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.4 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 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 Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) including:

  • Treatment of delayed union and nonunions
  • Accelerating the time to heal of fresh fractures
  • Treatment of stress fractures
  • Accelerating repair following osteotomy
  • Accelerating repair in bone transport
    procedures
  • Accelerating repair in distraction osteogenesis
    procedures
  • Treatment of joint fusion

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.

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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 is a Bioventus program that refunds patients their out-of-pocket expenses incurred in obtaining EXOGEN if progression of healing is not shown per criteria below. It is also designed to help reinforce patients’ adherence to the prescribed treatment.

Criteria
All patients who have purchased an EXOGEN designed for the treatment of a fracture, which was prescribed by a qualified physician to treat a stable, non-displaced, established nonunion, delayed union or acute fracture with a fracture gap less than 10 millimeters (excluding vertebra and skull fractures) are eligible.
All patients will automatically be enrolled in the program. Patients must treat their fracture with EXOGEN per product instructions, for at least 120 days with a minimum adherence of 90%.

Evaluation
To be eligible, the prescribing physician must determine that the fractured bone does not demonstrate evidence of progression to bony union based on patient’s X-rays, one taken prior to using EXOGEN compared to one taken after 120 days of EXOGEN treatment or later.
The EXOGEN device contains an internal patient usage monitor that records the date, time and duration of each treatment session. This monitor will be used by Bioventus to confirm that at least 90% treatment adherence is met.

Exclusions
  • Fracture types:
    • Unstable
    • Displaced
    • Greater than 10-millimeter fracture gap
    • Vertebra and skull
    • Pathological
  • Modified or altered devices
  • Patient treated with EXOGEN 4000+ model
  • The EXOGEN Performance Program is void if alternative interventions occur during the 120-day treatment period. If alternative intervention is needed, a new 120-day treatment period begins
  • EXOGEN must be purchased and received by the patient directly from Bioventus
  • The EXOGEN Performance Program applies only to patients for whom the device was prescribed
  • Any other costs associated with the purchase – only the patient’s out-of-pocket payments to Bioventus will be refunded
  • Valid only in Canada
Claims Patients may contact a Bioventus Customer Care representative at 1-855-771-0606 for assistance. All claims must be accompanied by the following:
  • Prescribing physician’s assessment: completion of the EXOGEN Performance Program evaluation form
  • Letter from the patient requesting a refund (including name, address and payment method)
  • 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 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 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 an acute, delayed or nonunion fracture. If the requirements of the program are met and no healing progression is shown, the out-of-pocket costs of obtaining the device will be refunded to the patient.

Customer Support
Bioventus Customer Care is available at 1-855-771-0606 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.

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