CeraShield™ resorbable envelope targets prevention of bacterial and highly lethal fungal infections and reduction of surgical site infections of pacemaker implantations
Dublin, Ohio, August 7, 2018—N8 Medical, LLC (N8 Medical) today announced that the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH) indicated its intent to fund N8 Medical’s STTR Phase I grant application for the development of a resorbable envelope to prevent surgical site infections associated with pacemaker implantation surgeries. N8 Medical will be working with researchers at Southwest Research Institute (SwRI), DaVinci Biomedical Research Products, Inc. and Brigham Young University to develop the envelope. N8 Medical is enthusiastic about the further development and validation of its breakthrough CeraShield™ technology in another key medical device application with a high unmet clinical need, representing a further milestone in its efforts to commercialize its core technology.
Surgical site infection is a serious complication of cardiac device implantation that is associated with significant morbidity or mortality. There are approximately 500,000 cardiac device surgical implantations each year in the United States, and the number is expected to climb with the United States’ aging population. Further, expansions of indications for cardiac devices has resulted in greater numbers of implants in sicker and more vulnerable patients that have a higher risk of infection. Coagulase-negative Staphylococcus and Staphylococcus aureus are responsible for the majority of these infections, and these organisms are increasingly resistant to methicillin. Fungal infections from Candida spp. also occur in a minority of cases and have catastrophic outcomes with mortality rates of approximately 30%.
With the emergence of deadly fungal pathogens such as Candida auris, there is a clinical need for devices that provide protection against bacterial and fungal pathogens. Even Candida albicans, historically viewed as a somewhat innocuous organism that is not directly pathogenic, has been found by researchers to lead to lethal results when co-localized with Staphylococcus aureus. N8 Medical believes that the CeraShield™ pacemaker envelope has the potential to inhibit Candida spp. growth, provide broad-spectrum antibacterial activity, and provide extended duration of activity compared to currently available devices—and thus provide significant lifesaving benefits for this critical and growing patient population.
Carl Genberg, Chief Executive Officer of N8 Medical, stated, “We are pleased that the National Heart Lung and Blood Institute has recognized the need for more effective clinical solutions and are grateful for their assistance to further the development of our CeraShield™ technology in this promising and critical medical device application.”
 For example, TYRX pacemaker envelope (Medtronic, Inc.), https://www.accessdata.fda.gov/cdrh_docs/pdf13/k130943.pdf.