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The Science of Bone Healing with EXOGEN

You can’t hear it working, but EXOGEN’s effects on bone healing have been evaluated in multiple clinical studies.*1-3,5,13-31

EXOGEN Mechanism of Action

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The EXOGEN Bone Healing System uses safe, painless, low-intensity pulsed ultrasound (LIPUS) to amplify natural bone healing three ways:

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Stimulation32EXOGEN sends ultrasound waves through the skin, creating movement that stimulates your body’s cells.
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Activation33EXOGEN ultrasound activates cells in your body.
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Upregulation34Upregulation is increased by EXOGEN ultrasound waves that increase factors that help jump start your body to heal your fracture.

EXOGEN Enhances Bone Healing at Every Stage†35

Within minutes of a bone fracture, the body begins a process to repair the damage. Healing a fracture involves several distinct stages. EXOGEN jumpstarts bone healing by stimulating your body’s natural healing process.

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1. Inflammation

When a bone breaks, white blood cells move in to clean up debris created by the break. This creates inflammation, which triggers the growth of new blood cells—the first stage of healing.
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3. Hard Callus

The body gradually replaces the soft callus with a hard callus, connecting the bone fragments more solidly. The stronger callus, which creates a bulge at the site of the fracture, can generally be seen in X-rays just a few weeks after the facture occurs.
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2. Soft Callus

Blood cells divide and multiply near the break, and new blood vessels develop to fuel the repair process. The body also begins to create fibrous tissue to bridge the break in the bone. This material is called soft callus.
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4. Bone Remodeling

In the final stage of bone fracture healing, the body replaces old bone with new in a process called remodeling. Remodeling makes bones stronger and more compact, and blood circulation in the bone improves.
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†In vivo data is not representative of clinical results

* As of 6/17/21, 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 Oxford Level of Evidence Criteria.
†In vivo data is not representative of clinical results

Summary of 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 orthopedically 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.

Full prescribing information can be found in product labelling, at EXOGEN.com, or by calling Customer Service at 1-800-836-4080.

* As of 6/17/21, 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 Oxford Level of Evidence Criteria.
†In vivo data is not representative of clinical results