Healthcare Industry News:  ultrasound 

Devices Orthopaedic Product Launch

 News Release - June 10, 2014

Bioventus Announces U.S. Debut of Feature-Rich New EXOGEN(R) Device

DURHAM, N.C.--(Healthcare Sales & Marketing Network)--Bioventus, a global leader in active orthopaedic healing, today rolled out the next generation of its market-leading1EXOGEN® ultrasound Bone Healing System, which includes a variety of new compliance capabilities and a new smartphone app. The new device, also available in Europe, Canada and Australia, is now available for U.S. customers.

EXOGEN – the clinically proven treatment for indicated* bone fractures – is a medical device that helps fractured bones heal. The device:
  • uses safe, effective low-intensity pulsed ultrasound to help stimulate the body’s natural healing process2
  • has an 86% heal rate for fractures not healing on their own3
  • offers 38% faster healing of indicated fresh fractures4,5
The new version of EXOGEN introduces new treatment compliance capabilities – such as a treatment tracking calendar and patient treatment history – to help physicians ensure that patients are appropriately using and benefiting from the device. Also available is a new EXOGEN smartphone app – EXOGEN CONNECTS – designed to help patients more easily adhere to their treatment regimen. The free app, available through the iTunes App Store and Google Play, provides treatment reminders, information on fracture healing, videos on how to use EXOGEN, customer service information, and more.

“As healthcare continues to evolve, focus on patient compliance, satisfaction, and quality of care will be even more important drivers. EXOGEN is a great solution to meet these requirements as it assists patients with fractures to help heal more rapidly. EXOGEN and low intensity pulsed ultrasound clinical evidence is well documented in over 654 published studies and is well known by practitioners that treat fractures,” explained Allison London Brown, Vice President of Global Marketing for Bioventus. “A theme that we heard regularly as we partnered with our customers including physicians, patients, and insurers/payers was the importance of adhering to the physician’s prescribed treatment regimen. This input informed the Next Generation EXOGEN development to incorporate new features including the treatment tracking calendar that will provide patients and physicians visual indications on their individual treatment status.”

Prescribed by thousands of physicians around the world, EXOGEN is a portable, lightweight device that features an ultrasound probe that patients place on their skin at the site of the bone break for 20 minutes a day. Patients can easily perform the treatment at home, and EXOGEN has no known contraindications.

The new EXOGEN, which replaces the previous EXOGEN 4000+ model, is portable and more user friendly, with its new color LCD screen, splash-proof casing, and sleeker, lightweight design; and more environmentally friendly, with its removable, rechargeable battery. For more information about EXOGEN, visit www.exogen.com.

About Bioventus

Bioventus is a biologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. The company’s innovative products include market-leading devices, therapies and diagnostics that make it a global leader in active orthopaedic healing. Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide.

For more information, visit www.BioventusGlobal.com or to follow the company on Facebook (www.facebook.com/bioventus) or Twitter (@BioventusGlobal or www.twitter.com/BioventusGlobal).

EXOGEN and the Bioventus logo are registered trademarks of Bioventus LLC.

*A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.

1. Based on company reports for global sales Jan-Dec 2011

2. 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.

3. Nolte PA, van der Krans A, Patka P, Janssen JMC, Ryaby JP, Albers GHR. Low-intensity ultrasound in the treatment of nonunions. J Trauma 2001;51:693–703.

4. 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.

5. 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. 1997;79-A (7):961-973.

EXOGEN Summary of Indications for use in the US:

EXOGEN ultrasound Bone Healing System is indicated for the non-invasive treatment of established non-unions* excluding skull and vertebra. 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 orthopaedically managed by closed reduction and cast immobilization. There are no known contraindications for the EXOGEN device. Safety and effectiveness has 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. Full prescribing information can be found in product labeling, at www.exogen.com or by contacting customer service at 1-800-396-4325.


Source: Bioventus

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