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 combined.1

Successful bone healing depends on both proven effectiveness and treatment compliance. EXOGEN delivers both.

Indications for Use

EXOGEN is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) that includes the treatment of delayed unions, nonunions, stress fractures and joint fusion. EXOGEN is also indicated for the acceleration of fresh fracture heal time, repair following osteotomy, repair in bone transport procedures and repair in distraction osteogenesis procedures.

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 licenced bone healing device worldwide.7

 *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 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 fractures.  If the requirements of the program are met and no healing progression is shown, the purchase price of EXOGEN will be refunded to the buyer.

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 clinician and reflected in a completed EXOGEN Performance Program evaluation form.
Bioventus may request to receive your patient's X-rays for any further evaluation.

Program Criteria
All patients who have purchased an EXOGEN device for the treatment of nonunion fractures that was prescribed by a qualified clinician to treat a stable, non-displaced, established nonunion fracture with a fracture gap less than 10 millimeters (excluding vertebra and skull fractures) are eligible.
Patients must treat their nonunion fracture with EXOGEN per product instructions, for a minimum of 120 days and achieve a 90% minimum level of adherence.

Exclusions

  • Fracture types:
    • Fresh fractures
    • Unstable
    • Displaced
    • Greater than 10 millimeters fracture gap
    • Vertebra and skull
    • Pathological
  • Treatment of multiple fractures (the guarantee is only valid to treat a defined fracture)
  • Modified and/or altered devices
  • Guarantee is void if alternative interventions occur during the 120-day treatment period
  • EXOGEN must be purchased and received directly from Bioventus
  • Valid only in the United Kingdom and Ireland

Claims for Refunds:

Patients/customers may contact a Bioventus Customer Care Representative at 0800 05 16 384 (UK) or 1800 552 197 (IR) for assistance.

All claims must be accompanied by the following:

  1. Registration form to the EXOGEN Performance Program sent to Bioventus within the first 30 days of the initial treatment
  2. Prescribing physician’s written assessment, using the EXOGEN Claim Form
  3. Prescribed EXOGEN device returned to Bioventus

Claims must be received by Bioventus within one year of first EXOGEN treatment date.

EXOGEN Personalized Patient Services

Your Goals Are Our Goals
EXOGEN Ultrasound Bone Healing System offers a full suite of support tools to help achieve the goals of your practice and your patients.

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

EXOGEN’s Full Suite of Support Tools

20-Minute Daily Treatments
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 clinicians.

EXOGEN Performance Program
The EXOGEN Performance Program guarantees that radiographic healing progression will be shown in nonunion or delayed fractures. If the requirements of the program are met and no healing progression is shown, the purchasing price of the device will be refunded to the patient.

Customer Support
Bioventus Customer Care is available at 0800 05 16 384 (UK) / 1800 552 197 (IR) 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.