ExThera Medical Receives MTEC Award for Pivotal Sepsis Trial

Randomized trial at LSU Health Shreveport will evaluate Seraph 100 Blood Filter's effectiveness in treating sepsis caused by wound infections.

ExThera Medical has been awarded funding by the Medical Technology Enterprise Consortium (MTEC) to perform a randomized controlled trial to evaluate the efficacy of the Seraph^® 100 Microbind^® Affinity Blood Filter (Seraph 100), a novel, broad-spectrum adsorbent hemoperfusion device, in the treatment of patients with sepsis caused by wound infections. The trial will be performed at LSU Health Shreveport.

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MTEC is a public-private partnership that is authorized to serve by the Department of Defense (DoD) to promote the development and delivery of innovative medical technologies to improve the health and safety of military personnel, veterans, and civilians.

Sepsis remains a leading cause of death in post combat related trauma. Developing or evaluating new medical countermeasures to address this concern remains a priority for the DoD.

Seraph 100 is a pathogen-agnostic filtration device designed to rapidly reduce the concentration of pathogens in the bloodstream to help control severe infections. It has been granted multiple Breakthrough Device Designations for patients suffering from life-threatening bloodstream infections, having been deemed a “First-In-Class” medical device by the United States Food and Drug Administration (FDA). Hundreds of patients have been treated in the U.S. under an Emergency Use Authorization granted by the FDA, and an ongoing prospective multicenter randomized control trial to treat patients suffering from pathogen associated shock.

“The MTEC collaboration reinforces our commitment to address unmet medical needs identified by the U.S. DoD,” said Erin Borger, chief executive officer of ExThera Medical. “Our ultimate goal is to make this breakthrough device available for military use, saving lives on the front lines in war-torn areas worldwide.”

"The chance to explore how medical devices can benefit patients, especially those risking their lives for their country, is important to us," said John A. Vanchiere, MD, PhD, Medical Director of the LSU Health Shreveport Clinical Trials Office. "We are excited to collaborate with ExThera Medical and use the Seraph 100 to help patients now, with the potential to assist many more in the future."

The MTEC trial began in December 2024 and is expected to enroll 330 patients. First patient enrollment is expected in late Q2, 2025.

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 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 applicable 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.

About LSU Health Shreveport

LSU Health Shreveport is one of two health sciences centers of the Louisiana State University (LSU) System and home to the only academic medical center in a 150-mile radius. The primary mission of LSU Health Shreveport is to teach, heal, and discover in order to advance the well-being of the state, region and beyond. LSU Health Shreveport encompasses the School of Medicine, School of Graduate Studies and School of Allied Health Professions, Graduate Medical Education (GME), and a robust research enterprise. For more information, visit www.lsuhs.edu.

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