Canadian Health Authority Grants ExThera’s Seraph 100 Blood Filter an Interim Order for Treatment of COVID-19

Canadian Health Authority Grants ExThera’s Seraph 100 Blood Filter an Interim Order for Treatment of COVID-19




Canadian Health Authority Grants ExThera’s Seraph 100 Blood Filter an Interim Order for Treatment of COVID-19

Proven treatment for critically ill COVID-19 patients gaining acceptance around the world

MARTINEZ, Calif.–(BUSINESS WIRE)–As areas in Canada are seeing significant growth in Delta variant cases, surpassing that of the prior surge, ExThera Medical’s Seraph® 100 Microbind® Affinity Blood Filter has been granted Interim Order 324822 by the Canadian Health Authority for use in relation to COVID-19.

The Seraph 100 is the first blood purification device to be shown to reduce both bacterial and viral loads in the bloodstream and has been used on more than 500 US and EU patients with COVID-19 since April 2020. The device has been in use under an Emergency Use Authorization in the United States since that time and has been shown in a preliminary clinical study to dramatically reduce mortality in severe COVID-19 cases.

“While the COVID-19 vaccine helps protect against illness severity, hospitalizations are rising and the medical community needs to be prepared for existing or emerging virus variants. The importance of having access to a proven treatment for critically ill patients in Canada is essential,” said Bob Ward, ExThera Medical Chairman and CEO. “The Seraph 100 treatment supports the ability to save lives for critically ill patients.”

In contrast to other blood purification technologies, which only remove inflammatory mediators caused by an infection, Seraph 100 quickly lowers the concentration of viruses, including SARS-CoV-2, bacteria and fungi that are in the bloodstream. In pre-clinical testing and in clinical use, Seraph 100 has been shown to significantly reduce the bloodstream concentration of both drug-susceptible and drug-resistant pathogens, providing a long-awaited therapy that addresses the severe problem of drug-resistance, and new and future microbial threats like the SARS-CoV-2 virus and the Delta variant.

Since 2019 the therapeutic device has been used throughout Europe under a CE Mark for the treatment of certain bloodstream infections. In the United States Seraph 100 is being used to treat critically ill COVID-19 patients, and recently celebrated investigational device exemption (IDE) approval by the FDA.

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 pathogens from the bloodstream of patients. Seraph can be used in hospitals, clinics, or field hospitals to address infections caused by battlefield wounds or pandemics. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from severe infections. With a growing body of outcome and health economic evidence from independent clinical studies, participation in the DARPA Dialysis-Like Therapeutics program, and from successful clinical use in the US and EU, the company is well positioned to serve healthcare professionals and patients alike. 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 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.

For more news stories on the Seraph 100 click here.

Disclaimer

All information contained in this news release derives from plausible reliable sources, which, however, have not been independently examined. There is no warranty, confirmation or guarantee, and no responsibility or liability is taken concerning correctness or completeness. As far as it is allowed by the relevant law, no liability whatsoever is taken on for any direct or indirect loss caused by the deployment of this news release or its contents. 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. The investment and/or the revenues that arise from it can rise or fall. A total loss is possible. Persons who are in possession of this news release are requested to obtain information concerning possible legal limitations and to observe them accordingly. We assume no responsibility to update or revise any forward-looking statements contained in this news release to reflect events, trends, or circumstances after the date of this news release.

Contacts

Lauren Popiel

lauren.popiel@resolutepublicaffairs.com
312-768-4773