FDA approves Orthofix's ultrasonic bone fracture healing system

Sporting autographed casts for months may one day become a thing of the past. The FDA has approved a noninvasive bone healing device designed to be worn after a fracture that uses ultrasound waves to help push the body to mend itself faster.

Developed by Orthofix Medical, the AccelStim system is a nonsurgical treatment designed to be worn for 20 minutes per day to repair fresh bone breaks and fractures that have not healed on their own.

According to the company, its low-intensity pulsed ultrasound treatment, or LIPUS, delivers waves of pressure to the tissue to help speed up bone formation; in studies, fresh fractures healed 38% faster, and the device demonstrated an 86% overall success rate for previous fractures that had not fully healed.

The ultrasound-based device joins Orthofix’s long-running portfolio of healing devices that rely on pulsed electromagnetic fields, or PEMFs, which generate weak electric currents through the bones to help stimulate cellular formation.

Employing technology first approved by the FDA in 1986, the company’s wearable CervicalStim and SpinalStim systems are used following spine fusion surgeries, while its PhysioStim device is designed for bone breaks that have been slow to heal. According to Orthofix, more than 1 million people have been treated with its PEMF devices.

“With the addition of the AccelStim device, Orthofix is now the first and only company to offer both PEMF and LIPUS bone growth stimulation devices,” the company’s global spine president, Kevin Kenny, said in a statement. “We believe that expanding access to patients should help grow the existing $100 million market for fresh-fracture LIPUS solutions.”

Orthofix said it plans to make its AccelStim device commercially available by the end of June through a targeted and phased launch plan.

Ultrasound-powered devices for bone healing also have a long history of use. Bioventus’ Exogen system uses a method initially approved by the FDA in 1994. However, a randomized clinical trial published in The BMJ in 2016 that included about 500 participants with lower leg fractures found no difference in the time it took for them to heal when compared to a sham device. 

Bioventus, which was spun out from Smith & Nephew in 2012, said the real-world study’s poor results were due to the majority of participants not adhering to the device’s treatment schedule, which included at least 18 minutes a day for at least four out of every five days for a year, according to a report from Stat.