Biotechnology company N8 Medical, LLC has submitted its Investigational Device Exemption (IDE) for its flagship CeraShield Endotracheal Tube (ETT) to the Food and Drug Administration (FDA) for its first-in-human clinical study intended to evaluate the safety and effectiveness of the product.
The product is a ceragenin-coated ETT that has been designated by FDA as a ‘breakthrough device’ based on its potential to prevent life-threatening infections from key clinically relevant pathogens. It is designed to prevent the growth of biofilms, therefore reducing the potential for infection. The hope is that this will lead to life-saving and complication-reducing benefits.
N8 Medical anticipates that human clinical studies will begin in the US in the first quarter of 2018, following FDA 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," said Carl Genberg, Chief Executive Officer of N8 Medical.