US-based biotechnology firm N8 Medical has secured emergency use authorisation from Health Canada for its CeraShield Endotracheal Tubes in mechanically ventilated COVID-19 (coronavirus) patients.
Health Canada has granted Dr. John Muscedere of Kingston General Hospital’s emergency request to commence using the CeraShield Endotracheal Tubes.
Clinical feasibility study of CeraShield Endotracheal Tube showed it does not have adverse side effects
Muscedere was the principal investigator in a clinical feasibility study of the N8 Medical’s CeraShield Endotracheal Tube of ten patients at Kingston General who were intubated with the tube.
The study showed that the use of the CeraShield Endotracheal Tube does not have adverse impact on the patients.
The company’s CeraShield Endotracheal Tube has a patented anti-fouling coating that is conceived to avert deadly bacterial infections that often occur in ventilated patients with respiratory viral infections.
In contrast, standard endotracheal tubes enable pathogenic bacteria to grow on the tube surfaces within hours and form slime-like aggregations of millions of pathogenic cells as a biofilm.
The mortality in coronavirus patients that requires ventilators ranges from 66% to 86%, according to a recently published reports.
N8 Medical expects that the rate of mortality can be reduced by using its CeraShield Endotracheal Tube.
N8 Medical chief scientific officer Carl Genberg said: “Biofilm growth on endotracheal tubes may lead to deadly secondary bacterial infections and exaggerated inflammatory responses requiring 8 to 9 days of additional mechanical ventilation.
“Preventing virally-infected patient exposure to bacterial biofilms on the endotracheal tube is critically important.
“In a time of severe shortage of mechanical ventilators, we believe that use of the CeraShield™ Endotracheal Tube has the potential to both reduce mortality and optimize ventilator capacity by getting patients off the ventilator sooner.
“We thank Dr. Muscedere for his efforts to secure use of the CeraShield Endotracheal Tube and the Canadian Government for granting his emergency request.”
Recently, Promega has secured approval for the usage of its GoTaq Probe 1-Step RT-qPCR System in Centers for Disease Control and Prevention’s (CDC) COVID-19 EUA diagnostic panel.
The system is now a recommended master mix option for the CDC’s 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel.
