ProductsAugment™ Bone Graft
The product is supplied in two primary sterile components:
At the point of use the two components are combined, mixed and subsequently applied to the surgical site. Following mixing the final consistency is similar to ‘wet sand’. The β-TCP component of Augment Bone Graft provides a porous, osteoconductive scaffold to support cell attachment and spreading. Augment Bone Graft is designed for use in open orthopedic surgical procedures. Augment Bone Graft was approved for use in Canada in November of 2009. Augment is currently under clinical investigation by the FDA, and is not yet available for sale in the U.S. Augment™ Bone Graft Package Insert | English Augment™ Bone Graft is commercially available in Canada only. 
Augment™ Injectable Bone Graft
Augment Injectable is being developed as an alternative to autograft in orthopedic surgery. In clinical studies, Augment Injectable has been evaluated as a healing adjunct to fusion in hindfoot and ankle surgeries and distal radius fractures. The product is supplied in two primary sterile components:
At the point of use the two components are combined, mixed and subsequently applied to the surgical site. Following mixing the final consistency is flowable paste, which can be extruded through a narrow gauge needle. Augment Injectable is designed for controlled delivery to open surgical sites, complement minimally invasive surgery or be used as a means to deliver rhPDGF-BB percutaneously. Augment Injectable is currently under clinical investigation and is not available for sale.
Future ProductsBioMimetic is committed to developing additional products to fully leverage the therapeutic benefits of rhPDGF-BB. These products, particularly in the areas of cartilage, ligament and tendon repair, are in various stages of preclinical development. Regulatory PathwayIn the United States our products are designated as Class III drug/device combination products and are reviewed by FDA by a Pre-Market Approval Application (PMA). The PMA approval process is most stringent regulatory pathway for medical devices. PMA approvals are predicated on availability of clinical data from randomized and controlled human studies that show the product is both safe and effective. The first two PMA modules for Augment™ Bone Graft are currently under review by the U.S. FDA. |
Augment Bone Graft is being developed as the first fully synthetic alternative to autograft in orthopedic surgery. In clinical studies, Augment has been evaluated as a healing adjunct to fusion in hindfoot and ankle surgeries.