Clinical Evidence

Study background

• First-in-human study
• 17 patients
• Single level TLIF with Posterolateral Fusion

Study results

• 93% fusion at 12 months
• Improvements in all clinical outcomes at 12 months (VAS, ODI, SF-36, GTO)
• No graft related adverse events

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 instructions for use for a full list of indications, contraindications, warnings and precautions.

           Key Publications

1. 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.
   
2. 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.
3. The efficacy of a nanosynthetic bone graft substitute as a bone graft extender in rabbit posterolateral fusion. Conway JC et al., Spine Journal, May 2021.
4. One-year launch of OssDsign Catalyst in U.S. – Preliminary Post-market Safety Review of first 511 patients. REF. 2022-2305 Rev01. (White Paper).
5. 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.
6. 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.  
   
   Additional References 
7. Pre-clinical ovine model demonstrating bone formation away from host bone. SIR2019-10; March 2020 (data on file).
8. Trauma defect pre-clinical lapine model. SIR2019-7; (Sept 2019) and SIR2019-8; April 2020 (data on file).
9. Effects of silicon compounds on biomineralization, osteogenesis, and hard tissue formation. Götz W, et al. Pharmaceutics. 2019 Mar 12;11(3):117.
10. The effect of silicate ions on proliferation, osteogenic differentiation and cell signalling pathways (WNT and SHH) of bone marrow.
    
    Active Clinical Trials
    
    OssDsign Spine Registry Study (PROPEL), U.S. Multi-center prospective spine fusion registry. Actively recruiting.
    

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