Table of Contents
rhBMP-2: origin, biology and preclinical safety
PPT Slide
Origin of rhBMP-2
Properties of rhBMP-2
rhBMP-2 induces bone rat ectopic implant assay
Mechanism of bone induction
Mechanism of rhBMP-2 action
Implantation of rhBMP-2 requires a matrix
Matrix = ACS (absorbable collagen sponge)
ACS = Helistat®
PPT Slide
rhBMP-2/ACS & LT- CAGE™ device
ACS augments rhBMP-2 retention at implantation site
PPT Slide
Safety information
rhBMP-2/ACS safety studies
Biodistribution studies of rhBMP-2/ACS
rhBMP-2 is slowly released from implantation site
ADME studies of rhBMP-2
rhBMP-2 is rapidly cleared from the systemic circulation
slow release from implant site + rapid clearance from circulation
Tumor biology studies
Effect on tumor growth (in vitro)
Additional tumor studies (FDA consultation)
rhBMP-2 toxicity studies
Additional safety studies
New studies (FDA consultation)
Preclinical safety findings
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