ExThera Medical has received CE Mark approval for its Seraph 100 Microbind Affinity Blood Filter (Seraph 100) to reduce pathogens during bloodstream infections (BSI).
The CE Mark approval means that ExThera’s Seraph 100 meets the safety and performance requirements for medical devices in the European Economic Area (EEA) as an adjunct to anti-infective therapy.
The company plans to begin shipping Seraph 100 for clinical use in selected member states of the European Union in October this year.
ExThera Medical president and CEO Bob Ward said: “Today marks a definitive turning point in advancing the care of bloodstream infections, the result of years of dedicated research, development and investment.
“Seraph 100 provides an innovative therapy for rapid and effective treatment of infections that might otherwise pose 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.”
Seraph 100 is a broad-spectrum ‘sorbent-type blood filter’ and provides a new option to treat BSI. It is capable of quickly reducing the concentration of bacteria, viruses and fungi in whole blood.
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The company has evaluated the therapeutic use of Seraph 100 in a dialysis-like extracorporeal circuit for treating patients with both drug-susceptible and drug-resistant bloodstream infections.
It was found that Seraph 100 could significantly reduce the concentration of both pathogens.
ExThera former vice-president and chief operating officer Kathleen White said: “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.”