MISSISSAUGA, Ontario--(BUSINESS WIRE)--Bioventus, a global leader in orthobiologics, today announced it has expanded the Performance Program* for its EXOGEN Ultrasound Bone Healing System to include delayed union and acute fractures. FDA PMA approved in 1994, EXOGEN has provided treatment to more than 1 million patients worldwide for more than 20 years and has a long clinical history. The product uses safe, effective low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural healing process.1
Since 2014, the Performance Program has been in place to refund patients their out-of-pocket payment for EXOGEN if progression of fracture healing for nonunion was not shown. The company is now expanding this program in Canada to include delayed union and acute (fresh) fractures, excluding the skull and vertebrae.
“Physicians and patients have enjoyed positive outcomes from EXOGEN and the expansion of the Performance Program to include all fracture types underscores our belief in the device,” said Tony Bihl, CEO, Bioventus. “If progression of healing is not shown, we will take the device back and refund the patient associated out-of-pocket costs for it.”
Absence of healing (progression to bony union) is determined by the prescribing physician by comparing the patient’s X-rays taken prior to using EXOGEN to one taken at 120 days or later. Patients must treat their fracture with EXOGEN per product instructions, for a minimum of 120 days and achieve maximum adherence of 90%. The device contains an internal patient usage monitor that records the date, time and duration of each treatment session.
Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The company has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN® Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSi, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.
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 and follow the company on Twitter @Bioventusglobal.
Bioventus, the Bioventus logo and EXOGEN are registered trademarks of Bioventus LLC.
*Certain restrictions apply, visit our website for full details.
1. 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.
Summary of Indications for Use: In Canada, the EU, Australia and New Zealand
EXOGEN Ultrasound Bone Healing System is indicated for the non-invasive treatment of osseous defects (excluding vertebra and skull) including:
• 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
† A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.
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. Full prescribing information can be found in product labeling at www.exogen.com.