The spine is a column of 26 vertebrae that provides structure and height to the body, supports the head and protects the spinal cord.
Spinal fusion is a surgical technique performed to rigidly fix one or more vertebrae together and is used to treat a number of painful spinal conditions, such as degenerative disc disease (DDD), which can no longer be managed with conservative methods. Spinal fusion is a commonly performed surgery, with over 500,000 procedures performed in the UnitedStates annually. Typically these surgeries are performed on vertebrae of lower back (lumbar) or neck region (cervical).
Similar to foot and ankle fusion, the surgical technique involves removing the cartilage at the affected area and applying metallic instrumentation (hardware) to rigidly fix the vertebrae together. Successful fusion surgery requires new bone to bridge the area previously occupied by the cartilage that is normally located between vertebrae. To enable this process, orthopedic surgeons often will take bone from another part of the body (i.e. hip) and use it to fill the space between adjacent vertebrae. Harvested bone, known as autograft, is considered by orthopedic surgeons to be the most reliable enhancer of bone healing.
In Several pre-clinical trials BioMimetic Therapeutics is currently investigating the ability of recombinant platelet-derived growth factor (rhPDGF-BB) with an osteoconductive scaffold to facilitate spine fusion.
Despite the advantages of the autograft, there are a significant number of disadvantages, including the need to perform a second surgery, additional operative time and/or resources, the potential for post-operative complications and long-term pain at the graft site. Further, the quality of autograft, in terms of its ability to facilitate bone regeneration, is believed to be diminished in the elderly, in smokers and in patients with systemic diseases such as diabetes and osteoporosis.
Most recently, a class of products called bone morphogenetic proteins (BMPs) has been commercialized, primarily to serve as an autograft replacement in spinal fusion surgery. These products have been successful commercially; however they have been associated with some severe and potentially life-threatening side effects, particularly when used in the neck. These clinical concerns underscore the need for a safe and effective alternative to autograft for spine fusion surgery.
BioMimetic Therapeutics is currently investigating the ability of recombinant platelet-derived growth factor (rhPDGF-BB)with an osteoconductive scaffold to facilitate spine fusion in pre-clinical studies. Additionally, in early 2011, the Company released results of its pre-clinical study of interbody lumbar spine fusion. The results demonstrated equivalency between Augment* products and 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.