SBIR/STTR Award attributes
PROJECT SUMMARY Approximately 80% of patients beginning hemodialysis (HD) in the United States use a catheter at treatment initiation, and 18.6% of all HD patients were using a catheter in 2017. However, the HD catheters (HDC) used for longer-term dialysis in patients have a high complication rate because of infections and dysfunction, with a catheter dysfunction rate of 0.5–3.42 episodes/1000 catheter-days. The most common catheter-related problems are infections (catheter-related bloodstream infections; CRBSI) and thrombosis. Fibrin sheath formation has a close relationship with pathogen colonization and biofilm formation on the catheter surface. The entry of pathogens into the bloodstream through the catheter-extraluminal and intraluminal routes and the seeding of pathogens that develop biofilm on the catheter surface cause CRBSI. In the US, annual HD treatment costs ~$89,000 per patient, with total costs of $42 billion. In 2016, 80% of patients used a catheter at initiation of HD and 18.6% of all HD patients in the US were using a catheter in 2017. However, no available solutions to prevent catheter dysfunction can successfully prevent both thrombosis and infection. FFMD is aiming to optimize and commercialize tethered liquid perfluorocarbon (TLP) coatings on medical devices. Our TLP coating stops the adhesion of all biological components (bacteria, fungi, blood components) to the surface of medical devices by immobilizing a thin layer of highly inert and biocompatible perfluorinated liquid. In preliminary work, we optimized our TLP coating technology for HDC by incorporating a thin fluoropolymer layer on the catheter surface. We also demonstrated that the optimized coating could reduce colonization by CRBSI pathogens by rt85% vs. uncoated polyurethane catheter while also effectively reducing fibrinogen adhesion and thrombosis on the catheter surface. The objective of this Direct to Phase II SBIR application is to complete our path toward marketability with our TLP-modified HDC (TLP HDC). Using a previously established domestic sheep model, we will test the central hypothesis that TLP HDC will out-perform standard HDC by decreasing fibrin sheath formation, which has a close relationship with both catheter dysfunction and biofilm formation. This will be achieved using three aims. Aim 1: Compare the in vivo effectiveness of TLP HDC and standard HDC (Palindrome®) at reducing fibrin sheath formation and catheter tip occlusion. Aim 2: Obtain GMP-manufactured TLP HDC. Aim 3: Initiate the 510(k) application process to obtain FDA premarketing approval and perform a biocompatibility study. These advances will allow FFMD to maximize the effectiveness of the TLP coating and dramatically improve HD patient care by reducing catheter dysfunction and the CRBSI rate in clinical settings.
