MiMedx filed with FDA to initiate an Investigational New Drug Phase III Achilles Tendonitis clinical study comparing AmnioFix® Injectable to saline placebo.
The prospective, double blinded, randomized controlled trial will enroll ~160 subjects with moderate to severe pain that failed conservative treatment for at least one month.
The announcement closely follows news of a Phase III study to evaluate AmnioFix Injectable vs. placebo in the treatment of Plantar Fasciitis.
Sources: MiMedx Group; ORTHOWORLD Inc.