N8 Medical News

N8 Medical Announces its CeraShield™ Coating inhibits COVID-19 Virus Growth on Endotracheal Tubes

Reduction in COVID-19 Virus Exposure May Benefit Patients, Doctors and Nurses

DUBLIN, OHIO—August 11, 2020—N8 Medical, LLC, a privately held biotechnology company, today announced that its CeraShield™ coated endotracheal tubes significantly reduced the growth of COVID-19 virus in recent testing. The testing shows statistically significant reduction in the growth of the COVID-19 virus on the tube surface in 60 minutes. Ordinary uncoated endotracheal tubes either allowed increased virus growth or had no inhibitory effect.

“Recent COVID-19 research has shown that the virus is able to adhere to plastic surfaces and is also able to be aerosolized and inhaled by people in close proximity, including doctors and nurses” says Ronald Bracken, President and Chief Operating Officer of N8. Mr. Bracken added “Most endotracheal tubes are made of plastic. COVID-19 patients who become mechanically ventilated will require use of one of these plastic tubes to connect to the mechanical ventilator.”

Ordinary endotracheal tubes lack any antifouling protection.  Within hours, these tubes become breeding grounds for biofilms, pathogenic bacteria, fungi and viruses. This often leads to deadly secondary infections that can be multidrug resistant, and other complications.

Dr. Michael Niederman, a leading expert in respiratory infections and a member of N8 Medical’s Scientific Advisory Board stated “Anything that can significantly reduce the presence of pathogens on the surface of an endotracheal tube is a welcome advance that has the potential to reduce a patient’s length of stay, reduce antibiotic and drug use and improve patient’s outcomes.  I look forward to the results of clinical studies to evaluate the magnitude of the potential benefit of the CeraShield™ endotracheal tube in COVID-19 patients.”

N8 Medical has previously completed first-in-human clinical trials in non-COVID, mechanically ventilated patients with no adverse effects.  Those clinical studies have shown that the CeraShield™ endotracheal tubes were able to completely prevent pathogenic bacterial and fungal biofilm growth of tube surfaces.

A leading market research firm recently awarded N8 Medical’s CeraShield™ endotracheal tube “Product Innovation of the Year” award for its CeraShield™ technology platform for prevention of hospital-acquired infections. FDA has designated the CeraShield™ endotracheal tube as a “breakthrough device.”

The company previously announced that Health Canada has granted Emergency Use Authorization for use of the CeraShield™ endotracheal tube in COVID-19 patients who require mechanical ventilation in Canada. The Company has pending EUA request with the FDA and with the MHRA in the UK.  Clinical studies are currently planned in COVID-19 hotspots. Hospitals that have an interest in participating in clinical studies are encouraged to contact N8 Medical at covid@n8medical.com.

Photo of endotracheal tube extubated from patient with COVID-19. Green coloration of the tube is indicative of extensive bacterial fouling.

 

ABOUT N8 MEDICAL

N8 Medical, LLC (www.N8Medical.com), headquartered in Dublin, Ohio, is a rapidly-growing, privately-held clinical stage 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. Key publications are available at www.N8Medical.com.

CAUTION: In United States, the CeraShield™ Endotracheal Tube and has not been granted marketing approval. These statements have not been evaluated by Health Canada or FDA.

Contact:
N8 Medical, LLC
(877) 686-3338, Ext. 55
Email: covid@n8medical.com
www.N8Medical.com

Previous Article