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ALung Technologies has received EUA from the US FDA for its Hemolung Respiratory Assist System (RAS) for Covid-19 treatment.
Currently, the system is being used in the FDA-approved VENT-AVOID trial for the study of extracorporeal carbon dioxide removal (ECCO2R) technology to treat acute exacerbation of chronic obstructive pulmonary disease (AE-COPD).
Additionally, Hemolung RAS is evaluated for the treatment of moderate to severe acute respiratory distress syndrome (ARDS) in the UK REST trial.
The company said that the system has been used in the treatment of a number of Covid-19 patients in the US under existing FDA emergency use provisions and in the EU, where it is CE-marked since 2013.
The FDA reviewed in vitro and in vivo information in support of ALung’s ongoing US VENT-AVOID clinical trial for the Hemolung RAS.
In addition, it also considered information about the clinical use of the system outside the US and additional biocompatibility, cytotoxicity and performance testing.
ALung Technologies chairman and CEO Peter DeComo said: “We are pleased with the FDA’s recognition that the Hemolung may be beneficial in the treatment of Covid-19 by removal of CO₂ directly from the blood during extracorporeal therapy.
“Many of the academic medical centres involved with our clinical trial have already requested the use of the Hemolung RAS for treatment of their Covid-19 patients.”
Hemolung RAS is believed to have the potential to treat lung failure as an adjunct to noninvasive or invasive mechanical ventilation.
It can reduce hypercapnia and hypercapnic acidosis and maintain normalised levels of the partial pressure of carbon dioxide (pCO₂) and pH in patients suffering from acute, reversible respiratory failure due to Covid-19.