ExThera Medical yesterday said it received CE Mark approval for is Seraph 100 Microbind Affinity Blood Filter.
The Seraph 100 is designed to reduce pathogens during bloodstream infections and the CE Mark allows the filter to be used as an adjunct to anti-infective therapy. ExThera’s filter quickly lowers the concentration of bacteria, viruses and fungi in whole blood and was shown in clinical testing to significantly reduct the concentration of drug-susceptible and drug-resistant pathogens.
“Today marks a definite turning point in advancing the care of bloodstream infections, the result of years of dedicated research, development and investment,” president and CEO Bob Ward said in a press release. “Seraph 100 provides an innovative therapy for rapid and effective treatment of infections that might otherwise prose a devastating risk to patients. We look forward to Seraph 100’s continued success in Europe, while demonstrating its potential to help healthcare providers and their patients around the world.”
“The ExThera team did an extraordinary job designing, testing and obtaining regulatory approval for Seraph 100, while also gaining certification of its Quality Management System. I thank them, our consultants and our clinical collaborators for their hard work and dedication to this revolutionary product,” former VP and chief operating officer Kathleen White said.
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