DJO Global said today that it plans to launch a clinical trial for a new indication of the company’s bone growth stimulator.
The company’s subsidiary, Encore Medical, is seeking an investigational device exemption trial evaluating a fresh fracture indication for its combined magnetic field device.
FDA-approved CMF devices are traditionally used with non-magnetic internal or external fixation systems to treat an established nonunion fracture acquired secondary to trauma, except for vertebrae and flat bones.
DJO Global’s randomized, double-blinded study will assess the use of the CMF device as a noninvasive adjunctive treatment for unstable, closed ankle fractures that require surgical remedy for stabilization.
The study began enrollment in January this year, according to the company.
In May, DJO Global reported its 1st quarter financial results.
San Diego-based DJO Global’s losses grew 4.3% to -$40.0 million on sales growth of 3.4% to $288.4 million for the 3 months ended April 1, compared with the same period last year.
Adjusted to exclude 1-time items (including a $15.8 million restructuring expense), EBITDA were $57.2 million, up 17% compared with Q1 2016, DJO said.