N8 Medical LLC

N8 Medical LLC is a clinical-stage medical device company specializing in antimicrobial coating technology based on ceragenins—a novel class of active compounds that mimic innate immune system antimicrobial peptides. The company's lead product, CeraShield, is an antimicrobial coating applied to indwelling medical devices and implants to prevent hospital-acquired infections (HAIs) and biofilm formation. The flagship device is the CeraShield Endotracheal Tube (ETT), designed to prevent Ventilator-Associated Pneumonia (VAP), the most common and costly HAI in ICU settings with estimated global treatment costs exceeding $10 billion annually. The FDA has designated CeraShield ETT as a "Breakthrough Device" and it is cleared for routine clinical use in Canada, Colombia, Brazil, and the UAE, with FDA approval anticipated. N8 Medical's pipeline includes additional CeraShield-coated devices: an antimicrobial absorbable pacemaker envelope for prevention of cardiac implantable electronic device (CIED) infections, and coated pedicle screws for orthopedic implant-associated infection prevention. The company is also developing CeraShield-coated hemodialysis catheters. N8 Medical operates as part of N8 Biosciences holding company and maintains a pharmaceutical subsidiary, Kinnear Pharmaceuticals, advancing therapeutic drug development using ceragenins for cystic fibrosis and other conditions. The company has received multiple NIH SBIR grants and maintains partnerships with government agencies including USAMRIID for biodefense applications.