AUGMENT® 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 and Australia in October of 2011. Augment Bone Graft is currently under clinical investigation by the FDA, and is not yet available for sale in the U.S. Augment® Bone Graft Package Insert - Configuration I | English Augment® Bone Graft Package Insert - Configuration II | English Augment® Bone Graft Package Insert - Australia | English 
AUGMENT® INJECTABLE BONE GRAFT
Augment Injectable Bone Graft 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 Bone Graft is designed for controlled delivery to open surgical sites, to complement minimally invasive surgery or to be used as a means to deliver rhPDGF-BB percutaneously. Augment Injectable Bone Graft is currently under clinical investigation in the United States and Canada 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. In the second quarter of 2011, the Company completed enrollment in a pilot clinical trial in Canada to assess the safety and clinical utility of Augment® Rotator Cuff Graft for the repair of large rotator cuff tears. This trial represents the first use of the Company's rhPDGF-BB platform technology directed at improving the healing of tendons and ligaments in humans. Additionally, in early 2011, the Company released results of its pre-clinical study of interbody lumbar spine fusion. The results demonstrated equivalency between the Augment products as compared to autograft, the current gold standard in spine fusion procedures. In humans, the Augment product candidates used in spine fusion procedures would spare the patient the increased pain and morbidity associated with harvesting autograft. |
Augment Bone Graft is being developed as the first engineered alternative to autograft in orthopedic surgery (free of human and animal product). In clinical studies, Augment has been evaluated as a healing adjunct to fusion in hindfoot and ankle surgeries.