ExThera Medical has secured a conditional investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to carry out the randomised control trial of the Seraph 100 Microbind Affinity Blood Filter (Seraph 100) to treat septic shock.
The multicentre trial will assess the safety and efficacy of Seraph 100 in critically ill patients with potentially fatal pathogen-associated shock (PURIFY-RCT), a type of septic shock.
The study’s endpoint is to determine the efficiency of Seraph 100 against different bloodstream infections, which may cause sepsis.
According to the company, the Seraph 100 is the first blood purification device that has been demonstrated to minimise both bacterial and viral loads in the bloodstream.
Since April last year, the device has been used on over 300 US and EU patients with Covid-19.
The device, which was in use under an emergency use authorisation, has been demonstrated to significantly minimise mortality in severe Covid-19 cases.
ExThera’s US randomised control study is part of the PURIFY programme conducted in collaboration with the Henry Jackson Foundation (HJF) for the Advancement of Military Medicine and Uniformed Services University of the Health Sciences (USUHS).
Earlier, the device was evaluated in collaboration with the Department of Defense and the Defense Advanced Research Projects Agency (DARPA).
The current study will assess the safety and efficacy of Seraph 100 blood purification therapy in patients across health centres in the US.
ExThera will use up to 15 US sites, including both community and military hospitals, for the study.
ExThera Medical CEO Robert Ward said: “We are proud to be saving lives during the Covid-19 pandemic under our FDA Emergency Use Authorisation.
“We are confident that this new trial will help lead to the expansion of approved indications for Seraph 100 in the United States in life-threatening bloodstream infections beyond Covid-19.”
The company already secured CE mark approval for the Seraph 100 device. It is commercially available in the European Union (EU) region.
