Fresenius Medical Care, the world’s leading provider of products and services for people with chronic kidney failure, will offer the Seraph 100 Microbind Affinity Blood Filter from ExThera Medical Corporation in several European countries as of now. Both companies have signed a co-marketing and distribution agreement, effective in January 2021 and covering Belgium, Denmark, France, Germany, Italy, Luxembourg, the Netherlands, Norway, Sweden and the United Kingdom.

ExThera Medical’s Seraph 100 adsorber is used in critical care for the extracorporeal removal of pathogens from the bloodstream and can be operated with Fresenius Medical Care acute dialysis machines. Similar to the dialysis process, the blood is purified by pumping it through the filter. The Seraph 100 has been CE-certified since 2019 for the reduction of pathogens during bloodstream infections, in addition to therapy with anti-infectives.

“With the innovative adsorber technology from ExThera Medical, we are strengthening our offering in the field of critical care solutions, which is one of the key areas of the company’s strategy 2025,” said Dr. Katarzyna Mazur-Hofsäß, Fresenius Medical Care’s CEO for Europe, Middle East and Africa. “Bloodstream infections often lead to kidney, lung or multiorgan failure. A treatment with the Seraph 100 can eliminate more than 90 percent of the pathogens in the patient’s blood for every pass through the filter. And the first treatment results of its use with COVID-19 patients are very promising.”

“We are very excited to partner with Fresenius Medical Care to broaden European availability of the Seraph 100,” said Bob Ward, Founder and CEO of ExThera Medical. “This distribution agreement ensures as many patients as possible will have access to a therapy that can help critically ill patients suffering from pathogen-oriented bloodstream infection.”

Fresenius Medical Care Ventures, the venture capital unit of Fresenius Medical Care, has a financial stake in ExThera Medical since 2016.

Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases of which around 3.5 million patients worldwide regularly undergo dialysis treatment. Through its network of 4,073 dialysis clinics, Fresenius Medical Care provides dialysis treatments for 349,167 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Along with the core business, the company focuses on expanding the range of related medical services in the field of Care Coordination. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS).

For more information visit the Company’s website at www.freseniusmedicalcare.com.

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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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