PRO-DENSE

BONE GRAFT SUBSTITUTE
PRO-DENSE™

Key Benefits

Predictable Bone Regeneration

    • Stronger New Bone*
    • Faster, Denser Bone Regeneration*
    • Remodel to Normal Bone*

*All claims based on a critically sized canine proximal humerus defect model. It is unknown how results from the canine model compare with clinical results in humans. Data on file at Wright.


PRO-DENSE Graft is a synthetic biomaterial. Combining calcium sulfate with calcium phosphate, has result​ed in a composite graft that is delivering where other materials may fall short.
​​
PRO-DENSE Graft has a triphasic resorption profile that provides an ideal environment​ for the direct deposition of bone resulting in a slow-resorbing matrix that supports healing across the defect.​†

†Growth factor binding based on in vitro data of BMP-2 and VEGF. Data on file.​

Faster than Autograft*
The accelerated rate of healing of the PRO-DENSE graft treated defects compared to those treated with autograft is principally evident by the higher density bone (i.e., 170% average increase in area fraction of new bone compared to autograft at 13 weeks) and superior average mechanical properties at 13 weeks.

Denser than Autograft*
Histomorphometry reveals that the amount of newly regenerated bone of the PRO-DENSE injectable graft treated defects at 13 weeks demonstrated a statistically significant 170% average increase in new bone formation versus defects treated with autograft. PRO-DENSE injectable graft new bone area fraction is on average 170% denser than autograft at 13 weeks.

Stronger than Autograft*
The newly regenerated bone in the PRO-DENSE injectable graft treated defects exhibited a 645% average increase in compressive strength at 13 weeks versus defects treated with autograft.

Intra-operative strength
Approximately 40MPa initial compressive strength (at 2 hours, wet conditions)* Reliable/consistent resorption 50% slower than pure calcium sulfate

*All claims are based on a critically sized canine proximal humerus defect model. It is unknown how results from the canine model compare with clinical results in humans.

Composite Makeup

75% CaSO4

  • Primary osteoconductive filler
  • Resorbs first primarily through simple dissolution to allow early vascular infiltration
25% CaPO4 (brushite and granular TCP)

  • Osteoclastic resorption
  • Secondary porous scaffold that is resorbed after primary filler
  • TCP granules are resorbed in the third and final phase

How PRO-DENSE Works


Tri-Phasic Resorption Results in an Injectable, Self-forming, Porous Scaffold In Vitro Accelerated Dissolution at 37°C in H2O (Samples embedded and cross-sectioned for analysis via SEM)

(Approximately six times faster than in vivo canine model)

*Data on file at Wright*

Proposed Mechanism of Action


PRO-DENSE Graft has a triphasic resorption profile that provides an ideal environment​ for the direct deposition of bone resulting in a slow-resorbing matrix that supports healing across the defect.​†

The following illustrations describe the basic steps in the process of new bone formation.

1. Angiogenesis is a key early event. The CaSO4 of the implant resorbs first, revealing a porous calcium phosphate scaffold conducive to vascular infiltration.

2. The resulting brushite/TCP scaffold with interconnecting pores binds free proteins such as VEGF and BMP-2 at the implant/defect interface.†

3. Resorption of the PRO-DENSE scaffold releases bound proteins. Active proteins recruit cells to the implant surface.†

4. Growth factors in the implant/defect interface region, including BMPs, stimulate proliferation and differentiation of mesenchymal stem cells.

5. Differentiated osteoblasts lay down osteoid which then mineralizes to become newly woven bone.

6. The principles of Wolff’s Law drive remodeling

​​†Growth factor binding based on in vitro data of BMP-2 and VEGF. Data on file.

Pre-Clinical Findings


Pre-clinical findings demonstrate that PRO-DENSE™ Bone Graft is stronger, faster, and more dense bone vs. Autograft.*

STRONGER NEW BONE*

Mechanical properties at 13 and 26 weeks: The PRO-DENSE regenerate on average demonstrated over six times the compressive strength vs. autograft at 13 weeks, and over three times greater ultimate compressive strength than normal, unoperated bone.

