Breakthrough Study for Life-threatening Bloodstream Infections Enters Next Phase With First Patient Enrollment

ExThera Medical Corporation has initiated the second phase of its PURIFY-RCT II trial aimed at assessing the effectiveness of pathogen removal in critically ill patients experiencing pathogen shock. The Mayo Clinic has enrolled the first patient for this study, marking a significant milestone following the successful completion of the initial phase. In the first phase, the study demonstrated that the Seraph 100 blood filter treatment does not reduce the bloodstream concentrations of key anti-infective medications, which are crucial in treating bloodstream infections.

Erin Borger, CEO of ExThera Medical, expressed enthusiasm about this progress, emphasizing that enrolling the first patient in this phase is a critical step towards making the Seraph 100 commercially available. The Seraph 100 is designed to control infection sources through rapid extracorporeal blood filtration of pathogens. This device has received multiple Breakthrough Device Designations from the U.S. FDA, recognizing it as a "First-In-Class" medical device for patients with life-threatening bloodstream infections.

Mink Chawla, M.D., Chief Medical Officer of ExThera Medical, highlighted the urgent need for effective pathogen reduction in ICU patients with bloodstream infections. Dr. Chawla expressed optimism about the study's potential to provide a viable treatment option for patients who do not respond adequately to anti-infective drugs or in situations such as future pandemics.

The PURIFY-RCT trial is sponsored by the Department of Defense, in collaboration with the Henry M. Jackson Foundation and the Uniformed Services University of Health Sciences. The trial will be conducted across multiple centers in the United States and aims to evaluate not only the safety and efficacy of the Seraph 100 MicroBind Affinity Blood Filter but also improvements in clinical outcomes and health economic endpoints.

ExThera Medical Corporation specializes in developing and commercializing extracorporeal blood filtration devices, including the Seraph 100 MicroBind Affinity Blood Filter. These devices are designed to remove a broad spectrum of pathogens from the bloodstream of patients. The Seraph 100 is versatile and can be employed in various settings, from hospitals and clinics to battlefields and other challenging environments. It addresses infections acquired in healthcare settings, community-acquired infections, and those resulting from battlefield injuries, pandemics, and biological warfare agents.

ExThera Medical's extracorporeal products have demonstrated life-saving capabilities for a range of critically ill patients, including those suffering from sepsis, COVID-19, and other severe bloodstream infections. The company's products have shown positive outcomes and health economic benefits in independent clinical studies, participation in the DARPA Dialysis-Like Therapeutics program, and successful clinical use in regions such as the U.S., the EU, and the Middle East. The Seraph 100 has attained CE Mark approval and is commercially available in the EU under a broad Indication For Use. Additionally, it has received FDA Emergency Use Authorization (EUA) for treating COVID-19 in the United States.

The Seraph 100 operates by passing a patient's blood through a filter containing small beads with receptors that mimic those on human cells. These beads capture and adsorb harmful substances, including pathogens, without introducing any foreign materials into the bloodstream. The device targets the pathogens causing the infection and also removes harmful substances generated by the infection and the body's response to it. The proprietary adsorption media in the Seraph 100, which includes chemically bonded heparin, ensures blood compatibility and the capability to bind circulating tumor cells, bacteria, viruses, fungi, and sepsis mediators that contribute to organ failure during sepsis.

This innovative approach offers a flexible platform for treating various severe infections and holds promise for improving patient outcomes in critical care settings.