObind) to support cancer treatment. ONCObind is part of the same platform technology as Seraph 100.

For more news stories on Seraph 100 and ONCObind, click here.

Disclaimer
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