Amplex™: Bone Graft Materials
Targeting Amplified Bone Repair
Amplex is fully synthetic and is provided in kit form. When prepared, it combines:
- B2A, a bioactive peptide targeting the BMP2 pathway
- Bi-phasic HA/bTCP ceramic granules, a bone-friendly graft material
B2A is intended to amplify the body’s natural bone-healing cascade, and the ceramic graft provides a scaffold on which new bone cells can grow. The result will be a fully off-the-shelf alternative to current bone graft limitations.
The Amplex Advantage
Amplex is being developed to:
- Eliminate the need for autograft from the hip or pelvis
- Use man-made materials to eliminate the risk of infection or disease transmission
- Easily incorporate into current surgical technique
- Provide long shelf life at room temperature storage
Amplex has been shown to increase bone repair and effectively induce spinal fusion in animal models.1,2,3 Clinical trials are currently underway to demonstrate if Amplex is safe and effective for lumbar spinal fusion and can replace the need for surgically harvesting bone graft from the iliac crest.
Find out more.
B2A Peptide amplifies bone repair 1,2,3
B2A was designed to work in concert with the body's natural healing response (BMP-2) at the cellular level to ultimately improve bone repair and fusion. B2A is provided as a lyophilized powder, then rehydrated at the point of use. Find out more.
Ceramic Granules Provide Bone-Growth Scaffold
The ceramic granules used in Amplex have been cleared in the U.S. for bone graft applications.4 This material is structurally similar to native bone and has characteristics associated with improved bone formation.5 In the Amplex application, the ceramic granules act as a scaffold for bone cells to infiltrate and help initiate the cellular repair process. Over time, the ceramic granules are resorbed and replaced by newly developed bone.
- Cunningham BW, Atkinson BL, Hu N, Kikkawa J, Jenis L, Bryant J, Zamora PO, McAfee PC. Ceramic granules enhanced with B2A peptide for lumbar interbody spine fusion: an experimental study using an instrumented model in sheep. J Neurosurg Spine 2009;10(4):300-7.
- Lin X, Elliot JJ, Carnes DL, Fox WC, Pena LA, Campion SL, Takahashi K, Atkinson BL, Zamora PO. Augmentation of osseous phenotypes in vivo with a synthetic peptide. J Orthop Res 2007;25(4):531-9.
- Smucker JD, Bobst JA, Petersen EB, Nepola JV, Fredericks DC. B2A peptide on ceramic granules enhance posterolateral spinal fusion in rabbits compared with autograft. Spine 2008;33(12):1324-9.
- U.S. Food and Drug Administration 510(k) number K063527.
- Habibovic P, Sees TM, van den Doel MA, van Blitterswijk CA, de Groot K. Osteoinduction by biomaterials--physicochemical and structural influences. J Biomed Mater Res A 2006;77(4):747-62.