Bioventus Updates U.S. Label for EXOGEN

By Julie A. Vetalice

Bioventus Updates U.S. Label for EXOGEN

Bioventus updated the indications for use of the EXOGEN® Ultrasound Bone Healing System as an adjunctive non-invasive treatment of established nonunions in select patients.

EXOGEN uses low-intensity pulsed ultrasound to help stimulate the body’s natural bone healing process and promote fracture healing. Studies indicate an 86% healing rate for fractures not healing on their own, and 38% faster healing of indicated fresh fractures.

The updated label now features indications for use of EXOGEN as an adjunctive non-invasive treatment of established nonunions in patients:

  • With internal or external fracture fixation hardware present
  • Undergoing treatment for infection at the fracture site
  • Believed to have diminished bone quality

Peter Shaw, MBBS DRCOG, Chief Medical Officer, said, “Patients with comorbidities such as osteoporosis and bone infection can benefit from use of EXOGEN by helping to progress fracture healing and resolve nonunion. In addition, EXOGEN will heal fractures in the presence of infection at the fracture site and also serve as an important adjunctive therapy when stabilizing fractures with instrumented fixation.”