MARTINEZ, Calif. – PURIFY OBS, an observational study of critically-ill COVID patients treated with the Seraph^® 100 Microbind^® Affinity Blood Filter (Seraph 100), has recently completed enrollment.

A multicenter effort led by the US Department of Defense (DOD) published interim results in April 2021. Observations included dramatic improvement in survival and reduction in median ICU length of stay for patients treated with the Seraph 100 vs controls.

Another interim analysis from the ‘COSA Registry,’ a multicenter European study of COVID-19 patients treated with the Seraph 100 Microbind Affinity filter, also yielded positive results: Patients treated with the Seraph 100 early in their ICU stay had higher survival rates than patients treated later in their ICU stay.

“We expect the first peer-reviewed PURIFY-OBS clinical trial publication soon, now that the study has concluded. We are pleased to see these consistent and very positive results and we’re pleased to know we have helped save the lives of many critically-ill COVID-19 patients,” said ExThera Medical CEO Robert Ward. “Having treated more than 800 patients with Seraph 100 in the US alone, we have increased confidence in its safety and ability to improve outcomes for critically ill patients with COVID 19 and other serious bloodstream infections.”

The PURIFY RCT (a multicenter randomized controlled trial studying blood purification for the treatment of pathogen associated shock) has been initiated and is expected to begin enrollment in early 2022. Multicenter RCT trials are rare in the field of extracorporeal therapy and require robust signals of efficacy. It is expected that the positive clinical results observed in PURIFY OBS will continue during PURIFY RCT.

Physicians across the country are using ExThera Medical’s Seraph 100 under Emergency Use Authorization from the U.S. Food and Drug Administration to treat COVID-19 patients admitted to the ICU with confirmed or imminent respiratory failure. In 2019, the Seraph 100 was granted CE mark in the European Union for the reduction of bloodstream pathogens.

The complete PURIFY observational study is expected to be published during Q1 2022.

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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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