Business Wire07.18.17
Bioventus has expanded the Performance Program* for its EXOGEN Ultrasound Bone Healing System to include delayed union and acute fractures. Approved by the U.S. Food and Drug Administration 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 of 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 percent. The device contains an internal patient usage monitor that records the date, time and duration of each treatment session.
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:
Bioventus is an orthobiologics company that delivers products that help people heal quickly and safely. 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 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 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 percent.
*Certain restrictions apply.
† A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.
Reference
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.
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 of 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 percent. The device contains an internal patient usage monitor that records the date, time and duration of each treatment session.
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
Bioventus is an orthobiologics company that delivers products that help people heal quickly and safely. 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 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 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 percent.
*Certain restrictions apply.
† A non-union is considered to be established when the fracture site shows no visibly progressive signs of healing.
Reference
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.