Bioventus Releases New EXOGEN and Performance Guarantee in Canada
Mississauga, Ontario, Canada – April 7, 2014 – Bioventus, a global leader in active orthopaedic healing, today announced that the next generation of its market-leading1 EXOGEN® Ultrasound Bone Healing System – including new compliance features and a healing progression Performance Guarantee – is now available in Canada. EXOGEN® – the clinically proven treatment for indicated* bone fractures – is a medical device that helps fractured bones heal.
- EXOGEN uses safe, effective low-intensity pulsed ultrasound to help stimulate the body’s natural healing process2
- It has an 86% heal rate for fractures not healing on their own3
- EXOGEN offers 38% faster healing of fresh fractures4
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 release of the new EXOGEN device is exciting news for those of us who treat fractures on a regular basis. This technology has become a very useful tool for fracture treatment. The new Performance Guarantee is unprecedented and provides reassurance that Bioventus stands behind its product,” said Dr. Paul Zalzal, Assistant Clinical Professor at the McMaster University Ontario, Canada; and Former Chief of Orthopaedic Surgery at Oakville Trafalgar Memorial Hospital, Canada.
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 innovative EXOGEN device is an example of the Bioventus commitment to create bone healing therapies that work to enhance the body’s natural healing process, thereby accelerating recovery and improving the patient’s quality of life. We work every day to bring orthobiologics to the forefront of orthopaedic care, so that patients everywhere can have the care they need, and return more quickly to living their normal, daily lives,” said Anthony Bihl, CEO of Bioventus.
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. For more information, visit www.BioventusGlobal.com.
*A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.
1. Data on file: 12000:08
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