Emergency Use Authorization Granted for N8 Medical CeraShield Endotracheal Tubes

N8 Medical LLC (N8 Medical) announced that Health Canada has granted Dr. John Muscedere of Kingston General Hospital’s emergency request to begin using the N8 Medical CeraShield Endotracheal Tubes in mechanically-ventilated COVID-19 patients.
 
N8 Medical’s CeraShield Endotracheal Tube has a patented anti-fouling coating that is designed to prevent deadly bacterial infections that frequently occur in ventilated patients with respiratory viral infections. In contrast, conventional endotracheal tubes allow pathogenic bacteria to grow on the tube surfaces within hours and form slime-like aggregations of millions of pathogenic cells as a biofilm. In the 1918 influenza pandemic, 95 percent of influenza patient deaths were caused by secondary bacterial infections.

Bacterial infections are a major source of mortality among ICU patients. According to recently published reports, the mortality in COVID-19 patients requiring advanced respiratory support (ventilators) ranges from 66 percent to 86 percent. N8 Medical believes that use of the CeraShield Endotracheal Tube may reduce this rate of mortality.
 
“Biofilm growth on endotracheal tubes may lead to deadly secondary bacterial infections and exaggerated inflammatory responses requiring eight to nine days of additional mechanical ventilation. Preventing virally-infected patient exposure to bacterial biofilms on the endotracheal tube is critically important,” said Carl Genberg, N8 Medical’s chief scientific officer. “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.”   
 
Frost & Sullivan recently issued its Product Innovation of the Year Award to N8 Medical for its platform technology designed to prevent hospital acquired infections. The U.S. Food and Drug Administration has designated the CeraShield Endotracheal Tube as a “breakthrough device” pursuant to the 21st Century Cures Act. The device is currently an investigational product.
 
Dr. Muscedere is an Intensivist at Kingston General Hospital, and co-chair of the Canadian Critical Care Trials Group (CCCTG) Knowledge Translation Committee. Dr. Muscedere was the principal investigator in a clinical feasibility study of the CeraShield Endotracheal Tube of ten patients at Kingston General who were intubated with the CeraShield Endotracheal Tube. That study indicated that use of the CeraShield Endotracheal Tube does not have adverse side effects and was able to prevent dangerous pathogenic bacteria from growing on the tube and in endotracheal tube aspirates. 
 
N8 medical is currently in discussions with other physicians regarding emergency use during this ventilator resource-straining pandemic.