Treatment for critically ill COVID patients results in significant improvement in survival rate according to new study
January 11, 2022

Patient survival doubles when Seraph 100 is used earlier during ICU stay 

MARTINEZ, Calif. – Critically ill patients treated with ExThera Medical’s Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) within 60 hours of ICU admission experienced a survival rate double that of patients treated after being in the ICU for 60 or more hours, according to a newly released study.

“Few treatments are available for critically ill COVID patients in the ICU. We have already seen data that demonstrates survival improvement1 – and now additional peer-reviewed data was generated that demonstrates ‘earlier is better’ when it comes to Seraph 100 use in the ICU,” said Robert Ward, ExThera Medical Chairman. “In addition, patients treated earlier in their ICU with the Seraph 100 may avoid intubation and mechanical ventilation.”

The new findings, published in Nephrology Dialysis Transplantation, found:
Survivability in ICU COVID patients that started Seraph 100 treatment within 60 hours of ICU admission was 65.5% while it was 37.5% in patients that started the treatment after more than 60 hours in the ICU.2

There is still a need for therapeutic treatment options, especially in critically ill patients, as COVID variants such as Omicron continue to emerge. 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 800 US and EU patients with COVID-19 since April 2020.

In 2019, the Seraph 100 was granted CE mark for the reduction of bloodstream pathogens in European Union. In April 2020, the FDA granted Authorization for Emergency Use for use in patients with COVID-19 admitted to the ICU with confirmed or imminent respiratory failure.

1. Chitty et al, A Multicenter Evaluation of Blood Purification with Seraph 100 Microbind Affinity Blood Filter for the Treatment of Severe COVID-19: A Preliminary Report, (2021)
2. Schmidt J., et al., Interim-analysis of the COSA (COVID-19 patients treated with the Seraph® 100 Microbind® Affinity filter) registry, Nephrology Dialysis Transplantation, 2021; gfab347, https://doi.org/10.1093/ndt/gfab347

 

# # #

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.

MM0044 Rev A

MM0006 Rev E