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 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 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.

MM0044 Rev A