Blood purification company ExThera Medical Corporation stated on Tuesday that critically-ill COVID patients treated with the Seraph 100 Microbind Affinity Blood Filter (Seraph 100) have completed enrollment under the PURIFY OBS observational study led by the US DOD.
The PURIFY RCT is a multicentre randomized controlled trial studying blood purification for the treatment of pathogen associated shock. The multicentre RCT trials are rare in the field of extracorporeal therapy and require robust signals of efficacy. It is expected to begin enrollment in early 2022It is expected that the positive clinical results observed in PURIFY OBS will continue during PURIFY RCT.
In addition, the complete PURIFY observational study is expected to be published during Q1 2022. The observations included dramatic improvement in survival and reduction in median ICU length of stay for patients treated with the Seraph 100 vs controls.
According to the company, physicians across the US are using the Seraph 100 under Emergency Use Authorization from the US Food and Drug Administration to treat COVID-19 patients admitted to the ICU with confirmed or imminent respiratory failure. In 2019, the Seraph 100 was granted CE mark in the EU for the reduction of bloodstream pathogens. As a patient's blood flows through the Seraph 100 filter, it passes over beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Harmful substances are quickly captured and adsorbed onto the surface of the beads and are thereby subtracted from the bloodstream.
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