Exogen Bone Stimulator for Fractures
For fractures that prove difficult to heel, including stress fractures, Mr Gordon has expertise in using the novel Exogen ultrasound device.
Faster healing for broken bones
The EXOGEN Ultrasound Bone Healing System is the clinically tested, FDA-approved treatment for indicated bone fractures. Using painless ultrasound waves, EXOGEN may help heal broken bones by speeding up your body’snatural repair process. In just 20 minutes a day, you can help ensure healing for stubborn-to-heal bone fractures or an indicated freshly broken tibia or broken radius. It’s faster healing for broken bones — and less hassle for you.
A broken bone slows you down. Whether you’ve fractured your leg or your smallest toe, you know life won’t be normal until you heal.
But did you also know there’s a way to help accelerate your healing process? It’s called EXOGEN, and it could get you back on your feet — or your toes, or your leg — sooner.
EXOGEN uses safe, painless ultrasound waves to activate cells near the site of your break. The waves stimulate your body’s healing cells, speeding its natural repair process. And it works in just 20 minutes a day, so you can help your fracture heal on a tight schedule.
Clinical studies have demonstrated that EXOGEN accelerates the healing of indicated* fresh fractures by 38%.2,12 It has also been shown to heal 86% of non-union* fractures1 — stubborn breaks that are not healing and might otherwise require surgery.
EXOGEN has been demonstrated to improve fracture healing in people who are older, obese or use tobacco.11,18,27 People who have these conditions are more likely to experience delayed bone healing. EXOGEN may accelerate the healing process by as much as 50% for patients who smoke.11
EXOGEN is the only bone growth stimulator available today that’s approved to treat indicated* fresh fractures. It also has a demonstrated heal rate of 86% for non-union* fractures,1 and it offers a fast, effective treatment time: just 20 minutes daily.
How Does It Work?
When it comes to healing a broken bone, your body usually knows what to do. But if the broken bone healing process doesn’t happen fast enough or never starts, EXOGEN may help.
Breaking down broken bone healing
To understand how EXOGEN works, first take a look at your body’s process for healing a broken bone.
When a bone breaks, your body sends white blood cells to the fracture site. The white blood cells remove debris9,28 in the area and create inflammation — the first step in broken bone healing.
Next, your body creates a callus around the fracture to bridge the break. This callus is really just fibrous tissue, and it hardens over time.
The final step in healing a broken bone is remodeling, when your body replaces the connective callus with new, more compact bone. Remodeling makes bones stronger.
EXOGEN: Helping speed each step of the broken bone healing process3
To help heal bones faster or simply start healing bones that won’t heal on their own,* EXOGEN emits low-intensity, pulsed ultrasound waves at the site of your break. Demonstrated in laboratory tests to jumpstart your body’s natural healing process, these waves move through your skin and soft tissue to stimulate critical cells.
EXOGEN has been shown to work at every stage of healing3 by:
- Encouraging your cells (osteoclasts and macrophages) to remove bony debris and bacteria9,28
- Stimulating immature bone marrow to produce the bone and cartilage cells necessary to heal broken bones5,7,29
- Speeding up the maturation and solidification of formed bone28
EXOGEN is approved by the FDA, so you can trust that it’s both safe and effective. It has been demonstrated to help accelerate the broken bone healing process for indicated* fresh fractures. It has also been demonstrated to effectively help heal broken bones that have stopped healing, known as non-union* fractures.
Evidence shows that it’s never too early or too late to use EXOGEN to help heal bones.3 Talk to your doctor about EXOGEN today.
How Much Does it Cost?
- Nolte PA, van der Krans A, Patka P, Janssen IM, Ryaby JP, Albers GH. Low-intensity pulsed ultrasound in the treatment of nonunions. J Trauma. 2001;51(4):693-703.
- Heckman JD, Ryaby JP, McCabe J, Frey JJ, Kilcoyne RF. Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J Bone Joint Surg Am. 1994;76(1):26-34.
- Azuma Y, Ito M, Harada Y, Takagi H, Ohta T, Jingushi S. Low-intensity pulsed ultrasound accelerates rat femoral fracture healing by acting on the various cellular reactions in the fracture callus. J Bone Miner Res. 2001;16(4):671-680.
- Leung KS, Cheung WH, Zhang C, Lee KM, Lo HK. Low intensity pulsed ultrasound stimulates osteogenic activity of human periosteal cells. Clin Orthop Rel Res. 2004;418:253-259.
- Ebisawa et al. Tissue engineering 5/6 2004 & Mukai et al., Ultrasound Med & Biol. 2005;31(12).
- Kokubu T, Matsui N, Fujioka H, Tsunoda M, Mizuno K. Low intensity pulsed ultrasound exposure increases prostaglandin E2 production via the induction of cyclooxygenase-2 mRNA in mouse osteoblasts. Biochem Biophys Res Comm. 1999;256:284–287.
- Sena K, Leven RM, Mazhar K, Sumner DR, Virdi AS. Early gene response to low-intensity pulsed ultrasound in rat osteoblastic cells. Ultrasound Med & Biol. 2005;31:703-708.
