Business Wire01.25.18
ExThera Medical Corporation, the leading developer of innovative therapies for removing bacteria and viruses from blood, today announced that the safety and effectiveness of its Seraph 200 Microbind Affinity Blood Filter (Seraph 200) has been demonstrated in pre-clinical testing. The fourth phase of DARPA’s Dialysis-Like Therapeutics (DLT) program was successfully completed in November by Battelle scientists. This final phase of testing employed Good Laboratory Practices to produce results for submission to the U.S. Food and Drug Administration (FDA). The written report, which is pending, confirms safety and efficacy of Seraph in the removal of drug-resistant pathogens from whole blood.
Seraph is a unique production-ready device that is capable of removing a broad range of sepsis-causing bacteria, viruses, toxins, and pro-inflammatory cytokines from whole blood. Validated in preclinical studies and currently under evaluation in a promising European clinical trial, a related device (Seraph 100) promises to address the significant unmet need for rapid treatment of bloodstream infections caused by a long list of pathogens, including many that are drug-resistant. Seraph 100 was recently designated by FDA for inclusion in the Expedited Access Pathway (EAP) program. EAP designation is granted to devices that have the potential to satisfy unmet clinical needs in the prevention of fatal or debilitating diseases.
Although similar in appearance, Seraph is very different from other blood filters, which are offered for the treatment, but not the prevention, of bacterial sepsis. Whereas other devices can remove only cytokines or endotoxins, and in one case viruses, Seraph quickly removes many bacteria, bacterial toxins, viruses, fungi and cytokines simultaneously, using a blood-compatible surface that does not injure the blood. As such, Seraph is designed to treat bloodstream infections quickly to prevent their progression to life-threatening sepsis and septic shock. Seraph 200 also binds endotoxins created by gram-negative bacteria.
ExThera Medical is focused on developing easy-to-use devices for the rapid treatment of life-threatening bloodstream infections, especially in the face of rising incidence rates and the spread of drug-resistant pathogens worldwide.
“Effective treatments for preventing and treating sepsis are critically needed, especially for members of our military for whom risk of exposure is significant. We are pleased to have been chosen for this important final phase of DLT testing, and to contribute to the collective efforts to save lives and healthcare dollars,” said Robert Ward, CEO of ExThera Medical.
Seraph is a unique production-ready device that is capable of removing a broad range of sepsis-causing bacteria, viruses, toxins, and pro-inflammatory cytokines from whole blood. Validated in preclinical studies and currently under evaluation in a promising European clinical trial, a related device (Seraph 100) promises to address the significant unmet need for rapid treatment of bloodstream infections caused by a long list of pathogens, including many that are drug-resistant. Seraph 100 was recently designated by FDA for inclusion in the Expedited Access Pathway (EAP) program. EAP designation is granted to devices that have the potential to satisfy unmet clinical needs in the prevention of fatal or debilitating diseases.
Although similar in appearance, Seraph is very different from other blood filters, which are offered for the treatment, but not the prevention, of bacterial sepsis. Whereas other devices can remove only cytokines or endotoxins, and in one case viruses, Seraph quickly removes many bacteria, bacterial toxins, viruses, fungi and cytokines simultaneously, using a blood-compatible surface that does not injure the blood. As such, Seraph is designed to treat bloodstream infections quickly to prevent their progression to life-threatening sepsis and septic shock. Seraph 200 also binds endotoxins created by gram-negative bacteria.
ExThera Medical is focused on developing easy-to-use devices for the rapid treatment of life-threatening bloodstream infections, especially in the face of rising incidence rates and the spread of drug-resistant pathogens worldwide.
“Effective treatments for preventing and treating sepsis are critically needed, especially for members of our military for whom risk of exposure is significant. We are pleased to have been chosen for this important final phase of DLT testing, and to contribute to the collective efforts to save lives and healthcare dollars,” said Robert Ward, CEO of ExThera Medical.