Health Canada expands emergency use of the CeraShield™ Endotracheal Tube to all hospitals in Canada
May help prevent deadly ventilator-associated bacterial infections and complications in COVID-19 patients
DUBLIN, Ohio, April 23, 2020 /PRNewswire/ -- N8 Medical, LLC (N8) today 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. 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% in China and 80% 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."
If you are a Canadian clinician or facility desiring to access CeraShield™ Endotracheal Tubes, please contact the company promptly at [email protected] as supplies are currently limited.
N8 has partnered with Hydromer Inc. (www.hydromer.com) 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 important effort.
ABOUT N8 MEDICAL
N8 Medical, LLC (www.N8Medical.com), headquartered in Dublin, Ohio, is a rapidly-growing, privately-held clinical stage biotechnology company developing a platform of anti-fouling medical devices designed to have significant, life-saving clinical impact through reduction of infection, related complications and mortality. Key publications are available at www.N8Medical.com.
CAUTION: 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.
SOURCE N8 Medical, LLC
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