ExThera Medical Partners with Predicate Healthcare Performance Group to Expand Reach of Proven COVID-19 Treatment

ExThera & Predicate HPG secure commercial partnership agreement in United States

MARTINEZ, Calif. – ExThera Medical and Predicate Healthcare Performance Group (Predicate HPG) have entered into a commercial partnership agreement in the United States for ExThera’s Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100).

“In Predicate HPG’s ongoing efforts to deliver evidence-based, technology-enabled care to every patient, we are pleased to partner with ExThera Medical to provide clinicians with an effective, disease-modifying treatment option for COVID-19. Medical innovations, such as the Seraph 100 are indispensable in the delivery of high-quality care for critically ill patients,” said Morris Nguyen, Founder and CEO of Predicate Healthcare Performance Group.

The Seraph 100 is the first blood purification device to be shown to reduce both bacterial and viral loads in the bloodstream and has been used on more than 600 COVID-19 patients in the United States alone since April 2020. The device has been available under an Emergency Use Authorization in the United States since that time and has been shown in a preliminary clinical study to dramatically reduce mortality in severe COVID-19 cases.

“ExThera’s partnership with Predicate HPG expands the Seraph 100 reach and visibility in the US. Overworked clinicians now have a therapy for treating critically-ill COVID patients whereas previously they were often administering hospice care to these patients,” said Bob Ward, ExThera Medical Chairman and CEO.

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About Predicate HPG
Predicate HPG is a healthcare advisory firm that develops strategies to reduce clinical variation, which is integral to decreasing overall costs and improving healthcare delivery globally. Through a breadth of experience in critical care, health economics, and process engineering, Predicate HPG collaborates with interdisciplinary stakeholders to tailor solutions that solves large-scale challenges at the national and individual hospital level. Using a unique multifaceted approach, the Predicate HPG Solutions Architecture™ creates unified clinical guidelines incorporating the most advanced medical technologies and reinforced by behavioral science to provide sustainable, evidence-based practice change.

For more information visit www.predicatehpg.com.

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
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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