BY SEAN WHOOLEY

rthofix Medical (Nasadaq: OFIX)+ today announced new data investigating pulsed electromagnetic field (PEMF) stimulation with lumbar spinal fusion.

Lewisville, Texas-based Orthofix evaluated PEMF stimulation as an adjunct to lumbar spinal fusion procedures in patients at risk for pseudoarthrosis. Patients treated with the SpinalStim bone growth device demonstrated a high rate of successful fusion. They also showed significant improvements in pain, function and quality of life, despite having risk factors for pseudoarthrosis.

SpinalStim, an FDA-approved bone growth stimulation therapy, offers an adjunct treatment for lumbar spinal fusion. It also functions as a nonsurgical treatment for spinal pseudoarthrosis. The device utilizes PEMF technology that provides 360 degrees of treatment coverage around the fusion site.

Orthofix says its system has an overall success rate of 92% in treating spinal fusion surgery patients.

Researchers published their data evaluating the SpinalStim system in the International Journal of Spine Surgery. Lead author Dr. Marc Weinstein said the data reinforced the use of PEMF stimulation after lumbar fusion surgery to improve outcomes.

Investigators conducted the study across 10 U.S. centers, analyzing a total of 142 patients. The study assigned participants in-home use of the SpinalStim device for six months following surgery. It determined fusion by radiographic imaging at 12 months.
Successful fusion for patients with one, two or three or more risk factors came in at 88.5%, 87.5% and 82.3%, respectively. Patient-reported outcomes showed significant improvements compared to baseline, too. Those factored in disability, function, pain, quality of life and overall wellbeing.

“The SpinalStim bone growth therapy device provides a noninvasive and cost-effective means to augment spinal fusion procedures that enables the patient to continue their healing at home,” said Kevin Kenny, president, Orthofix Global Spine. “This new data is important as it adds to the body of evidence supporting the use of PEMF for high-risk patients who face challenges with bone fusion healing.”