Blood Purification and Pathogen Reduction Treatment for Sepsis and COVID-19 Set for Pan-European Distribution Launch
May 26, 2021

Fresenius Medical Care and ExThera Medical offer Seraph® 100 Microbind® Affinity Blood Filter in European Market

MARTINEZ, Calif. – ExThera Medical’s Seraph 100® Microbind® Affinity Filter (Seraph 100) is now being distributed in Europe by Fresenius Medical Care, the world’s leading provider of products and services for individuals with renal diseases. Since 2019 the therapeutic device has been used throughout the continent under a CE Mark for the treatment of bloodstream infections. In the United States Seraph is being used to treat critically ill COVID-19 patients. The two companies signed a co-marketing and distribution agreement earlier this year.

Physicians across Europe and the United States have observed improvements in mortality and reduced use of vasopressors with the use of the Seraph 100. 1,2 In a recent study conducted by eight physicians at six medical centers in Germany, (COSA Registry), preliminary data on survival rates for patients treated with the Seraph 100 were significantly higher than predicted for this critically ill patient population1 . Additionally, an ongoing United States-based multicenter observational study has bolstered the Seraph 100’s results in treating critically ill COVID-19 patients as reported in a recent publication2 .

“Our goal is to increase the availability of Seraph 100 to patients in the EU by partnering with Fresenius Medical Care which we expect will result in reduced mortality and shorter hospital stays for critically ill COVID-19 and sepsis patients,” said ExThera Medical Chairman and CEO Bob Ward. “We are confident that expanded clinical use of Seraph 100 therapy will further demonstrate its life saving potential and ability to address a multitude of pathogen-related illnesses.”

“Making the Seraph 100 filter available for critically ill patients in ICUs is exciting for us and we are looking forward to demonstrating clinical benefits of SERAPH 100 in conjunction with our established treatment options. Based on first promising clinical results in EMEA and NA, I am looking forward to seeing more evidence supporting the current and future indications.” said Gunther Klotz, Executive Vice President Business Development & Marketing, EMEA from Fresenius Medical Care.

The Seraph 100 Microbind Affinity Blood Filter is used in intensive care medicine for the extracorporeal removal of pathogens from the blood 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 is indicated for the reduction of pathogens during bloodstream infections, in adjunction to therapy with anti-infectives. The device has been shown to be effectively bind pathogens like COVID-19, MRSA, and other drug-resistant bacteria. A randomized clinical trial, PURIFY RCT, is expected to begin later this year.

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

1.Schmidt et al, Abstract – Registry for the evaluation of safety and effectiveness of the Seraph 100 Microbind Affinity Blood Filter in the therapy of COVID-19 patients (COSA), AKI-CRRT San Diego, (2021), 41

2. Chitty et al, Preprint – A Multicenter Evaluation of Blood Purification with Seraph 100 Microbind Affinity Blood Filter for the Treatment of Severe COVID-19: A Preliminary Report, (2021)

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. With a growing body of outcome and health economic evidence from independent clinical studies, participation in the DARPA Dialysis-Like Therapeutics program, and successful clinical use in the US and EU, the company is well-positioned to serve healthcare professionals and patients alike. 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 are 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. 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 news stories on the Seraph 100 click here: https://extheramedical.com/news

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