SBIR-STTR Award

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to disrupt renal replacement therapy (RRT) by increasing access to peritoneal dialysis (PD). Over 500,000 kidney failure patients in the United States (US) require RRT each year, with only 52,000 patients receiving PD, despite it having a lower cost of care. PD adoption has been limited due to high rates of peritonitis, which occurs in over 30% of PD patients each year and is linked to 1 out of 6 PD patient deaths. This project will reduce the risk of infection in PD, providing current patients with safer care and enabling more RRT patients to receive PD. This would save the US healthcare system over $100 million annually in peritonitis-related hospitalizations. This Small Business Innovation Research (SBIR) Phase I project will evaluate the technical feasibility of delivering a safe, easy-to-operate internal tube disinfection protocol for PD to make it more practical in non-clinical settings. Existing efforts to prevent catheter-associated infections largely involve education and antimicrobial hub caps. However, education measures rely on patient compliance and antimicrobial caps leave catheter ends vulnerable to contamination when removed for treatment. This project aims to develop a device that demonstrates sufficient microbial disinfection within a connected PD system using an antimicrobial solution. Disinfection in a closed system eliminates the risk of secondary contamination events. However, significant concerns exist with regards to exposure of the patient’s abdomen to the antimicrobial solution. To address this, rodent animal studies will be conducted to evaluate the acute systemic response and repeat exposure risk of antimicrobial residue to the peritoneal cavity. This study aims to demonstrate a sufficiently minimal toxicity risk compared to existing effects from dialysate solution use. 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

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.