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 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
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 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.
Kebomed may request to receive your patient's X-rays for any further evaluation.
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.
- Fracture types:
- Fresh fractures
- Greater than 10 millimeters fracture gap
- Vertebra and skull
- 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 Kebomed
- Valid only in Finland
Claims for Refunds:
Patients/customers may contact Kebomed at 020 793 1090 for assistance.
All claims must be accompanied by the following:
- Registration form to the EXOGEN Performance Program sent to Kebomed within the first 30 days of the initial treatment
- Prescribing physician’s written assessment, using the EXOGEN Claim Form
- Prescribed EXOGEN device returned to Bioventus
Claims must be received by Kebomed within one year of first EXOGEN treatment date.
EXOGEN Personalized Patient Services
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 physicians.
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.