SBIR Phase II: Antibiotic-Dispensing Spacer for Improved Periprosthetic Joint Infection (PJI) Treatment

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project will help total knee replacement patients who have a joint infection. Periprosthetic Joint Infection (PJI) is a potentially life-threatening bacterial infection of a total joint replacement. Beyond immediate treatment, infections can develop years later from unrelated injuries, increasing PJI incidence as older patients opt for replacement joints. Roughly 15.6 million people in the US currently use a replacement joint, and without improved treatment, PJI will represent an estimated $2.2 billion annual US healthcare burden by 2023. The current standard of care treatment cannot generate sufficiently high antibiotic concentrations within the joint over enough time to eradicate bacterial biofilms on the implant and tissue, the known cause of persistent infection. This project will advance a proprietary implantable drug delivery system to easily generate and maintain an antibiotic concentration in the joint sufficient to eradicate biofilm and resolve an infection with less surgical trauma, easier patient recovery and lower healthcare cost than the current standard of care provides. This Small Business Innovation Research (SBIR) Phase II project will advance translation of a novel implantable drug delivery system with an externally worn controller that communicates through skin to a simple implant comprising a pump and reservoir. When therapy is complete the pump can be left in place with no requirement to remove it, avoiding additional surgery common with current implantable pump technology. This project advances the development of the implant and controller to generate prototypes for thorough testing, including efficacy evaluation for biofilm eradication within a simulated environment. 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.