N8 Medical, LLC, a privately held medical device company developing novel solutions for the prevention of hospital-acquired infections from multidrug-resistant pathogens, has announced that FDA has approved the company’s request to designate its CeraShield™ endotracheal tube as a “breakthrough device” pursuant to the recently enacted 21st Century Cures Act. A "breakthrough device" is one that may prevent a life-threatening or irreversibly debilitating disease or condition.
According to N8, each year over 4 million Americans who are hospitalized in intensive care units require the use of an endotracheal tube attached to a ventilator to assist in breathing. Bacteria and fungi quickly grow on these tubes and may lead to potentially deadly respiratory infections and other severe complications. N8 supported its filing with FDA with recent data from the U.S. Centers for Disease Control and Prevention (CDC) showing that the antimicrobial compound in the CeraShield endotracheal tube was able to inhibit growth of all 100 strains of Candida auris — an emerging highly lethal fungal infection. While Candida auris infections have been found overseas they have only recently been found in U.S. hospitals with recent outbreaks in Boston and New York City. N8 also supplied FDA with peer reviewed published data showing efficacy against multidrug-resistant bacterial strains such as colistin-resistant Pseudomonas and Acinetobacter. Colistin is regarded as the antibiotic of last resort.
The 21st Century Cures Act enables companies to use a combination of premarket and postmarket approval studies to meet the requirements for a faster pathway toward approval. This significantly expedites access for US patients and their physicians to innovative medical devices. The statute was enacted in January 2017 for medical devices that demonstrate the potential to address unmet medical needs for life-threatening or irreversibly debilitating diseases or conditions, such as ventilator associated pneumonia and ventilator associated tracheobronchitis as well as other respiratory infections.
Ceragenins are mimics of molecules found within the human body’s own innate immune system, and were invented by Dr. Paul B. Savage, The Reed Izatt Professor of Chemistry and Biochemistry at Brigham Young University (Provo, UT). There are over 40 peer reviewed journal articles on the ceragenin technology, and the technology is protected by issued patents through 2033. BYU has licensed the ceragenin technology to N8 Medical for certain fields of use, including application to medical devices.