ExThera’s Blood Filter Treats COVID-19 Patients in Europe
By ExThera Medical | 04.06.20
Treatments are expected to begin in the U.S. soon.
Treatment of COVID-19 with ExThera's Seraph100 Microbind Affinity Blood Filter (Seraph 100) has begun in hospitals in Germany and Italy. Seraph 100 treatments of COVID-19 are also expected to begin soon in France and the U.S.A.
Seraph 100 is a “hemoperfusion device” approved for the reduction of pathogens in blood. In recent EU clinical cases improved lung function and rapid reduction of drug-resistant bacterial pathogens occurred with Seraph 100 treatment. Stabilization of blood pressure has also been observed, including during COVID-19 treatment. Another potential benefit of Seraph 100 treatment of COVID-19 is reduction in bloodborne virus/RNA, and the simultaneous treatment of bacterial and fungal “secondary infections”.
How It Works
The Seraph 100 blood filter provides a needed option for treating life-threatening bloodstream infections using new technology. Whereas first-generation hemoperfusion devices remove only molecules, Seraph 100 also quickly lowers the concentration of bacteria, viruses, and fungi in blood. Seraph 100 is able to significantly reduce the bloodstream concentration of both drug-susceptible and drug-resistant pathogens, providing a long-awaited adjunctive therapy that addresses the severe problem of drug-resistance, and new and future bacterial, fungal and viral threats like COVID-19.
Clinical results and virus binding studies suggested that Seraph 100 treatment should help in the treatment of COVID-19, and in future epidemics, before vaccines are available. More clinical results are needed to confirm patient benefit in COVID-19, but lab studies with cytokines and other pathogens have accurately predicted Seraph 100 clinical results in other bloodstream infections.
One consideration is whether SARS-CoV-2 is present in the bloodstream of infected patients in measurable concentrations, and if so, at what stage of the infection. Very recent publications and clinician feedback confirm the presence of the virus (RNA) in the blood of critically ill COVID-19 patients. The measured binding capacity of a single Seraph 100 filter (about the size of a 12-ounce soda can) is huge in comparison to the amount of virus present in the bloodstream of critically-ill patients.
President and CEO of ExThera Medical, Robert Ward NAE stated, “We are very pleased to confirm the feasibility of Seraph 100 treatment of COVID-19. Since Seraph 100 treatments have also consistently produced improved oxygenation/lung function, we believe that this feature together with virus reduction may be a useful combination for treating COVID-19, while simultaneously treating the dangerous secondary infections that can occur in COVID-19 patients.”
Seraph 100 has CE Mark approval in the European Union but is not currently approved by the FDA for use in the United States. ExThera has received clinician interest in individual emergency use of Seraph 100 in the USA and expects COVID-19 treatments to begin there soon, when they meet the criteria outlined in the FDA Guidance.
Seraph 100 is a “hemoperfusion device” approved for the reduction of pathogens in blood. In recent EU clinical cases improved lung function and rapid reduction of drug-resistant bacterial pathogens occurred with Seraph 100 treatment. Stabilization of blood pressure has also been observed, including during COVID-19 treatment. Another potential benefit of Seraph 100 treatment of COVID-19 is reduction in bloodborne virus/RNA, and the simultaneous treatment of bacterial and fungal “secondary infections”.
How It Works
The Seraph 100 blood filter provides a needed option for treating life-threatening bloodstream infections using new technology. Whereas first-generation hemoperfusion devices remove only molecules, Seraph 100 also quickly lowers the concentration of bacteria, viruses, and fungi in blood. Seraph 100 is able to significantly reduce the bloodstream concentration of both drug-susceptible and drug-resistant pathogens, providing a long-awaited adjunctive therapy that addresses the severe problem of drug-resistance, and new and future bacterial, fungal and viral threats like COVID-19.
Clinical results and virus binding studies suggested that Seraph 100 treatment should help in the treatment of COVID-19, and in future epidemics, before vaccines are available. More clinical results are needed to confirm patient benefit in COVID-19, but lab studies with cytokines and other pathogens have accurately predicted Seraph 100 clinical results in other bloodstream infections.
One consideration is whether SARS-CoV-2 is present in the bloodstream of infected patients in measurable concentrations, and if so, at what stage of the infection. Very recent publications and clinician feedback confirm the presence of the virus (RNA) in the blood of critically ill COVID-19 patients. The measured binding capacity of a single Seraph 100 filter (about the size of a 12-ounce soda can) is huge in comparison to the amount of virus present in the bloodstream of critically-ill patients.
President and CEO of ExThera Medical, Robert Ward NAE stated, “We are very pleased to confirm the feasibility of Seraph 100 treatment of COVID-19. Since Seraph 100 treatments have also consistently produced improved oxygenation/lung function, we believe that this feature together with virus reduction may be a useful combination for treating COVID-19, while simultaneously treating the dangerous secondary infections that can occur in COVID-19 patients.”
Seraph 100 has CE Mark approval in the European Union but is not currently approved by the FDA for use in the United States. ExThera has received clinician interest in individual emergency use of Seraph 100 in the USA and expects COVID-19 treatments to begin there soon, when they meet the criteria outlined in the FDA Guidance.
