Conditional Investigational Device Exemption Granted by the FDA for Seraph 100 Seraph 100 used under FDA EUA to treat COVID-19

MARTINEZ, Calif. – ExThera Medical’s Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100), a blood purification device with many potential applications including the treatment of sepsis, will be studied in an upcoming randomized control trial. The endpoint of the trial is to determine the Seraph’s effectiveness against a variety of bloodstream infections that can lead to sepsis. 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 300 US and EU patients with COVID-19 since April 2020. The device has been in use under an Emergency Use Authorization since that time and has been shown to dramatically reduce mortality in severe COVID-19 cases.

ExThera Medical, the manufacturer of the Seraph 100 has obtained conditional approval from the US FDA to conduct the multicenter study on the treatment of critically ill patients with potentially fatal pathogen-associated shock (PURIFY-RCT), a form of septic shock. The trial – the first US Randomized Control Trial to test this class of sepsis treatments – is part of the PURIFY program conducted in partnership with the Henry Jackson Foundation (HJF) for the Advancement of Military Medicine and Uniformed Services University of the Health Sciences (USUHS). The device has previously been tested successfully in partnership with the Department of Defense and the Defense Advanced Research Projects Agency (DARPA).

The study will evaluate the safety and efficacy of Seraph 100 blood purification therapy in critically ill patients with pathogen-associated shock across health centers in the United States. Approximately 15 US sites have been recruited, including both community and military hospitals.

“We are 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 that this new trial will help lead to the expansion of approved indications for Seraph 100 in the United States in life-threatening bloodstream infections beyond COVID-19.”

“The innovations behind the Seraph 100 has brought a transformational treatment approach to the battle against severe COVID-19 cases in the United States. We are confident we can take the device beyond that narrow indication,” said Lakhmir Chawla, MD, Scientific Advisory Board Chair at ExThera Medical. “The data behind the Seraph 100 is promising and we look forward to the opportunity to prove that the device can be effective in saving the lives of many more patients suffering from a wide variety of bloodstream infections.”

The new study comes on the heels of preliminary observational data from PURIFY-OBS – the multicenter observational study of SERAPH 100 – showing very significant improvement in survival rates among critically-ill COVID-19 patients treated with the Seraph 100. The filter is currently available in the United States for the treatment of COVID-19 and in ‘CE Mark countries’ for the reduction of bloodborne pathogens during bloodstream infections.

ExThera Medical recently announced a European distribution partnership with Fresenius Medical Care, the world’s leading provider of products and services for individuals with renal diseases. Click here for more information.

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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 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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