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N8 Medical Announces First-in-Human Use of its CeraShield(TM) Endotracheal Tube
DUBLIN, Ohio, April 25, 2019 /PRNewswire/ -- N8 Medical, LLC (N8 Medical) today announced its first-in-human clinical trials of its flagship CeraShield™ endotracheal tube (CeraShield™ ETT) for intensive care unit patients expected to require mechanical ventilation for more than 48 hours. N8 Medical is encouraged by preliminary study data and believes that the CeraShield™ ETT will demonstrate safety and a significant reduction in bacterial and fungal fouling of the tube. Fouling of endotracheal tubes is associated with an increased risk of respiratory complications, increased antibiotic usage, infection and longer stays in the ICU. The clinical studies received the requisite ethics approvals from Health Canada and Western IRB prior to commencement in December 2018.
Ronald Bracken, Chief Operating Officer of N8 Medical, stated, "We are pleased with these developments regarding the initial clinical usage of the CeraShield™ technology. We believe the data continues to validate the potential of this transformative platform technology to reduce hospital-acquired infections and complications. We now expect to add clinical sites both in Canada and elsewhere to fully demonstrate the potential of this breakthrough technology."
N8 Medical is enthusiastic about reaching this further milestone in its efforts to commercialize the CeraShield™ technology in a medical device application with a high unmet clinical need in this challenging clinical environment. N8 Medical believes that the CeraShield™ ETT has the potential to improve ICU patient outcomes by reducing respiratory and intubation-related complications, antibiotic usage and length of stay. The United States Food and Drug Administration (FDA) previously designated the CeraShield™ ETT as a "breakthrough device."
The company also believes that there is an urgent clinical need for surface-protected devices like the CeraShield™ ETT designed to combat both bacterial and fungal colonization—including deadly fungal threats such as Candida auris, an emerging highly lethal fungal pathogen recognized by the Centers for Disease Control and Prevention as a "serious global health threat." Patients who require breathing tubes in the ICU are at an elevated risk for Candida auris and other serious fungal infections.
ABOUT N8 MEDICAL
N8 Medical, LLC (www.N8Medical.com), headquartered in Dublin, Ohio, is a rapidly-growing, privately-held biotechnology company developing a platform of antimicrobial surface-protected medical devices designed to have significant, life-saving clinical impact through reduction of infection, related complications and mortality. N8 Medical's CeraShield™ technology is based upon novel compounds called ceragenins that are small molecule, non-peptide, functional mimetics of naturally-occurring antimicrobial peptides that kill bacteria and fungi by membrane disruption, leading to rapid cell death.
CAUTION: In Canada, the CeraShield™ Endotracheal Tube obtained Health Canada Investigational Testing Authorization and remains the subject of investigational testing regarding the safety of the CeraShield™ ETT. In the United States, the CeraShield™ Endotracheal Tube has not been granted marketing approval by FDA and is not yet available for commercial sale. The statements in this release have not been evaluated by Health Canada or FDA.
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SOURCE N8 Medical, LLC