Produktsida - Jenny test

A breakthrough in nanosynthetic bone grafting

933143
A breakthrough in nanosynthetic bone grafting

Designed to engage dual bone formation pathways

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.

Nanotech and ion therapy

– Nanoscale structure enables interaction with bone cells
– Silicate ions amplify the bone formation process

Dual bone formation pathways

– Most bone grafts engage the intramembranous pathway at the edges of the fusion
– Catalyst also engages the endochondral pathway at the center of the fusion
– Simultanous bone formation is observed at early time points

First class handling

– Available for immediate use
– Easy intra-operative manipulation
– Mixes well 1:1 with local autograft
– Packs well into an interbody cage
– Pushes easily down a canula

933931

Now indicated for interbody fusion

OssDsign Catalyst is indicated for use with interbody cages cleared for use with a bone void filler.* Click on the image to read more.

Histology_pink_top_small_image

Mode of Action

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.

Histology_blue_top_small_image

How Does It Work?

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.

933148
933149

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.

933490
933489
933488
933487

"I have been using Catalyst for over a year and am very pleased with its performance for my interbody fusion cases."

34

K. Brandon Strenge, MD

The Orthopaedic Institute of Western Kentucky Paducah, KY

"My clinical experience with Catalyst is excellent. As the primary investigator in the ongoing clinical trial, receiving interbody fusion clearance reaffirms my choice of Catalyst as the premier bone graft for spine surgery."

67

Joseph O'Brien, MD

Ortho Bethesda Bethesda, MD

hypo-2

Unprecedented Results: A Posterolateral Spine Fusion Model

OssDsign Catalyst demonstrates:
- 80% fusion rate at early six-week time point
- 90% fusion rate at 12 weeks
- 100% fusion rate at 26 weeks

Equivalance to gold standard ICBG*

hypo-1

Standalone Trauma Defect Model: Histomorphometry quantification

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).

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

img-1

Reconstructed µCT images of defects

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

782397

Clinical Program

Publications & References

1. 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.

2. 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.

3. Pre-clinical ovine model demonstrating bone formation away from host bone. SIR2019-10; (March 2020), data on file.

4. Trauma defect pre-clinical lapine model. SIR2019-7; (Sept 2019) and SIR2019-8; (April 2020), data on file.

5. First-In-Human Study with a Novel Synthetic Bone Graft, OssDsign Catalyst, in Transforaminal Lumbar Interbody Fusion with Instrumented Posterolateral Fusion (TOP FUSION). A Lazary et al., Biomedical Journal of Scientific & Technical Research, January 2024. 10.26717/BJSTR.2024.54.008570.


Additional References

6. Effects of Silicon Compounds on Biomineralization, Osteogenesis, and Hard Tissue Formation. Götz W, et al. Pharmaceutics. 2019 Mar 12;11(3):117.

7. The effect of silicate ions on proliferation, osteogenic differentiation and cell signalling pathways (WNT and SHH) of bone marrow.

8. White Paper – One-year launch of OssDsign Catalyst in U.S. – Preliminary Post-market Safety Review. REF. 2022-2305 Rev01.

Ongoing Research

9. OssDsign Spine Registry Study (PROPEL), U.S. Multi-center prospective spine fusion registry. Actively recruiting.

This website uses cookiesfor statistics and user experience.

This website uses cookies to improve your user experience, to provide a basis for improvement and further development of the website and to be able to direct more relevant offers to you.

Feel free to read ours privacy policy. If you agree to our use, choose Accept all. If you want to change your choice afterwards, you will find that option at the bottom of the page.

Cookies