A Prospective Interventional Multicenter Randomized Controlled Trial

MARTINEZ, Calif. – 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.”

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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 http://www.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
All information contained in this news release derives from plausible, reliable sources, however they have not been independently examined or verified. There is no representation, warranty, or guarantee provided herein. Except as otherwise required by appliable law, all liability for any direct or indirect claims, damages or losses are hereby disclaimed whether or not foreseeable. 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. Accordingly, the investment and/or the revenues that arise from it can rise or fall or fail entirely. We assume no responsibility to update or revise any statements contained in this news release, including forward-looking, to reflect events, trends, or circumstances that might arise after the date of this news release. Results from case studies (reviews) may not be predictive of future results.

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