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REGENESORB Biocomposite Material

Overview

REGENESORB Material is an advanced biocomposite shown to be absorbed and completely replaced by bone within 24 months in pre-clinical studies.1

  • REGENESORB Material is a unique formulation of PLGA, ß-TCP, and calcium sulfate – each of which has been proven safe and biocompatible over decades of clinical use.2
  • ß-TCP and calcium sulfate have been individually shown to act during a different stage in the bone healing process and through different mechanisms – physical and biochemical.
  • Most biocomposite materials rely solely on the osteoconductive properties of ß-TCP, which provides sustained bone formation over 18 months3 and acts primarily as a scaffold for enhancing new bone formation.4 REGENESORB material includes a second osteoconductive material, calcium sulfate, which has been shown to work in the early stages (4-12 weeks) of bone healing5 and is associated with increased levels of local growth factors.6

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References

  1. In vivo animal testing has demonstrated that REGENESORB material is bioabsorbable and is replaced by bone. Implants (9x10 mm) were implanted in ovine cancellous bone and compared to an empty defect (9x10 mm) at 6, 12, 18, and 24 months (n=6). Micro-CT analysis demonstrated that by 24 months, bone in-growth into this material (289.5 mm3) was significantly greater (p<0.05) than bone in-growth into an empty defect (170.2mm3) and reaches a bone volume not statistically different from intact bone (188.2 mm3). Results of in vivo simulation have not been shown to quantitatively predict clinical performance. Data on file at Smith & Nephew in report 15000897.
  2. Peltier et al. Ann Surg (1957) Vol. 146(1). Suchenski et al. Arthroscopy (2010) Vol. 26(6).
  3. Costantino PD, Friedman CD. Craniofacial Skeletal Augmentation and Replacement (1994) Vol. 27(5).
  4. Ogose et al (2006) Biomaterials Vol. 27(8).
  5. Costantino PD, Friedman CD. Craniofacial Skeletal Augmentation and Replacement (1994) Vol. 27(5).
  6. Walsh et al. Clin. Orthop. and Rel. Res. (2003) Vol. 406.
  7. Suchenski et al. Arthroscopy (2010) Vol. 26(6).
  8. Chih-Chu Chang, Section IV:44, “Biodegradable Polymeric Biomaterials” in The Biomedical Engineering Handbook. Bronzino JD Ed. CRC Press.
  9. See note 5 above.
  10. See note 4 above.
  11. See note 5 above.
  12. Pietrzak and Ronk (2000) J Craniofacial Surg. Vol 11(4).
  13. See note 6 above.