Bioventus is to commission an innovative series of real-world evidence, direct-to-patient studies to validate the ability of its Exogen ultrasound bone-healing system to mitigate the risk of a fracture progressing to nonunion in the presence of known risk factors.
Recent publications analysing data from a large registry of almost 8,000 fractures treated with Exogen suggest that the device supports healing fractures in patients despite the presence of associated comorbidities or medication use, according to a company release.
This new clinical research, known as the Bioventus Observational Non-interventional Exogen Studies (BONES), is intended to build on this evidence and supplement the product’s broad body of clinical knowledge in a prospective population-based innovative clinical development program.