Urinary catheter coating agent

According to the US Centre for Disease Control (CDC), the urinary tract is the most common site of infections acquired in a hospital, or hospital-like setting, accounting for more than 40% of the total number reported by acute-care hospitals and affecting an estimated 600,000 patients a per year. Most of these infections - 66% to 88% - are as a result of urinary catheterization. 

There is an urgent need to control and reduce the number of infections acquired by patients after their admission to the hospital. These hospital acquired (nosocomial) infections, many of which are caused by in-dwelling medical devices, pose a threat to any patient admitted to a hospital and contribute considerably to the costs and morbidity associated with hospitalization.

In-dwelling medical devices are responsible for the vast majority of nosocomial infections. The most common cause of device-related infection is the urinary catheter. Urinary catheterization is involved in up to 90% of all nosocomial urinary tract infections (UTI), as the catheter surface serves as a platform for the growth of bacteria as biofilm. As the duration of catheterization increases, catheter associated UTI rates approach 100%. Patients who acquire a UTI will stay longer in hospital an average of six days longer than those who do not, and will contribute to an extra $1.8B in hospital costs.

Recent studies have shown an abundance of evidence that anti-microbial catheters provided benefits when compared to standard uncoated catheters. Furthermore, there is a vast support for the assertion that the increased cost of an effective coated catheter is justified with even a modest reduction in the rate of UTI. Due to these facts, and the Centre for Disease Control and Prevention’s recommendations for the use of anti-microbial coated catheters, there is a growing market demand for these types of products. The current $175 million US anti-microbial coating market is forecast to grow to over $500 million by 2012.

Kane Biotech is building a pipeline of non-antibiotic catheter coatings for the prevention of catheter-associated infections. The Company’s lead coating for urinary catheters is PS/CHX. In a recent study, PS/CHX was compared to silver hydrogel coated and uncoated commercially available catheters in a recognized in vivo model. Study results demonstrated that the PS/CHX coated urinary catheters were significantly less likely to be colonized b bacteria than either the silver-hydrogel coated or uncoated catheters. Furthermore, the study showed that PS/CHX coated urinary catheters were significantly less likely to cause catheter related infections than either the silver-hydrogel coated or uncoated catheters. All the results comparing PS/CHX to other test groups were statistically significant.

There are a limited number of coated urinary catheters in the market today, predominantly made up of those coated with silver. Although the anti-microbial activity of silver is documented, the use of silver on medical devices is continually debated based on lack of conclusive evidence supporting its ability to reduce infection. The results of the Kane Biotech study were consistent with the concerns cited regarding the efficacy of silver. Of even greater concern, multi-drug resistant bacterial strains continue to increase their prevalence in the hospital environment. According to leading experts, catheter associated UTI are perhaps the prime reservoir for antibiotic resistant pathogens. There is an opportunity for Kane Biotech’s non-antibiotic coating, PS/CHX, to positively impact the antibiotic resistance problem by reducing the need for systematic antibiotics, while preventing the ability for dangerous resistant pathogens to take hold through the formation of biofilm on the catheter surface.