Towards clinical proof of concept of fibre reinforced patches for fracture fixation and bone repair

Purpose and goal

The purpose of the project was to take important steps towards clinical trials of an innovative fibre reinforced adhesive patch (FRAP), designed for customized bone fracture fixation. The objectives that were met in this project include the development of a biocompatible adhesive with strong adhesion to bone in a biologically relevant environment. A safety study of the material was performed and an application method for surgical environments was performed. This project has successfully laid the foundation for an initial evaluation of FRAP on humans.

Expected results and effects

During the project a benign adhesive composition with strong adhesion to wet bone substrates was developed. The adhesives revealed high biocompatibility in a safety study conducted under the GLP process. Results from the safety study justify further evaluation of FRAP materials on humans. The collective outcome is a critical first step towards clinical trial of the FRAP methodology and future studies will be based on these findings. Additionally, the impact of this study will increase global exposure and activities around the FRAP method, both from surgeons and medtech companies.

Planned approach and implementation

The project first addressed the development of an adhesive with strong adhesion to wet bone substrates in which the components were thought to be of high biocompatibility. The adhesives bind strongly to the wet leg and are manufactured under the mild conditions similar to current methodologies used in dentistry. A safety study of the adhesives was performed as the first step in obtaining a medical implant approved for clinical use. The test revealed high biocompatibility of the achieves and was corroborated by preclinical animal studies with good results.