US-based orthobiologics firm Bioventus has started patient enrolment in the Bioventus Observational Non-Interventional Exogen Studies (BONES) clinical development programme for its Exogen Ultrasound Bone Healing System.
Exogen employs safe and effective low-intensity pulsed ultrasound (LIPUS) to trigger the natural bone healing process in the body.
The BONES programme comprises three observational, non-interventional, direct-to-patient studies that will gather real-world data on the use of the device.
The studies will assess the incidence of fracture non-unions in patients using Exogen when compared to patients who were just given standard of care (SoC).
The SoC data will be taken from a national health insurance claims database in the country.
Bioventus senior vice-president and chief scientific officer Alessandra Pavesio said: “Accomplishing this ambitious goal requires an alternative methodology to randomised controlled trials and involves epidemiologically grounded research of large patient cohorts enrolled both prospectively and within the big data available from US health insurance claims.”
The BONES studies will involve long and small bones of upper and lower extremities, with the primary endpoint being the ability of the device to reduce the risk of fracture progression to non-union in the presence of known factors.
Exogen has been used to treat more than one million patients and is reported to have an average of less than 1% complaints in relation to lack of efficacy.
Image: Exogen Ultrasound Bone Healing System. Photo: courtesy of Bioventus LLC.