ExThera Medical is a company dedicated to developing innovative blood purification technologies. Since its establishment in 2007, the company has focused on creating extracorporeal devices designed to address blood infections, particularly those that are drug-resistant or affect high-risk patient populations.
Understanding the Seraph 100 Device
The Seraph 100 Blood Purification System is an extracorporeal device that filters blood outside the body. It connects to standard blood purification equipment, including bloodlines and a pump system, and can deliver blood flow rates up to 350 mL per minute. It is for single use and can operate for up to 24 hours.
The Seraph 100 has received CE Mark approval in Europe. In the United States, it has been granted Emergency Use Authorization (EUA) for treating certain patients with COVID-19 infection. The FDA has also given it multiple Breakthrough Device Designations for conditions like antibiotic-resistant sepsis and severe SARS-CoV-2 infection.
How the Seraph 100 Cleans Blood
The Seraph 100 purifies blood through adsorption, where harmful substances bind to specialized materials. The filter contains heparin-coated beads. This heparin-coated surface mimics receptors found on human cells that pathogens target during invasion.
As blood flows through the Seraph 100, pathogens like bacteria, viruses, and fungi, along with certain toxins and inflammatory mediators, adhere to these beads and are removed. Blood cells and other beneficial components pass through largely unaffected. The device is designed to reduce the incoming bloodstream pathogens by up to 95% with each pass.
Conditions Addressed by Seraph 100
The Seraph 100 is used as an adjunctive therapy for severe medical conditions, particularly those involving bloodstream infections. It is applied in cases of sepsis, a life-threatening organ dysfunction caused by a dysregulated response to infection, and septic shock, which involves extremely low blood pressure. The device also targets bacteremia (bacterial presence in the blood) and viremia (viral presence in the blood), including SARS-CoV-2, as well as fungemia.
The blood purification offered by Seraph 100 aims to quickly reduce the pathogen load in the blood. This can be particularly beneficial for patients with drug-resistant infections or when the specific pathogen causing the infection has not yet been identified. By removing pathogens and inflammatory mediators, the device supports the body’s response and can potentially improve patient outcomes in these severe infection scenarios.
Patient Experience and Safety
During a Seraph 100 treatment, blood is drawn from the patient, passes through the filter, and is then returned to the body. The procedure typically involves connecting the patient to the device using standard bloodlines and a pump system. A session can last for several hours, with some treatments extending up to 24 hours.
The Seraph 100’s safety profile is consistent with other extracorporeal treatments. While generally well-tolerated, potential considerations include the need for anticoagulation, often with heparin, to prevent clotting in the circuit. Patients are closely monitored for vital signs and laboratory indices. Adverse events, such as premature termination due to circuit failure, have been reported in a small percentage of treatments.