ExThera’s proprietary Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is a first-of-its kind, CE Marked, technology designed to reduce bloodborne pathogens during bloodstream infections. Validated in preclinical studies and in a clinical trial in Europe, the device promises to address significant unmet needs for immediate treatment, even before the pathogen is identified.
Seraph’s broad-spectrum ability to reduce the pathogen bioburden without harming the treated blood gives it many potential clinical applications. The company has evaluated the therapeutic use of Seraph 100 in a dialysis-like extracorporeal circuit for treating patients with both drug-resistant and drug-susceptible bloodstream infections.
Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) can be used to safely reduce the concentration of bacteria, viruses, fungi, and sepsis mediators in blood.
The Seraph 100 has broad applications for the safe reduction of drug-susceptible and drug-resistant pathogens – including the following pathogens which have been found to bind to Seraph 100 in studies by multiple independent laboratories.
• SARS-CoV-2 (COVID-19)
• E. coli (CRE)
• S. aureus and MRSA
• S epidermidis and MRSE
• K. Pneumonia (CRE, ESBL, MDR)
• S. pneumoniae
• E. faecalis (VRE)
• E. faecium
• A. baumannii
• S. marcescens
• C. albicans
• S. pyogenes
Seraph 100 Blood Filtering Medical Device - How it Works
Seraph 100 is a broad spectrum, anti-thrombogenic hemoperfusion device. The filter contains polymeric microbeads coated in heparin, a compound similar in structure to heparan sulfate.
Over time, pathogens in the body have evolved to target heparan sulfate, the predominant glycoprotein found on the lining of the blood vessels (another name for the surface that lines the inside of blood vessels is the endothelial glycocalyx).
The heparin coating on the Seraph 100 beads is designed to mimic the behavior of the glycocalyx inside the human body and serve as a binding site for pathogens circulating in the blood.
When used with hemodialysis machines, Seraph 100 has helped reduce various viruses, gram negative, gram positive and drug-resistant bacteria.
CLINICAL USE APPLICATION FOR COVID-19
Can Treatment with Seraph 100 Benefit COVID-19 Patients?
1. SARS-CoV-2 has been reported to bind to heparin in a publication released on March 2, 2020.
2. Independent lab results confirm that Seraph 100’s heparin-coated microbeads bind large amounts of SARS-CoV-2/RNA.
3. Doctors have commented that they have “seen stabilization of blood pressure, reduced need for vasopressors, and decreased levels of inflammatory markers such as ferritin and d-dimers” in COVID-19 patients.
4. Use of Seraph 100 in adjunction to antibiotics for patients who present with lymphocytopenia, secondary bacterial, or fungal infections could help rapidly reduce circulating pathogens to help improve outcomes.
Post-Market Data on Patients with Pneumonia and ARDS
There are several interesting findings to note from the European clinical study and post-market cases using Seraph 100:
1. Several cases have shown that Seraph 100 is able to clear bacteremia from a single treatment resulting in negative cultures.
2. Universal improvement in oxygen saturation during Seraph 100 treatment.
3. In a patient with MRSA pneumonia and ARDS, the attending physician reported that lung function improved “dramatically” while using Seraph 100.
4. In another patient, LDH levels (a marker of tissue injury) decreased significantly while Seraph 100 was used.
Safety & Effectiveness
1. An EU clinical trial showed no device or treatment-related adverse or serious events.
2. Rapid reduction of pathogens can occur in as little as 3 to 4 hours.
3. Can be used as early intervention, prior to pathogen identification due to broad-spectrum binding.
4. Easy to use and is compatible with all blood pumps and bloodlines using luer lock fittings.
5. A short 6-minute video on how to install the filter to a dialysis machine can be found on YouTube https://youtu.be/SR928cFN5OU
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