Plans to Initiate First-in-Human testing in First Quarter of 2018
DUBLIN, OHIO – February 8, 2018 – N8 Medical, LLC today announced the submission of 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.
N8 Medical’s CeraShield™ ETT is a ceragenin-coated ETT that has been designated by FDA as a “breakthrough device” pursuant to the 21st Century Cures Act based on its potential to prevent life-threatening infections from key clinically relevant pathogens. In the United States, an estimated 100,000 persons die each year from such infections in Intensive Care Units (ICUs).
N8 Medical anticipates initiating initial human clinical studies in the United States later in the first quarter of 2018 following FDA IDE approval. The company believes that its compelling preclinical in vitro, in vivo and ex vivo studies completed to date for the CeraShield™ ETT are highly likely to translate to clinical efficacy in human studies.
The CeraShield™ ETT is designed to prevent the growth of biofilms, thus reducing the potential for infection, a major cause of mortality and increased length of stay among intubated patients. This is anticipated to lead to life-saving and complication-reducing benefits including a lower rate of mortality, shortened length of stay, and reduction in antibiotic usage—in other words, lower overall cost and better patient outcomes.
Ronald Bracken, N8 Medical’s President and Chief Operating Officer, formerly Vice President of Research and Development for C.R. Bard, stated: “We are looking forward to bringing our breakthrough CeraShield endotracheal tube device to patients and hospitals that we believe will realize a substantial benefit.” “We are pleased that FDA designated the CeraShield endotracheal tube 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,” added Carl Genberg, Chief Executive Officer of N8 Medical.
N8 Medical’s CeraShield™ ETT is an endotracheal tube that has been modified with a proprietary ceragenin-infused CeraShield™ coating designed to prevent bacterial and fungal growth on the tube’s surfaces. Patients who require mechanical ventilation in the intensive care unit are intubated with ETTs to provide air to the patient’s lungs to assist with breathing. However, within hours, bacteria and fungi start to grow on the tube and form slime-like microbial aggregations known as biofilms. Biofilms act as a reservoir of infectious agents that may lead to life-threatening respiratory infections.
CAUTION: In the United States, the CeraShield™ Endotracheal Tube has not been granted marketing approval by FDA and is an investigational device that is not available for commercial sale. These statements have not been evaluated by FDA.
N8 Medical, LLC
(877) 686-3338, Ext. 55