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 nonunions4
  • 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.

The EXOGEN device has also been reported as effective as an adjunctive non-invasive treatment of established nonunions in patients:

  • With internal or external fracture fixation hardware present. EXOGEN cannot penetrate metal and therefore should not be applied directly over hardware.
  • Undergoing treatment for infection at the fracture site. EXOGEN is not intended to treat the infection.
  • Believed to have diminished bone quality. EXOGEN is not intended to treat diminished bone quality.

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

1 Stimulation
EXOGEN sends ultrasound waves through the skin and soft tissue to the fracture.

2 Activation
EXOGEN ultrasound activates cell surface mechanoreceptors called integrins, initiating an intracellular cascade that leads to upregulation.

3 Upregulation
EXOGEN ultrasound increases upregulation of genes and expression proteins and growth factors critical to bone healing.

Proven Effectiveness

EXOGEN has over double the number of Level 1, 2 and 3 clinical studies than all competitors combined.1
EXOGEN has the most clinical evidence for efficacy of any FDA-approved bone healing device. No other bone stimulator comes close.

*These studies, which reflect the body of evidence of the bone stimulator EXOGEN, include evaluations of applications outside the approved label. Assignment of evidence levels was based on the updated level of evidence rating system in the Journal of Bone and Joint Surgery. 2015;97(1):1-2.

The EXOGEN Rewards Program

Ease patient financial concerns about out-of-pocket costs while driving compliance and better outcomes

Better compliance with treatment leads to better health outcomes. The EXOGEN Rewards Program encourages compliance by easing financial concerns about the out-of-pocket cost of choosing EXOGEN. The program reimburses up to $500 of paid out-of-pocket costs if the patient is 95% compliant with daily treatment, and if:

 

  • The patient uses EXOGEN daily for a minimum of 120 days (recorded automatically by the device)
    or
  • Should healing occur prior to 120 days, proof of healing is provided

The EXOGEN Rewards Program Evaluation and Exclusions

Evaluation
The EXOGEN device contains an internal usage monitor that records the date, time and duration of each treatment session. This monitor will be used by Bioventus to confirm that your patient complied with the treatment regimen at least 95% of the time.

Exclusions

  • EXOGEN devices that have been modified or altered
  • EXOGEN devices that were not sent to the patient directly from Bioventus
  • Patients for whom EXOGEN was not prescribed
  • Costs other than the patient’s out-of-pocket payment to Bioventus
  • EXOGEN treatment outside the United States
  • Patients with any federal, state, or other government plans, including, but not limited to, Medicare (including a Medicare Part D or Medicare Advantage plan), Medicaid, TRICARE/CHAMPUS, Veterans Administration or Department of Defense health coverage, the Puerto Rico Government Health Insurance Plan, or any other federal or state health care programs or pharmaceutical assistance program

If the patient heals prior to 120 days, they will need the prescribing physician to fill out the attestation form for proof of healing.

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.

  • Convenient patient resources
  • High level of treatment compliance5
  • Improved clinical outcomes2-4
  • Maximized patient satisfaction

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 the tracking of treatment compliance convenient for patients and verifiable for physicians.

EXOGEN Rewards Program
Better compliance leads to better health outcomes. The EXOGEN Rewards Program encourages compliance with daily treatment by easing patients’ financial concerns about their out-of-pocket cost for EXOGEN.

Customer Support
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.