This Small Business Innovation Research (SBIR) Phase I project is focused on developing an innovative catheter design for peritoneal dialysis patients that is not reliant on patient compliance. Currently, 50% of PD patients (on average) experience peritonitis within the first 18 months. The risk of infection rapidly multiplies in subsequent months. Treatment for peritonitis includes long-term antibiotic treatment that causes multiple side effects and does not always eradicate the infection. Every year, roughly 25-50% of PD patients are forced to switch to HD as a result of complications from infections. Such complications can involve catheter removal, which costs at an average of $20,000 per infection episode, and ~$200Million annual cost to the healthcare system. Many more patients are never administered PD in the first instance because of risk from infection and the complexity involved with current sterilization protocol. Anticipated results with this innovative catheter are around 50% decrease in infection risk.
The broader impact/commercial potential of this project addresses the challenge of infection related to dialysis. Chronic Kidney Disease incidence is growing at over 7% for these age groups. In the US, nearly 400,000 patients receive dialysis treatment every year. The global market for peritoneal dialysis exceeds $2Billion. Moreover, PD has proven to show up to 27% lower mortality risk and enhanced quality of life, at ~25% lower cost. By reducing the incidence of peritonitis and by decreasing the time, complexity, and training involved in the current sterilization protocol, our solution will transform the dialysis paradigm, enabling a much broader group of patients to enjoy the substantially improved quality of life that PD can provide. Moreover, a more clear understanding of infections related to catheter-related bacteremia will help find solutions to lessen hospitalizations resulted from infection in other catheter-related cases as well (including urinary, IV catheters, and PICC lines). Infections related to catheters are still a major global problem and this solution can save more than $35 Billion in catheter-related bacteremia costs.
Catheter-related bacteremia results in bllions of healthcare dollars in the U.S alone, 250,000+ infections a year, 50,000+ deaths annually from peritoneal dialysis and central venous line catheter infections alone. Standard medical protocols for disinfection are at times not enough to prevent catheter-related bacteremia, especially if they are not rigorously followed. There is a dire clinical need to reduce catheter-related infections. It is also important to note that typically patients on peritoneal dialysis have weaker immune systems, sometimes due to other comorbidities, and are more prone to severe infections. PuraCath Medical ‘s Disinfection Device showed statistically significant 90+% reduction of infection, compared to controls, in the following organisms: Staphylococcus aureus, Streptococcus pneumonia, Streptococcus epidermitis, Escherichia coli, and Candida albicans. This data achieved was with remarkably low p-values and 95% confidence intervals. PuraCath has worked on optimizing the device design for patient comfort and wear as well. With the advent of PuraCath’s Disinfection Device, PuraCath’s technology has promise in reducing infections in peritoneal dialysis – permitting more patients on dialysis to benefit the quality of life benefits of peritoneal dialysis (predominant form of home dialysis treatment). This technology is also beneficial and has promise in reducing catheter-related infections in other applications as well.
