Winning Solution: Nitric Oxide-Eluting Disposable Hemodialysis Catheter Insert to Prevent Infection and Thrombosis

Despite substantial efforts by the nephrology community to reduce utilization of dialysis catheters, the majority of ESRD patients in the USA initiate hemodialysis (HD) with a tunneled dialysis catheter (TDC) with approximately one-quarter of them remaining catheter-dependent thereafter. TDCs are associated with decreased patient survival as well as multiple complications, such as central venous stenosis, infection, and thrombosis. The yearly cost of hemodialysis for patients using a TDC is approximately $20,000 greater as compared to dialyzing through an AVF. There are two major pathologic entities that lead to TDC dysfunction and associated complications: infection and platelet activation leading to thrombosis. Nitric oxide (NO) is an endogenously formed gaseous molecule that is well known to play a key role in preventing infection and thrombosis. The very short half-life of NO is a major advantage because only a relatively low steady-state level of NO present at the inner and outer surfaces of the TDC is required to achieve the desired antimicrobial and antithrombotic effects. Further, there is no risk of systemic effects when using NO release materials/devices that emit NO at rates that are near physiological levels.

This proposal aims to develop an innovative NO releasing TDC insert device. The disposable NO release insert will be replaced at each dialysis session (every 2-3 days). The proposed project is designed to meet two specific KidneyX goals: 1) to improve quality of life for dialysis dependent patients by minimizing burden on the family and care partner(s) and improving their ability to work, travel, and engage in recreational activities; and 2) to improved renal replacement therapy access. These goals will be achieved by a decreasing the rate of infections, thrombosis, fibrin sheath formation, and central vein stenosis, which will, in turn, reduce hospitalizations, morbidity, and mortality associated with TDC use.

The NitriCap team is seasoned with experience in entrepreneurship, medicine, research, and both business development strategy and execution. The team possesses the balanced skillsets needed to transform proven research technology to commercial release via 510(k) clearance pathway.