FASTER, DENSER BONE REGENERATION*

Histology at 13 weeks: The PRO-DENSE specimen (right) demonstrated consistently denser and thicker trabeculae vs. autograft (left) at the same time point. Basic Fuchsine and Toluidine Blue, 75x
* No 26 week data is available for Autograft.

*All claims are based on a critically sized canine proximal humerus defect model. It is unknown how results from the canine model compare with clinical results in humans.STRONGER THAN NORMAL BONE*: At 13 weeks; Urban, et al… CORR, June 2007.

FASTER THAN AUTOGRAFT*: The accelerated rate of healing of the PRO-DENSE graft treated defects compared to those treated with autograft is principally evident by the higher density bone (i.e., 170% average increase in area fraction of new bone compared to autograft at 13 weeks) and superior average mechanical properties at 13 weeks.

DENSER THAN AUTOGRAFT*: Histomorphometry reveals that the amount of newly regenerated bone of the PRO-DENSE injectable graft treated defects at 13 weeks demonstrated a statistically significant 170% average increase in new bone formation versus defects treated with autograft. PRO-DENSE injectable graft new bone area fraction is on average 170% denser than autograft at 13 weeks.

STRONGER THAN AUTOGRAFT*: The newly regenerated bone in the PRO-DENSE injectable graft treated defects exhibited a 645% average increase in compressive strength at 13 weeks versus defects treated with autograft.

Published Clinical and Pre-Clinical Data


PubMed Abstract
Increased bone formation using calcium sulfate-calcium phosphate composite graft.

Authors: Urban RMTurner TMHall DJInoue NGitelis S.

Department of Orthopedic Surgery, Rush University Medical Center, Chicago, IL 60612, USA.


PubMed Abstract
Use of a calcium sulfate-calcium phosphate synthetic bone graft composite in the surgical management of primary bone tumors.

Authors: Evaniew NTan VParasu NJurriaans EFinlay KDeheshi BGhert M.

Department of Surgery (NE, BD, MG), Division of Orthopaedics, the Faculty of Health Sciences (VT), and the Department of Radiology (NP, EJ, KF), McMaster University, Hamilton, Ontario, Canada.


PubMed Abstract
Function after injection of benign bone lesions with a bioceramic.

Authors: Fillingham YALenart BAGitelis S.

Department of Orthopedic Surgery, Rush University Medical Center, Chicago, IL 60612, USA.


STRONGER THAN NORMAL BONE*: At 13 weeks; Urban, et al… CORR, June 2007.

FASTER THAN AUTOGRAFT*: The accelerated rate of healing of the PRO-DENSE™ graft treated defects compared to those treated with autograft is principally evident by the higher density bone (i.e., 170% average increase in area fraction of new bone compared to autograft at 13 weeks) and superior average mechanical properties at 13 weeks.

DENSER THAN AUTOGRAFT*: Histomorphometry reveals that the amount of newly regenerated bone of the PRO-DENSE™ injectable graft treated defects at 13 weeks demonstrated a statistically significant 170% average increase in new bone formation versus defects treated with autograft. PRO-DENSE™ injectable graft new bone area fraction is on average 170% denser than autograft at 13 weeks.

STRONGER THAN AUTOGRAFT*: The newly regenerated bone in the PRO-DENSE™ injectable graft treated defects exhibited a 645% average increase in compressive strength at 13 weeks versus defects treated with autograft.

Data on file*

Applications where PRO-DENSE™ graft has been used:
> Osseous Defects
> Core Decompression procedures

*All claims are based on a critically sized canine proximal humerus defect model. It is unknown how results from the canine model compare with clinical results in humans.

See package insert for indications, contraindications, and warnings

*All claims are based on a critically sized canine proximal humerus defect model. It is unknown how results from the canine model compare with clinical results in humans.

See package insert for indications, contraindications, and warnings.