Donia Al watanBioventus, a global leader in orthobiologics, today announced it will commission an innovative series of real-world evidence, direct-to-patient studies to further 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. FDA PMA approved in 1994, EXOGEN has provided treatment to more than 1 million patients worldwide for more than 20 years and has a long clinical history. The product uses safe, effective low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural healing process.1
Recent publications analyzing 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.2,3,4 This new clinical research, known as the Bioventus Observational Non-interventional EXOGEN Studies (BONES), will build on this evidence and supplement the product’s broad body of clinical knowledge in a prospective population-based innovative clinical development program.
The BONES studies will compare the incidence of fracture nonunions in patients utilizing the EXOGEN device with patients from a national health insurance claims database who received standard of care alone. The studies will include bones representative of long and small bones of upper and lower extremities. The unique design was discussed with FDA during its development.
“BONES represents a significant investment in developing epidemiologically grounded rigorous clinical evidence to support use of EXOGEN in fractures at risk, and to underscore the product’s clinical utility in mitigating the risk of nonunions, a highly debilitating and costly condition,” said Alessandra Pavesio, Senior Vice President and Chief Science Officer, Bioventus. “It will build upon knowledge gained from extensive research conducted by Bioventus and recently published in JAMA Surgery, in over 700,000 fracture patients that has identified 40-plus factors which place a patient at an increased risk of progression to a nonunion.5”