Bioventus Announces European Launch of Next Generation EXOGEN Device
HOOFDDORP, THE NETHERLANDS – (July 4, 2013) – Bioventus, a global leader in active orthopaedic healing, today unveiled the next generation of its market-leading1 EXOGEN® Ultrasound Bone Healing System. The new EXOGEN has begun shipping in Europe and will be released in the United States, Canada and Australia later this year.
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
• received guidance from the UK’s National Institute for Health and Care Excellence (NICE) supporting the use of the cost-effective device (guidance MTG12) as an alternative to surgery for nonunions
The new version of EXOGEN introduces new compliance capabilities – such as a log and patient treatment history – to help physicians ensure that patients are appropriately using and benefiting from the device.
“The value of EXOGEN and how it helps fracture patients has long been known and documented,” explained Duncan Fatkin, Vice President of Global Marketing and Reimbursement for Bioventus. “However, patients may not see results unless they adhere to their physician’s prescribed treatment regimen. That’s a theme we heard over and over again as we partnered with physicians, payers and patients to develop the next generation EXOGEN. Achieving better healing outcomes for patients was something they asked us to focus on, and our new features including the reminder calendar address this.”
“The acceleration and promotion of bone healing continues to be an important goal in the treatment of fractures, non-unions and limb reconstruction. Research continues but progress is slow and demanding,” said Gavin De Kiewiet, Director of Trauma for Limb Reconstruction for Sunderland Royal Hospital in the UK. “The EXOGEN device with low-intensity pulsed ultrasound has greatly contributed to our ability to help these patients. Backed by sound basic science research, level 1 studies and published successful treatment trials, EXOGEN has significantly enhanced treatment modalities available to all clinicians. Patient friendly, doctor successful, and importantly today, cost effective, it is a treatment that has significantly aided our treatment of fractures and non-unions.”
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 replaces the previous models available in Europe – EXOGEN 4000+ and EXOGEN Express. The new device is more portable and user friendly, with its new color LCD screen, splash-proof casing, and sleeker, lightweight design; more environmentally friendly, with its removable, rechargeable battery; and more adaptable with an SD card that determines the number of treatments for the device.
For more information about EXOGEN, visit www.exogen.com.
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.
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.
EXOGEN summary of indications for use in the EU, Canada and Australia:
EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) that includes: Treatment of delayed union and non-unions, 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 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 at www.exogen.com.
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.
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