Martinez, Calif. – August 11, 2020 – A new peer-reviewed case-study by COL Stephen Olson, M.D. and colleagues at Walter Reed Army Medical Center determined that ExThera Medical’s Seraph 100 extracorporeal blood filter may improve patient stability in COVID-19 cases requiring mechanical ventilation and vasopressor support. This is a significant advance in the search for treatments during the current pandemic.
The patients, who were admitted into the ICU at Walter Reed Military Medical Center, were the first in the U.S. to be treated with the Seraph 100 filter. During and after the treatment with the Seraph 100, both patients experienced quantitative clinical improvement, and there were no device-related adverse events.
These treatments, which were performed in spring 2020, led the way to Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) and the recent announcement of a multi-center trial of Covid-19 treatment using the Seraph that will be funded by the U.S. Department of Defense (DOD) set to begin in September 2020. The DOD selected the Seraph as one of its main interventions in a prospective observational study for COVID-19 patients.
In preliminary data based on cases reported to ExThera Medical, survival rate of critically ill COVID-19 patients treated with Seraph 100 in the EU is approximately 75%. The company expects to see similar results in the USA as clinicians become more familiar with ‘hemoperfusion therapy’ and initiate it earlier in the course of the disease.
COVID-19 treatment with Seraph 100 showed great promise to help significantly reduce the patient’s viral levels and address the “cytokine storm”, allowing the patient to more quickly begin the recovery process and potentially reduce the need for respirators.
“The published study and several more recent cases indicate that Seraph has the potential to provide a greatly-needed solution for CCOVID-19 patients that other therapies and treatments are not able to address,” said Robert Ward, President and CEO of ExThera Medical. “Patients who are critically ill with SARS-CoV-2 virus have very limited options and we were very pleased to receive confirmation that the Seraph 100 treatment produced rapid and sustained improvement.”
Seraph 100 is the only device capable of removing a broad range of bacteria, viruses, toxins, and pro-inflammatory cytokines from whole blood. There is currently no other blood purification therapy known to bind and remove SARS-CoV-2 virus/RNA and bacteria while also improving vital signs and laboratory parameters associated with inflammation and tissue damage. Over a dozen hospitals in the U.S. now have the device on hand, including locations in several COVID-19 outbreak hotspots.
The US military first learned of ExThera’s blood filters during the $72-million Defense Advanced Research Projects Agency (DARPA) Dialysis Like Therapeutics (DLT) program, in which Seraph was the only technology evaluated in the final phase of the program. The Seraph filters provide a long-awaited therapy that addresses the severe problem of drug-resistance, sepsis and the treatment of new and future microbial threats like the SARS-CoV-2 virus.
Because of the encouraging treatment of COVID-19 patients reported in this case study, the Seraph 100 has been granted Emergency Use Authorization (EUA) by the FDA for treatment on respiratory-impacted COVID-19 patients during the current pandemic. The device is also designated by the 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 other fatal or debilitating diseases. Seraph 100 was approved in 2019 for use in the European Union under CE Mark where it has been widely used, treating bacterial bloodstream infections as well as COVID-19 patients.
The full report can be read here.
About the Seraph® Microbind® Affinity Blood Filter
Seraph 100 is the first device ever approved for the reduction of pathogens in blood. As a patient’s blood flows through the Seraph filter, it passes over tiny 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 removed from the bloodstream. Seraph does not add anything to the blood, which is returned to the patient with blood cells and proteins intact. Seraph 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.
About ExThera Medical
Based in Martinez, California, near San Francisco, and in Vaals, The Netherlands, ExThera Medical Corporation is a privately held medical device company developing innovative blood filters capable of removing a broad range of harmful substances from the blood. The company develops therapeutic products to treat patients in the hospital or clinic, during epidemics, or on the battlefield. Led by an accomplished management team with decades-long experience in the development and manufacture of blood-contacting implants, devices, and enabling biomaterials technology, the company has strong patent protection and a growing body of data from independent laboratory studies, from its participation in DARPA’s Dialysis-Like Therapeutics program, and from successful clinical use in the EU.
* DISCLAIMERS
In the USA Seraph is available under Emergency Use Authorization (EUA200165) by the USFDA for the treatment of COVID-19
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