Major Advance in Critical Care Medicine
DUBLIN, OHIO [June 15, 2021] — N8 Medical (“N8” or the “Company”) today announced that its CeraShield Endotracheal Tube (ETT) has been approved by Health Canada for a Medical Device License (“MDL”) for use in mechanically ventilated patients. N8 is the clinical stage,US based developer of the CeraShield platform technology for medical devices to prevent hospital acquired infections. The CeraShield ETT is its first product approved for use in Canada.
The CeraShield ETT is designed to reduce the need for anti biotics and to reduce the risk of patients developing respitory infections including a potentially fatal respiratory complication known as Ventilator Associated Pneumonia (“VAP”). Although conventional ETTs are packaged as sterile, once the tube is inserted into the trachea it is rapidly fouled with bacterial biofilms which are impervious to antibiotic therapy. These biofilms act as a reservoir of endotoxin and infectious agents that can migrate to the patient’s respiratory tract and cause infections and sepsis. Elderly patients and those with pre-existing neurocognitive decline are also at high risk of developing delirium, dementia and Alzheimer’s following mechanical ventilation due to exposure to endotoxin which leads to inflammatory cytokine cascades and high levels of IL-6.
Today’s approval represents the first full regulatory approval for this device from a Tier 1 health care regulatory system. The Canadian regulatory process is among the most stringent in the world and requires that sponsors of medical devices also obtain Medical Device Single Audit Program (MDSAP) certification as part of the approval process.
Health Canada MDL approval will allow N8 to obtain near term regulatory approvals for the CeraShield ETT in other countries that recognize and follow Health Canada’s regulatory approvals, including Israel, the Kingdom of Saudi Arabia, Egypt and the Republic of Colombia, among others. N8 Medical is actively seeking distributors outside the US. The CeraShield ETT is an investigational device in the United States and has been designated as a “breakthrough device” by the United States Food & Drug Administration
About N8 Medical
N8 Medical is a clinical stage US based developer of the CeraShield platform technology for medical devices to prevent hospital acquired infections. Frost & Sullivan previously awarded N8 its “Product Innovation of the Year Award” for its platform CeraShield technology for medical devices.