Clinical Evidence

OssDsign Catalyst® delivers rapid and robust bone formation, with high fusion rates (93%) observed within 12 months—even in complex, multi-level spinal surgeries. Patients experience significant relief, with sharp reductions in pain and disability and marked improvements in quality of life. Catalyst's versatility shines across diverse procedures and challenging cases, while its user-friendly, putty-like consistency streamlines surgery.

• 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.*
• First-in-patient case study of a novel nanosynthetic bone graft substitute: OssDsign Catalyst. PP Varga et al., Biomedical Journal of Scientific & Technical Research, December 2022.*
• One-year launch of OssDsign Catalyst in U.S. – Preliminary Post-market Safety Review of first 511 patients. REF. 2022-2305 Rev01. (White Paper).
• OssDsign Catalyst® Bone Graft Performance in a Three-Level Extreme Lateral Interbody Fusion (XLIF®). KB Strenge et al., Biomedical Journal of Scientific & Technical Research, June 2024.
• Evidence of Rapid Fusion in a Two Level ACDF Patient Using OssDsign Catalyst® Bone Graft Substitute. S Sadrameli et al., Biomedical Journal of Scientific & Technical Research, June 2024.  

*Note that the referenced publication describes an investigational clinical study performed in Europe. The use of OssDsign Catalyst described in the publication may not be cleared in all markets. Please refer to your IFU for a full list of indications, contraindications, warnings, and precautions.

OssDsign Catalyst® drives rapid, reliable bone formation and outperforms—or rivals—traditional autografts at all time points in clinically relevant animal models. In trauma defect studies, it demonstrated exceptional graft incorporation and remodeling, underscoring its effectiveness as a breakthrough solution for bone healing applications.

1. The efficacy of a nanosynthetic bone graft substitute as a bone graft extender in rabbit posterolateral fusion. Conway, Jordan C. et al. The Spine Journal, Volume 21, Issue 11, 1925 - 1937
2. Trauma defect pre-clinical lapine model. SIR2019-7; (Sept 2019) and SIR2019-8; April 2020 (data on file).

Note: Results from pre-clinical testing may not be predictive of clinical experience in humans. For important safety and intended use information, please refer to your local IFU.

Additional References 

• Pre-clinical ovine model demonstrating bone formation away from host bone. SIR2019-10; March 2020 (data on file).
• Effects of silicon compounds on biomineralization, osteogenesis, and hard tissue formation. Götz, W., Tobiasch, E., Witzleben, S., & Schulze, M. Pharmaceutics. 2019 Mar 12;11(3):117.
• The effect of silicate ions on proliferation, osteogenic differentiation and cell signaling pathways (WNT and SHH) of bone marrow. Han, P., Wu, C., & Xiao, Y. 2012 Dec 12. Biomaterials Science, 1 (4), 379–392.

The PROPEL Spine Registry Study is a multi-center, post-market observational trial tracking real-world outcomes of spine fusion surgeries with OssDsign® bone grafts. Targeting a minimum of 300 patients, it delivers critical insights over a 24-month follow-up, enhancing clinical surveillance.