MARTINEZ, Calif.--(BUSINESS WIRE)--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.
About ExThera Medical Corporation
ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph® 100 Microbind® Affinity Blood Filter for removing a broad range of harmful substances from the bloodstream of patients. Seraph can be used in hospitals, clinics, or field hospitals to address infections caused by battlefield wounds or pandemics. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from severe infections. With a growing body of outcome and health economic evidence from independent clinical studies, participation in the DARPA Dialysis-Like Therapeutics program, and from successful clinical use in the US and EU, the company is well positioned to serve healthcare professionals and patients alike. The Seraph 100 is CE marked and commercially available in the EU, and has FDA Emergency Use Authorization (EUA) for treatment of COVID-19 in the USA.
For more information visit the company’s website at www.extheramedical.com
About Seraph 100
As a patient's blood flows through the Seraph 100 filter, it passes over beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Harmful substances quickly captured and adsorbed onto the surface of the beads and are thereby removed from the bloodstream. Seraph 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 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 bacteria, viruses, fungi, and important sepsis mediators reported to contribute to organ failure during sepsis. The ‘antithrombogenic’ heparin media can be combined with other ExThera-proprietary media to tailor the capability of future Seraph products for the treatment of specific diseases, or to further broaden Seraph’s capability.
For more news stories on the Seraph 100 click here: https://www.extheramedical.com/news
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