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Home/Company News/Bioventus Expands Patient Nonunion Assurance Program
Company News

Bioventus Expands Patient Nonunion Assurance Program

July 26, 2017 2 min read Premium comments

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Bioventus Expands Patient Nonunion Assurance Program
EXOGEN Ultrasound Bone Healing System / Courtesy of Bioventus
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Bioventus, based in Durham, North Carolina, has announced that it will be expanding its novel patient performance assurance program for EXOGEN Ultrasound Bone Healing System to include delayed union and acute fractures.

Under the Performance Program Bioventus will refund out-of-pocket expenses to patients with a nonunion for whom EXOGEN does not deliver improved fracture healing. The company is now expanding this program in Canada to include delayed union and acute (fresh) fractures, excluding the skull and vertebrae.

According to the company, EXOGEN has been used to treat more than 1 million patients worldwide for more than 20 years. “The product uses safe, effective low-intensity pulsed ultrasound (LIPUS) to help stimulate the body’s natural healing process,” says the July 17, 2017 news release.

“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.”

Anthony Doyle, director of Canadian Operations for Bioventus, told OTW, “Bioventus is excited to offer the expansion of the EXOGEN Performance Program to include all fracture types—fresh fracture, delayed union and nonunions—to patients who have out-of-pocket costs for the device. EXOGEN is proven to heal fractures and Bioventus stands behind it. If progression of healing does not occur in 120 days and the patient meets the program criteria, Bioventus will refund the patient their out-of-pocket cost for the device.”

“The original EXOGEN Performance Program, introduced in 2014, covered nonunion fractures. The expanded program covers all fracture types—fresh fracture, delayed union and nonunion. The patient claim process has also been simplified. The treating physician simply completes and signs an evaluation/claim form stating that the patient’s fracture shows no visible progressive signs of healing and confirms that there was no progression to bony union measured by written evaluation of X-rays taken prior to the patient’s fitting of EXOGEN at least 120 days (or more) after first use.”

“EXOGEN is a proven bone healing system with no contraindications. Clinical studies show that EXOGEN has an 86% heal rate for nonunions and accelerates fresh fracture healing by 38%. The EXOGEN Performance Program provides added confidence to physicians and patients—Bioventus stands behind EXOGEN.”

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Discussion

14
DS
Dr. Sarah MitchellOrthopedic Surgeon · Mayo Clinic

This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?

8
JT
James Thornton, MDSpine Fellow · HSS

Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.

5
RP
R. PatelSports Medicine · Stanford

We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.

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