EXOGEN has demonstrated proven clinical effectiveness2-4 and 91%12 treatment compliance. Using low-intensity pulsed ultrasound (LIPUS) technology, EXOGEN activates a biological healing response at the molecular level.6 EXOGEN makes treatment compliance tracking convenient for your patients and verifiable for you, with a built-in treatment tracking calendar.
- #1 prescribed bone healing system7
- 20-minute daily treatment
- 38% faster healing of indicated* fresh fractures2,3
- 86% healing of nonunions†4
- Clinically proven high level of treatment: 91%12
- Over double the number of Level 1, 2, and 3 clinical studies than all competitors combined1
Successful bone healing depends on both effectiveness and treatment compliance. EXOGEN delivers both.
Indications for Use
The EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of established nonunions† excluding skull and vertebra. In addition, EXOGEN is indicated for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature individuals when these fractures are orthopaedically managed by closed reduction and cast immobilization.
There are no known contraindications for the EXOGEN device. Safety and effectiveness have not been established for individuals lacking skeletal maturity, pregnant or nursing women, patients with cardiac pacemakers, on fractures due to bone cancer, or on patients with poor blood circulation or clotting problems. Some patients may be sensitive to the ultrasound gel.
†A nonunion is considered to be established when the fracture site shows no visibly progressive signs of healing.
Mechanism of Action
EXOGEN sends ultrasound waves through the skin and soft tissue to the fracture.
EXOGEN ultrasound activates cell surface mechanoreceptors called integrins, initiating an intracellular cascade that leads to upregulation.
EXOGEN ultrasound increases upregulation of genes and expression proteins and growth factors critical to bone healing.
The EXOGEN Performance Program underlines our confidence in the effectiveness of EXOGEN, as proven by published studies. It also serves as an extra stimulus for optimal compliance by the patient.
The EXOGEN Performance Program guarantees that radiographic healing progression will be shown in nonunion and delayed fractures. If the requirements of the program are met and no healing progression is shown, out-of-pocket expenses incurred in obtaining the EXOGEN device will be refunded to the patient.
Guidelines for Assessment of Healing Progression
Absence of documented healing, defined as progression to bony union, is measured by written evaluation of X-rays taken prior to the patient’s treatment with EXOGEN ultrasound and at least 120 days (or beyond) of first use. The assessment of absence of healing progression must be made by the prescribing physician and reflected in a completed EXOGEN Performance Program evaluation form.
All EXOGEN patients who have been diagnosed by a health care professional as having a nonunion fracture (skull and spine fractures excluded) are eligible to participate. A nonunion fracture is considered to be established when the fracture site shows no visible signs of progressive healing.
EXOGEN has been shown to be effective when used daily for 20-minute treatments. To be eligible for the program, participants must treat their nonunion fracture with EXOGEN for 20 minutes a day, for a minimum of 120 days, with a 90% minimum adherence to the treatment regimen.
The EXOGEN device contains an internal patient usage monitor that records the date, time, and duration of each treatment. This monitor will be utilized to confirm that the 90% treatment compliance threshold is met and that the device has not been modified or altered. Any devices which have been modified and/or altered will not be eligible to participate in the EXOGEN Performance Program.
Patient Claims for Refunds
Please contact the Bioventus Customer Service at 1-800-836-4080 for assistance. All claims must be accompanied by the following.
- Prescribing HCP written assessment
- The prescribed EXOGEN device
Claims must be received at Bioventus within one year after the EXOGEN device is applied. No refund will be made if examination of the returned EXOGEN device reveals that it has been deliberately rendered inoperative or altered in any way. The EXOGEN Performance Program is only for FDA-approved nonunion fractures and the patient for whom the device was prescribed.
EXOGEN Personalized Patient Services
Your Goals Are Our Goals
EXOGEN Ultrasound Bone Healing System offers personalized patient services and a full suite of support tools to help achieve the goals of your office and your patients.
EXOGEN’s Full Suite of Support Tools
20 Minutes of Treatment
With treatments lasting just 20 minutes, EXOGEN fits easily into the patient’s daily routine.
Treatment Tracking Calendar
EXOGEN’s built in treatment tracking calendar tracks completed and missed treatments, making treatment compliance tracking convenient for patients and verifiable for physicians.
EXOGEN Performance Program
The EXOGEN Performance Program guarantees that radiographic healing progression will be shown following EXOGEN treatment of a nonunion fracture. If the requirements of the program are met and no healing progression is shown, out-of-pocket costs will be refunded to the patient.
Bioventus Customer Service is available at 1-800-836-4080 to answer your patients' questions and help them stay consistent with their EXOGEN treatment.
Patient Smartphone App
EXOGEN CONNECTS is a free smartphone app that sends automated treatment reminders and provides helpful healing information.