Martinez, Calif. – March 18, 2019 – ExThera Medical Corporation (ExThera) today announced Dr. Stefan Büttner, a senior staff member of the Department of Nephrology, Dialysis and Kidney Transplantation at University Hospital Frankfurt, will present on his clinical experience with the ExThera’s Seraph® 100 Microbind® Affinity Blood Filter (Seraph) at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) in Brussels, Belgium on Wednesday, March 20. ExThera, an early-stage medical technology company in the San Francisco Bay Area, is a developer of therapies for reducing bacteria and viruses in the blood.
During his presentation, entitled Extracorporeal Pathogen Elimination is on the Horizon, Dr. Büttner will share insights from his clinical experience using Seraph in the treatment of bacteremia during dialysis. Dr. Büttner is a nephrology specialist, clinical researcher, and expert in blood purification techniques, and his viewpoint is of particular interest due to his experience with plasmapheresis and the use of extracorporeal therapies for renal replacement therapy, liver failure and infectious diseases. Dr. Büttner’s presentation will take place onsite at the Symposium in the Tent during the Blood Purification session and will run from 4:30-4:45 p.m. local time.
Seraph is designed to reduce the duration and intensity of bloodstream infections to improve clinical outcomes. It is the first and only broad-spectrum filter that reduces pathogens in whole blood. By using immobilized heparin with a unique molecular architecture, Seraph mimics the heparan sulfate binding sites on endothelial cells that are targeted by invading pathogens. Seraph’s high surface area quickly reduces large amounts of drug-resistant and drug-susceptible bacteria, viruses, toxins, and sepsis mediators in flowing blood.
In its effort to eradicate life-threatening bloodstream infections and their progression to sepsis, ExThera is working towards CE Mark approval and product introduction into the EU in mid-2019.
“The need for advances in the treatment of bloodstream infections have, until now, gone largely unmet. However, ExThera’s technology has repeatedly shown promise in preclinical studies and clinical testing as a safe and effective option,” said Robert Ward, CEO of ExThera. “We’re excited for the opportunity to educate the medical community at the important ISICEM meeting about Seraph® through Dr. Büttner’s experience, and to make it available for use in treating these infections in the near future.”
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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
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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