SBIR Phase II: Application of a Durable Self-sealing Material for Hemodialysis Blood Access

This Small Business Innovation Research (SBIR) Phase II project focuses on the development of a novel self-sealing materials technology for the primary application of designing durable blood access systems for hemodialysis patients. Nearly 580,000 people in the United States alone have end stage renal disease (ESRD), and over 400,000 people are treated using hemodialysis as the primary mode of treatment. Current access systems are neither designed for repeated access nor managing bleeding after hemodialysis treatment, and as a result commonly lead to secondary complications. The research aims of the proposal are to: 1) Develop manufacturing methods for device production, 2) Determine biocompatibility of the materials technology, and 3) Develop an animal model to evaluate potential clinical impact. The broader impact/commercial potential of this project, if successful, will yield a unique and novel material that will create a paradigm shift from the treatment of complications due to hemodialysis to prevention. This will address clinical market needs and shift reimbursement policies to create better clinical outcomes and contain costs. Currently, $27 billion is spent on the delivery of hemodialysis treatment for ESRD patients. The materials technology under development will lead to vascular access devices suitable for nearly the entire hemodialysis patient population, thereby creating an estimated addressable market size of more than $500 million. This research will enhance scientific understanding by introducing novel engineering and manufacturing methods for a broad range of applications beyond hemodialysis where repeated access and reliable sealing is required.