Statistically Significant Improvement Found in Multiple Signals of Clinical Outcome

MARTINEZ, Calif. – 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 Bob 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 (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 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.

MM00048 Rev B