Medical Devices

THE HAI PROBLEM

Infections are a leading cause of death and illness worldwide. With the rapid rise of drug-resistant bacteria, nearly 70 percent of infections in the U.S. are now drug resistant, making the problem one of the most serious in the medical field. Hospital-acquired infections and healthcare-associated infections (HAIs) are a large and growing problem and cost the U.S. healthcare system $33 billion annually. They are estimated to affect more than 6 million persons annually in the United States, European Union and Japan combined. Of the approximately 1.7 million HAIs in the United States annually, nearly 100,000 patients die from these infections and many more require extended hospitalization and medical treatment. HAIs can occur during any procedure that breaches the skin or introduces a foreign object into the body, including catheterization, intubation, intravenous procedures and the use of surgical implants and devices., which account for 70 percent of HAIs.

Many hospitalized patients are immunocompromised, and are thus at high risk for infections. Materials commonly used to manufacture medical devices, such as silicone, PVC, polyurethane, stainless steel and titanium, provide a breeding ground for microbes and the formation of biofilms. Biofilms essentially function as a reservoir of infectious agents and are highly resistant to conventional antibiotics. In some cases the only way to treat a patient whose implanted or indwelling device has become colonized with biofilm and bacteria is to surgically remove the device, which is extremely costly and is associated with high morbidity and risk of re-infection.

N8 Medical is developing several ceragenin coating approaches that can be deployed as a platform across the medical device market and that provide the flexibilty and customization needed to address infection prevention in each medical device category. N8 Medical is able to incorporate CSAs cergenins into hydrogel and other coatings to be applied to a wide variety of medical devices. This is our CERASHIELD™ technology.  Upon exposure to body fluids, the ceragenins elutes out slowly over time and is able to prevent the growth of bacterial and fungal biofilms on the surfaces of devices for clinically relevant time periods.  In a NIH funded 12 week study, ceragenin-containing silicone coating on orthopedic fracture fixation plates was shown to be able to provide 100% protection against an implanted biofilm challenge of MRSA.  All of the control animals (sheep) developed osteomyelitis.  In addition to eluting forms of our coating, we are developing covalent attached coatings in which the CSAs are permanently attached to the device and are eligible for 510(k) review and clearance by the FDA.