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.
Genezen agrees manufacturing collaboration with Galibra Neuroscience
FDA grants Breakthrough Therapy Designation to Legacy Healthcare's CINAINU (LH-8)
FDA approves Vantis Vascular's 6F CrossFAST model
Blue Lake Biotechnology reports interim data from Phase 1/2a paediatric clinical trial of BLB201
Agilent to acquire Proscia for up to USD270m to expand digital pathology capabilities
Bristol Myers Squibb reports positive Phase 3 results for RYZ101 in neuroendocrine tumours
US WorldMeds awarded 2026 Vision of Hope Award
Urolution Medical secures FDA clearance for OpenFlo urinary catheter
Natera secures FDA Breakthrough Device designation for multi-cancer early detection assay
Medincell partner Teva secures FDA approval for monthly schizophrenia treatment
FDA approves Genentech's Tecentriq combination therapy for stage III colon cancer
Lupin Limited receives FDA approval for Phytonadione Injectable Emulsion USP
argenx reports positive Phase 2 results for FB102 in coeliac disease
Vir Biotechnology's VIR-5500 receives FDA Fast Track designation for prostate cancer