Fresenius Medical Care and ExThera Medical provide Seraph® 100 Microbind® Affinity blood filters in the European market

Martinez, California--(BUSINESS WIRE)--ExThera Medical’s Seraph 100® Microbind® affinity filter (Seraph 100) is now distributed in Europe by Fresenius Medical Care. Senius Healthcare is a leading global supplier of products and services for patients with kidney disease. Since 2019, the treatment device has used the CE mark throughout the continent for the treatment of bloodstream infections. In the United States, Seraph is used to treat severe COVID-19 patients. The two companies signed a joint marketing and distribution agreement earlier this year.

Doctors in Europe and the United States have observed that the mortality rate has improved after the use of Seraph 100.1,2, and the use of vasopressors has been reduced. Patients treated with Seraph 100 are significantly higher than the predicted value of this critically ill patient group1. In addition, an ongoing multicenter observational study based in the United States supports the results of Seraph 100 in the treatment of critically ill COVID-19 patients, as reported in a recent publication2.

"Our goal is to increase the availability of Seraph 100 to EU patients through cooperation with Fresenius Medical Care, which we expect to reduce mortality and length of stay in patients with severe COVID-19 and sepsis," said Bao, Chairman and CEO of ExThera Medical Byward. "We believe that expanding the clinical application of Seraph 100 therapy will further prove its life-saving potential and its ability to solve a variety of pathogen-related diseases."

"It is exciting for us to make the Seraph 100 filter available for critically ill patients in the intensive care unit. We look forward to demonstrating the clinical benefits of SERAPH 100 in combination with our established treatment plan. The first promising based on EMEA and NA With clinical results, I look forward to seeing more evidence supporting current and future indications," said Gunther Klotz, Executive Vice President of Business Development and Marketing for Fresenius Medical Care Europe, Middle East and Africa.

The Seraph 100 Microbind Affinity blood filter is used in intensive care medicine to remove pathogens from the blood outside the body and can be operated with Fresenius Medical Care acute dialysis machines. Similar to the dialysis process, blood is pumped through a filter to be purified. Seraph is used to reduce pathogens during bloodstream infections as an adjunct to anti-infective treatment. The device has been proven to effectively bind pathogens such as COVID-19, MRSA and other resistant bacteria. A randomized clinical trial called PURIFY RCT is expected to begin later this year.

Fresenius Medical Care Ventures is the venture capital arm of Fresenius Medical Care and has held financial shares in ExThera Medical since 2016.

ExThera Medical Corporation develops and commercializes extracorporeal blood filtration equipment, including Seraph® 100 Microbind® Affinity Blood Filter, which is used to remove various harmful substances from patients' blood. Seraph can be used in hospitals, clinics or field hospitals to solve infections caused by battlefield wounds or epidemics. With more and more results and health economic evidence from independent clinical research, participation in DARPA-like dialysis therapy programs, and successful clinical applications in the United States and the European Union, the company is ready to provide services to healthcare professionals and patients.

For more information, please visit the company's website www.exthermedical.com

When the patient's blood flows through the Seraph 100 filter, it passes through 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 to the surface of the beads, thereby being removed from the bloodstream. Seraph targets the pathogens that cause infections, and it also binds and removes pathogens and harmful substances produced by the body's response to infections. Seraph’s adsorption medium (beads) constitutes a flexible platform that uses immobilized (chemically bonded) heparin because it has good blood compatibility and binds bacteria, viruses, fungi and reportedly cause organ failure during sepsis. The unique capabilities of important sepsis mediators. "Anti-thrombosis" heparin media can be combined with other ExThera proprietary media to customize future Seraph products' ability to treat specific diseases, or to further expand Seraph's capabilities. Seraph 100 has the CE mark, can be marketed in the European Union, and has obtained an FDA emergency use authorization (EUA) to treat COVID-19 in the United States.

For more news reports on Seraph 100, please click here: https://www.extheramedical.com/news

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Media Contact Matthew Saidel-917.232.2931 Matthew.Saidel@resolutepublicaffairs.com

Fresenius Medical Care is the world's leading provider of kidney disease products and services and is distributing ExThera Medical's Seraph 100 in Europe.

Media Contact Matthew Saidel-917.232.2931 Matthew.Saidel@resolutepublicaffairs.com