SBIR Phase I: Localized and Sustained Antibiotic Delivery For Treatment of Periprosthetic Joint Infection (PJI) in Arthroplasty Patients

Reselute, Inc., Durham NC

Investigators

Abstract

The broader impact of this Small Business Innovation Research (SBIR) Phase I project is develop an innovative medical technology for localized and sustained antibiotic treatment in the case of periprosthetic joint infection (PJI). The proposed activities may result in commercialization of an implant with novel reservoir technology to be placed at the infected site, and which will locally deliver antibiotics to eradicate the infection. This solution may improve patient care as well as reduce costs associated with treatment of infection. The development of an implantable, antibiotic-eluting orthopedic spacer which enables patients to return to ambulatory conditions while providing sustained, appropriate, anti-infection resistance for a sustained duration could benefit patients and reduce medical costs. The proposed product seeks to reduce infections and reduce the need for surgical revision and significant antibiotic treatments. If successful, this technology will reduce the burden associated with unresolved infections and avoid amputations. This team will design, develop, and validate the proof of concept for an orthopedic spacer. The system will be 3-D printed using a novel porous medium capable of controlled antibiotic elution. The product will be tested using benchtop mechanical testing and in vitro studies of implanted system viability and controlled elution. The objectives include a study of the prototype's ability to meet design criteria for mechanical performance, as well as a demonstration of a superior antibiotic elution profile over an extended-release period. The mechanical testing to be performed include load, stress, and cycle testing within current standards, in conjunction with in vitro laboratory elution testing of the specified antibiotic substance over a sustained duration of time (up to >180 days). 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.