A pivotal trial designed to relieve pain, revive hope
and regenerate bone growth

In order to offer a better quality of life to those suffering from hindfoot and ankle pain, BioMimetics Therapeutics, Inc. has commenced a prospective, randomized, controlled, multi-center pivotal clinical trial to evaluate the safety and effectiveness of its investigational GEM OS^®1to autologous bone graft as a bone regeneration device in foot and ankle fusions.

Patients who have failed to receive adequate and sustained relief from conservative care and are candidates for ankle joint fusion, subtalar fusion, calcaneocuboid fusion, talonavicular fusion, triple arthrodesis or double fusions may be eligible to participate in this study.

Study participants will be randomized into either the control group (Group I) or the treatment group (Group II). Group I will receive Standard Rigid Fixation + ABG, and Group II will receive Standard Rigid Fixation + GEM OS1.

General inclusion/exclusion criteria include:

• Participants must be at least 18 years of age and skeletally mature
• Must have a bone defect in the hindfoot or ankle requiring fusion using open surgical technique with bone graft/substitute
• Must need one of the following procedures: ankle joint fusion, subtalar fusion, calcaneocuboid fusion, talonavicular fusion, triple arthrodesis or double fusions

The trial is enrolling 396 patients at up to 35 study sites.

If you have any questions or feel you have patients who may benefit from this study, call 1-615-844-1280 or please contact us.