New Study Shows Seraph 100 Removes Pathogens, Improves Outcomes
A newly published study in Nature’s Scientific Reports finds that use of ExThera’s Seraph® 100 blood filter in septic patients following cardiac surgery significantly improved outcomes by rapidly reducing pathogen load in the bloodstream.
Sepsis—a life-threatening condition caused by the body’s extreme response to infection—can lead to organ failure and death if not treated quickly. Patients undergoing surgery for infective endocarditis (IE), a serious infection of the heart’s inner lining, face particularly high risk of developing post-operative sepsis due to widespread bacterial contamination in the blood.
The hospital-led study, conducted at the ICU of Papardo Hospital in Messina, Italy, evaluated patients who developed sepsis after cardiac surgery for IE. Thirteen patients were treated with the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100), and their outcomes were compared to a retrospective control group of fifteen patients who did not receive the treatment.
Within just four hours of using the Seraph 100 filter, pathogen load in the bloodstream dropped significantly. In addition to fighting the infection, patients who received this treatment also showed signs of faster recovery, including:
- Lower levels of inflammation in the body based on various biomarkers
- More stable blood pressure
- Reduced need for medications that support blood pressure
- Shorter stays in the ICU
Importantly, only 15% of patients who received the Seraph 100 developed acute kidney injury (AKI) that required dialysis—a common and serious complication of sepsis—compared to 40% in the untreated group. Impressively, in this study, two dangerous and difficult-to-treat pathogens – Pseudomonas and Candida – were effectively removed. Candida organisms have been identified as “superbugs” with few treatment options. These data suggest that the Seraph 100 may have utility for these difficult-to-treat infections.
“These results suggest the Seraph 100 device can help critically ill patients recover more quickly by removing harmful and difficult-to-treat pathogens like Staph, Pseudomonas, and Candida species,” said Mink Chawla, MD, Chief Medical Officer of ExThera. “The authors document improved clinical outcomes with the use of Seraph 100 technology and also demonstrated the ability for the filter to capture intact pathogens thereby allowing the Seraph 100 to be an effective diagnostic tool for blood-borne pathogens.”
The results of the study were published in Nature’s Scientific Reports.
About ExThera Medical Corporation
ExThera Medical Corporation develops 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 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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Contacts
Stephanie Connolly
media@extheramedical.com
