MARTINEZ, Calif.– 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.
