OssDsign Catalyst nanosynthetic bone graft putty is designed to engage dual bone formation pathways resulting in rapid and reliable bone formation at early time points throughout the entire fusion mass.1

>  Nanoscale Structure + Silicate Ion Chemistry

Catalyst is the same size scale as human bone allowing for physiological interaction with bone cells. The incorporated silicate ions, bioidentical to those in human bone amplify the bone formation process providing rapid and reliable bone formation.1,2

>  Endochondral Bone Formation

Unlike traditional synthetics, Catalyst engages the endochondral bone formation pathway as well as the more typical intramembranous pathway allowing for early bone formation in the avascular center of the fusion mass.1,2

>  First Class Handling

1.  Available for immediate use

2.  Easy intra-operative manipulation

3.  Mixes well 1:1 with local autograft

4.  Packs well into an interbody cage

5.  Pushes easily down a canula

>  Interbody Clearance

Now indicated for use with interbody cages cleared for use with a bone void filler.

Surgeon Testimonials

Hear what surgeons are saying about OssDsign Catalyst.

A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. OssDsign does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery. Please refer to the instructions for use for a full list of indications, contraindications, warnings and precautions.

How Does It Work?

Traditional synthetics focus only on the intramembranous bone formation pathway, relying on a good vascular environment, whereas human body uses two bone formation pathways to produce bone: the intramembranous pathway in vascular environments, e.g. bone remodeling, and the endochondral pathway in avascular environments, e.g. skeletal development and fracture repair.

With a combination of nanoscale structure and silicate enhanced chemistry, OssDsign Catalyst is designed to engage both the intramembranous and endochondral pathways, allowing for bone formation in more challenging avascular environments such as the center of a fusion mass.1,2,5,6

For more information, read more here >   

Evidence of Dual Bone Formation Pathway1

OCG = OssDsign Catalyst Granule; EB = Endochondral Bone

Histology showing bone formation via the endochondral bone formation pathway, adjacent to OssDsign Catalyst (EB) at the center of the fusion mass, in an uninstrumented, posterolateral spine fusion model

OCG = OssDsign Catalyst Granule; IB = Intramembranous Bone; MNC = Multinucleated Cells (graft remodeling)

Histology showing intramembranous bone formation (IB) on and between OssDsign Catalyst granules (OCG), coupled with remodeling of the granules by endogenous multinucleated cells (MNC). 

Data from a recently published pre-clinical study show that OssDsign Catalyst achieves fusion in 100% of the studied subjects at 26 weeks, compared to 60% in the group where a comparable market-cleared device was used.

>  In hypoxic environments OssDsign Catalyst engages the endochondral ossification pathway, leading to rapid bone formation at the center of a fusion mass, even in challenging, poorly vascularized environments.

>  In well vascularized environments OssDsign Catalyst engages the intramembranous ossification pathway via the recruitment of endogenous mesenchymal stem cells.

>  The engagement of these dual bone formation pathways results in rapid and reliable bone formation throughout the fusion mass.

Unprecedented Results in an Uninstrumented Posterolateral Spine Fusion Model1

   Read more here

OssDsign Catalyst in a Standalone Trauma Defect Model3

Histomorphometry quantification of the total bone formed (dark purple) and remaining graft material (light purple) in a defect filled with standalone OssDsign Catalyst. 
Data are the mean + SEM (n=5).

Reconstructed µCT images of defects filled with standalone OssDsign Catalyst 
showing excellent graft incorporation (left) and remodelling (right).

Key Handling Properties of OssDsign Catalyst

1.  Available for immediate use

2.  Easy intra-operative manipulation

3.  Mixes well 1:1 with local autograft

4.  Packs well into an interbody cage

5.  Pushes easily down a canula

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Clinical Program

Ongoing Research
>  OssDsign Spine Registry Study (PROPEL), U.S. Multi-center prospective spine fusion registry. Actively recruiting.
>  Prospective case series (TOP FUSION), Europe. Recruitment complete, 12 month follow-up completed.

References and Disclaimers
1. The efficacy of a nanosynthetic bone graft substitute as a bone graft extender in rabbit posterolateral fusion. Conway JC, et al., Spine J. 2021 May 23:S1529-9430(21)00270-9.
2. Pre-clinical ovine model demonstrating bone formation away from host bone. SIR2019-10; (March 2020), data on file.
3. Trauma defect pre-clinical rabbit model. SIR2019-7; (Sept 2019) and SIR2019-8; (April 2020), data on file.
4. First-in-Patient Case Study of a Novel Nanosynthetic Bone Graft Substitute: OssDsign Catalyst. PP Varga et al., Biomed J Sci & Tech Res, 2022 December.
5. Effects of Silicon Compounds on Biomineralization, Osteogenesis, and Hard Tissue Formation. Götz W, et al. Pharmaceutics. 2019 Mar 12;11(3):117.
6. The effect of silicate ions on proliferation, osteogenic differentiation and cell signalling pathways (WNT and SHH) of bone marrow

*Data from preclinical models may not be representative of clinical outcomes in humans.

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