STTR Phase II: Development of a Antibiotic Releasing Intramedullary Nail for Treatment of Fracture Related Infections

Reselute, Inc., Durham NC

Investigators

Abstract

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase II project is a novel implantable orthopedic medical device and procedure to reduce the recovery duration and infection risks associated with severe traumatic fractures of the long bones. The system aims to reduce existing issues with open fractures that pose incremental risks to the wound and surrounding tissue due to prolonged exposure to the environment. The system aims to improve the current standard-of-care using metallic plates, screws, and nail implants. These frequently become colonized by bacteria, and systemic antibiotics are not always effective for preventing or treating fracture related infections. Effective treatment of fractures and prevention of infectious complications will expedite healing and weight-bearing rehabilitation, and ultimately reduce overall medical care cost. The device has an estimated market of 24,000 US cases each year and aims to provide a new standard of care for the total $500M annual intramedullary nail market. This Small Business Technology Transfer (STTR) Phase II project aims to advance and optimize a novel intramedullary nail providing local antibiotic release at the fracture site. The proposed work advances the company’s biocompatible 3D printed photoresin embedded within an orthopedic implant that elutes commercially available antibiotic. During this project the objectives are to complete (1) preliminary mechanical and drug release testing, (2) complete simulated testing of the device and new procedure with orthopedic trauma surgeons in cadavers, (3) develop the manufacturing processes, (4) complete initial safety testing in a preclinical ovine model to demonstrate fracture healing and systemic safety of the antibiotic release. The success criteria include demonstration of safety and effectiveness through the combined benchtop and preclinical models. The results will establish the procedural confines, safety profile and systemic release characteristics of local antibiotic delivery. Upon completion, the company will move to first in human clinical phase to further establish the device's safety and efficacy performance towards the future goal of US regulatory approval. 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.