Statistically Significant Improvement Found in Multiple Signals of Clinical Outcome

Brooke Army Medical Center published positive results for critically ill patients treated with ExThera Medical’s Seraph® 100 Microbind® Affinity Blood Filter. “The use of the Seraph 100 blood filter was associated with statistically and clinically significant improvements in hemodynamic parameters and decreased vasopressor requirements in patients with septic shock and SARS-CoV-2 infection.” This was the conclusion of BAMC’s multidisciplinary team after studying a diverse cohort of critically ill patients suffering from septic shock. Additionally, two of the treated patients were infected with Candida fungus. CDC has issued a recent warning considering the threat of Candida auris to public health, so emerging evidence of Seraph 100 successful treatment of Candida infections is timely.

The Seraph 100 is an extracorporeal blood filter used to remove pathogens from the bloodstream of patients who are critically ill from infections that cause septic shock, i.e., the reduced blood pressure that often leads to cascading illness and death. ExThera Medical previously confirmed that Seraph 100 is effective at removing many different bacteria, viruses and fungi, including the often-deadly Candida auris strain. Drug-resistant fungal infections like Candida auris are increasing in US hospitals.

“We were impressed with the rapid improvement in key clinical indicators when patients were initiated with the Seraph 100,” according to the authors of the recently published study. “These indicators are tied directly to survival outcomes and given the rise of drug-resistant pathogens and persistently high mortality in septic shock, additional novel therapies [e.g., Seraph 100] are needed.”

The BAMC study included a diverse population of patients across multiple modes of extracorporeal delivery, including successful use in extracorporeal membrane oxygenation (ECMO), with no device-related adverse events. The average Sequential Organ Failure Assessment (SOFA) score for the entire cohort was 13 ±2.3. Survival at this (high) level of SOFA Score is widely expected to be ≈1%, whereas survival in those patients treated with Seraph 100 was found to be 44%.

Statistically significant (p ≤ 0.05) improvements observed included:

• Blood pressure/patient stabilization from shock
• Reduced heart rate
• Weaning of supplemental oxygen
• Serum lactate biomarker of infection
• Reduction of acidosis
• Reduced need for vasoactive drugs to manage septic shock (Norepinephrine, Vasopressin, Dobutamine, Angiotensin II)

“We are delighted with the improvement in survival among these very sick patients! We also note that the BAMC results agree with recent findings from a European case study (in press) in which six of the treated patients had Candida infections. Candida infections are increasingly drug-resistant, and Seraph 100 appears to be an effective therapy. Seraph also improved outcomes in other cases, regardless of the source of the infection,” said Robert Ward, President and CEO of ExThera Medical.

“This is yet another peer-reviewed publication demonstrating clinical benefit,” said ExThera Medical Scientific Advisory Chair Lakhmir Chawla, M.D. “We are excited to continue our partnership with US Military clinicians in new areas, where often the critically ill have few treatment options for survival.”

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 nosocomial and community-acquired infections as well as those caused by battlefield wounds and pandemics. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis, COVID-19 and other severe 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 US, the EU, and the Middle East, the company is well positioned to serve healthcare professionals and patients alike. The Seraph 100® attained CE mark and is commercially available in the EU. The Seraph 100 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 subtracted from the bloodstream. Seraph 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 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.

For more news stories on the Seraph 100 click here.

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