Pathogen Agnostic Treatment for Septic Shock Targets SARS-CoV-2 Pathogen Directly

Martinez, Calif. – April 26, 2021 – ExThera Medical announced today the release of preliminary clinical study data demonstrating significantly improved survival rates among critically ill COVID-19 patients when treated with the Seraph® 100 Microbind® Affinity Blood Filter compared to contemporaneous controls. The device is being investigated under the PURIFY OBS trial facilitated by the Henry Jackson Foundation for the Advancement of Military Medicine and the Uniformed Services University of the Department of Defense.

The Seraph 100 is designed to treat critically ill COVID-19 patients irrespective of variant, including those recently proven to be resistant to antibodies. It was originally developed as a pathogen agnostic treatment for septic shock, and directly targets pathogens with a mechanism of action that uniquely adsorbs pathogens in the bloodstream, earlier in the patient journey, sometimes before intubation/mechanical ventilation or dysregulated inflammatory response.

The ongoing study includes preliminary analysis of 99 patients admitted to the ICU enrolled in the DoD funded multicenter observation clinical study (PURIFY OBS). Among the study cohort of 53 Seraph 100 treated patients and 46 control subjects:

• Mortality was much lower in the Seraph 100 treated group compared to the historical controls: 37.7% vs. 67.4% respectively (p=0.003)
• Multivariable logistic regression analysis yielded an odds ratio of 0.27 (95% confidence interval 0.09-0.79, p=0.016): Nearly 4X improvement in survivability odds when severely ill COVID-19 patients are treated with Seraph 100
• These results support the 2021 launch of a US multicenter randomized controlled feasibility trial of the Seraph 100 for septic shock due to any pathogen

“Broad spectrum pathogen removal as an adjunct to standard therapy to help achieve source control in the bloodstream could represent paradigm shift in the way we manage sepsis,” said Col. Kevin K. Chung, MD, a leading critical care physician and PURIFY OBS investigator. “These devices do not care how often COVID mutates or if we are dealing with the next emerging pathogen.”

“I am very encouraged by the data that shows such an improvement in mortality in this retrospective study,” said Stephen Chitty, MD, lead author on the study and Georgia critical care physician. “Our study team feels like the Seraph 100 holds promise as a lifesaving tool in severe COVID-19. Further research is warranted and I am eager for the results moving forward.”

“These results are a testament to the hard work that healthcare providers have been committed to since the onset of the COVID-19 pandemic.” said ExThera Medical Chairman and CEO Robert Ward. “With a more thorough clinical understanding of the capabilities that extracorporeal hemoperfusion devices have to offer, we can continue to treat critically ill COVID-19 patients and address many other medical challenges related to viremia, bacteremia, and septic shock.”

The Seraph 100 operates by filtering the SARS-CoV-2 pathogen from the blood, addressing the risk of multi-system organ failure and death in severe COVID-19 patients. The device, filled with heparin coated beads, mimics the biological structures in the bloodstream to filter a variety of pathogens, including SARS-CoV-2 and many drug resistant bacteria, from the bloodstream. The Seraph-100 received an Emergency Use Authorization (EUA) from the United States Food and Drug Administration (FDA) to treat critically ill COVID-19 patients in April 2020 and has been approved under a European Union CE Mark in 2019 for broad application against bloodstream infections.

“This study greatly enhances our understanding of the Seraph-100 in a clinical setting” Said ExThera Medical Scientific Advisory Chair Lakhmir Chawla, MD. “We are pleased that these results demonstrate great promise in this class of treatments and look forward to the continued opportunity to help patients fight COVID-19, which is on the rise yet again.”

A randomized clinical trial, PURIFY RCT, is expected to begin later this year. Click here for the full study.

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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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