Health Canada Expands Emergency Use of CeraShield Endotracheal Tube

N8 Medical LLC (N8) announced that Health Canada has granted emergency use access marketing approval of the company’s CeraShield Endotracheal Tube for all Canadian mechanically-ventilated COVID-19 patients. The U.S. Food and Drug Administration (FDA) has previously designated the CeraShield ETT as a “breakthrough” device. N8 plans to continue to seek emergency use authorizations in other countries. 
 
N8’s CeraShield tube has a patented anti-fouling coating designed to prevent deadly bacterial infections that frequently occur in ventilated patients. Conventional endotracheal tubes allow pathogenic bacteria to rapidly grow on the tube surfaces and are a source of infection that may lead to acute kidney injury, sepsis and death.
 
“There is growing concern over the reported high death rates among mechanically ventilated COVID-19 patients. Death rates as high as 50 percent in China and 80 percent in New York have been reported. Patients infected with the COVID-19 virus who require mechanical ventilation are highly susceptible to exposure to bacterial pathogens and ventilation complications. The coating on the CeraShield tube prevents the formation of biofilms that routinely foul the plastic surfaces of unprotected conventional endotracheal tubes and lead to bacteria growth,” said Carl Genberg, N8’s chief scientific officer.
 
“N8’s CeraShield Endotracheal Tube may reduce secondary bacterial infections, save lives and expand ventilator resource capacity by getting patients off ventilators sooner,” said Ronald Bracken, N8’s president and chief operating officer. “We are pleased that Health Canada is now allowing all hospitals to have access to this potentially life-saving technology.”   
 
N8 has partnered with Hydromer Inc. and its wholly owned subsidiary and med-tech division, Biosearch Medical Products Inc., in connection with material supply and production of the CeraShield Endotracheal Tubes for this effort.
 
In United States, the CeraShield Endotracheal Tube is investigational and has not been granted marketing approval. These statements have not been evaluated by Health Canada or FDA.