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)
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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 http://www.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
All information contained in this news release derives from plausible, reliable sources, however they have not been independently examined or verified. There is no representation, warranty, or guarantee provided herein. Except as otherwise required by appliable law, all liability for any direct or indirect claims, damages or losses are hereby disclaimed whether or not foreseeable. This communication includes forward-looking statements regarding events, trends and business prospects that may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Accordingly, the investment and/or the revenues that arise from it can rise or fall or fail entirely. We assume no responsibility to update or revise any statements contained in this news release, including forward-looking, to reflect events, trends, or circumstances that might arise after the date of this news release. Results from case studies (reviews) may not be predictive of future results.
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