N8 Medical Chooses Colombia and bioaccess™ for the Clinical Trial of its CeraShield™ Endotracheal Tubes in Mechanically Ventilated COVID-19 Patients

[Orlando, FL, August 7, 2020] — N8 Medical, LLC (N8 Medical) –a clinical-stage medical device company focused on commercializing medical devices that incorporate a novel class of active compounds called ceragenins– has chosen Colombia and bioaccess™ as its contract research organization (CRO) to conduct a clinical trial of its CeraShield™ Endotracheal Tubes in mechanically ventilated COVID-19 patients. bioaccess™ will help N8 Medical with its institutional review board (IRB)/ethics committee approval and regulatory approval at Colombia's regulatory agency (INVIMA).

N8 Medical’s CeraShield™ Endotracheal Tube has a patented anti-fouling coating that is designed to prevent deadly bacterial infections that frequently occur in ventilated patients with respiratory viral infections. In contrast, conventional endotracheal tubes allow pathogenic bacteria to grow on the tube surfaces within hours and form slime-like aggregations of millions of pathogenic cells as a biofilm.

In the 1918 influenza pandemic, 95% of influenza patient deaths were caused by secondary bacterial infections. Bacterial infections are a major source of mortality among ICU patients. According to recently published reports, the mortality in COVID-19 patients requiring advanced respiratory support (ventilators) ranges from 66% to 86%.

N8 Medical believes that the use of the CeraShield™Endotracheal Tube may reduce this rate of mortality. “Biofilm growth on endotracheal tubes may lead to deadly secondary bacterial infections and exaggerated inflammatory responses requiring 8 to 9 days of additional mechanical ventilation. Preventing virally-infected patient exposure to bacterial biofilms on the endotracheal tube is critically important,” said Carl Genberg, N8 Medical’s Chief Scientific Officer. “In a time of severe shortage of mechanical ventilators, we believe that the use of the CeraShield™ Endotracheal Tube has the potential to both reduce mortality and optimize ventilator capacity by getting patients off the ventilator sooner,” also said Carl Genberg.

Frost & Sullivan recently issued its Product Innovation of the Year Award to N8 Medical for its platform technology designed to prevent hospital-acquired infections. FDA has designated the CeraShield™ Endotracheal Tube as a “breakthrough device” pursuant to the 21st Century Cures Act. The device is currently an investigational product.

Dr. John Muscedere –an Intensivist at Kingston General Hospital, and Co-Chair of the Canadian Critical Care Trials Group (CCCTG) Knowledge Translation Committee– was the Principal Investigator in a clinical feasibility study of the CeraShield™ Endotracheal Tube of ten patients at Kingston General who were intubated with the CeraShield™ Endotracheal Tube. That study indicated that the use of the CeraShield™ Endotracheal Tube does not have adverse side effects and was able to prevent dangerous pathogenic bacteria from growing on the tube and in endotracheal tube aspirates.

About N8 Medical, LLC

N8 Medical, LLC, headquartered in Dublin, Ohio, is a rapidly-growing, privately-held biotechnology company developing a platform of anti-fouling 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 (also referred to as CSAs). There are over 90 peer-reviewed journal articles regarding the ceragenin technology, which was invented by Professor Paul B. Savage, Professor of Chemistry and Biochemistry at Brigham Young University (Provo, UT). More information at www.n8medical.com.

About bioaccess.™

bioaccess™ is a Florida-based clinical research organization (CRO) and market access consulting company which mission is to help innovative medical device companies conduct clinical research and commercialize their innovations in Colombia and the rest of Latin America. The company provides its clinical research clients with support services to ensure their first-in-human trials are a success in Colombia (e.g., regulatory submission, logistical support, project management, and study monitoring; among others). For more information, please visit www.bioaccessla.com.

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bioaccess™ Press Contact:

Julio G. Martinez-Clark, CEO
Tel: +1 (954) 903-7210
Email: jmclark@bioaccessla.com