- Lai C, et al. Effects of low-intensity pulsed ultrasound, dexamethasone/TGF-β1 and/or BMP-2 on the transcriptional expression of genes in human mesenchymal stem cells: chondrogenic vs. osteogenic differentiation. Ultrasound Med & Biol. 2010;36(6):1022-33.
- Freeman T, Patel P, Parvizi J, Antoci V Jr, Shapiro IM. Micro-CT analysis with multiple thresholds allows detection of bone formation and resorption during ultrasound treated fracture healing. J Orthop Res. 2009;27(5):673-779. doi: 10.1002/jor.20771.
- Based on a mathematical simulation through soft tissue; Data on File at Bioventus.
- Cook SD, Ryaby JP, McCabe J, Frey JJ, Heckman JD, Kristiansen TK. Acceleration of tibia and distal radius fracture healing in patients who smoke. Clin Orthop Rel Res. 1997;337:198-207.
- Kristiansen TK, Ryaby JP, McCabe J, Frey JJ, Roe LR. Accelerated healing of distal radial fractures with the use of specific, low-intensity ultrasound. A multicenter, prospective, randomized, double-blind, placebo-controlled study. J Bone Joint Surg Am. 1997;79(7):961-73.
- Data on file: 12000.01.
- Highest rate of healing reported among pre-market approval submissions to FDA based on variable fracture types, sites and conditions. See EXOGEN – PMA 900009 – 10/05/1994, EXOGEN – PMA 900009, Supplement – 02/23/2000, Bioelectron – PMA P850022 – 02/18/1986, EBI – PMA P790002 – 11/06/1979, Orthofix/AME – PMA P850007 – 02/21/1986, Orthologic – PMA P910066 – 03/04/1994, EBI – PMA P790005 – 01/25/1980.
- Schofer MD, Block JE, Aigner J, Schmelz A. Improved healing response in delayed unions of the tibia with low-intensity pulsed ultrasound: results of a randomized sham-controlled trial. BMC Musculoskelet Disord. 2010;11:229.
- Gebauer D, Mayr E, Orthner E, Ryaby JP. Low-intensity pulsed ultrasound: effects on nonunions. Ultrasound Med & Biol. 2005;31(10):1391-402.
- de Ana FJ. Internal Report (2007). Data on file. Bioventus.
- Premarket Approval P900009/Supplement 6. Bioventus.
- Simulation of ultrasound transmission for the human-femur model. Internal Report (2005). Teijin Pharma Ltd.
- Lotsova EI. Effect of ultrasound on the strength of metal fixing pins for fractures and joint injuries. Mechanics of Composite Materials. 1979;15:330.5
- Gersten JW. Effect of metallic objects on temperature rises produced in tissues by ultrasound. Amer J Phys Med. 1988;37:75-82.
- Lehman JF, Brunne GD, Martinis AJ, McMillan JA. Ultrasonic effects as demonstrated in live pigs with surgical metallic implants. Arch Phys Med Rehabil. 1979;40:483-488.
- Aaron RK, Ciombor DM, Bruce J. Treatment of nonunions with electric and electromagnetic fields. Clin Orthop Relat Res. 2004;419:21-29.
- Heckman JD, Sarasohn-Kahn J. The economics of treating tibia fractures. The cost of delayed unions. Bull Hosp Jt Dis. 1997;56(1):63-72.
- Agency for Healthcare Research and Quality. ICD-9-CM principal diagnosis code 733.82, Nonunion Of Fracture. HCUPnet. http://hcupnet.ahrq.gov/HCUPnet.jsp. Accessed Dec. 30, 2010.
- EXOGEN [package insert]. Durham, NC: Bioventus, LLC; 2012.
- Zhou S, Bachem MG, Seufferlein T, Li Y, Gross HJ, Schmelz A. Low intensity pulsed ultrasound accelerates macrophage phagocytosis by a pathway that requires actin polymerization, Rho, and Src/MAPKs activity. Cell Signal. 2008 Apr;20(4):695-704. Epub 2007 Dec 14.
- Sant’Anna EF, Leven RM, Virdi AS, Sumner DR. Effect of low intensity pulsed ultrasound and BMP-2 on rat bone marrow stromal cell gene expression. J Orthop Res. 2005 May;23(3):646-52.
- Tang CH, Lu DY, Tan TW, Fu WM, Yang RS. Ultrasound induces hypoxia-inducible factor-1 activation and inducible nitric-oxide synthase expression through the integrin/integrin-linked kinase/Akt/mammalian target of rapamycin pathway in osteoblasts. J Biol Chem. 2007 Aug 31;282(35):25406-15. Epub 2007 Jun 21.
- Naruse K, et al. Prolonged endochondral bone healing in senescence is shortened by low-intensity pulsed ultrasound in a manner dependent on COX-2. Ultrasound Med Biol. 2010;36(7):1098–1108.
- Leung KS, Cheung WH, Zhang C, Lee KM, Lo HK. Low intensity pulsed ultrasound stimulates osteogenic activity of human periosteal cells. Clin Orthop Rel Res. 2004;418:253–259.