LEADERSHIP R & D CLINICAL DEVELOPMENT PATIENTS INVESTORS NEWSROOM CAREERS CONTACT US HOME Augment™ Clinical Trials   Clinical Studies relating to Augment™ product candidates BioMimetic Therapeutics product candidates are regulated by the U.S. FDA and other worldwide regulatory agencies. As a result, all of the Company's product candidates are subject to evaluation in human clinical trials before they can be marketed. The company is sponsoring multiple clinical studies to evaluate Augment™ in a variety of indications. BioMimetic has previously released pre-pivotal clinical data demonstrating that the Augment™ technology has stimulated bone regeneration in four human clinical trials and in three anatomic sites, including the jaws, foot and ankle and distal radius (wrist). Foot and Ankle Fusion There are approximately 70,000 foot and ankle fusions performed annually in the United States. Foot and ankle fusion procedures are primarily performed in patients with severe osteoarthritis, who do not respond to more conservative treatments. In a fusion procedure, the joint space between adjacent bones is surgically prepared and treated with a graft material to stimulate a fusion, or permanent connection of the two bone ends. This connection eliminates the pain associated with the movement of the joint. Typically, foot and ankle fusions are performed with bone material harvested from the patient, which is obtained as the result of a second surgical procedure. Harvesting bone graft material has significant drawbacks, which include requiring of a second surgery to harvest the graft material, pain and morbidity associated with the second surgery and inconsistent volume and quality of the bone material harvested. Augment Bone Graft, which is being developed as a fully synthetic bone graft substitute for harvested bone graft, eliminates the need for this second surgery. BioMimetic is evaluating use of the Augment Bone Graft and Augment Injectable Bone Graft product candidates as a substitute for autologous bone graft (bone harvested from the patient) for this indication. Foot/Ankle Fusion-United States Study Type: Pivotal Product: Augment Bone Graft Purpose: Evaluation of the safety of the product and its potential for accelerating bone fusion Enrollment Status: Enrolling For more information about enrolling in the Company's ongoing foot and ankle fusion clinical study, please email BioMimetic at clinicaltrials@biomimetics.com. To speak directly to a member of BioMimetic's clinical team, please call 615-236-4436. Foot/Ankle Fusion-Canada Study Type: Pivotal (Registration) Product: Augment Bone Graft Purpose: Evaluation of the safety of the product and its potential for accelerating bone fusion Enrollment Status: Complete Foot/Ankle Fusion-Europe Study Type: Pivotal (Registration) Product: Augment Bone Graft Purpose: Evaluation of the safety of the product and its potential for accelerating bone fusion Enrollment Status: Enrolling Foot/Ankle Fusion-Canada Study Type: Pilot Product: Augment Injectable Bone Graft Purpose: Evaluation of the safety of the product and its potential for accelerating bone fusion Enrollment Status: Complete Distal Radius (Wrist) Fracture Wrist fracture is the most commonly observed traumatic fracture. This fracture is typically the result of a fall onto an outstretched hand. The fracture is managed through immobilization of the affected area with internal or external fixation, a cast, or similar device. While the fracture heals, the patient may be subject to a loss of mobility and a significant reduction in quality of life. Long periods of immobilization can result in muscle atrophy and post-recovery weakness. Additionally, there is strong evidence to suggest that patients with other systemic diseases, such as diabetes and osteoporosis, have compromised fracture healing capacity and thus may heal more slowly than otherwise healthy individuals. BioMimetic is evaluating the use of Augment Bone Graft and Augment™ Injectable Bone Graft to improve fracture healing and treatment outcomes following distal radius fracture. Distal Radius Fracture-Sweden Study Type: Pilot Product: Augment Bone Graft and Augment Injectable Bone Graft Purpose: Evaluation of the safety of the product and its potential to improve fracture healing Enrollment Status: Complete Please review the Company press releases below relating to the Augment™ Bone Graft clinical trials: Positive Results Achieved with Augment Injectable Bone Graft to Enhance Healing in Foot and Ankle Fusions BioMimetic Therapeutics Reports Positive Clinical Results for GEM OS®1 in Canadian Foot and Ankle Fusion Study; Clinical Success Rate of 90% Achieved in a High Risk Patient Population BioMimetic Therapeutics' Clinical Investigator Presents Positive Interim Data on U.S. and Canadian Foot and Ankle Clinical Trials BioMimetic Therapeutics Initiates Enrollment in E.U. Registration Trial for GEM OS®1 Bone Graft; U.S. GEM OS1 Pivotal Study Protocol Amended to Allow Shorter Follow-Up Time and More Patients BioMimetic Therapeutics Announces Positive Results; GEM OS1 Stimulates Bone Healing Comparable to Autograft BioMimetic Therapeutics' Clinical Investigator Highlights Results of Orthopedic Clinical Trial in Canada BioMimetic Therapeutics Reports Positive Clinical Results Using GEM OS®1 to Treat Distal Radius Fractures Clinical Trials Initiated in the United States, Canada and Sweden Enrollment Completed for Three Orthopedic Clinical Trials; Canadian Study Expanded This page will be updated as additional clinical trials and studies are undertaken. You may also e-mail us if you have a question. BioMimetic Therapeutics, Inc. For more information, please e-mail us. Website development and managed hosting by Acuity Marketing Communications, Inc.