Bioventus, a Durham-based orthobiologics company, says it will commission a series of clinical studies to further validate the ability of its EXOGEN Ultrasound Bone Healing System to lessen the risk of a fracture not healing properly in the presence of known risk factors.
The research, known as the Bioventus Observational Non-interventional EXOGEN Studies (BONES), will compare the incidence of fracture “nonunions” in patients using the EXOGEN device with patients from a national health insurance claims database who received standard of care alone, the company said in a news release. Nonunion is a medical term for broken bones that don’t rejoin properly, even after proper medical treatment.
“BONES represents a significant investment in developing epidemiologically grounded rigorous clinical evidence to support use of EXOGEN in fractures at risk, and to underscore the product’s clinical utility in mitigating the risk of nonunions, a highly debilitating and costly condition,” said Alessandra Pavesio, senior vice president and chief science officer for Bioventus.
About 5 percent of fractures result in nonunions, according to the company’s research.
The BONES studies will build on knowledge gained from other Bioventus research published in the Sept. 7, 2016, edition of the journal JAMA Surgery. That research identified 40-plus factors that place a patient at an increased risk of progression to a nonunion, Pavesio said. The risk factors include high body mass index, smoking, alcoholism, medication use, and diseases such as obesity, osteoarthritis and osteoporosis.
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 low-intensity pulsed ultrasound to stimulate the body’s natural healing process. Recent publications analyzing data from a large registry of almost 8,000 fractures treated with EXOGEN suggest that the device supports healing fractures in patients “despite the presence of associated comorbidities or medication use,” the company said.
EXOGEN is the No. 1 prescribed bone healing system in the U.S., Bioventus said.
Bioventus was formed in 2012 when Smith & Nephew, a global medical technology business, spun out its biologics division in Durham in partnership with Essex Woodlands, a healthcare growth equity firm, and other investors. The company has about 660 employees worldwide and annual revenues of about $250 million, according to its website.
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