SBIR Phase I: Application of a Self-sealing Composite Structural Material for Hemodialysis Blood Access

This Small Business Innovation Research (SBIR) Phase I project proposes to develop a novel self-sealing material to be applied to the design of durable blood access systems for hemodialysis patients. 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 a self-sealing hemostatic material, 2) Create designs suitable for vascular access applications, and 3) Assess safety and efficacy of the designs in a chronic animal model. The research will draw upon knowledge in cross-disciplinary fields to complete the aims of the proposal, and demonstrate enhanced performance relative to commercial predicate technology. The broader impact/commercial potential of this project will yield a unique and novel material that will create a paradigm shift from the treatment of complications to prevention to create better clinical outcomes and contain costs. 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. This materials technology will lead to vascular access devices suitable for the entire hemodialysis patient population, thereby creating an estimated market size of more than $400 million. And this materials technology platform may be applied to a broad range of applications beyond hemodialysis where repeated access and reliable sealing is required.