DUBLIN, OHIO – November 7, 2019 – N8 Medical, LLC (N8 Medical) today announced it has been selected as the winner of a North American New Product Innovation Award by Frost & Sullivan, a leader in global research and consulting solutions.
N8 Medical is developing disruptive medical devices that prevent hospital-acquired infections and their expensive and potentially fatal consequences. N8 Medical earned the award for its proprietary platform CeraShield™ technology that provides significant surface antifouling benefits for indwelling medical devices. N8 Medical’s CeraShield™ platform development is led by its flagship product, the CeraShield™ Endotracheal Tube, previously designated by the United States Food and Drug Administration (FDA) as a “breakthrough device” based on its life-saving potential.
After medical devices are inserted into patients, they quickly become fouled with bacteria, fungi and their biofilms. These fouled devices are a leading cause of hospital-acquired infections. “The emergence of resistant pathogens and lethal pathogens such as Candida auris has heightened the need for new approaches to prevent medical device fouling,” said Carl Genberg, N8 Medical’s Chief Scientific Officer.
N8 Medical’s core technology uses a patented synthetic mimic of the body’s innate immune system to protect the surfaces of medical devices and prevent bacterial and fungal adhesion. Biofilm growth on medical devices acts as a reservoir for bacteria and can lead to several problems, including increased length of hospital stays, overuse of antibiotics and even death.
N8 Medical’s CeraShield™ technology is broadly applicable to nearly all medical devices at risk for biofilm fouling, including endotracheal tubes, urinary catheters, orthopedic implants and cardiac devices. N8 Medical’s promising endotracheal tube initial clinical study results in the demanding intensive care unit environment support the CeraShield™ antifouling technology’s broad platform potential.
“We thank Frost & Sullivan’s for recognizing the CeraShield™ Endotracheal Tube and our CeraShield™ platform as a major advance in preventing hospital acquired infections” said Ronald Bracken, President and COO of N8 Medical. Mr. Bracken was previously the VP of R&D of C.R. Bard.
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.