DUBLIN, OHIO – 11 Nov, 2017 – N8 Medical, LLC, a privately-held clinical-stage biotechnology company developing drug-eluting medical devices for the prevention of serious hospital-acquired infectious conditions, today announced the scientific publication of “Preclinical testing of a broad-spectrum antimicrobial endotracheal tube coated with an innate immune synthetic mimic” in the October 4, 2017 issue of the Journal of Antimicrobial Chemotherapy (JAC). 1 N8 Medical’s CeraShield™ Endotracheal Tube (ETT) is a ceragenin-eluting ETT that has been designated by the U.S. Food and Drug Administration (FDA) as a “breakthrough” medical device pursuant to the 21st Century Cures Act based on its potential to prevent life-threatening infections from Candida auris and other multidrug resistant pathogens such as colistin-resistant Pseudomonas and Acinetobacter.
N8 Medical’s CeraShield™ ETT has a hydrogel film coating supplied by Hydromer, Inc. that contains CSA-131. The CeraShield™ ETT testing studied elution (drip-flow and static systems), antifungal and antibacterial activity (repeated inoculation in growth media), biofilm formation (electron microscopy), and safety (intubation of pigs with coated and uncoated endotracheal tubes).
The optimized CeraShield™ hydrogel coatings containing CSA-131 provided controlled slow release of CSA-131, with concentrations released of less than 1ug/ml per 24 hours. The eluting CSA-131 prevented fungal and bacterial colonization of coated ETTs exposed to high inocula for up to 14 days, while uncoated ETTs had extensive biofilm growth after 24 hours. CeraShield™ coated ETTs were well tolerated in intubated pigs. The authors also found that the CeraShield™ ETTs also significantly reduced endotoxin levels.
N8 Medical anticipates initiating initial human clinical studies in the United States in the first quarter of 2018 following FDA IDE approval.
CAUTION: In the United States, the CeraShield™ Endotracheal Tube has not been granted marketing approval by FDA, and is an investigational device and not available for commercial sale. These statements have not been evaluated by FDA.
Image caption: Scanning Electron Microscopy (SEM) images of ETT surfaces: A: biofilm of C. auris (CDC 383) on an uncoated tube after 14 days (daily inoculation). B: surface of a coated tube after 14 days (daily inoculation with C. auris). C: mixed species biofilm of MRSA and PA01 on an uncoated tube after 48 h. D: surface of a coated tube after 48 h (inoculation with MRSA and PA01). E: mixed species biofilm of PA01 and C. auris on an uncoated tube after 48 h. F: surface of a coated tube after 48 h (inoculation with PA01 and C. auris).
1. Hashemi MM et al. Preclinical testing of a broad-spectrum antimicrobial endotracheal tube coated with an innate immune synthetic mimic. J Antimicrob Chemother 2017 Oct; doi 10.1093 jac dkx347.
Company Name: N8 Medical, LLC
Contact Person: Carl Genberg
Country: United States