ExThera Medical is set to commence a trial to analyse its Seraph 100 Microbind Affinity Blood Filter, a blood purification device that could potentially be used to treat sepsis among others.
The Seraph 100 has demonstrated the ability to lower both bacterial and viral loads in the bloodstream.
In August 2019, ExThera received CE Mark approval for Seraph 100 to reduce pathogens during bloodstream infections.
Hospitals in Germany and Italy began using Seraph 100 Microbind to treat Covid-19 in March last year.
So far, the device has been used on more than 300 Covid-19 patients in the US and the European Union since April last year.
Authorised for emergency use, the device was found to lower mortality in severe cases of Covid-19.
ExThera obtained conditional approval from the US Food and Drug Administration to conduct the randomised, control, multicentre PURIFY-RCT study to treat critically ill subjects with pathogen-associated shock, a type of septic shock.
The study will assess the safety and efficacy of Seraph 100 blood purification treatment in subjects enrolled at various health centres in the US.
ExThera noted that nearly 15 US sites were selected for the trial, including both community and military hospitals.
Analysing the efficiency of Seraph 100 against a variety of bloodstream infections that can cause sepsis will be the trial’s goal.
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 US in life-threatening bloodstream infections beyond Covid-19.”
The latest study comes after initial data from a multicentre observational PURIFY-OBS study showed that SERAPH 100 provided substantial enhancement in survival rates in critically-ill Covid-19 subjects.
In a separate development, doctors at Portsmouth’s Queen Alexandra Hospital in the UK are conducting medical trials of a blood test that could be used for predicting sepsis even before people show symptoms.
Created at the Defence Science and Technology Laboratory ten years ago, the blood test is now being developed by Presymptom Health.
Presymptom noted that the technology can forecast if a person will develop sepsis around three days before symptoms become evident, thereby allowing doctors to provide quick and efficient treatment.