N8 Medical said today it submitted an investigational device exemption application to the FDA for a first-in-human study of its CeraShield endotracheal tube.
The Dublin, Ohio-based company’s CeraShield ETT is a ceragenin-coated ETT designed to prevent the growth of biofilms and reduce potential for infection for intubated patients.
“We are looking forward to bringing our breakthrough CeraShield endotracheal tube device to patients and hospitals that we believe will realize a substantial benefit,” prez & COO Ronald Bracken said in prepared remarks.
N8 said it is hopeful it will be able to initiate human clinical trials in the US during the first quarter of this year after it receives IDE approval.
“We are pleased that FDA designated the CeraShield ETT as a breakthrough device in light of its life-saving potential, and we are also thankful that the NIH, NIAID and CDC provided valuable testing services that have enabled us to reach this important milestone,” CEO Carl Genberg said in a press release.
