As part of the process for obtaining FDA approval, the company has a US.Advent study underway. The study has already enrolled approximately 100 patients at 15 centers. The company plans to add 10 additional sites during the fourth quarter this year and the first quarter next year, and expects to enroll a total of 450 patients in the study from all of these sites. Orthofix anticipates submitting the results to the FDA seeking its approval for the company to begin marketing the device in the US.
