Martinez, Calif. – August 6, 2019 – ExThera Medical Corporation (ExThera) announced today that it has received CE Mark approval for its Seraph^® 100 Microbind^® Affinity Blood Filter (Seraph 100) for the reduction of pathogens during bloodstream infections (BSI). This CE Mark signifies that Seraph 100 meets the safety and performance requirements for medical devices in the European Economic Area (EEA) as an adjunct to anti-infective therapy, and it gives ExThera access to a market of 500 million people. In October 2019 ExThera plans to begin shipping Seraph 100 for clinical use in selected member states of the European Union, providing a completely new treatment option for a large, at-risk patient population. Distributors for Italy, Germany and other EU countries will be announced early in September.

Bloodstream infections are a leading cause of death around the world, with mortality as high as 50%. In Europe, the annual incidence rate is estimated at 1.2 million. In addition to rapid diagnostic tests, quick and effective therapeutic products are needed to successfully treat these infections for which every hour of delay ineffective treatment can increase mortality by up to 7%. The challenge of quickly reducing pathogens is severely complicated during increasingly common drug-resistant infections, which are estimated to kill 10 million people annually by 2050.

As a broad-spectrum ‘sorbent-type blood filter’ Seraph 100 provides a new option for treating bloodstream infections. Whereas existing devices remove only molecules, e.g. cytokines and/or endotoxin, Seraph 100 can also quickly lower the concentration of bacteria, viruses and fungi in whole blood. In pre-clinical and clinical testing, Seraph 100 was able to significantly reduce the concentration of both drug-susceptible and drug-resistant pathogens, providing a long-awaited adjunctive therapy for bloodstream infections.

In March 2019, Dr. med. Stefan Büttner of the Department of Nephrology, Dialysis and Kidney Transplantation at University Hospital Frankfurt, presented research findings at the International Symposium on Intensive Care and Emergency Medicine (ISICEM), highlighting Seraph 100 excellent clinical results, including the safe treatment of bacteremia during dialysis.

“Today marks a definitive turning point in advancing the care of bloodstream infections, the result of years of dedicated research, development and investment,” according to Bob Ward, NAE, President / CEO of ExThera. “Seraph 100 provides an innovative therapy for rapid and effective treatment of infections that might otherwise pose a devastating risk to patients. We look forward to Seraph 100’s continued success in Europe, while demonstrating its potential to help healthcare providers and their patients around the world.”

“Bloodstream infections pose a continuing challenge for healthcare providers worldwide, with the threat of catastrophic consequences for the patient, often leading to sepsis and even death if not treated effectively,” said Prof. Dr. med Jan T. Kielstein, FASN, FERA, Director, Medical Clinic V:
Nephrology, Rheumatology and Blood Purification, Academic Teaching Hospital Braunschweig, Germany. “Seraph 100 adds a critical tool to our clinical arsenal that can be used to treat a wide range of infections, including those that are proven to be drug-resistant. It’s an option we were not previously able to employ, and we are excited to have it available.”

According to consultant Kathleen White, ExThera’s former V.P. and Chief Operating Officer, “The ExThera team did an extraordinary job designing, testing and obtaining regulatory approval for Seraph 100, while also gaining certification of its Quality Management System. I thank them, our consultants and our clinical collaborators for their hard work and dedication to this revolutionary product.”

1. Neuner, Elizabeth A., et al. “Treatment and outcomes in carbapenem-resistant Klebsiella pneumoniae bloodstream infections.” Diagnostic microbiology and infectious disease 69.4 (2011): 357-362.
2. Goto, M., and M. N. Al‐Hasan. “Overall burden of bloodstream infection and nosocomial bloodstream infection in North America and Europe.” Clinical Microbiology and Infection 19.6 (2013): 501-509.
3. Kumar, A. et.al. “Duration of Hypotension Before Initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock”, Crit. Care Medicine, 2006;34(6):1589-1596.
4. Review on Antimicrobial Resistance. Antimicrobial Resistance: Tackling a Crisis for the Health and Wealth of Nations. 2014.
5. Larm O, Larsson R, Olsonn P (1983) A new non-thrombogenic surface prepared by selective covalent binding of heparin…. Biomater Med Devices Artif Organs 11: 161– 173.

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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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