LDGraft™ *

Feed the Fusion

*For investigational use only, not approved for sale

LDGraft™, our 100% pre-encapsulated rhBMP-2 product, eliminates:

 

  • In theatre liquid addition of rhBMP-2
  • Reliance on surface attachment of rhBMP-2
  • Soak time-dependent rhBMP-2 dose variability1

It is not just the total dose, but timing of that dose that matters2,3,4

We have designed a product that controls and extends the release of rhBMP-2 over a ~5-week period5

.

What is the preclinical evidence?

We have completed an endplate sparing lateral interbody fusion model in 120 sheep. Our results have been presented at both Spine Week (2023) and NASS (2023).

We reported all three rhBMP-2 doses tested were equivalent to iliac crest bone graft in terms of fusion at 6 months. Importantly, our controlled and extended-release product showed no signs of osteolysis or ectopic bone growth6,7.

** Note: Preclinical results may not be representative of clinical outcomes.

LDGraft has also received an FDA Breakthrough Device designation for the Anterior Lumbar Interbody Fusion (ALIF) indication at one level from L3-S1 for skeletally mature patients with degenerative disc disease.

*For investigational use only, not approved for sale

References:

  1. Medtronic Sofamor Danek USA, Inc. Infuse™ Bone Graft LT Cage™ Lumbar Tapered Fusion Device Technical Review. 2002.
  2. Raiche, A. T., & Puleo, D. A. (2004). Cell responses to BMP-2 and IGF-I released with different time-dependent profiles. Journal of biomedical materials research. Part A, 69(2), 342–350. https://doi.org/10.1002/jbm.a.30006
  3. Yu, Y., Yang, J. L., Chapman-Sheath, P. J., & Walsh, W. R. (2002). TGF-beta, BMPS, and their signal transducing mediators, Smads, in rat fracture healing. Journal of biomedical materials research, 60(3), 392–397. https://doi.org/10.1002/jbm.1289
  4. Si, X., Jin, Y., Yang, L., Tipoe, G. L., & White, F. H. (1997). Expression of BMP-2 and TGF-beta 1 mRNA during healing of the rabbit mandible. European journal of oral sciences, 105(4), 325–330. https://doi.org/10.1111/j.1600-0722.1997.tb00248.x
  5. Shakesheff K, et al. Interbody fusion using a new controlled release BMP-2 matrix https://doi.org/10.1016/j.spinee.2023.06.142
  6. Data on file from study LBI2022-1
  7. Representative sheep study image – animal number W3686

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