Seraph 100 used for Blood Purification and Pathogen Reduction in Sepsis and COVID-19 Treatments
MARTINEZ, Calif. – ExThera Medical and Fresenius Medical Care, the world’s leading provider of products and services for individuals with renal diseases, announced the expanded distribution of ExThera’s Seraph® 100 Microbind® Affinity Blood Filter in Mexico. In 2021, ExThera Medical and Fresenius Medical Care partnered to distribute the Seraph 100® in select European countries.
The Seraph 100 is used in intensive care medicine for the reduction of pathogens in the blood and can be operated with Fresenius Medical Care acute dialysis machines. Similar to a dialysis procedure, the blood is purified through extracorporeal equipment, but Seraph 100 uniquely captures circulating pathogens from the bloodstream; adsorbed pathogens include a myriad of infectious agents, including SARS-CoV-2, MRSA and even super-resistant bacteria.
“ExThera’s growing partnership with Fresenius Medical Care allows more critically ill patients access to a treatment for broad pathogen-oriented shock, including COVID-19, at a crucial time when cases are spiking and hospitals are overwhelmed,” said Robert Ward, ExThera Medical Chairman and CEO.
“We need every tool available in Mexico as new variants will no doubt continue to put a burden on hospitals working tirelessly to deliver life-saving care to patients with COVID-19,” said Alfredo Merino, President of Fresenius Medical Care Mexico. “As experts in extracorporeal therapy, we are excited to help deliver this new filter to improve treatment for people impacted by a range of bacterial and viral infections.”
The Seraph 100 has been used to treat more than 800 COVID-19 patients, in over 70 hospitals, globally. Early results have demonstrated reduced mortality and reduced ICU length of stay in severe/critically ill COVID-19 patients in preliminary clinical studies1,2. The device received European CE mark in 2019 for the for the reduction of bloodstream pathogens, and was granted Emergency Use Authorization (EUA) by the FDA in 2020 for use in patients with COVID-19 admitted to the ICU with confirmed or imminent respiratory failure.
1) Chitty et al, A Multicenter Evaluation of Blood Purification with Seraph 100 Microbind Affinity Blood Filter for the Treatment of Severe COVID-19: A Preliminary Report, (2021)
2) Schmidt et al, Interim-analysis of the COSA (COVID-19 patients treated with the Seraph® 100 Microbind® Affinity filter) registry, NDT, 2021; gfab347
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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 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
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