SBIR Phase II:A Novel Disinfection Method to Prevent Infection in Peritoneal Dialysis

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is to increase access to peritoneal dialysis (PD). Over 554,000 kidney failure patients in the US require some form of dialysis each year but only 58,000 receive PD, despite its lower cost of care. Despite the many benefits and advantages of PD compared to in-center dialysis, adoption is limited due to the risk of peritonitis, an infection of the peritoneal membrane. Peritonitis occurs in nearly 30% of PD patients each year and is responsible for the death of 1 out of every 6 patients who receive PD. The proposed device significantly and broadly reduces the risk of peritonitis, resulting in nearly $2 billion in Medicare savings and improved clinical outcomes.This Small Business Innovation Research (SBIR) Phase II project will further develop a medical device that internally disinfects catheter tubes in a closed system. This innovative disinfection method is designed to prevent microbial infection threats during peritoneal dialysis. The aim will be to demonstrate the safety and efficacy of the disinfection prototype, including evaluations of its ease of use. The technology will be designed to meet medical device design and safety standards. The project will perform optimization studies, develop cGMP-ready manufacturing processes, and develop an advanced prototype.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.